Pfizer
Psychological symptom reports
Female, 40 - 59 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 40 | 2021-01-01 | disturbance in attention |
Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Sev...
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Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Severe headache starting again on day 4 lasting through day 5. Unable to focus, eat because of headache. Sore arm for 24 hrs post vaccine.
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| 40 | 2021-01-03 | confusional state |
Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ...
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Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ER. BP noted to be 163/100. After one hour and a half, BP in the 120's systolic and 90's diastolic. Continued to have blurred vision. Blood pressure became labile and continued to be in the range of 160's over 100's to 130/90's. After 48 hours, vision no longer blurred, Blood pressure returned to normal baseline and maintained. Took BP for over one week after, morning, noon, and night on the Left arm and Right arm. My BP stayed in the 117/70-120/80 range. Wanted to make sure I had no underlying hypertension. No other adverse issues.
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| 40 | 2021-01-03 | impaired work ability |
Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. ...
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Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. Whole top of foot and toe was really swollen and a lot bigger than the other couldnt walk or put pressure on my foot. Have been home unable to work since december 30th
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| 40 | 2021-01-04 | feeling abnormal |
About 10 mins after I noticed some tingling and numbness on the right side of my head (ear and cheek...
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About 10 mins after I noticed some tingling and numbness on the right side of my head (ear and cheek were numb). I also had some numbness on the top of my thigh. I sat for monitoring for a couple hours and was sent home. The tingling moved to the back of my head for a little while last night and seemed to had resolved before I went to bed around 10p. The tingling seems very minimal this morning...on a scale of 1-10, 10 being the most noticeable, yesterday was a 10. Today seems to be a 1 or 2. Only noticeable if I am sitting still and be more along my ear and not my head or shoulder. There is still the weird feeling (similar to numbness) in my face and my thigh. My face is getting better.
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| 40 | 2021-01-05 | anxiety |
Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. R...
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Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.
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| 40 | 2021-01-05 | excessive sleepiness |
I received the vaccine at 1050hrs on 12/16/20. At around 0900hrs on 12/18/20, I began to experience...
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I received the vaccine at 1050hrs on 12/16/20. At around 0900hrs on 12/18/20, I began to experience severe fatigue. At ~1330 on the same day, I had a mildly elevated temperature - normal baseline for me is 97.6, with that reading at 99.4. Due to the fatigue, I slept from 1400 hrs until 0500 on the following day, 12/19/20. No other symptoms to report besides a tender injection site for the first 48 hours.
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| 40 | 2021-01-05 | sleep disorder |
Second dose of vaccine. Unable to sleep post vaccine evening zero. Severe fatigue post vaccine day o...
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Second dose of vaccine. Unable to sleep post vaccine evening zero. Severe fatigue post vaccine day one. Headache. Arm pain out of proportion to previous IM vaccinations.
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| 40 | 2021-01-06 | impaired work ability | Body aches. Stayed home from work |
| 40 | 2021-01-06 | impaired work ability |
I received the vaccine at 0930 am 1/6, about 6 hours later I started feeling extreme fatigue and a s...
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I received the vaccine at 0930 am 1/6, about 6 hours later I started feeling extreme fatigue and a slight sore throat. I left work early at that time. When I got home I couldn't stay awake and fell asleep around 6pm. Then starting having GI distress cramping, pain and diarrhea around 9pm-11pm. At 2 am I woke up with chills and fever, I took a Tylenol around 3-4 m and then broke out if huge sweat, then finally fell asleep. 1/7/21 I mostly have soreness, headache and fatigue now.
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| 40 | 2021-01-07 | anxiety |
After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Ra...
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After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.
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| 40 | 2021-01-07 | feeling abnormal |
Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and ...
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Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and it made me feel short of breath or as though I had to cough. After about a minute I thought it might be SVT so I did a valsalva maneuver and it stopped. I was resting in bed, no alcohol or caffeine, and this has never happened to me before. Since then, I have felt at least one heart palpitation per day, sometimes many more. The last few days I have felt extremely fatigued and have had an odd sensation in my chest. On 1/7 I developed a dry cough, and was swabbed for Covid because I felt so bad. It was negative. This made me wonder if the odd sensation in my chest was related to my heart and not my lungs. I am due for my second vaccine today, and am unsure if I should get it.
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| 40 | 2021-01-07 | feeling abnormal |
low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hour...
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low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hours (no more than 10) arm pain (at injection site)-it is a bit warm to the touch and a small bruise- still occuring (approximately 12 hours after it started this morning)
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| 40 | 2021-01-07 | feeling abnormal |
0920 VAC. ; 0930: AFTER VAC. SHOT- NAUSEA/VOMITING, "FOGGY FEELING"; 0930: VS: BP: 145/90, P:...
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0920 VAC. ; 0930: AFTER VAC. SHOT- NAUSEA/VOMITING, "FOGGY FEELING"; 0930: VS: BP: 145/90, P: 89; T: 98.3 DEG. F; 02 SAT: RA: 97%; 0948: VS: BP: 129/82, P: 85, O2 SAT: 98 %R.A.
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| 40 | 2021-01-07 | feeling abnormal |
Severe body aches, chills, headache, fever, joint pain, back pain, fatigue, brain fog, diarrhea, los...
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Severe body aches, chills, headache, fever, joint pain, back pain, fatigue, brain fog, diarrhea, loss of appetite
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| 40 | 2021-01-07 | impaired work ability |
12 hours from vaccine #2, I started with rigors, myalgias/arthralgias, severe headache, temperature ...
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12 hours from vaccine #2, I started with rigors, myalgias/arthralgias, severe headache, temperature 100-101, nasal congestion, and profound fatigue. Symptoms resolved after 36 hours with Tylenol/Advil and supportive care. Sent for COVID Rapid PCR which was negative; missed 1 day of work.
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| 40 | 2021-01-09 | excessive sleepiness |
11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, sev...
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11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain and kidney pain
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| 40 | 2021-01-09 | sleep disorder, feeling abnormal |
I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I ...
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I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl
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| 40 | 2021-01-10 | anxiety |
Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain unde...
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Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,
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| 40 | 2021-01-10 | anxiety | c/o rapid pulse, anxiousness |
| 40 | 2021-01-10 | confusional state, insomnia, panic reaction, feeling abnormal |
Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; conf...
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Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-10 | impaired work ability |
believed it was injected incorrectly because she didn't have pain in her deltoid but she did have al...
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believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa; received the first dose 17DEC2020 / received the second dose 4JAN2021; anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of COVID 19 vaccine; can't actively use shoulder / can't move her arm; weakness in her hand; bone pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not provided) via an unspecified route of administration in the left arm on 17Dec2020 13:30, and the second dose (lot number EK9231, expiry date not provided)via an unspecified route of administration in the left arm on 04Jan2021 13:30, for COVID-19 immunization. There was no relevant medical history. The patient's concomitant medications were not reported. The patient experienced anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of the vaccine on 04Jan2021, and couldn't actively use shoulder. She believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa, and she couldn't move her arm and felt weakness in her hand. She noticed the pain and all other symptoms immediately when they were injecting it. She told the nurse who said she was tensing up. The events were considered medically significant by the patient. She also reported experiencing bone pain, unable to put in sutures at work. She was taking 600mg Ibuprofen and 1000mg paracetamol (TYLENOL) every 6-8 hours. The events were not resolved. The pain had gotten worse. The other symptoms were persisting.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-10 | loss of personal independence in daily activities |
shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours af...
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shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours after vaccination and developed loss of range of motion, weakness, inability to lift arm, tingling and numbness down the length of arm. Severe pain prohibiting ADLs; needing assistance with every day functions. Pain is incrementally improving but after 4 days still without recovery. Suspect nurse placed too high, injecting into bursa instead of deltoid muscle. RN seemed concerned after injection. She also was not sitting during injection, increasing the likelihood of injecting too high.
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| 40 | 2021-01-11 | agitation |
Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia...
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Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia Pain - bone, and muscle Vomiting Nausea Agitation Diarrhea Inflammation, edema, heat firm induration at injection site
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| 40 | 2021-01-12 | impaired work ability |
lightheadedness, fatigue, fever and pain & stiffness in the arm were the vaccine was administered. T...
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lightheadedness, fatigue, fever and pain & stiffness in the arm were the vaccine was administered. These symptoms lingered into the next day causing me to stay home from work the following day.
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| 40 | 2021-01-13 | amnesia |
Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting....
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Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting. Unable to walk due to pain and weakness for 24 hrs
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| 40 | 2021-01-13 | anxiety |
Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observatio...
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Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observation period after vaccine administration. A Rapid Response (RR) code for an anaphylactic reaction was activated. Vital signs were SPO2 100%, HR106 BPM and BP 150/100 mmHg. Patient received Epinephrine 0.3mg IM, Benadryl 50mg IV and Solucortef 200mg IV by RR code protocol. She was transfer to the ER. After transfer vital sings were 146/106 mmHg, HR 145 BPM and 120 BPM, RR 22, O2 sat 100% and 99%.
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| 40 | 2021-01-13 | nervousness |
Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hand...
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Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89
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| 40 | 2021-01-14 | anxiety |
Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report fro...
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Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
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| 40 | 2021-01-15 | loss of personal independence in daily activities |
My right temple started to get sore to the touch, I?m about day 3 post injection. It is fine unless ...
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My right temple started to get sore to the touch, I?m about day 3 post injection. It is fine unless I touch it, but if I do bump it or make contact with it, it hurt like the area was very bruised or recently injured. The pain has improved but it is still very sensitive. I didn?t think it was related to the shot, but I could not recall any injury. I can function like normal. My dr suggested I do a round of steroids, but to contact her immediately or go to ER if it worsened. I am to follow up with her in 2 weeks.
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| 40 | 2021-01-17 | confusional state |
Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint ...
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Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint pain, chills, low grade temperature, diaphoresis, lethargy confusion (day 1 only) headache- symptoms last 4 days with height at 24-48 hours
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| 40 | 2021-01-17 | impaired work ability |
102 F fever through 1 gram acetaminophen (104.6 prior to medication), extreme body aches and headach...
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102 F fever through 1 gram acetaminophen (104.6 prior to medication), extreme body aches and headache, overwhelming fatigie, and diapohretic x 2days. Swelling of arm from elbow to axilla during same. Unable to work during symptoms. Moderate fatigue, body aches, headache, and site tenderness persist to date of reporting.
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| 40 | 2021-01-17 | loss of personal independence in daily activities | - My fingers are tingling - I can't grab anything or type very well |
| 40 | 2021-01-18 | anxiety |
patient began to experience chest pain (6 on 10 scale) 10 minutes after administration. no other as...
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patient began to experience chest pain (6 on 10 scale) 10 minutes after administration. no other associated symptoms. Vital signs normal. Evaluated in Emergency Dept. Discharged. Note that patient was very anxious prior to and after vaccination.
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| 40 | 2021-01-18 | impaired work ability | chills, fever, body aches, fatigue. called in sick to work. |
| 40 | 2021-01-18 | impaired work ability |
I woke up at 2am (about 12 hrs after vaccine) with fever and sweats. Took acetaminophen and went bac...
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I woke up at 2am (about 12 hrs after vaccine) with fever and sweats. Took acetaminophen and went back to bed. Up at 6am feeling very fatigued and exhausted. Fever again. Got a shower but couldn't stand up that long too exhausted, dizzy and naseau. Went back to bed and called in sick to work. Took IBU 800mg. Back to sleep. Up at 9m more Tylenol. This continued all day trying to keep fever down. 48hrs later still taking acetaminophen to manage symptoms (back to work) still feeling tried and low grade fever.
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| 40 | 2021-01-18 | insomnia | Aching Fever low grade Chills Muscle pain Headache Insomnia |
| 40 | 2021-01-19 | restlessness, sleep disorder |
Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in undera...
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Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in underarm and body aches. Overnight I was restless and unable to sleep well, body aches and hot and then chilled and cold. By morning my arm was so sore and swollen it was difficult to move it, continued with all over body aches, fatigue to the point of unable to sit up, no fever but alternated chills/cold and hot/sweat. I did take ibuprofen every 4-6 hours throughout the day. This is the same type of reaction I had to tetanus when a teen.
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| 40 | 2021-01-20 | excessive sleepiness |
Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upp...
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Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upper and lower extremity numbness causing ER visit; Severe fatigue; slept for two days straight; Sore throat; Headache; Neck and shoulder pain; Neck and shoulder pain, Lower extremity joint pain; Kidney pain; This is a spontaneous report from a contactable other health professional. A 40-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly in the right arm on 29Dec2020 at 10:00 at 40-years-old at a single dose for COVID-19 immunization. : The patient did not get another vaccine in four weeks around the time of the suspect vaccine. The patient's medical history was reported as none. Concomitant medications were not reported. On 07Jan2021 at 05:00, the patient experienced: severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue, slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain, and kidney pain (2 days as reported); and the patient went to the emergency room. The patient underwent lab tests and procedures which included COVID-19 PCR-MHS: unknown (COVID test type post vaccination=Nasal Swab, COVID test name post vaccination=COVID19 PCR-MHS) on 07Jan2021, Rapid Strep with Reflex: negative (COVID test type post vaccination=other, COVID test name post vaccination=Rapid Strep with Reflex) on 07Jan2021. The clinical outcome of the events was recovered on an unspecified date in Jan2021.
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| 40 | 2021-01-21 | feeling abnormal |
I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm...
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I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-21 | nervousness, feeling abnormal |
Within a few minutes I felt like my throat was getting tight, constricted, and maybe even the descri...
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Within a few minutes I felt like my throat was getting tight, constricted, and maybe even the description would be inflamed. I was still able to breathe okay and swallow with only some restriction so I didnt say anything. I felt a little foggy and shaky as well for about another 2 hours and then was fine.
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| 40 | 2021-01-24 | excessive sleepiness |
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst...
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Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
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| 40 | 2021-01-24 | sleep disorder |
beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea,...
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beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea, feeling warm -- temp of 100.7; chills, fever, and nausea all morning of 1/21/21; fever and chills continued through 1/22/21 around 11am. Treated with Tylenol and Zofran. On 1/22/21 noticed lymph node swelling on arm where vaccine given. Neuropathy 1/22/21. Treated wtih ibuprofen 600mg TID. Lymph node remains swollen as of 1/25/21. Lymph node is hard.
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| 40 | 2021-01-25 | feeling abnormal, nervousness |
1:42 injection 1:58 reported tingly lip and feels funny, Benadryl 50mg given, no injection site reac...
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1:42 injection 1:58 reported tingly lip and feels funny, Benadryl 50mg given, no injection site reaction, lip and tongue unremarkable POX 99, P 78, bp 128/66 2:05 feels "funny, " dropping papers, appears nervous 2:20 DNS reported improved tingle 2:30 Dr. evaluated cleared resident to go home before Benadryl kicks in, tired. She stated "I feel fine"
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| 40 | 2021-01-25 | feeling abnormal, restlessness |
I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I ...
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I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.
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| 40 | 2021-01-25 | insomnia |
difficulty falling asleep; Lightheaded; This is a spontaneous report from a contactable other health...
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difficulty falling asleep; Lightheaded; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249), via an unspecified route of administration on the left arm on 06Jan2021 10:15 at a single dose for COVID-19 immunization. Medical history included Hashimoto, seasonal allergies, ripe food, allergies to weed, grass, trees. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), fexofenadine hydrochloride (ALLEGRA) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took erythromycin, Bactrim and experienced allergies. Patient did not have COVID and did not receive other vaccines four weeks prior to vaccination and was not pregnant. The vaccine was received at a workplace clinic. On 06Jan2021 10:45, the patient experienced difficulty falling asleep and was lightheaded. No treatment was received for the events. The patient has not tested for COVID post vaccination. Outcome of the events was recovered with lasting effects. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-01-26 | anxiety |
Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a co...
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Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication includes vitamins NOS (MULTIVITAMIN). The patient did not receive other vaccines in the last four weeks. The patient received the vaccine in a facility. About 5 minutes after (31Dec2020 11:35 AM) the patient received the vaccine, the patient's pulse started racing, and she felt dizzy, short of breath and anxious. The adverse events result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The patient has not been Covid tested post vaccination. The outcome of the events was recovered on an unspecified date. The following information on the batch/lot number has been requested.
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| 40 | 2021-01-26 | feeling abnormal |
Case received dose at 11:25 am and at 12:25 pm felt a rush of heat throughout her body, back of thro...
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Case received dose at 11:25 am and at 12:25 pm felt a rush of heat throughout her body, back of throat "fuzzy", heart rate 140/min for 20 minutes. Her breathing was as if she was "trying to catch my breath" which lasted 5 minutes. At 1pm she experienced fatigue, chills, had fog, and weakness which lasted or approximately 18 hours. She felt much better 48 hours later.
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| 40 | 2021-01-26 | impaired work ability |
I received the second dose of the vaccine on 1/4/21 and experienced fatigue, muscle aches, headache,...
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I received the second dose of the vaccine on 1/4/21 and experienced fatigue, muscle aches, headache, and a fever of 99.6 beginning 36 hours after the vaccine was administered extending to about 60 hours after administration. I missed work on 1/6/21 due to symptoms.
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| 40 | 2021-01-26 | loss of personal independence in daily activities |
body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels li...
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body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Information about batch/lot number has been requested.
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| 40 | 2021-01-26 | sleep disorder |
RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AR...
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RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AROUND 2AM I WOKE UP WITH A FEVER (99F), CHILLS, BODY ACHES, SORENESS IN LEFT ARM AND LEFT SIDE OF NECK, HEADACHE, NAUSEA & VOMITTING. I TOOK 4 X 200MG IBUPROFEN. I FINALLY WAS ABLE TO SLEEP AGAIN AROUND 7AM. I HAD A HEADACHE, BODY ACHES, NAUSEA AND FATIGUE THROUGH THE REST OF THE DAY. I SLEPT MOST OF THE DAY. AFTER 48 HOURS MOST SIDE EFFECTS WERE GONE, EXCEPT FATIGUE AND SORENESS IN LEFT ARM AND SIDE OF NECK.
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| 40 | 2021-01-27 | confusional state |
weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy;...
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weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.
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| 40 | 2021-01-27 | feeling abnormal | Fever of 101-102.5. Muscle aches all over. Shivers and cloudiness. Headache |
| 40 | 2021-01-27 | impaired work ability |
Fever since evening of the injection, continuous headache, muscle aches, unable to work today, palpi...
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Fever since evening of the injection, continuous headache, muscle aches, unable to work today, palpitations, general malaise.
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| 40 | 2021-01-28 | sleep disorder |
I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injectio...
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I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injection site. I around home about 6:00 p.m. immediately I start having chills, fever, muscle ache , nausea , and headaches. I could not sleep all night I was back and forth with chills and fever up to 102 for two days. On third day I felt better but headache and nausea linger still.
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| 40 | 2021-01-30 | feeling abnormal | 45 minutes of dizziness and woozy, "I feel drugged" |
| 40 | 2021-01-31 | feeling abnormal |
chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot...
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chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot do her daily duties/ could not even put her seat belt or roll up the window in her car; extreme headache; received first dose of the vaccine on 24Dec2020/the second dose on 11Jan2021; Chills; feeling horrible/feels foggy; feeling tired/ exhausted; body aches; arm was really sore; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), intramuscularly on 11Jan2021 07:45 at single dose in left arm to prevent covid, since she worked in a hospital with covid patients. Medical history provided as none. There were no concomitant medications. She gets the flu vaccine annually. The patient previously received first dose of BNT162B2 vaccine intramuscularly on 24Dec2020 23:45 in left arm for COVID-19 immunization with no adverse events. There were no other prior Vaccinations within 4 weeks. The patient experienced chills on 11Jan2021, feeling horrible on 11Jan2021, extreme headache on 12Jan2021, chest discomfort/something heavy on her chest on 13Jan2021, feeling tired/ exhausted on 11Jan2021, chest discomfort, feeling tired/ exhausted was reported as worsened; body aches on 11Jan2021, feels foggy on 13Jan2021, arm was really sore on an unspecified date in Jan2021, cannot even get out of bed on 12Jan2021. Specifically, it was reported that the patient worked 12 hours overnight, she slept and when she woke up she felt chills and felt horrible. States it carried on 12Jan2021. Today on 13Jan2021 she has an extreme headache, she clarifies the headache started on 12Jan2021 (yesterday). She feels like something heavy on her chest, chest discomfort. She has body aches and feels tired. She cannot cook right, she is so exhausted and cannot do her daily duties. She is assuming it is the immune reaction. Her son told her she looks really sick. States she rarely gets sick and when she gets sick she does get chills. Her chest feels like something is heavy on her. States if she did not have a strong heart, she cannot imagine what someone that does not have a strong heart would feel like. Since she works in a hospital she deals with covid all year around and she has been strong and healthy this year. Reports her headache is strong and today on 13Jan2021 she feels foggy. States yesterday on 12Jan2021, she was horrible and today (13Jan2021) is better in regards to chills. Her arm was really sore and now her arm is better, she could not even put her seat belt on 12Jan2021 (yesterday) or roll up the window in her car. She is nervous about the chest discomfort and headache. Asking where it could be coming from. She thinks it could be a possible immune response. If the chest discomfort continues she will go get seen. Advised to contact hcp. States she feels like crap. States she never gets headaches. Yesterday on 12Jan2021, her body aches were horrible and she cannot even get out of bed. The outcome of events chills, body aches was recovering, outcome of events extreme headache, chest discomfort/something heavy on her chest, feeling tired/ exhausted was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 40 | 2021-02-01 | impaired work ability |
after the vaccine, I started to feel Body aches, chills, nausea, gum pain, I felt fine prior to the ...
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after the vaccine, I started to feel Body aches, chills, nausea, gum pain, I felt fine prior to the vaccine, I went to an Express Care they did a Covid 19 test, result was negative, I had a video visit with my doctor because I developed cough, chest tightness and shortness of breath, they did a 2nd Covid 19 test result was negative, The cough become persistent and the cough caused pain in my chest and back, The Doctor prescribed guaifenesin with codeine, albuterol and something for my gums. the cough and pain in chest was worsen and the Doctor gave me the zpack, I was out of work for 10 days. they said I had an acute URI
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| 40 | 2021-02-01 | nervousness |
Elevated temperature (almost 100); Feel weak and shaky; Feel weak and shaky; Coughing; Nasal congest...
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Elevated temperature (almost 100); Feel weak and shaky; Feel weak and shaky; Coughing; Nasal congestion; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccine location: left arm) on 20Jan2021 11:45 for COVID-19 immunization. Facility where the recent COVID-19 vaccine was administered: Other-Drive thru vaccine POD. Medical history included Hashimoto's thyroiditis, allergies to penicillin, and sinus infection. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Other medication the patient received within 2 weeks of vaccination included doxycycline 'hydroxylate' for a sinus infection. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021 12:00, the patient had an elevated temperature (almost 100), felt weak and shaky, coughing and nasal congestion, and a headache. The events were considered as non-serious by the reporter. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events. No follow-up attempts are possible; information about batch number cannot be obtained.
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| 40 | 2021-02-02 | feeling abnormal |
tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles o...
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tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-02-02 | impaired work ability |
EE states she received Covid vaccine on Wednesday 1/27/21. She had to call off work on Thursday (1/2...
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EE states she received Covid vaccine on Wednesday 1/27/21. She had to call off work on Thursday (1/28/21) due to headache, general body aches and nausea. Came back to work today (1/29/21) and came to EH with c/o uppder body aches, intermittent headaches and a rash to back, chest and bilateral underarms. EE afebrile at this time. EE medicated with Benadryl PO, as per standing order.
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| 40 | 2021-02-03 | impaired work ability |
Report left arm soreness and HA 6 hours after vaccination: Treatment: Tylenol with no improvement. O...
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Report left arm soreness and HA 6 hours after vaccination: Treatment: Tylenol with no improvement. Outcome: unable to go to work, but does not interfere with ADLs.
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| 40 | 2021-02-03 | sleep disorder, impaired work ability |
December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Mond...
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December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.
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| 40 | 2021-02-04 | feeling abnormal |
Shortly after the vaccination I was still having the abdominal distention so I called to see if I co...
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Shortly after the vaccination I was still having the abdominal distention so I called to see if I could defer the 2nd vaccine because I wasnt feeling well and still experiencing AE from the 1st dose. I was advised I still had to get the vaccine so I did and by 2:30pm I begin to have severe facial swelling causing asymmetrical shaping of my face, my head was hurting extremely bad, fatigued and felt really bad. I had to lay down because my head was hurting, felt like I had pressure on the top of my head, neck and back. The pain was so bad I was transported to the ER and was isolated d/t previous COVID infection and all while there the my body felt as if it was steady swelling. I was hurting so bad I couldnt stand to be touched. I was given another round of steroids. I was advised I had COVID pnemonia and was given IM decadron, IM regalin and a subQ injection of immatrex for the headaches and administered ibuprophen and tynenol for the headache as well. I was discharged with a prescription of regalin and decadron. The ER dr. states I shouldnt have taken the 2nd vaccine because I was still suffering from COVID-19. The abdominal distention had dissolved but the congestion just will not clear up even after 3 rounds of steroids. Asoumedrol was prescribed by my ENT but it didnt help either so I have a CT Scan scheduled for next week with my ENT and has not been able to return to work since the 1st dose 12/22. I have be retested for COVID-19 on both 1/15 and 1/25 and both results are still positive for COVID.
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| 40 | 2021-02-04 | impaired work ability |
With the 1st dose I had myalgia, arthralgia and pain at the injection site which began the next morn...
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With the 1st dose I had myalgia, arthralgia and pain at the injection site which began the next morning when I woke up at around 10:00 am and lasted 48 hours. For the 2nd dose, the reaction was more profound. I had pain at the injection site within 6 hours of the injection and by the next day around 11:00 am I woke up with myalgia, arthralgia, fever of 101.2 F, fatigue, headache, and sore throat. Symptoms lasted for 4 days and I missed 2 days of work.
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| 40 | 2021-02-07 | anxiety |
Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose,...
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Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose, she felt anxious, increased heart rate and had a metallic taste in back of her throat. Patient was sent to ER for evaluation at 10:27am. Patient felt better and discharged at 12:11pm
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| 40 | 2021-02-08 | nervousness |
hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she f...
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hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.
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| 40 | 2021-02-09 | feeling abnormal |
Raised rash on face; Raised rash on face and injection site; flushed feeling face; chills; Body ache...
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Raised rash on face; Raised rash on face and injection site; flushed feeling face; chills; Body aches; brain fog/ overall not up to feeling like myself; This is a spontaneous report from a contactable nurse reported for herself. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the right arm on 22Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing and cerebrovascular accident from an unknown date and unknown if ongoing. The patient previously took morphine and experienced drug hypersensitivity. On 23Jan2021 10:30, the patient experienced raised rash on face and injection site, flushed feeling face, chills, overall not up to feeling like myself, body aches and brain fog. No treatment was received for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 40 | 2021-02-09 | nervousness |
Shortly after receiving the vaccine, I felt a very slight tingle in my lips- so slight that I though...
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Shortly after receiving the vaccine, I felt a very slight tingle in my lips- so slight that I thought I was imagining it and so I didn't say anything. As I was driving home, I started to feel it more and also felt it in my tongue. When I got home, the only antihistimine I had was claritin, so I took that. Then, I got nervous, felt tightness in my chest and went to the ER. They gave me benadryl and that helped. I stayed in the ER for an hour to be monitored and they said everything was fine.
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| 40 | 2021-02-09 | panic reaction | Systemic: Other- chest tightness, flushing, and signs of panic |
| 40 | 2021-02-09 | sensation of foreign body |
5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heart...
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5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heartrate as high 120-150 I started to get really dizzy, I had shortness of breath I felt like I was getting ready to faint . I started having getting cotton mouth(Dry mouth). 8 hours post vaccine I started the heart rate went down but I started feeling like I had something in my throat . the bumps on the back on my tongue was swollen. I took Zyrtec and Pepcid Blood pressure was high Glucose was high
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| 40 | 2021-02-10 | impaired work ability | FEVER AND CHILLS RESULTING IN 24 HOURS OF LOST WORK TIME. |
| 40 | 2021-02-10 | impaired work ability |
Started having nausea, dizziness, head ache, weakness and fatigue and chills lasted for 3 days. As t...
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Started having nausea, dizziness, head ache, weakness and fatigue and chills lasted for 3 days. As these were new symptoms and were a week and a half out from the vaccine. Went and was tested for COVID-19 and received a negative test. Missed 3 days of work. No one else in my house hold had any symptoms. No one else in the house hold has been vaccinated.
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| 40 | 2021-02-11 | feeling abnormal | I felt stupid |
| 40 | 2021-02-12 | disorientation, confusional state, restlessness |
Heart rate sped up very much immediately after the injection. I felt ancy & it lasted for a day. I a...
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Heart rate sped up very much immediately after the injection. I felt ancy & it lasted for a day. I also felt confused, disoriented, out of it.
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| 40 | 2021-02-12 | sleep disorder, loss of personal independence in daily activities |
Injected arm started throbbing. Woke up out of sleep twice that night to take NSAIDS to try and make...
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Injected arm started throbbing. Woke up out of sleep twice that night to take NSAIDS to try and make it bearable. Still 3 weeks later not able to push or pull with arm, drive care, or lift with left arm-including taking off shirt, without pain. Able to pinpoint exact place injection was given and pain associated when pushing spot. Taking NSAIDS all day long to be able to move. Finally after 2 1/2 weeks made general physician appt because it is crazy how long and how bad my arm hurts. At that time still not able to lay on left arm or lift over head. Have been to chiropractor 3 time to help relieve shoulder/muscle pain.
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| 40 | 2021-02-15 | insomnia | Extreme thirst for 3 days; Extreme energy/hyperactivity for 2 days; Insomnia for 3 nights |
| 40 | 2021-02-16 | feeling abnormal |
Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of brea...
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Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of breath. Within 30 minutes she had nausea, emesis and a strange feeling in her mouth/throat. Patient was monitored and did not require EpiPen. She was given Benadryl. She was recommended to not have a second injection due to immediate allergic reaction. She did
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| 40 | 2021-02-16 | insomnia |
4 hours after the 2nd dose I started coughing and feeling a little achy. about 8 hours later I start...
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4 hours after the 2nd dose I started coughing and feeling a little achy. about 8 hours later I started getting chills and major aches and pains. By 12 hours after I had the worst headache of my life along with major chills and awful body aches. The chills and aches were so back I couldn't sleep through them and was up most of the night bundled up under 4 blankets shivering and achy. I felt so dehydrated and drank water all night long. Every time I'd try to stand up out of bed I felt like I was going to throw up. About 24 hours after the shot the symptoms started to ease and I was able to stand and move again. Just been completely drained of all energy and have had no appetite since (at about the 30 hour mark).
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| 40 | 2021-02-18 | loss of personal independence in daily activities |
Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into lar...
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Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into large welts a few hours later that then turned into 2 large welts on the side/back of my upper thighs. 2 days later and ever since I have severe nerve pain that is constant and is affecting my ADLs.
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| 40 | 2021-02-19 | anxiety |
Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiet...
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Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiety and hypertension. Initial BP 161/102 (pulse 102); final BP 132/88 (pulse 95). Benadryl PO given.
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| 40 | 2021-02-21 | disturbance in attention |
malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to ...
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malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to focus, and fatigue - day 3-6 chills- day 7 tingling in legs and feet/hands - day 4 and continue off an off for past 2.5 weeks after vaccine headaches- continued off and off for past 2.5 weeks
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| 40 | 2021-02-21 | feeling abnormal |
complained of feeling weird and heart racing. HR 120s BP 168/78 at 1510. by 1600 HR down to 92, BP 1...
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complained of feeling weird and heart racing. HR 120s BP 168/78 at 1510. by 1600 HR down to 92, BP 142/76. Patient reported feeling better. Denied shortness of breath, chest pain and denied other symptoms. Advise to see primary care physician.
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| 40 | 2021-02-22 | loss of personal independence in daily activities |
Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memor...
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Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memorable symptoms began on Feb. 19th, the worst day was Feb. 20th, when I was unable to complete my usual daily activities. My symptoms have begun to improve today, Feb 23rd. On Dec. 17th, 2020 I was diagnosed with COVID19.
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| 40 | 2021-02-23 | disorientation, feeling abnormal |
Following the injection, after approximately four hours later I began to feel some slight disorienta...
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Following the injection, after approximately four hours later I began to feel some slight disorientation and tiredness. Later the same evening I experienced brain fog and confusion for the next several days as well as a terrible headache. Additionally my tongue felt tingly. All of these symptoms passed within several 3- 4 days following the vaccination. injection site discomfort was also a symptom.
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| 40 | 2021-02-23 | insomnia | Insomnia, nerve pain in ears and legs, headache, fatigue after the insomnia, chills. |
| 40 | 2021-02-28 | confusional state |
Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throug...
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Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throughout my body My chest, arms and legs felt heavy. It wasn?t hard to breathe exactly, but it just felt like it was hard to actually do it. If that makes sense Then, the scary one. My brain and my mouth were saying two different things. I became really pale (per medic) and I had a hard time figuring out how to say no. My mind just wouldn?t work correctly. And when I tried to speak, it was very confusing and I was told I wasn?t making sense by the medic. Then as quickly as it started, it stopped. Periodically through out the day today, I have gotten more confused than normal about simple things. Earlier I tried to say chicken. I said potato. I was thinking chicken but my stupid mouth said something different. The medic compared my symptoms to a stroke. Which was terrifying
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| 40 | 2021-02-28 | hallucination |
felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Fri...
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felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; dizziness; chills; headache; weird hallucinations; sore arm; felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, second dose) intramuscular in left arm on 28Jan2021 at 09:15 (at the age of 40-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Past drug history included allergies: cefazolin sodium (ANCEF). Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on 05Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had a sore arm and felt groggy on Thursday night (28Jan2021). The patient was feverish (highest temp was 100.4 F) with dizziness and chills and headache all day Friday, on 29Jan2021. On Friday night (29Jan2021) the patient had weird hallucinations (I hallucinated?, I guess, I was awake and talking to my husband and he said I seemed awake? but that my bed was breaking in half and sinking into the floor, and I kept telling him I couldn't breathe but he said I was breathing normally). No treatment was provided for the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache. The outcome of the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache was recovered on 31Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The reported event hallucination was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-02-28 | impaired work ability |
Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, ...
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Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.
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| 40 | 2021-03-01 | anxiety, sensation of foreign body |
Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath,...
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Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath, rapid heart beat, flush feeling, intense shaking (especially in legs), pain in chest, lightheadedness, dizziness (ruled anxiety) and was monitored for 40 minutes. Was given orange juice and water and allowed to remove mask to catch breath. Almost everyday since this event, the same event keeps repeating it self (almost daily for 3 weeks). I am unable to control these episodes. Emergency department (ED) has been called and I have gone to see my nurse practitioner. Been trying to make an appointment with my doctor for this week. I have lost 5 pounds (down to 105 lbs. so I can't afford to loose more weight) since this first happened and I have also lost my appetite and unable to function normally.
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| 40 | 2021-03-02 | feeling abnormal |
Once injected, I felt a Swooshing in my brain, immediate numbness in my arm and fever in fifteen...n...
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Once injected, I felt a Swooshing in my brain, immediate numbness in my arm and fever in fifteen...nurse had me lay down for ten mins. Still felt weird and numb in arm, she said it was normal and sent me to leave. Tem mins into my car ride home my left cheek starting tingling and going numb. The nerves in my left leg began tingling all over. By the time I got to the hospital, I had similar symptoms of Temporary paralysis on left side yet my limbs were still functioning. When I left the hospital a few hours later, I was like 50 percent numb on my left side, all test results showed everything was good, blood, EKG and cat scan. I felt like I'd been injected with novacaine all over the left side of my body and I was in the stage where it is starting to wear down with tingling and itching on my hand leg and cheek on my left side. My back on left side and neck locked up. The numbing in my face took two weeks to decipate. While exercising never agitation occurred and felt like nerves were firing for two weeks. Severe ear nerve pain occured within first week. Followed up with personal doctor had mri of brain w/ and without contrast and that looked good. I am pretty healthy, maybe a few extra covid lbs. EKG good, CT scan good, blood work good. I am waiting to see neurologist for more testing. There is still random tingling in and out, very faint on left side of my body only. Use of my left hand feels
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| 40 | 2021-03-02 | loss of personal independence in daily activities |
chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue seve...
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chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue severe enough to prevent normal activity; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), intramuscularly into the left arm on 28Jan2021 14:15 at a single dose for COVID-19 immunisation. Medical history included Polycystic ovarian syndrome (PCOS), depression, obesity and allergies to latex. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN), colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B12). The patient previously took tetracycline and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly into the right arm on 06Jan2021 03:15 PM at a single dose for COVID-19 immunisation. On 28Jan2021 20:00, patient experienced chills, fatigue, migraine-like headaches, dizziness, nausea and migraine-like headache and fatigue severe enough to prevent normal activity. The events were reported as non-serious. The patient did not receive any treatment for the events reported. Outcome of events was unknown.
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| 40 | 2021-03-02 | memory impairment |
Pt stated that about 10 minutes after receiving vaccine she felt like she was "hit in the back of th...
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Pt stated that about 10 minutes after receiving vaccine she felt like she was "hit in the back of the head", and had developed a severe headache. Pt also c/o numbness and tingling on the L side of her face. Checked for signs of a stroke, none noted. Vitals- B/P- 148/90; P- 108; R-14; SpO2- 94-96% on RA. Lung sounds clear. Pt denies any itching, difficulty breathing, or chest heaviness. No rash noted. Pt called her PMD who told her to have her husband bring her over to his office for evaluation. PHN called pt on 3/3/21 to check on status. States she still has a headache and some numbness on her face. States she is also having trouble finding words when she is talking. Encouraged to f/u with PMD again today.
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| 40 | 2021-03-02 | sensation of foreign body |
10 minutes after getting her first COVID-19 vaccine, patient experienced L sided numbness and tingli...
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10 minutes after getting her first COVID-19 vaccine, patient experienced L sided numbness and tingling of her face, 5 minutes later this was followed by a globus sensation. Patient had CN 2-12 grossly intact and 5/5 muscle strength of the upper extremity. She had a patent airway without stidor. She was able to swallow liquids. Due to her history of angioedema, she was evaluated by EMS and sent to ED for further evaluation.
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| 40 | 2021-03-04 | anxiety |
At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating a...
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At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.
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| 40 | 2021-03-05 | impaired work ability, confusional state, anxiety |
8 minutes after the administration of the vaccine (while in the observation area) I started to feel ...
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8 minutes after the administration of the vaccine (while in the observation area) I started to feel really off (dizzy, anxious, ringing in right ear). I ended up becoming unconscious with seizure like activity. They rushed me to the ER and kept me for 6 hours with lots of testing. XRay, blood test, CT of head, EKG, Urine test...all came back normal. Doctor said it was likely a reaction to the vaccine. I am 40 years old with no history of seizures or allergic reactions to vaccines. The week following I experienced confusion, migraines, dizziness, slow cognitive processing, eye strain, word finding difficulties, and exhaustion. I had to take a week off of work to recover. This is the second week and I am still experiencing headaches and occasional dizziness/eye strain.
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| 40 | 2021-03-05 | nervousness |
Pt stated she currenty has a post nasal drip and she feels like her throat swelling comes and goes. ...
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Pt stated she currenty has a post nasal drip and she feels like her throat swelling comes and goes. Pt stated she just got very nervous and wanted to be checked out. Pt seen by EMS on site BP: 158/88, P:100, O2:99% on RA. Pt declined to go to hospital. EMS educated pt on signs and symtoms to report and go to the hospital. RN
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| 40 | 2021-03-07 | anxiety | Pt had some nausea and anxiety after vaccine . Pt was OBS in car and released |
| 40 | 2021-03-07 | disorientation |
Lightheaded following COVID -19 vaccine. Injection at 12:15 pm Vital Signs: B/P: 142/82 HR: 71 Resp....
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Lightheaded following COVID -19 vaccine. Injection at 12:15 pm Vital Signs: B/P: 142/82 HR: 71 Resp.: 16 O2Sat: 95% Skin Signs: Warm and dry Circulation: Cap refill <2sec Resp.: Breath Sounds Clear Bilaterally Treatment: Pt assisted to cot. Requested to remain in sitting position. C/O dizziness and vertigo with head movements. Denies nausea , No flushing, skin p/w/d. Repeat Assessment: 12:45 pm Vitals: B/P: 132/82 HR: 74 Resp.: 16 O2Sat: 98% Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sounds bilaterally Treatment: Remains in seated position- Offered fluids- refused. Repeat Assessment: 13:02 pm Vital Signs: B/P: 122/88 HR: 73 Resp.: 16 Skin signs: Warn and dry Circulation: Cap refill <2sec Resp.: Breath Sounds clear bilaterally Treatment: Lightheaded, states "easier to focus eyes." No syncope, No increased light or vertigo with movement of head. 13:20 pm Pt released via wheelchair to vehicle to home with a friend. ALOx3, skin p/w/d. No further c/o dizziness . F/U Call: 2/4/2021 Fine after returning home. Woke up in the middle of night fell in BR x2 (no head injury) sweating, fevers, syncope, weakness, vertigo "spinning" disoriented felt delirious with 2nd fall in BR. Extremely nauseated.
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| 40 | 2021-03-07 | feeling abnormal |
First dose on 02/14/2021 received 10:15 am. Symptoms started approximately 8 to 10 hours later. I ex...
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First dose on 02/14/2021 received 10:15 am. Symptoms started approximately 8 to 10 hours later. I experienced Brain fog, fatigue, weakness generalized malaise, headache, sore arm . No treatment, symptoms resolved after 4 days.
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| 40 | 2021-03-09 | feeling abnormal |
A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt v...
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A few hours after receiving my 2nd dose vaccine I got sores on my tongue. The following day I felt very fatigued, had a low fever for a couple hours, sore neck and shoulder to the injection site, sore throat, headache, light sensitivity and hazy/foggy feeling. I also had a finger feel sore and inflamed for about 5 days. It has been 1 week now and I still have major fatigue, headaches, brain fog, morning sore throat and just a feeling of ?not well?. I try to workout, but after I get so fatigued I can?t perform regular daily tasks. I have been so foggy, I can?t help my kids with their school work.
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| 40 | 2021-03-11 | impaired work ability |
Excruciating shoulder pain began in evening. Range of motion gone. Couldn't lift left arm. Notified ...
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Excruciating shoulder pain began in evening. Range of motion gone. Couldn't lift left arm. Notified Health Department and employer on 3/1/21, missed work. Told to heat and take ibuprofen. Did as instructed and 2 weeks later still have excruciating pain with certain movements. Injection was administered very high and far back on shoulder.
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| 40 | 2021-03-12 | loss of personal independence in daily activities, feeling abnormal |
Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I...
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Immediately after administer, I felt ?weird?. Almost a little light headed. As the minutes passed, I began feeling dissociated. Almost out of body, like I was under the influence. I began to struggle to answer questions and stay awake. I willed myself to stay calm and stay awake. I was given water and observed for an hour. My face began to feel numb and the roof of my mouth itchy. The ?high? feeling was eventually replaced by the feeling of being extremely tired. After and hour I was good to drive but extremely tired when I got home. About an hour after the shot I can taste a blood or metallic taste in my mouth. I still feel ?drugged? or tried.
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| 40 | 2021-03-14 | anxiety |
Patient reported "my throat is closing up", then devoped generalized pruritis, more tightening and d...
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Patient reported "my throat is closing up", then devoped generalized pruritis, more tightening and dyspnea. Epinephrine 0.3IM and EMS called. She refused transport. She called her primary care office who also urged her to go to ER 15 minutes later symptoms recurred along with anxiety EMS administered Epi IM, benedryl and solumedrol IV. She then refused transport again and departed. 10:22 - 114/81 P-111 02 98% 10:31 137/70, 102, 99% 10:40 130/80, 106. 98%
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| 40 | 2021-03-15 | anxiety |
Progress Notes Expand AllCollapse All Patient: ...
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Progress Notes Expand AllCollapse All Patient: DOB: 4/11/1980 Date: 3/16/2021 MRN: Subjective Patient is a 40 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience generalized weakness, "need for a quick snack". She denied rash, shortness of breath, difficulty swallowing or syncope This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to red flag findings ALLERGY REVIEW OF SYSTEMS Previous Reactions: none Objective Vitals Vitals: 03/16/21 0944 BP: (!) 158/103 Pulse: (!) 102 SpO2: 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is not ill-appearing or diaphoretic. Comments: Anxious on arrival to bay, "I think I just need a snack to feel better." HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Musculoskeletal: General: Normal range of motion. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert. Motor: No weakness. Psychiatric: Comments: Anxious affect Clinically, post injection anxiety related event. Elevated BP on arrival, improved with rest and granola bar. Salient anxious affect, post injection histamine response, requiring warm blanket, prolonged rest Ambulated with assist, additional snacks provided and pt discharged after 45" stay Assessment/Plan Treatment included: snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)
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| 40 | 2021-03-18 | anxiety |
Patient is a 40 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 3...
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Patient is a 40 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/19/2021. The patient experienced the following reaction(s) during the immediate of observation: 12:07pm Patient c/o numbness to bilateral hands. Denies tingling, shortness or breathing, or difficulty breathing. Patient reports anxiety. Patient was treated/managed as follows: 12:09pm VS BP 150/82, HR 80, RR 18, O2 sat 98% on room air. States symptoms are subsiding. 12:20pm VS BP 154/84, HR 74, RR 18, O2 sat 99% on room air. Patient reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 12:28pm. Patient escorted to car by RN.
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| 40 | 2021-03-18 | disturbance in attention, feeling abnormal |
I felt extremely foggy headed. It was like I was struggling to put thoughts together at times. Also,...
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I felt extremely foggy headed. It was like I was struggling to put thoughts together at times. Also, it was like I was having trouble focusing on and off. The foggy headed last mainly the first day of vaccination, then some on the second day after. This happened about 15 minutes after receiving the vaccine. Also, exhausted feeling on and off the first night of vaccination.
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| 40 | 2021-03-18 | feeling abnormal |
heart started pounding out of chest; blood pressure was high; Cough; ended up in ER with tachycardia...
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heart started pounding out of chest; blood pressure was high; Cough; ended up in ER with tachycardia; Anemic; lightheaded, foggy, kind of disconnected; lightheaded, foggy, kind of disconnected; chest got tight; hard time of breathing; chills and body aches; chills and body aches; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on Left arm on 21Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. It was reported that she was sick in October, she was exposed to COVID, but tested negative, she got sick. She got the vaccine on 21Jan2021, she started having about 4 hours after, chills and body aches, which is normal, then her heart started pounding out of chest, her chest got tight and she had a hard time of breathing. It lasted a couple minutes, the pounding of her heart, but it slowed down, it was fast but not as bad, and she took some Benadryl and after a half hour things settled down, her breathing went back to normal. She contacted her doctor who said to let him know if it happened again, and the next day (22Jan2021) she was kind of out of it, lightheaded, foggy, kind of disconnected, almost like a hangover feeling, just yucky and ran down, Saturday she was feeling a little better, then had 2 more episodes of heart pounding and continued shortness of breath. She ended up in the ER with tachycardia on23Jan2021. She is still having problems. In ER, they found out she was anemic on 23Jan2021.On 23Jan2021 they did bloodwork that day, she had an X-ray and EKG. EKG showed fast rate, normal rhythm, appeared to be no damage to heart. Her blood pressure was high and X-ray of lungs was clear, she had another X-ray this morning, since she developed a cough on 30Jan2021, a barky cough, is coughing up phlegm, Cough started on Saturday, this past Saturday, and is ongoing and worsening, it turned into a cough with a whistle into a barky cough, they are thinking it is connected to asthma response. She is supposed to have pulmonary function tests on the 19th and on the 15th, and endoscope and colonoscope due to anemia to ensure no bleed anywhere. They did another X-ray (on 04Feb2021) this morning and it was clear. They only thing they found is she is anemic, and her doctor is wondering if it is underlying asthma or long haul COVID or a combination of anemia and the shot kicked up stuff. It was reported that she had some asthma like symptoms, which were fully resolving, but kicked back up again since the shot. The events were considered as non-serious. The outcome of the event was chills and body aches was recovered, outcome of the event cough was not recovered and outcome of other events was unknown.
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| 40 | 2021-03-19 | insomnia |
Immediate but for 24 hrs only: bad taste in mouth elevated blood pressure/heart rate dizziness la...
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Immediate but for 24 hrs only: bad taste in mouth elevated blood pressure/heart rate dizziness lasted two days: fever muscle/joint pain still continues: insomnia
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| 40 | 2021-03-20 | anxiety |
c/o lightheaded ness & heart palpitations for min. post injection. h/o increased BP; no meds take...
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c/o lightheaded ness & heart palpitations for min. post injection. h/o increased BP; no meds taken this AM. Symptom quickly improved with mask removal & fresh air. Reported most likely R/T anxiety. On recheck - reported symptoms resolved. BP 130/86; HR 86; drove off lot independently.
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| 40 | 2021-03-20 | anxiety |
summons to vehicle for c/o. " slight throat tightness" She reports is most likely. R/T Anxiety. ...
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summons to vehicle for c/o. " slight throat tightness" She reports is most likely. R/T Anxiety. Resolved with removal of mask, fresh air & emotional support. BP 118/76 - P 55; 16 Resp unablored. Symptom resolved within 3 mins. time.
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| 40 | 2021-03-20 | feeling abnormal |
This report is in relation to acute sudden onset tinnitus in left year one day following first shot ...
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This report is in relation to acute sudden onset tinnitus in left year one day following first shot of COVID vaccination. Received first COVID vaccine shot in my left arm. I felt a bit tired and foggy but nothing too bad or out of the ordinary. Exactly 31 hours later, I was talking with my daughter when a very loud ringing noise entered my ears. It subsided slightly but then a persistent ringing -- tinnitus -- remains in my left ear. I saw an audiologist who indicated a slight dip in hearing acuity in the left ear at a higher pitch. I am currently on prednisone (20mg 1x per day) and doxycycline but it has been 4 days with no dissipation or relief. I have not suffered from tinnitus before.
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| 40 | 2021-03-20 | feeling abnormal |
About 30 minutes after getting the vaccine I was driving home and suddenly felt like I was losing co...
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About 30 minutes after getting the vaccine I was driving home and suddenly felt like I was losing consciousness. It lasted for a few seconds and then the feeling went away. I called 911 because I didn't know what was happening and other than a bit of an elevated heartrate I was ok so I deferred the option to go to the hospital. At the time that the paramedics were checking on me, one of them noticed a red area on the inside of my right elbow. I hadn't noticed it until then, but it could have been there and I just missed it. After about 2 days the rash appeared on my left inner elbow. It didn't really itch but it was painful and felt very dry and irritated. I was told it looked like eczema so I began using eczema cream. It has seemed to help a little. I have never had eczema prior to this. I contacted my doctor and he said he had no way of really knowing if it was an allergic reaction.
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| 40 | 2021-03-21 | insomnia |
Moderate to severe joint pain in entire body ongoing. 19 hours since onset. Insomnia night of first ...
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Moderate to severe joint pain in entire body ongoing. 19 hours since onset. Insomnia night of first dose. Facial flushing and fatigue ongoing, 19 hours since onset.
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| 40 | 2021-03-21 | sleep disorder, loss of personal independence in daily activities, anxiety |
Within hours of the vaccination, my ears started ringing (tinnitus) and worsened throughout the week...
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Within hours of the vaccination, my ears started ringing (tinnitus) and worsened throughout the week. There has been no change, no easing of symptoms. It persists, disrupts my daily life, including increased anxiety and lack of sleep. In addition to the ringing, my ears feel full and hurt. I've been to 3 doctors (PCP, Allergist, ENT) since Thursday March 18, and no one has been able to help me or offer much advice. In addition to ear issues, I have loss of appetite, nausea, and diarrhea that also persist. Odd sensations in my head, like shooting pains or soreness, also occur.
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| 40 | 2021-03-22 | impaired work ability |
On the fourth day I began feeling a headache and weakness. On 5th day my symptoms increased to nause...
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On the fourth day I began feeling a headache and weakness. On 5th day my symptoms increased to nausea , vomiting, headache, dizziness, weakness, fatigue, diarrhea, trouble breathing, rapid heart beat. These symptoms persisted for a few days. Then came on again on March 21, 2021. I have visited urgent care center and have tested negative for covid. I have been prescribed pain for headaches and nausea. My symptoms continue and persist as of now. I have missed work due to reactions.
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| 40 | 2021-03-23 | anxiety |
Patient presented with tightness in chest after 1st dose of COVID vaccine. Patient has history of se...
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Patient presented with tightness in chest after 1st dose of COVID vaccine. Patient has history of severe allergic reactions to vaccinations. Administered 50mg of Benadryl PO. Patient condition worsened rapidly with hives and anxiety. 911 contacted for transport. 0.3mg Epi administered in right deltoid. Epi began working quickly. Care transferred to EMS and transferred to Hospital.
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| 40 | 2021-03-23 | impaired work ability |
1/7 vaccination 1/10 I woke up at 4-5 am, incredibly nauseous. I had diarrhea, thought i was going ...
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1/7 vaccination 1/10 I woke up at 4-5 am, incredibly nauseous. I had diarrhea, thought i was going to vomit. Felt very ill. I couldn't work as I felt so ill even for zoom meeting. Symptoms were off and on for 2 weeks. 2 weeks after I went to see PCM. Couple days later, relapse into severe nausea, diarrhea. Went to telehealth, went to ER. Blood panel; ok. It seemed very coincidental.
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| 40 | 2021-03-24 | confusional state, fear, disorientation |
2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It wa...
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2.5 hours after vaccination, I was sitting watching tv when I had a sudden neurological event. It was like a seizure. I was unable to talk, my eyes rolled back, and my right shoulder and arm seized up. I was sputtering and unable to make it stop. Lasted for a minute or two then stopped for a minute and happened again. I felt disoriented, confused, scared. I was unable to walk straight or visually focus on anything. I contacted my primary care doctor and she recommended I be seen immediately but advised I call Providence and speak with a nurse. I did that and the nurse said to come in to the ER immediately. I did.
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| 40 | 2021-03-24 | confusional state |
11:26am mild dizziness and confusion. Roof of mouth itching 11:35am moderate to severe dizziness a...
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11:26am mild dizziness and confusion. Roof of mouth itching 11:35am moderate to severe dizziness and confusion. Roof of mouth itching and mild tongue swelling. Saw nurse at observation site and was taken to paramedics. They took vitals and blood glucose which were normal. They gave me two shots of 25 mg of Benadryl, which helped tongue swelling but nothing helped dizziness and confusion. Agreed to go to the hospital by ambulance. By the time I was seen in the ER, symptoms resolved other than fatigue from benadryl. Discharged around 2:30pm
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| 40 | 2021-03-24 | feeling abnormal |
dizzy; feeling drugged; numbness; loss of most use in hands; took extreme amount of planning and eff...
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dizzy; feeling drugged; numbness; loss of most use in hands; took extreme amount of planning and effort to speak a singular word or move any part of body; nausea; vomitting; Hands/ fingers, legs, eye, all developed tics; Legs were twitching all night; little achey; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 40-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: UNKNOWN), via an unspecified route of administration in the left arm on 06Feb2021 at 16:30 PM (at the age of 40 years) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included bupropion hydrochloride (WELLBUTRIN), gabapentin, fluvoxamine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took cephalexine and experienced drug hypersensitivity. On 06Feb2021 at 17:30 PM, the patient started to get dizzy, feeling "drugged", numbness, then loss of most use in hands (significant weakness- could not hold a cup), took extreme amount of planning and effort to speak a singular word or move any part of body, nausea, vomiting, hands/ fingers, legs, eye, all developed tics, legs were twitching all night, little achy. No treatment was taken for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 18Feb2021, Nasal Swab: Negative. Information on the lot/batch number has been requested.
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| 40 | 2021-03-24 | excessive sleepiness |
Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At no...
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Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At noon I had severe pain the entire length of my right arm, and I felt drowsy so I fell asleep for several hours and the pain in my arm was moderate and restricted to injection sight when I woke up. I went to bed at 10 pm and woke up at 1 am with diarrhea. I spent the the next hour having a few diarrhea bowel movements. On 3/20 my right arm was still in moderate pain and injection site was swollen and red. At 8 am I woke up with a headache and so I went back to bed. By afternoon I had the chills and went to bed for another nap and when I woke up the chills were gone. On 3/21 my right arm still had moderate pain. On 3/22 I had another bout of diarrhea for one bowel movement, and my arm pain was still moderate. On 3/23 the swelling and redness at the injection site went away but the area is still slightly tender to the touch on 3/25. On 3/25 at 1 am I was in bed trying to sleep, but I kept having intense dizzy spells that lasted 3-4 hours.
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| 40 | 2021-03-24 | nervousness |
PATIENT MENTIONED SHE WAS NERVOUS, I MADE SURE SHE WAS BREATHING REGULARLY AND NOT HOLDING HER BREAT...
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PATIENT MENTIONED SHE WAS NERVOUS, I MADE SURE SHE WAS BREATHING REGULARLY AND NOT HOLDING HER BREATH. AFTERWARDS HAD HER SIT IN WAITING ROOM FOR THE 15 MINUTES. AFTER A COUPLE OF MINUTES SHE APPROACHED COUNTER AND SAID SHE WAS NOT FEELING WELL, I HAD HER SIT BACK DOWN, HAD MY TECHNICIAN CALL 911, AND RETRIEVED THE EPI-PEN. AS I WAS APPROACHING HER SHE SLUMPED OVER. I TRIED TALKING TO HER, THERE WAS NO RESPONSE AND WAS TURNING PALE. I ADMINISTERED THE EPI-PEN AND WITHIN A FEW SECONDS SHE WAS RESPONDING. THERE WAS A NURSE IN THE STORE WHO BEGAN MONITORING THE PATIENTS HEART RATE AND BLOOD PRESSURE. THE PATIENT WAS TALKING TO US BUT STILL NOT FEELING WELL. A COUPLE MINUTES LATER THE EMS ARRIVED AND TOOK HER TO THE HOSPITAL
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| 40 | 2021-03-24 | panic reaction, sensation of foreign body, sleep disorder |
03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve fo...
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03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid
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| 40 | 2021-03-25 | anxiety |
Patient reports nausea and dizziness following vaccinations. Patient states she was feeling anxious ...
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Patient reports nausea and dizziness following vaccinations. Patient states she was feeling anxious . Took patient vitals to find them stable. Patient states her symptoms had recovered and refused transport to ED.
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| 40 | 2021-03-27 | loss of personal independence in daily activities |
Significant pain in both shoulders and neck. Bilateral shoulder pain has lasted for 3.5 weeks despit...
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Significant pain in both shoulders and neck. Bilateral shoulder pain has lasted for 3.5 weeks despite only receiving vaccine in left arm, both times. Pain feels arthritic in nature and has made it hard to function. After the first shot, I got my period early and after the second shot, I have not had my period/missed a period (I have never missed a period before in my life except when pregnant 6 years ago). Also had left breast swelling that lasted around 1 week after the second shot.
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| 40 | 2021-03-28 | anxiety |
After receiving the vaccination the patient presented about 10 to 15 minutes later with a spotted pu...
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After receiving the vaccination the patient presented about 10 to 15 minutes later with a spotted purple-red rash on the inner aspect of the forearms. This was the only symptom reported at this time. The patient was monitored for about 45 minutes. During this time the patient reported having a racing heart and some mild dizziness. As time passed no worsening of the rash was seen or reported. After sitting calmly for a period anxiety symptoms also subsided. After making sure the patient was able to walk and function normally she was instructed to get immediate medical attention if there was any worsening of symptoms or if there was no improvement.
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| 40 | 2021-03-29 | anxiety | Pt felt anxious. 17:30 took Xanax 10mg, O2 sat 98% RA, BP 128/82, HR 85 |
| 40 | 2021-03-30 | anxiety |
Lightheadedness, palpitations, sweating, Anxious/jittery, headache, Tingling-face. Patient was Tac...
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Lightheadedness, palpitations, sweating, Anxious/jittery, headache, Tingling-face. Patient was Tachycardic after the vaccination. 21540: pulse 139, 15:45: Pulse116, 15:50 Pulse 106, 15:55 pulse 100 O2 sat: 98 Patient placed on recumbent position, water given and was sent home at 1606.
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| 40 | 2021-03-30 | anxiety |
Anaphylaxis 40 y.o. female with multiple environmental allergies, migraines, asthma, mild OSA, and ...
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Anaphylaxis 40 y.o. female with multiple environmental allergies, migraines, asthma, mild OSA, and anxiety presents to the emergency department from the vaccine clinic with syncope and allergic reaction.She says shortly after getting her COVID-19 vaccine, she felt lightheaded, had near syncope. Per bystanders at the clinic, she had a brief episode of unresponsiveness and then spontaneously returned. She was conversant with multiple members of the code and rapid response team at the bedside. Did initially have some labored breathing but significantly improved. She had no vomiting but had mild nausea also significant improvement. In the field, IV was established and 125 mg of Solu-Medrol was administered. She was also given 1 IM dose of epinephrine. Her symptoms resolved she is at her baseline. Medically stable for discharge. Discharge home with short course of steroid, H2 blocker and Benadryl as needed. Advised patient to follow-up with PCP post discharge. Resume other home medicationS as listed. Of note, the patient had a similar reaction with influenza vaccine.
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| 40 | 2021-03-30 | anxiety |
Patient received vaccine and within 5 minutes began feeling itchy all over and reported shortness of...
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Patient received vaccine and within 5 minutes began feeling itchy all over and reported shortness of breath and reported throat was beginning to feel tight. Epi-Pen administered per RN at 1046. BP was 100/62 HR 70 bpm, oxygen saturation 99%. Nasal canula applied at 1048 due to decreasing oxygen saturation. Oxygen saturation promptly returned to 100%. Stat team called and responded, patient taken to ED at 1055 with resolving symptoms, decreased anxiety, and no shortness of breath with an oxygen saturation of 100%.
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| 40 | 2021-03-30 | feeling abnormal |
Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; t...
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Fever for over 3 days, going up to 103F; severe migraines; dizziness; brain fog; loss of appetite; throat ache; ear ache; unable to get out of bed for 3 days; extremely swollen lymph nodes; This is a spontaneous report from a contactable Other Health Professional, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:15 AM as a single dose for covid-19 immunisation. Medical history included allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (IBUPROFEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EJ1686) via an unspecified route of administration, in the left arm on 08Jan2021 at 10:00 AM as a single dose for covid-19 immunisation. On 30Jan2021 at 12:00 PM the patient exepereinced fever for over 3 days, going up to 103F, extremely swollen lymph nodes, severe migraines, dizziness, brain fog, loss of apetite, ear and throat ache, unable to get out of bed for 3 days. No treatment was given to the events. The events were assessed as non-serious by the reporter. Outcome of the events were not recovered.
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| 40 | 2021-03-30 | excessive sleepiness |
Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree feve...
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Nerve pain in all of my skin (including hair follicles and teeth); extreme headache; 101 degree fever; lethargy; shivers; slept for 17 hours on and off; numbness in my face and fingers; numbness in my face and fingers; zinging pain in my teeth; This is a spontaneous report from a contactable Other HCP. This 40-year-old female Other HCP (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9267) via an unspecified route of administration from 11Feb2021 at 03:00 pm to 11Feb2021 at 03:00 pm at single dose (dose number; 2) on left arm for covid-19 immunisation. Vaccine facility type was reported other. Patient was 40 years old and not pregnant at the time of vaccination. Patient's medical history included Known allergies: Sulfa (unspecified dates). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9262) via an unspecified route of administration from 21Jan2021 at 3:30 pm to 21Jan2021 at 03:30 pm on left arm at single dose (dose number; 1) on left arm for covid-19 immunisation. Concomitant medications included (other medications in two weeks) Ibuprofen and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN-C) and birth control from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. If other vaccine in four weeks; no. On 12Feb2021 at 02:00 pm, patient experienced nerve pain in all of her skin (including hair follicles and teeth), extreme headache, 101 degree fever, lethargy, and shivers. This hit her at almost 24 hours after injection. She slept for 17 hours on and off. She awoke this morning with numbness in her face and fingers, but also zinging pain in my teeth. The reported adverse events did not result in emergency room or physician's office visit. Treatment received was reported as no for the adverse events. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of events was recovering.
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| 40 | 2021-03-31 | anxiety |
Anxiety induced reaction to vaccine, felt heart rate / beat higher than normal, white in face, nause...
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Anxiety induced reaction to vaccine, felt heart rate / beat higher than normal, white in face, nausea, vomitting in bathroom, dizzy, requested 911, left with paramedics
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| 40 | 2021-03-31 | anxiety |
Pt. developed severe red rash on face, neck, and chest within five minutes of vaccination noted by t...
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Pt. developed severe red rash on face, neck, and chest within five minutes of vaccination noted by two volunteer doctors on site at clinic. Pt. also c/o anxiety. Doctors on site administered Benadryl 25 mg po @1105. 1110: BP 153/98, Pulse 109, O2 sat 98%. Moved pt. to cot and continued to assess. No hives, itching, or swelling noted. 1120: BP 143/86, P 97. Pt.'s rash, flushing, and anxiety improved. 1130: BP 139/81, P 81. Pt. continued to improved and deny lightheadedness or SOB, left vaccination site @1150.
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| 40 | 2021-03-31 | confusional state | high fever, sweating, aches, extreme confusion, fatigue |
| 40 | 2021-03-31 | impaired work ability |
At 10:30 I started feeling fatigued and over the next hour got the chills. I added layers and turne...
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At 10:30 I started feeling fatigued and over the next hour got the chills. I added layers and turned on a heater, started feeling worse and by 12:15 I had to give up working and spent 5 hours in bed. Low grade fever- 99.4 F. Also nauseous from 12:30 got about an hour. My heart rate was elevated from 10:30 am until 2:30am the next morning (my smart watch showed close to 100 for most of the time period.
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| 40 | 2021-03-31 | restlessness |
Developed fatigue within 5 hours. Developed severe full body aches, chills, night sweats, headache, ...
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Developed fatigue within 5 hours. Developed severe full body aches, chills, night sweats, headache, fatigue, restlessness, and sore muscles 11 hours after injection. As of 31 hours post-vaccination, side effects continue.
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| 40 | 2021-04-01 | emotional distress |
I experienced severe gender dysphoria symptoms starting the morning after the vaccine, including unc...
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I experienced severe gender dysphoria symptoms starting the morning after the vaccine, including uncontrollable sadness, crying and inability to be around others. I have not experienced these at anywhere near that level since June 2020. I could not shake these for several hours even though I am normally able to do so with more mild symptoms after just a few minutes which happen more frequently, multiple times per week. I also experienced headaches and fatigue until the Tuesday following the vaccine (4 days later).
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| 40 | 2021-04-01 | feeling abnormal |
She got her vaccine, and within the first 15 minutes felt like her tongue was fat. The reaction sta...
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She got her vaccine, and within the first 15 minutes felt like her tongue was fat. The reaction started at 1:15 and her headache was getting bad and turning into a migraine, and took her migraine medicine. She was getting a stretching and painful sensation in her skin over her head. She lost her ability to swallow, and everything around her face and neck were numb. She called the hotline and called her doctor, and was able to focus very hard and able to swallow but felt very narrow passageway. She then felt like she had a bubble in her throat, and then decided to call 9-1-1. The first responders came to her house and said that they could not see anything in her throat, they gave her Benadryl and within the hour everything seemed to dissipate and they stayed with her until she stabilized. Her BP was high and her heart rate was high as well, 98-100. Her temperature was 98.5. She felt really awful and nothing was going on with her throat or breathing after the Benadryl and felt foggy and tired and by the third day she was completely fine.
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| 40 | 2021-04-02 | feeling abnormal |
WITHIN FEW MINUTES AFTER THE VACCINE, PATIENT FELT LIKE ELECTRICITY IN VEINS, HEAD FELT HOT LIKE B...
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WITHIN FEW MINUTES AFTER THE VACCINE, PATIENT FELT LIKE ELECTRICITY IN VEINS, HEAD FELT HOT LIKE BOILING, DIZZY, VERY HOT, FEELING LIKE VOMITING.
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| 40 | 2021-04-02 | nightmare |
woke up from nightmares; When I went to bed Tuesday night, my joints started aching; This is a spont...
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woke up from nightmares; When I went to bed Tuesday night, my joints started aching; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9267, Expiry Date: Unknown), via an unspecified route of administration on left arm on 22Feb2021 12:45 PM at single dose for covid-19 immunization. Patient was not pregnant at the time of vaccination. Patient's medical history included asthma, obesity, and allergies to sulfa, penicillin, most trees in Oklahoma. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's concomitant medications included levocetirizine dihydrochloride (XYZAL), methylcellulose (CITRUCEL) caplets (medications the patient received within 2 weeks of vaccination). On 22Feb2021 10:30 PM the patient experienced woke up from nightmares and when I went to bed tuesday night, my joints started aching. Event was reported as follows she got the shot on Monday and felt fine. When she went to bed on Tuesday night, her joints started aching. Several times throughout the night, she woke up from nightmares, but they all seemed to be related to the fact that her joints (it felt like all of them) hurt to move. From what she can tell, she did not move the entire night, yet she was fine by the time her alarm went off. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. Patient reported no for serious, seriousness criteria-results in death, seriousness criteria-Life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-Disabling/incapacitating, seriousness criteria-congenital anomaly/birth defect. Patient did not received any treatment for events. The outcome of events was recovered.
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| 40 | 2021-04-03 | feeling abnormal | low grade fever; brain fog. Took tylenol. Resolved by Sunday morning. |
| 40 | 2021-04-03 | feeling abnormal |
she felt like she had been in a car accident. My entire body was sore; I was very hungry - ate three...
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she felt like she had been in a car accident. My entire body was sore; I was very hungry - ate three breakfasts and a big lunch and was still starving; I had a 101 temp; chills; extreme joint pain; muscle aches; dizziness; exhaustion; she felt off; unusual hair loss; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 17:15 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation, 40 years old at doctor's office/urgent care. Medical history included coeliac disease, sjogren's syndrome, hypersensitivity (known allergies), all from an unknown date, and Covid-19 from Nov2020 (First, I had a mild case of COVID in Nov2020 and recovered fully). No other vaccine in four weeks and not other medications in two weeks. Patient is not pregnant. The patient's concomitant medications were not reported. On 06Mar2021 09:00, the day after first vaccine, patient had a 101 temp, chills, extreme joint pain, muscle aches, dizziness, exhaustion. The following morning on 07Mar2021, she felt like she had been in a car accident. My entire body was sore, she was exhausted, and she was very hungry - ate three breakfasts and a big lunch and was still starving. The following week (Mar2021) she felt off and experienced some unusual hair loss. She does not feel comfortable taking the second shot. Patient was asking some guidance on whether to take the second shot. Treatment was not given for the events. Outcome of the events was recovering.
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| 40 | 2021-04-04 | disturbance in attention, memory impairment |
4am the day after my first shot I woke up to swollen, blood shot eyes which were irritated and itchy...
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4am the day after my first shot I woke up to swollen, blood shot eyes which were irritated and itchy. After an hour and a half the symptoms were not getting better so I decided to take claritin since it was similar to the allergic reaction I have to mold. An hour later my eyes were better but still sore around them. The next day they were completely better. Also, since taking the vaccine I seem to forget things easily, things that I put in the microwave are sitting there the next morning which is very unusual for me to be so forgetful so many times and even at work my focus was scattered and things that were routine were becoming challenging to remember to complete. After 2 weeks it seems to have faded, although once I became aware of what was happening I have made a conscious effort to remember things. I realize that these may seem like small events, but I feel that it is something that should be looked into as it was/is rather concerning since this was only my first shot and the second is supposed to react worse. I am still contemplating whether getting a second shot is wise for me.
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| 40 | 2021-04-04 | feeling abnormal |
Client reported that she felt a "Charlie horse" in the muscle near her wrist on left arm. Client sta...
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Client reported that she felt a "Charlie horse" in the muscle near her wrist on left arm. Client stated she felt "something " run down her arm when she rec'd her vaccine. Vital signs BP= 102/70 HR 81 R: 24: No complaint SOB or difficulty breathing. No visible injury to left arm or rash. Waited 75 6B 15 minute in parking lot.
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| 40 | 2021-04-04 | insomnia |
Injection site pain beginning same day and lasted for about 5 days. Trouble sleeping the same night....
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Injection site pain beginning same day and lasted for about 5 days. Trouble sleeping the same night. Headache, diarrhea, and general not feeling well began the day after and lasted for 2 days.
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| 40 | 2021-04-04 | panic attack |
Pt reported feeling dizziness, nausea and feels like she is having a panic attack. Pt also is diaph...
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Pt reported feeling dizziness, nausea and feels like she is having a panic attack. Pt also is diaphoretic, appears pale and low blood pressure. BP 80/50 pulse 78, Resp. Rate 18, pulse ox 100%
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| 40 | 2021-04-05 | sleep disorder |
Site: Pain at Injection Site-Mild, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area...
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Site: Pain at Injection Site-Mild, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: arms and hands and at bedtime cant sleep due to pain and numbness
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| 40 | 2021-04-06 | loss of personal independence in daily activities |
I woke up with acute vertigo on Thursday. The room was spinning. I could not function from about 8:0...
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I woke up with acute vertigo on Thursday. The room was spinning. I could not function from about 8:00 a.m. until about 6:00 p.m. I went to the doctor the next day, Friday, and was diagnosed with labyrinthitis due to allergies. I had no allergy symptoms. By Saturday, I was no longer dizzy but my ears felt full and continue to feel clogged 6 days after the onset of the vertigo.
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| 40 | 2021-04-09 | anxiety |
1/5/21: coughing, hoarse voice 1/6/21: increased anxiety, nausea, episode of dizziness, coughing, l...
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1/5/21: coughing, hoarse voice 1/6/21: increased anxiety, nausea, episode of dizziness, coughing, later in the day itching . Severe itching in the evening. 1/7/21: Redness on skin / hives, increased anxiety, tightness in throat, coughing - went to ER 1/8/21: Previous symptoms continued, along with tongue swelling. Went back to the ER. 1/9/21 + days symptoms continued.
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| 40 | 2021-04-09 | excessive sleepiness |
slept over 20 hours day 4, plus 12 day 5; Joint and muscle pain; Joint and muscle pain; extreme fati...
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slept over 20 hours day 4, plus 12 day 5; Joint and muscle pain; Joint and muscle pain; extreme fatigue/exhausted; Congested with runny nose; Congested with runny nose; itchy eyes; generally feeling ill; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 40-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: unknown) intramuscular, administered in Arm Left on 29Jan2021 09:45 am (at the age of 40-years-old) at a single dose for covid-19 immunisation. Medical history included sinus tachycardia, panic disorder, depression, chronic fatigue syndrome, PCOS. Allergies to medications, food, or other products was Penicillin. Concomitant medication patient received within 2 weeks of vaccination included Metformin 500mg, Metoprolol 50 mg, Paroxetine 50 mg and vitamin D. The patient previously took first dose of BNT162B2 (lot number: EL0140) on 08Jan2021 on right arm at a single dose for covid-19 immunisation and 2 weeks or so after first shot, noticed severe itching on my left upper thigh with bumps and after this shot, itching has spread to face and arms. The patient experienced joint and muscle pain, extreme fatigue/exhausted on 31Jan2021, slept over 20 hours day 4, plus 12 day 5 on 01Feb2021 and congested with runny nose, itchy eyes, generally feeling ill in 2021. The event was considered as non-serious. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included Oropharyngeal: negative on 01Feb2021. The outcome of all the events was not recovered.
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| 40 | 2021-04-09 | memory impairment, disturbance in attention, confusional state |
Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head ...
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Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head and she had no control over it; Did not remember some of it; Confused; Unable to focus with her eyes; Extreme fatigue; Walking is unsteady; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 59267-1000-03), via an unspecified route of administration, administered in left arm on 24Mar2021 16:45 as single dose for COVID-19 immunization. Medical history included asthma, bronchitis, anxiety, allergy to Aspirin, NSAIDs, agave, soy, and dairy. The patient has no history of COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not COVID tested post vaccination. Concomitant medications included venlafaxine and progesterone taken for an unspecified indication. On 24Mar2021, 19:30, the patient experienced seizure like events. She began sputtering, her shoulder and neck seized up, eyes rolled back in her head and she had no control over it and did not remember some of it. It happened twice in a row. She had been confused, unable to focus with her eyes, extreme fatigue, and her walking was unsteady. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the events. The patient was requested for testing and referral for neurologist for MRI. The patient has not recovered from the events. Follow up attempts are possible. Further information is expected.
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| 40 | 2021-04-10 | feeling abnormal |
Adverse effects were Covid-19 like symptoms that consisted of; foggy brain, extreme thirst, chills, ...
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Adverse effects were Covid-19 like symptoms that consisted of; foggy brain, extreme thirst, chills, shakes, cold, fever, body aches, loss of taste and extreme exhaustion.
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| 40 | 2021-04-10 | sleep disorder |
I had mild upper left back ache for a few days before vaccination. However, I was still able to do m...
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I had mild upper left back ache for a few days before vaccination. However, I was still able to do my physical exercises even with the back ache and could sleep properly. The night after vaccination, I started to feel lethargic and tired and right arm (vaccination site) became heavy and painful which was expected. However, my upper left back pain magnified so much that I woke up at 2 am and could not find a comfortable posture to sleep in. Next morning, I tries hot pack, massage, ointment and lay down the whole day but the pain was there. I took Tylenol before going to bed the next night and woke up again around 2 am due to back pain which was coming in spasms or kind of radiating from neck to upper left back. I used hot pack again this morning. Pain seems mild now but not gone completely. Not sure if vaccine caused it or it was just a coincidence. After vaccination on Friday, I did not work out so don?t know how the back ache flared up. I have not been to a doctor but will go on Monday Apr 12 if it does not get better.
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| 40 | 2021-04-11 | insomnia |
Insomnia. I also had insomnia after my first dose. I felt very sleepy right after I took my first a...
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Insomnia. I also had insomnia after my first dose. I felt very sleepy right after I took my first and second dose for a few hours- and then I had bursts of energy.
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| 40 | 2021-04-11 | nervousness, panic attack |
Approximately 48 hours after receiving Pfizer Covid-19 mRNA vaccine, patient starting immediately th...
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Approximately 48 hours after receiving Pfizer Covid-19 mRNA vaccine, patient starting immediately throwing up with diarrhea and then developed chest pain and breaking out into hives, then her face started swelling on R side, phlegm in her throat, rashes on her feet; had full blown panic attack once she saw the face swelling; was too nervous to use her epinephrine pens. Took Xanax, Zyrtec and Benadryl.
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| 40 | 2021-04-14 | anxiety, panic attack, feeling abnormal, confusional state |
15-20 minutes post injection symptoms included tingling and numbness in the limbs, flushed face, rac...
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15-20 minutes post injection symptoms included tingling and numbness in the limbs, flushed face, racing heartbeat, fogginess, confusion, extreme fatigue, panic/anxiety. Symptoms increased in severity over the course of 9-10 hours and dissipated following sleep. Migraine headache followed at 24 hours post injection.
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| 40 | 2021-04-14 | feeling abnormal, sleep disorder |
Terrible body aches, extremely painful headache, chills, nausea, tiredness. Could not get out of bed...
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Terrible body aches, extremely painful headache, chills, nausea, tiredness. Could not get out of bed for 24 hours. Couldn?t eat more than a bite of a cracker drink fluids. Could not sleep because of headache. Started to feel better after approximately 24 hours, but still weak and tired and not feeling normal for several days after second vaccine.
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| 40 | 2021-04-14 | feeling abnormal |
April 14th Sore throat, dry cough, body aches, headache, foggy head, sinus pressure April 15th All ...
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April 14th Sore throat, dry cough, body aches, headache, foggy head, sinus pressure April 15th All of the above plus a little dizzy
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| 40 | 2021-04-14 | nervousness |
Immediately after vaccine pt began feeling lightheaded, shakey legs, chest tightness and warmth. Den...
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Immediately after vaccine pt began feeling lightheaded, shakey legs, chest tightness and warmth. Denies tunnel vision, hearing changes and shortness of breath. Pt transported to obs at 1743 via wc. Around 1749 pt states she feels cold, lightheaded when sitting up and persistent chest tightness. Pt declines call to EMS and EMS transportation. She does agree to drive herself to urgent care for further evaluation. Pt states she feels safe to drive. Pt released by self at 1803. Vitals as follows: 1744 BP 134/90 HR 64 SPO2 100; 1749 BP 135/78 HR 65 SPO2 100; 1756 BP 155/87 HR 74 SPO2 100
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| 40 | 2021-04-14 | sleep disorder | Increase in symptoms of trigeminal neuralgia--pain/sensations/numbness, increased inability to sleep |
| 40 | 2021-04-15 | disturbance in attention |
Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Tod...
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Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Today Three weeks later I experienced same icy sensation plus numbness/weakness, decreased sensation in fingertips. 2. Still have bad Headaches still after 3 weeks 3. Extreme Fatigue still after 3 weeks 4. Last few days, three weeks after shot, I have worsening/ Increased joint pain, spiky pain in joints, chills and entire body aches like I have the flu. No fever, no runny nose, etc. Just the body aches, joint pain like people experience with the flu. 5. Decreased mental sharpest last 2 weeks since shot. 6. Light headedness, dizziness. 7. Immediately after shot I experienced metal taste in my mouth. Since the shot, I still experience occurrences of metal taste every day. 8. Today experiencing slight numbness in right foot. 9. Swelling in fingers
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| 40 | 2021-04-15 | feeling abnormal |
I had flu like symptoms the first 48 hours with fogginess, tiredness, and achiness. The these sympto...
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I had flu like symptoms the first 48 hours with fogginess, tiredness, and achiness. The these symptoms seemed to get better after eating meals then got worse again off and on over the first 48 hours. When I woke up the day after the 2nd vaccine my left leg felt like it was going to give out walking on it almost like the feeling when you are pregnant and the muscles relax. This did not happen with the first dose. It lasted most of the day and part of the next eventually resolving with the right leg not showing that symptom at all. About 48 hours after the dose I experienced very painful lymph nodes. I'm breastfeeding and called my OB and described what felt like mastitis without red streaks or fever. My armpit, arm, and wrist ached. I have only experienced the wrist ache once with mastitis about 9 years ago. I'm currently taking sunflower lethicin and benadryl. Today is April 16th and I still have swollen lymph nodes and a sore arm and wrist.
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| 40 | 2021-04-16 | insomnia |
Asymptomatic until bedtime, 101.9 fever for 6 hours and currently 100.3, but it's fluctuating. Sever...
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Asymptomatic until bedtime, 101.9 fever for 6 hours and currently 100.3, but it's fluctuating. Severe shaking chills, and throbbing bone and joint pain. My perineum also oddly feels as though I've been kicked rather hard. Sleepless night until chills subsided. Then experienced mild nausea, and pain in both palms while hand washing. No congestion, but dry inflamed sinuses and eye pain. I developed a headache this morning, but only while standing.
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| 40 | 2021-04-16 | insomnia |
Started with chills and body aches on the 4th day. Pain level increased by midnight, unable to sleep...
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Started with chills and body aches on the 4th day. Pain level increased by midnight, unable to sleep. Took Ibuprofen. By the 5/6th day, severe pain, fatigue, no appetite, little nausea, and occasional low degree fever (99-101F) Alternated Ibuprofen and Acetaminophen every 5 hours. 8th day around 9pm, left arm went numb and tingling at the fingertips. 9th day, appetite is back and feels back to self.
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| 40 | 2021-04-16 | sensation of foreign body |
Within 4 minutes of getting her second dose she complained of tingling from head to toe, feeling as ...
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Within 4 minutes of getting her second dose she complained of tingling from head to toe, feeling as if something was caught in her throat, chills and shaking
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| 40 | 2021-04-17 | anxiety |
10 MINS AFTER VACCINE, FELT ITCHY THROAT AND TOP OF MOUTH. WATER GIVEN IN OBS, IMPROVED AFTER A FEW ...
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10 MINS AFTER VACCINE, FELT ITCHY THROAT AND TOP OF MOUTH. WATER GIVEN IN OBS, IMPROVED AFTER A FEW MINUTES, STATES JUST FEELS LIKE MILD ALLERGY TICKLE/IRRITATION IS ALL THAT REMAINS. INSTRUCTED ON BENADRYL IF NEEDED AT HOME AND TO MONITOR AND SEEK FURTHER EVAL IF WORSENS. ESCORTED TO EXIT TO MEET SPOUSE WITHOUT ISSUES AT 1545. 1530 INITIAL BP 172/97 HR 98 RR 20 SATS 98% ON RA (REPORTS SITUATIONAL ANXIETY) 1540 BP 131/88 HR 73 RR 18 SATS 100% ON RA
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| 40 | 2021-04-17 | confusional state, amnesia |
Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down d...
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Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.
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| 40 | 2021-04-17 | feeling abnormal |
At approximately 6pm on 4/16/21, I began feeling as if I were in a fog (second dose of COVID-19 vacc...
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At approximately 6pm on 4/16/21, I began feeling as if I were in a fog (second dose of COVID-19 vaccine received at 10:30am previous day). I began to feel weak and tired; all I wanted to do was lay down. I laid in bed and took my temperature via ear. 100.8 in the right ear and a reading of 101.2 in the left ear (I've not had a fever since maybe 12 years of age). I was also experiencing a headache (back of head) and neck discomfort. I felt hot, specifically ears and face. I took 400mg of ibuprofen at approximately 7pm and 1000mg of acetaminophen at approximately 10pm. by 10:30 my temp was 98.9. I woke up at 1:30am on 4/17/21 and was completely drenched I sweat. I assumed this was from the fever break but I woke up again at approximately 4am drenched again. After waking and getting up around 8am on 4/17/21, I felt great; back to normal. I went about my day. I woke again around 1:30am on 4/18/21 with a sore neck and the back, lower area of the head hurting (this wasn't the same feeling as having a stiff neck or laying in an awkward position). When I sat up, I felt some sore, throbbing on the top of my head which then subsided. I woke again at 4:30am with the same issue. I was also, again, completely drenched in sweat but no fever this time that I am aware of. My pajamas were soaked. I felt some relief with the head and neck discomfort when I got up at 6;30am. As I type this now, my head and neck feel basically normal. I also wish to report that in addition to injection site soreness which I think is always to be expected, I have been experiencing quite a bit of soreness and discomfort under my left arm. It runs down my left side from my arm pit to the side of my left breast. This area has been sore and tender since the evening of the day I received the shot (4/15/21). I'm assuming this could be due to stolen lymph nodes which I was told by a health care professional, could be a side effect of the vaccine.
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| 40 | 2021-04-17 | hallucination |
hallucinations; strong flu symptoms; This is a spontaneous report received from a contactable other ...
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hallucinations; strong flu symptoms; This is a spontaneous report received from a contactable other HCP (patient). A 40-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), second dose via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:00 (at the age of 40 years old, not pregnant), single dose for covid-19 immunisation. Medical history included chronic migraines secondary to an old neck injury. The patient previously took tetracycline, minocycline, experienced allergies. The patient had her first dose of bnt162b2 (lot_number=EM9809)for covid-19 immunisation on 13Feb2021 11:00, left arm. On 07Mar2021 0100, patient woke up at 1 am with strong flu symptoms and hallucinations. She saw a gigantic bunny standing next to her, and three clowns who were talking to her. The clowns and bunny were not concerning to her, but very real, and she vividly remembers having a conversation with them for hours. Later, she found it funny, but they were just so real. Again, it wasn't a problem since she was lying in bed anyway, so was interesting and so real. The bunny and clown stayed with her until 5am when she fell back asleep and were gone when she awoke at 9am. The outcome of the events was recovered on 07Mar2021 0900. No treatment received for the events.; Sender's Comments: Information provided was so limited to prevent a meaningful medical assessment. Other than a temporal association, there was no evidence or argument to suggest a causal relationship for BNT162B2 in development of serious Hallucination and non-serious Influenza. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-04-17 | irritability |
Extreme head ache, irritability, dry mouth, numbness and tingling of my left arm, my tongue feels ti...
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Extreme head ache, irritability, dry mouth, numbness and tingling of my left arm, my tongue feels tingly. I feel like I drank about ten red bulls my heart feels like its racing!
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| 40 | 2021-04-18 | amnesia | Suffering from short term memory loss. It has not yet resolved. |
| 40 | 2021-04-18 | confusional state |
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Exhaustion / ...
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Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Severe
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| 40 | 2021-04-18 | loss of personal independence in daily activities |
Second dose at 9am 4-15-2021 9am- vaccine administered at 9:10 916- heaviness in head 11am- fatigue ...
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Second dose at 9am 4-15-2021 9am- vaccine administered at 9:10 916- heaviness in head 11am- fatigue low level 2pm- heavy fatigue. Soreness arm. 4pm- nausea and headache 5:30pm- vomiting 745pm- vomiting and headache severe. Chills started 815pm- vomiting 930pm- vomiting 1005pm- vomiting. No chills. Friday April 16, 2021 1:30am- chills back no fever 4am- no chills 5:30am- chills no fever 7am- woke slight headache and mild body aches. Low energy 12noon- aches worsen 4pm- headache and aches more significant. Heavy fatigue. Chills on and off Saturday April 17, 2021 1am- woke up same symptoms since 4pm. Headache throbbing. Slept until 11am which is very unusual Noon- headache mild. Body aches/pain significant continue. Fatigued. 6pm- woke up after sleeping since 130pm. Headache mild and significant aches/pain continue. 10pm- no headache. Body aches/pain significant. Took a bath to relive aches which helped some. Sunday April 18, 2021 12am- body aches significant return 9am- woke up with significant aches/pain still Tried to move around & cook breakfast. 11:00am- aches/pain worse after moving & cooking. Rested and slept until 3:30pm 4:00pm- pain significant. Took hot bath helped some. Tried stretching. Pushed fluids. 11:00pm-8:00am slept. Monday April 19, 2021 2:00am- woke in a sweat which is unusual 8:00am woke sweaty which is unusual and no muscle pain. More mild muscle aches. Most significant and distressing reaction was the vomiting due to intensity, duration and frequency
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| 40 | 2021-04-18 | loss of personal independence in daily activities |
Approximately 3 to 4 minutes after receiving my first vaccine, I had a hot feeling travel from my to...
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Approximately 3 to 4 minutes after receiving my first vaccine, I had a hot feeling travel from my toes up to my head. I then became dizzy and felt very faint. The tip of my tongue also became numb. I was too embarrassed to alert the hospital worker. The sensation lasted about a minute. However, the last 2 1/2 days I have been having a fast heart rate after doing minimal activities. I feel very winded by the slightest task. I did go to a clinic today to get my vitals checked. They were fine- but I still continue to feel like my heart rate spikes when I do something as minimal as emptying the dishwasher. It?s very scary and uncomfortable and makes me fearful of taking the second shot.
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| 40 | 2021-04-19 | nervousness, excessive sleepiness, sleep disorder |
Twelve hours after vaccine, woke at 2 am due to violent vomiting. Vomiting was nonstop and could not...
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Twelve hours after vaccine, woke at 2 am due to violent vomiting. Vomiting was nonstop and could not even keep a sip of water down. Began vomiting large amounts of bile. The vomiting did not stop until 11am after I took one dose of Zolfran. Following that, I slept all rest of that day (4/17) into next day. That next day, felt very shaky/dizzy with chills. Ate for first time since vomiting episode (toast and scrambled egg) and proceeded to have diarrhea for rest day. The GI symptoms finally subsided on 4/19 but still tired and somewhat shaky.
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| 40 | 2021-04-21 | sleep disorder, feeling abnormal, loss of personal independence in daily activities, impaired work ability |
-LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF REC...
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-LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF RECEIVING VACCINE - LASTED FOR 6 DAYS -UNABLE TO MOVE LEFT ARM, RAISE IT, OR LIFT ANYTHING FOR THE PAST 18 DAYS -UNABLE TO GRASP OBJECTS WITH LEFT ARM FOR THE PAST 18 DAYS -UNABLE TO SLEEP ON LEFT SIDE - CAUSES EXTREME PAIN -TINGLING AND NERVE SHOOTING PAIN ON LEFT ARM FROM FINGERS TO NECK, FRONT AND BACK CHEST LEFT SIDE -MUSCULAR NODULE DEVELOPED ON LEFT SHOULDER UP TO MY KNECK - CAUSING SEVERE EAR PAIN -EXTREME FATIGUE - LETHARGIC FOR THE PAST 18 DAYS -SEVERE JOINT/PAINT THROUGH OUT ENTIRE BODY -LOST OF TASTE -NIGHTSWEATS FOR PAST 18 DAYS -FEVERS RANGING BETWEEN 99.0 - 103 F FOR PAST 18 DAYS -NAUSE FOR PAST 18 DAYS -LOST OF APPETITE -DIARRHEA AND LOOSE STOOLS FOR THE PAST 8 DAYS (NO BLOOD) -BRAIN FEELS FOGGY ALL THE TIME - FEELING AS IN A DAZE FOR PAST 18 DAYS -SHORTNESS OF BREATH - JUST FROM WALKING OR MOVING AROUND -SKIN IS SUPER SENSITIVE AND ITCHY -UNABLE TO DRIVE BECAUSE OF THE FATIGUE AND UNABLE TO USE LEFT ARM. -UNABLE TO WORK - RELYING ON OTHERS TO TAKE CARE OF ME.
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| 40 | 2021-04-22 | confusional state |
Headache, confusion, muscle and joint pain, inflammation, fatigue, etc etc. Including LUPUS FLARE- ...
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Headache, confusion, muscle and joint pain, inflammation, fatigue, etc etc. Including LUPUS FLARE- aggravated Systemic Lupus- which still continues 2 months later.. Also, developed DVT?s in both arms- previously dx.ed with APS- Antiphospholipid Syndrome and was already on anticoagulant therapy. Possible clot in/near artificial heart valve- further testing being done next week. After 2nd dose Also increase in Lupus Flare, as well as severe Fibromyalgia Flare- aggravated FMS. Extreme muscular pain/neurological pain, confusion, fatigue, etc etc.
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| 40 | 2021-04-22 | disorientation |
RN called to vaccine room to assess patient who reports feeling dizzy, and severe HA immediately aft...
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RN called to vaccine room to assess patient who reports feeling dizzy, and severe HA immediately after pfizer injection @15:25pm. Patient escorted to medical bay area to further assess. Patient reports feeling "dizzy with 9/10 headache". Denies worst HA of life. When RN asked patient her name and where she was, patient had trouble responding and appeared to be disoriented staring off and not responding to questions. PA arrived on scene to bedside and performed neurological assessment. Pt slow to respond however A and O x 4, pt reports baseline weakness to RUQ/RLE. PA and RN recommended patient go to the emergency room due to medical history and patient's presentation. Patient started crying hysterically and refused 911 call. Spouse of patient called to bedside to gather more information.Husband confirmed hx of MS and baseline right sided weakness of RUE/RLE. No previous history of epi use with allergic reaction Pt intermittently slow to respond to questions. Then at 16;02 pt reported moderate throat Itchiness. 25 mg IM benadryl given to patient. Pt reported improvement of itchiness. RN and PA again strongly recommended ER transport to higher level of care. Both agreed, and 911 called at 1614. At this time, patient is AAOx3, but is slow to answer questions. Will continue to monitor. EMS arrived on scene @ 1635. Transported to ER at 1645 to Hospital.
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| 40 | 2021-04-22 | feeling abnormal |
Immediate temperature fluctuation, fogginess, it lifted fast and was able to drive home. About 30 mi...
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Immediate temperature fluctuation, fogginess, it lifted fast and was able to drive home. About 30 minutes after I was home hives on my scalp, they disappeared in about an hour. 6 hours after the vaccine my hands broke out, and then I checked the rest of me, my chest was sunburn red, which is usually my first symptom when I?m having a reaction. I took an antihistamine and it all calmed down. No hives today, but I?m itchy. Pretty wicked headache. The antihistamine is almost out of my system.
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| 40 | 2021-04-22 | sleep disorder |
I have Had A MIGRAINE Along with HIGH BLOOD PRESSURE... It started 2 weeks after my 2nd Pfizer Shot....
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I have Had A MIGRAINE Along with HIGH BLOOD PRESSURE... It started 2 weeks after my 2nd Pfizer Shot... I was admitted into the hospital because after A Cat Scan, MRI, And A Spinal Tap looking for Menengitis They Couldn't Find ANYTHING WRONG... I was in the Hospital for 8 days... They where unsure WHAT WAS WRONG SO THEY TREATED ME WITH MANY DIFFERENT MEDICATIONS INCLUDING HEPRINE FOR BLOOD CLOTS... AS OF TODAY 4/23/2021.. I CONTINUE TO EXPERIENCE THESE UNBEARABLE HEADACHES... HAVEN'T SLEPT IN A MONTH.. AND I CONTINUE TO HAVE SUPER HIGH BLOOD PRESSURE... IF THIS CONTINUES I AM NOT SURE HOW I WOULD LIVE... THE PAIN IS HORRIBLE... SO SO BAD
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| 40 | 2021-04-23 | depression |
About 24 hours after vaccination, I began feeling very fatigued and over time began having severe up...
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About 24 hours after vaccination, I began feeling very fatigued and over time began having severe upper back muscle aching and pain. The next day the pain was gone but felt an overwhelming feeling of severe depression, hopelessness, thoughts of not wanting to live and crying that lasted 48 hours. It resolved on its own but was terrifying and was something I have never felt before.
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| 40 | 2021-04-24 | impaired work ability, excessive sleepiness |
Dizziness occurred within the first hour after injection and lasted about 2-3 hours. About 7 hours a...
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Dizziness occurred within the first hour after injection and lasted about 2-3 hours. About 7 hours after injection, I developed a headache. Overnight, I had a hot flash. When I woke up the following morning, about 19 hours after injection, I had a fever. I went to work and developed chills and sweats (about 21-22 hours after injection) that lasted for at least 5 hours. I also had nausea at that time. I did take 1,000 mg of acetaminophen after checking my temperature that morning and again in the afternoon. I went home early from work, around 3 pm (about 30-31 hours after injection) and went to bed. I slept for 13 hours and when I awoke the following morning, I had a minor headache and some malaise, but it was much improved. I took 1,000 mg of Tylenol and felt better in the afternoon (about 53 hours after injection).
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| 40 | 2021-04-26 | anxiety |
Generalized itching w/o hives, HX of asthma. Feels seasonal allergies are getting worse. No airway e...
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Generalized itching w/o hives, HX of asthma. Feels seasonal allergies are getting worse. No airway edema. Given 25mg PO Benadryl. Pt states she usually takes 50 -75mg at home and request that but is driving home, denied by medical team. Feels symptoms have resolved @1140. Reports "tingling" all over body from anxiety.
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| 40 | 2021-04-26 | anxiety |
I took a Benadryl one hour after my shot - because I felt my throat was getting a little itchy. And ...
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I took a Benadryl one hour after my shot - because I felt my throat was getting a little itchy. And I do get anxiety. The first side affect - my arm got super sore. That lasted 24 hours. The second day, about 26 hours later (from vaccine) - I got a mild backache. Mild headache, too, which I actually got 7 days after the vaccine. Five days after the vaccine, GI upset - diarrhea - it lasted five days. I talked to my doctor about it - my doctor told me to stay hydrated.
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| 40 | 2021-04-26 | feeling abnormal, anxiety |
weird feeling, itchy all over mostly arms. increased phelgm with throat / tongue/ swelling; anxiou...
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weird feeling, itchy all over mostly arms. increased phelgm with throat / tongue/ swelling; anxious.
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| 40 | 2021-04-26 | feeling abnormal |
Received the vaccine at 9:30 am. Originally felt fine with mild soreness in the arm. Woke up around...
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Received the vaccine at 9:30 am. Originally felt fine with mild soreness in the arm. Woke up around 2:15 am to use the restroom, and got extremely dizzy... started to feel weird, and felt like there was a rush all over. My head started to feel like it was closing in and there was a static, crackling, speaker-like sound along with tinnitus in my ears making it feel like I was in a tunnel. I sat on the floor and waited several minutes until the feeling passed and was able to get back into bed. I waited several more minutes until I felt "normal" again. Was able to get back to sleep, and feel better this morning, with no dizziness, but will continue to monitor any additional symptoms closely.
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| 40 | 2021-04-26 | feeling drunk |
Wed, April 14: headache, light headed, feeling of going to pass out, blurred vision, very tired, we...
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Wed, April 14: headache, light headed, feeling of going to pass out, blurred vision, very tired, weak, diarrhea. Thur April 15 ? very light headed, feeling of going to pass out, numb pinky, very weak, very shaky, very tired. Went to ER after almost passing out they gave me fluids, did a chest xray and ekg, covid test, pregnancy test. They sent me home saying I was dehydrated. ? slept for 4 hours after ER, felt tired, hard to focus, diarrhea then that night slept all night. Fri April 16 ? a bit better in morning but vision still not right, at dinner table felt drunk (did not have any alcohol), very tired, face felt flushed (no fever), hard to focus, headache came on before bed (took 2 Aleve) Sat April 17 ? tired, went to doctor for additional blood work, slept after appointment, face flush (no fever), vision still not right. Doctor said this is likely vaccine related. Sun April 18 ? felt same as Saturday Mon April 19 ? very tired, vision still not right, hard to focus at work, want to sleep, face felt hot and tingly (no fever) Tue April 20 ? allergy type symptoms in morning. Sneezing, runny nose, slight headache. These symptoms went away. From April 21-28 - other symptoms mostly going away except vision issues. April 28th most symptoms went away but vision is still blurry, see floaters, feels like I have Vaseline over my eyes. Going to see an eye doctor ASAP.
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| 40 | 2021-04-26 | sleep disorder |
Symptoms began approximately 11 hours post vaccine and occurred in the following order: -slightly ac...
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Symptoms began approximately 11 hours post vaccine and occurred in the following order: -slightly achy -fatigued -chills -uncontrollable teeth chattering -fever up to 102.8 -significant nausea -diarrhea -inability to sleep -headache Symptoms resolved completely within 24 hours. Symptoms were very pronounced. I haven?t felt that sick in years.
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| 40 | 2021-04-27 | abnormal dreams |
Body aches, slight fever of 99.4 degrees F, fatigue for 24 hours. Vivid dreams for 2 weeks. Soreness...
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Body aches, slight fever of 99.4 degrees F, fatigue for 24 hours. Vivid dreams for 2 weeks. Soreness in arm that received vaccine for 4 days.
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| 40 | 2021-04-28 | disturbance in attention |
Moderate itchiness of the entire arm that received the injection. Itchiness is very distracting and...
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Moderate itchiness of the entire arm that received the injection. Itchiness is very distracting and is preventing me from being able to concentrate on my work. All I can do is scratch. Minor itchiness of lower left leg and left side of face. All the itchiness is on the left side of the body. No visible rash. Injection site is not swollen. No other symptoms. It's been four hours since the injection.
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| 40 | 2021-04-29 | insomnia |
Fever of 102°, extreme muscle pain, chills while burning up, nausea and insomnia even though I have...
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Fever of 102°, extreme muscle pain, chills while burning up, nausea and insomnia even though I have been very fatigued.
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| 40 | 2021-05-06 | impaired work ability |
4/8 negative rapid covid screen for work. 4/9 845 received shot, 1200pm begain with moderate dry ha...
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4/8 negative rapid covid screen for work. 4/9 845 received shot, 1200pm begain with moderate dry hacking cough, injection site pain, muscle aches. 4/10 symptoms more severe. 4/11 rapid covid test negative, worked as a hospice nurse. 4/12 coughing more severe, telehealth visit with PCP, nebulizer treatments xopenex and budesonide ordered. 4/13 symptoms unchanged. 4/14 attempted to go back to work rapid covid test positive. PCR nasal swab performed at pharmacy. 4/17 results from PCR come back positive for Covid 19. 4/18 hospitalized with COVID pneumonia. Discharged from Hospital 4/25
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| 40 | 2021-05-09 | anxiety, panic attack |
Severe flu like symptoms. Body hurts to even touch from head to toes, uncontrollable shaking/shiveri...
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Severe flu like symptoms. Body hurts to even touch from head to toes, uncontrollable shaking/shivering, freezing hold or suffocating hot, eyeballs keep loosing focus, feeling like I'm having a anxiety or panic attack, short of breath. First day I felt fine, next day I woke up feeling like I was hit by a car and second day after I'm feeling all the symptoms listed above on a scale of 1-10 I'm at a 10 for discomfort
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| 40 | 2021-05-13 | anxiety |
anxiety; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 va...
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anxiety; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine; mental problem; so sick; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. Medical history included bipolar from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Mar2021, the patient experienced sleepiness. On an unspecified date, the patient experienced anxiety, they felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine, mental problem, so sick. She had really serious problem, had to leave work and go to the hospital and get treated for anxiety in the emergency room. Causing her anxiety to go crazy. After taking the Vistaril yesterday it calmed the girlfriend down. Outcome of events anxiety, felt soreness in the arm, mental problem, so sick was unknown. Outcome of Sleepiness was recovered in 2021. No follow-up attempts are needed. No further information is expected.
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| 40 | 2021-05-14 | feeling abnormal |
difficulty walking; difficulty with speech / slurred speech; fingers are going numb holding the phon...
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difficulty walking; difficulty with speech / slurred speech; fingers are going numb holding the phone; feels like she is coming down with a respiratory illness; nausea; vomiting; cough; sweating; headache; body pain, achy and uncomfortable; body pain, achy and uncomfortable; overall feeling badly; cognition was not there; Problems with breathing; aspirating; sleepiness; fatigue; stomach pain; her nerve response is strong/affected; swelling in hands and feet; had arm soreness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0162), via an unspecified route of administration in the left arm, on 23Apr2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing neuropathy (few years ago, at least since 2015 or 2016), seizures or epilepsy (had focal/absence seizures since a kid; not on any seizure medication, do have a neurologist), hard time with her vision, cancer from an unspecified date to an unspecified date (cancer as a teenager but has been cancer-free for a very long time), and glaucoma. The patient had a family history of cancer and heart problem. Concomitant medications included latanoprost (MANUFACTURER UNKNOWN) taken for glaucoma from Apr2021 and ongoing and gabapentin (MANUFACTURER UNKNOWN) taken for neuropathy from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER8730), intramuscularly in the left arm, on 02Apr2021 for COVID-19 immunisation and experienced not very many side effects with first dose, not enough to be a problem; influenza vaccine (MANUFACTURER UNKNOWN) in 2021 (maybe) for immunisation; and polio vaccine (MANUFACTURER UNKNOWN) as a child for immunisation and experienced severe pain in her legs and she had trouble walking because of pain. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced difficulty walking and difficulty with speech / slurred speech on 23Apr2021, which required hospitalization from Apr2021 to 26Apr2021. The patient also experienced body pain, achy and uncomfortable, overall feeling badly, cognition was not there, and problems with breathing on 23Apr2021; sweating and headache on 26Apr2021; vomiting and cough on 27Apr2021; feels like she is coming down with a respiratory illness and nausea on 28Apr2021; sleepiness, fatigue, stomach pain, her nerve response is strong/affected, swelling in hands and feet, aspirating, and had arm soreness in Apr2021; and fingers are going numb holding the phone on 29Apr2021. The clinical course was reported as follows: The patient stated that she works in healthcare support and she is a first responder; she identifies as a person with a disability (unspecified). She stated that she did not have very many side effects with first dose, not enough to be a problem. By dinnertime, closer to 18:00-19:00 on 23Apr2021, she started experiencing difficulty walking and with her speech. She was concerned about having a stroke but that she is active and generally healthy. This was unusual for her and she started feeling pain through her body and overall feeling like crap. She did not expect the neurological stuff. By the end of the night on 23Apr2021, she realized she was not feeling good and went to the hospital either that night on 23Apr2021 or early the next day on 24Apr2021 and was admitted to the hospital. The patient stated that her cognition was not there, and her speech was kind of slurry, she felt like everything was slowing, and did not feel like herself. She could not get up unassisted, could not get up out of the bed, chair, or go to bathroom, and still requires the use of a walker and bedside commode, but now with the walker and assistance caller can make it to the bathroom. She also had problems with breathing, but she had a negative COVID-19 PCR test in Apr2021 both arriving to and leaving from the hospital; she did not believe them to be COVID-19 symptoms. At the hospital they did an x-ray or computerized tomography (CT) scan and a magnetic resonance imaging (MRI) on her brain in Apr2021 with unknown results. They gave her 3 or 4 intravenous (IV) unspecified medications and she had her complete blood count (CBC) labs done in Apr2021 with unknown results. There was an issue with her lungs, and she is currently waiting for her doctor to read report to see if there is an issue there. The patient stated that she never experienced anything like this after a vaccine. She cannot even get up and move around it is pretty serious. Caller states that at first when she had the symptoms, she thought she was going to wait it out, maybe her immune system is overresponding, give it a chance to resolve. She reported that she could not stand up, legs were shaking and that she had pain that was from her breasts down; felt like a ton of bricks. The patient stated that she is cognitively alert now, speaking normal. There are times it goes in waves where she feels like she can walk with walker but then a few hours later that is not the case. On Tuesday, 27Apr2021 night, the patient had a light dinner but then she was vomiting. Caller states that the pain was throughout her body and felt like someone lighting firecrackers. The patient initially stated 28Apr2021 was when the cough started, but later clarified she first noticed it on 27Apr2021, but at that time she was vomiting and thought it was due to that. However, the next day 28Apr2021, she still had this cough and that the cough was getting worse. She felt like she has a respiratory issue and has been coughing. She was not able to stay awake, even without taking any medications. She does take medications regularly but did not take the medications those days and not having medications would not cause sleepiness. She thought the doctor gave her sedative, but they did not. She states she had fatigue to the point where she was dead asleep, and nurse would come in to take vitals or do whatever and she would wake up suddenly with someone in front of her. She was sitting up with the nurse trying to read the discharge instructions and she fell asleep sitting up. She also complained of stomach pain. The patient had not been to work and not been having to use her brain and talking like she would for 8+ hours a day. She stated that the cough hurts, it feels like somebody is lighting firecrackers in her body. It also feels like this when she sneezes; the nerve response is strong. She reported that it is not a constant hacking cough, not really a dry cough; the cough is in-between productive and dry cough and cough is a bit better now and worse towards the evening. She still has swelling in her feet and hands. It looks like it has gone down a bit. She has a history of neuropathy and that her fingers are going numb holding the phone now. She got the shot in her left arm and those fingers are going numb. She was so tired and feels like did not get enough sleep. The fatigue had a slight improvement. She is more awake than when she was in the hospital. However, it depends as the day goes on, she is wiped out and has to go lay down. She stated that her nerve response is affected, and she had a difficult time with the neuro exam in Apr2021 with unknown results in the hospital. She was having an issue with her arms. She can't say anything about whether it affected her vision because she already has a hard time with her vision. She stated that she was throwing up pretty bad; the pain was really severe through her whole body while vomiting. After the vomiting stopped, the coughing got worse and she was coughing a little bit before the vomiting, but during the vomiting it was to the point she felt like she was drowning. She reported that she was vomiting through her nose and aspirating. After her MRI she started to get a really bad headache. Then when the nurse was coming to read the discharge information, she started to get sweats. She is not menopausal so she cannot blame the sweating on menopause, as reported. The patient also had arm soreness, but does not care about that long as it does not leave any scars. This was not a big deal for her at all. This started shortly after getting the vaccine. She waited for the observation time and no sensation out of the normal, then later towards the night started feeling like having really bad mensural cramps, like an achy feeling where have to go lie down. Then her lower half started to get worse. Her arms were affected and difficult time with the neuro testing. The patient stated she is now on the road to recovery. The clinical outcome of difficulty walking, difficulty with speech / slurred speech, body pain, achy and uncomfortable, nausea, sleepiness, fatigue, and stomach pain was recovering and of overall feeling badly, cognition was not there, problems with breathing, sweating, headache, vomiting, cough, feels like she is coming down with a respiratory illness, her nerve response is strong/affected, swelling in hands and feet, aspirating, had arm soreness, and fingers are going numb holding the phone was unknown.
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| 40 | 2021-05-21 | excessive sleepiness |
broke out in canker sores all over mouth again; Slept 17 hours q day; severe fatigue; Sinus and ear ...
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broke out in canker sores all over mouth again; Slept 17 hours q day; severe fatigue; Sinus and ear pressure; Sinus and ear pressure; Generalized aching; break out in canker sores all over my mouth; sore muscles all over; joint pain; mild itching to upper torso, breasts and under arms; low grade fever; chills; face became pink and warm; felt burning sensation throughout my body; This is a spontaneous report from a contactable nurse (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid left on 03Feb2021 12:00 (Batch/Lot number was not reported) as 1st dose, single at age of 40-years-old for covid-19 immunization. Medical history included Asthma, 3 herniated discs in neck, hx of pneumonia, hypertension (HTN). Known allergies included: Ceclor, PCN, Doxycycline, Bactrim DS, Codiene, berries and anaphylaxis to Latex. Concomitant medications the patient received within 2 weeks of vaccination included: lisinopril; hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event started on 03Feb2021 14:00 PM, within first 24 hours the patient experienced mild itching to upper torso, breasts and under arms, also had low grade fever and chills in this time. Within first 24 hours, face became pink and warm, and felt burning sensation throughout her body. At this point the patient took Pepcid and Benedryl and it seemed to control symptoms. On 09Feb2021, the patient begun to break out in canker sores all over her mouth, total of 5 (the patient did not have a canker sore since high school), began to develop sore muscles all over and joint pain that progressed to severe by 12Feb2021. Worse in mornings. Got a flu and covid test (Nasal Swab). They were negative. 17Feb-20Feb2021 severe fatigue and cont. Joint pain. Slept 17 hours q day. Sinus and ear pressure. Generalized aching. The patient did not get 2nd vaccine. 01Mar2021 broke out in canker sores all over mouth again. Took 4 days to resolve. The patient was still having significant joint pain throughout her body, worse in mornings. The patient never had this before vaccine. Events resulted in disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event canker sores was recovered, of other events was not recovered. Follow up needed, further information has been requested.; Sender's Comments: "Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded" The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-05-24 | irritability, emotional distress |
Menstrual period delayed by 8 days. Heavy PMS symptoms including breast tenderness, irritability, he...
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Menstrual period delayed by 8 days. Heavy PMS symptoms including breast tenderness, irritability, headache, cramping and bloating lasting for 10 days accompanied by a heavier than usual menstrual period but lasting a shorter amount of time than typically experienced previously (typical period is about 5-6 days long, this period was only 4 days in duration). Worth noting the reason I was hyper aware that my period was late is 1) it has never been late in my entire life and I am 41 years old. 2) I use an app to track my cycle and it kept alerting me that it was late. I am on birth control and knew that I was not pregnant, however, it caused distress because I didn't know what was wrong with me and no one wants to have severe PMS for 10 days with no relief in sight.
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| 40 | 2021-05-24 | memory impairment, feeling abnormal, disturbance in attention |
Severe chills; Joint pain; Severe Headache; Stomach Ache; Cold feet/ Cold hands; Forgetfulness; Mumb...
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Severe chills; Joint pain; Severe Headache; Stomach Ache; Cold feet/ Cold hands; Forgetfulness; Mumbled speech; Numbness; Tingling all over; Difficulty focusing; Body Aches; Fatigue, Tiredness; Foggy head; This is a spontaneous report from a contactable other hcp (Nurse). A 40-years-old female non pregnant patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number was EL0142), intramuscular, administered in Arm Left on 28Jan2021 at 08:00 as 2nd dose, single for COVID-19 immunization. Historical vaccine of bnt162b2 as first dose (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm right on 08Jan2021 at 03:00 PM (Batch/Lot Number was EL0140) as first dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No allergies were found. Patient was not pregnant at the time of vaccination. Patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 28Jan2021 at 17:00 patient experienced severe chills, joint pain, severe headache, stomachache, cold feet/ cold hands, forgetfulness, mumbled speech, numbness, tingling all over of, difficulty focusing, body aches, fatigue, tiredness and foggy head. No treatment was received. The outcome of the events was recovering. Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
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| 40 | 2021-05-25 | feeling abnormal |
TINNITUS bilateral, loud, persistent Joint soreness Foggy thinking Pain at injection site Headache W...
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TINNITUS bilateral, loud, persistent Joint soreness Foggy thinking Pain at injection site Headache Weird twinges all over body randomly
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| 40 | 2021-05-26 | confusional state |
After receiving vaccination, patient was reported to have fainted, with a potential seizure, and fal...
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After receiving vaccination, patient was reported to have fainted, with a potential seizure, and fallen over resulting in injury to head and laceration to forehead. Pharmacist was notified in which patient was immediately placed in laying position with elevation to her head and support to neck. Patient reported nausea, confusion, attempted to vomit without success. Patient was able to report name when prompted. 911 was called, fire service and ambulatory service arrived for further assessment. Patient was deemed safe without necessity of going to emergency room.
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| 40 | 2021-05-26 | excessive sleepiness, loss of personal independence in daily activities |
My first shot came with full body hives, sweats, and I slept for three days straight. Felt normal in...
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My first shot came with full body hives, sweats, and I slept for three days straight. Felt normal in a little over a week. My second shot, I work up the next morning with one of the worst headaches I've ever had. I started to develop a fever. 101.5. It spiked at 102. The fever was off and on for three days. I couldn't stop sleeping. I could only stay awake for a couple of hours at a time. That lasted for four days. Now today marks the two week anniversary and I can only stay awake for six or seven hours at a time, then I'll sleep for seven or eight, and repeat. I am SO tired I can barely function. I talked to a doctor friend who suggested I file a report here. I don't have health insurance and can't go to the doctor.
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| 40 | 2021-05-26 | memory impairment |
I became very light headed and passed completely out. I do not remember anything leading up to this ...
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I became very light headed and passed completely out. I do not remember anything leading up to this or while it was happening. When I came too, I couldn't hear, had ringing in my ears, couldn't walk on my own, and my husband said I was very cold. Two days later and i still have dizzy spells and extreme fatigue.
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| 40 | 2021-05-27 | disturbance in attention |
Right side of body tingling and heaviness; Right side of body tingling and heaviness; slurred speech...
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Right side of body tingling and heaviness; Right side of body tingling and heaviness; slurred speech; difficulty walking; difficulty concentrating; urinary incontinence; This is a spontaneous report from a contactable other health professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided), via intramuscular, in right arm, on 05Feb2021 10:30 (at the age of 40-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included known allergies, and hypertension. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication was reported as "no". Patient did not receive other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and expiration date not provided), via intramuscular, in right arm, on 15Jan2021 14:00 (at the age of 40-year-old), at single dose, for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Feb2021, the patient experienced right side of body tingling and heaviness, slurred speech, difficulty walking, difficulty concentrating, urinary incontinence. Patient was hospitalized for 2 days. Events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures after the vaccination, which included COVID-19 test (Nasal Swab) was negative on 12May2021. No treatment received for events. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the events of right side of body tingling and heaviness, slurred speech, difficulty walking, difficulty concentrating, urinary incontinence cannot be excluded completely. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
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| 40 | 2021-05-27 | sleep disorder |
1. Severe chest pain (stabbing) 15 hrs later that woke me up in the middle of the night. Went to eme...
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1. Severe chest pain (stabbing) 15 hrs later that woke me up in the middle of the night. Went to emergency room around 11am (day after vaccine). 2. No menstral cycle for 7 weeks after the first injection. Visited OB/GYN
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| 40 | 2021-05-28 | insomnia |
Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, jo...
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Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, joint pain, bone pane, teeth pain, inability to sleep.
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| 40 | 2021-05-31 | insomnia, feeling abnormal |
April 15- second Covid shot April 22 - first big vertigo spell. Deafness then ringing in right ear A...
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April 15- second Covid shot April 22 - first big vertigo spell. Deafness then ringing in right ear April 23 - mild ringing in both ears and thumping, pressure in head May 4th - very noticeable ticking in right ear May 9th - felt sick, off, hard to take a deep breath, pounding head, fullness in ears, ringing, emotional May 11th - ENT visit. Ears clear, hearing fine May 18th - May 23- off and on headaches, difficulty breathing May 24th - Headache that didn?t go away with medicine. Fullness in ear. Nausea May 25th - Sleepless night, stiff neck, very full head. Medicine providing no relief(Excedrin, Sudafed, Flexeril) can feel fast heartbeat, ringing, and pulsation in ears, stiff jaw May 26-28 - light head congestion May 29- headache returns May 30- head congested even after Sudafed. Ears feel ?wet? hard to take a deep breath, lots of yawning. Flushed face and blotchiness on neck. May 31 - Difficulty breathing, ringing in both ears
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| 40 | 2021-06-01 | amnesia, memory impairment |
On 5/31/21, patient's husband described that the patient fainted and experienced seizure-like activ...
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On 5/31/21, patient's husband described that the patient fainted and experienced seizure-like activity. She reported nausea and dizziness before and after the episode. It took approximately 2 minutes for her to regain consciousness and she didn't have any recollection of what had happened. On 6/1/21, patient's daughter contacted nurse triage after she experienced forgetfulness and word-finding trouble, performed a FAST exam, and patient was admitted. Work-up pending.
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| 40 | 2021-06-01 | impaired work ability, confusional state |
I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had...
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I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had what looked like blinds (white/black) lines in my vision, then half moon shape in my vision in my right eye for days. Dizziness (I felt like I was on a boat dock), confusion, tiredness and pain the back of the eye for two weeks, numbness of the eyes. I went to the Opthalmologist who stated that I was having an ocular migraine. My Neurologist also said I was having an Ocular Migraine, but I?m stuck in the Postdrome Stage. Gave me Topiramate daily and told me stay away from screens and reading (that means no working and no TV). With the meds, I?m 70% back to my old self, I can drive again, run errands, do yard work, but I can?t work. We increased the dose, still can?t use screens and side effects pushed us to find another drug. Started new drug Amitriptyline on May 30, and symptoms are not disappearing. I have had symptoms (mostly eye numbness, vision issues, dizziness) continuously all day, everyday for 3 39 days and counting
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| 40 | 2021-06-02 | impaired work ability, insomnia |
I woke up on the 4/13/2021 with hives all over my body I did not know what it was I had no pain at i...
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I woke up on the 4/13/2021 with hives all over my body I did not know what it was I had no pain at injection site I felt fine I went about my business the next day I felt like there were ants crawling under my skin by Thursday the feeling of heat kept rising in my skin i would look and it would be hives the following the bloody noses began every three days i get nose bleeds. the hives has gotten worse I am now taking 6 Benadryl's a day just to avoid itching my skin off I went to medical facility where i received 2 steroid injections. The dr does not know what to do, I had to go to the hospital to cauterize the inside of my nose they could not figure out the cause. I had a stroke back in Oct and I thought maybe something was going on but the Dr said it was not associated. Ever since I received the shot I have not been the same. Right before the hives appear, it feels like the stinging burning feeling right after someone slaps your skin. This lasts for 30 seconds. My skin is dark but my skin turns red with the hives. They gave me Zofran for the nausea, they also gave me a nose pincher thing that I use when I have nosebleeds. Also, I thought it was allergies but I have congestion that have no diagnosis. It is hard to breathe. I feel like I have Covid but I do not. The doctors say I have insomnia, I have headaches due to the congestion. I also feel tired. I have dizziness that feels like I am on a merry go round that I can't get off. Walking up stairs exhausts me which is unusual because I am a physically fit individual. I have had to take a lot of days off from work due to these side effects. Taking as many Benadryl's as I do causes drowsiness and I am a single mother of 4, I cannot be drowsy.
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| 40 | 2021-06-03 | anxiety | Complaints of anxiety and chest tightening |
| 40 | 2021-06-03 | feeling abnormal |
violently vomiting; nauseous; losing weight; my labs are a mess; losing hair; short of breath; dizzy...
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violently vomiting; nauseous; losing weight; my labs are a mess; losing hair; short of breath; dizzy; I have never felt so awful for so long.; can barely eat; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 16Mar2021 09:00 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included Lupus, Postural orthostatic tachycardia syndrome (POTS), depression, Axial Spondyloarthritis, Degenerative Disc Disease. Concomitant medications included unspecified medications, the patient was on quite a few, she didn't fit. The patient's known allergies Ambient, augmentin, doxycycline (not anaphylaxis). No other vaccine in four weeks. Vaccine 16Mar2021, day after she started violently vomiting. She had vomited al-most every day since, she was nauseous 24/7, she can barely eat so she was losing weight and her labs were a mess, she had to get IV Iron yesterday (19May2021), and she had a ton other GI tests coming up. She was losing hair, I'm getting barely any nutrients. She was now short of breath and dizzy too. She had never felt so awful for so long. Adverse event start date was 17Mar2021. Adverse event start time was 07:00 AM. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included intravenous Iron, tried different medicine, lots of appts. No covid prior vaccination. No covid tested post vaccination. The adverse events did not result in death, did not cause/prolong hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. All events considered as serious due to being medically significant. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 40 | 2021-06-03 | impaired work ability |
Neuropathy initially in right arm, then subsided after two days. Neuropathy/tingling of fingers and ...
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Neuropathy initially in right arm, then subsided after two days. Neuropathy/tingling of fingers and toes returned with increasing sensation on May 21, 2021. On friday May 28, 2021 lips are now tingling and more feeling of full body tingling and weakness followed by close to fainting spells. Sunday night worst headache of life, followed by chills, almost fainted, went to ER and all tests normal. Neuropathy has not left. Sent home with no answers. Wednesday June 2, 2021 tingling of hands, feet and lips more extreme followed by moments of shortness of breath and fainting. Went back to ER all vitals normal. Two days later I have missed two days of work because my body is so weak and the nreopathy remains. Please help. I cannot continue to live with these symptoms. I had zero health issues leading up to this and all of the dr's are stumped.
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| 40 | 2021-06-03 | nervousness |
doesn't have much of appetite; 148/70 on the blood pressure; allergic response; tongue was a little ...
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doesn't have much of appetite; 148/70 on the blood pressure; allergic response; tongue was a little numb; hard to swallow; Throat was closing up; mouth feeling numb; couldn't really speak; Coughing; super shaky; feet was also feeling numb; face looked swollen; Chest tightness; chest pain; abnormal EKG; Her throat was a little sore; tired; This is a spontaneous report received from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left Arm on 17May2021 12:30 (Batch/Lot Number: EW0167) as single dose (at the age of 40-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number EW0158) on 15Apr2021 at 12: 50PM (at the age of 40-year-old) in the left arm for covid-19 immunisation and on 15Apr2021 her arm was numb on the side where she received the injection for more than 24 hours, it went numb pretty quickly after the first dose - then it was numb for about 24 hours. It went away completely in two days, but the patient was unsure if that is an adverse reaction. The patient experienced tongue was a little numb on 17May2021 with outcome of recovering , hard to swallow on 17May2021 with outcome of recovering , mouth feeling numb on 17May2021 with outcome of recovering , throat was closing up on 17May2021 with outcome of recovering , couldn't really speak on 17May2021 with outcome of recovering, coughing on 17May2021 with outcome of recovering, super shaky on 17May2021 with outcome of recovering, feet was also feeling numb on 17May2021 with outcome of recovering, face looked swollen on 17May2021 with outcome of recovering, chest tightness on 17May2021 with outcome of unknown, chest pain on 17May2021 with outcome of unknown, abnormal EKG on 17May2021 with outcome of unknown, her throat was a little sore on 17May2021 with outcome of unknown, tired on 17May2021 with outcome of unknown, doesn't have much of appetite on 20May2021 with outcome of unknown. Details as described as follows: Reports she went to sit in the waiting area, after 5 minutes she noticed her tongue was a little numb. She took her card out of her purse, and noticed it was a little hard to swallow, this was within about 8 to 10 minutes. She sat for another 5 minutes and then decided to ask about her tongue feeling numb and was taken to the nurses station. She told them about her tongue, and as she was talking her mouth was feeling more numb and it was getting harder to swallow. As the nurse was talking to her it was like she couldn't really speak. The nurse said this is way past Benadryl and called to another nurse for an Epipen. Caller states she started to cough as her throat felt like it was closing up. They jabbed her with the Epipen within 15 minutes of receiving the vaccine. She got some relief for a couple of minutes and then her body went back into the allergic response. They put her on the oxygen finger machine and then her throat started to close again. They gave another Epipen and then the ambulance arrived. She is unsure how long after she got the second Epipen that the ambulance arrived but it was no more than 5 minutes. They told her they had to call 911 right after giving the first Epipen. When the ambulance team came, she felt like she had novocaine in her mouth, her mouth was super numb and she was super shaky. They said the shaking was normal from an Epipen. Adds her feet were also feeling numb. She didn't know before that the shaking was from the Epipen. She was able to walk to the ambulance and her husband came and the med team was asking him if her face looked swollen and he said her face looked swollen. States her mouth felt like it was moving funny and she was exaggerating her speech trying to make her mouth move right. Adds she was still unaware that this could be an allergic reaction and was just trying to remain calm. At the site, she noticed her vitals on the machine and she saw 148/70 on the blood pressure. Adds it was about the same in the ambulance, it was 148/64. She was not able to collect any information about the Epipen other than they were yellow with a blue cap and they held it in her leg for three seconds. No lot or expiration date known for the Epipens. In the ambulance she was treated with Intravenous (IV) steroids and dose of Benadryl 50mg. As she was being transported to the hospital, she started to have chest pain. They did an EKG in the ambulance with no remarkable findings. Adds she has a follow up with her Primary Care Provider (PCP) today. When she arrived at the Emergency Room (ER) they monitored her for a couple of hours. She had another EKG at the ER and was told that it was normal so they released her. She has no product information for the steroids or the Benadryl that she received. No lot or expiration date known. When she got home everything was calming down. Her throat was a little sore and she was tired. The next morning her chest was still tight. She called the doctor who told her to just relax and come back to the ER if she has palpitations or difficulty breathing. Mentions she got the results of the EKG in ER now, and it said it was abnormal as compared to a previous EKG she had, and something about the T axis. Adds now she doesn't have much of appetite and her tongue still feels a little off. Caller interrupts the call to say her doctor just called and she needs to go. Unable to complete the report at this time. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.
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| 40 | 2021-06-03 | sleep disorder |
Within minutes of shot, felt left cheek numbness and left eyelid felt off but resolved within the ho...
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Within minutes of shot, felt left cheek numbness and left eyelid felt off but resolved within the hour. For past week or so (vaccine 5/18, today 6/4) have felt random pins and needle stabs on my hands and feet. Past couple nights felt uncomfortable sensation bilateral lower legs that kept from being able to sleep, so walked around some before went away and could rest. This morning (6/4) woke and had right corner mouth spasms off and on for approximately 2 hours. (Unlikely due to low potassium as ate potato and banana night before).
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| 40 | 2021-06-04 | feeling abnormal, thinking abnormal |
pain in my right boob; maybe it is swollen; aching in my upper right arm; burning pain in my joints ...
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pain in my right boob; maybe it is swollen; aching in my upper right arm; burning pain in my joints of the vaccinated arm; extreme tiredness; all joints in my arm began to sting; extremely nauseous; sweaty; light-headed/mild dizzy spells; unable to think clearly; sudden down in blood sugar; foggy-headed; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 13:30 as 1st dose, single dose for COVID-19 immunization. Patient did not receive any vaccine in four weeks and not had COVID prior vaccination. Medical history included high blood sugar, asthma, scarlet fever survivor and patient had known allergy to latex. Concomitant medications included cinnamomum verum (CINNAMON TABLETS), quercetin, rhodiola rosea (RHODIOLA), and st johns (as reported). On 02Mar202 01:30, within 1 minute after vaccination, patient experienced all joints in arm began to sting. and was extremely nauseous, sweaty, light-headed, and unable to think clearly- very much like experiencing a sudden down in blood sugar. The doctor had patient to drink water and eat fruit. Patient reported it took about 15 minutes to be able to think clearly and was foggy headed for at least 24 hours. On 03Mar2021, (the after) patient experienced burning pain in joints of the vaccinated arm, extreme tiredness, and mild dizzy spells. On 05Mar2021, 3 days (yesterday) after vaccination, had pain in right boob and patient think maybe it was swollen as well as aching in upper right arm. Patient reported it still hurts today. Patient not tested COVID post vaccination. The patient underwent lab tests and procedures which included blood glucose: high. Therapeutic measures were taken as a result of extremely nauseous, sweaty, light-headed, and unable to think clearly- very much like experiencing a sudden down in blood sugar with water and fruit. The outcome of the events reported as recovered with sequelae (Recovered with lasting effects). No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-06-04 | sleep disorder |
Mild metal taste in mouth approx. 1 minute after shot was administered; Soreness in left arm, around...
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Mild metal taste in mouth approx. 1 minute after shot was administered; Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye; Fatigue; ended up sleeping nearly 12 hours; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 40-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0186), via an unspecified route of administration in Arm Left on 28May2021 15:00 (age at vaccination 40years old, No pregnancy at time of Vaccination) as single dose for covid-19 immunization. Medical history included lactose intolerance from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with covid-19. Concomitant medication(s) included Vitamin C, Vitamin D, Calcium Citrate, Iron taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination the patient was not diagnosed with covid-19. The patient received other medications in two weeks. On 28May2021 21:00 the patient experienced mild metal taste in mouth approx. 1 minute after shot was administered; dissipated a few minutes afterward. Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; no swelling. Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye. Fatigue; ended up sleeping nearly 12 hours. After 42 hours, migraine has gone away; remaining symptom is soreness - now reduced to half the area and still concentrated around site injection area. Patient was not received treatment for the events. Since the vaccination, the patient has not been tested for covid-19. The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-06-06 | feeling abnormal |
Pt reported difficulty breathing, swelling of face and throat, dizziness and weakness, pain, swellin...
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Pt reported difficulty breathing, swelling of face and throat, dizziness and weakness, pain, swelling and redness at injection site, sore throat, swollen lymph nodes, pain/tightness in chest, shortness of breath, headache, body aches, muscle aches, upset stomach, nausea, brain fog, fatigue, dizziness, and vertigo for six days after vaccination.
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| 40 | 2021-06-06 | feeling abnormal | mom states that pt had to go to the er due to serious adverse reaction, high fever, feeling badly |
| 40 | 2021-06-06 | impaired work ability |
After receiving the vaccine, I had a sore arm. The next day I felt extremely drowsy. I would sleep f...
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After receiving the vaccine, I had a sore arm. The next day I felt extremely drowsy. I would sleep for 4hrs wake for 2hrs and then need a nap again. This became a cycle. This was unusual because after the first vaccine, I only experienced common and minor side effect like aches and mild fever etc. The week after the vaccine, I began to have migraines with extreme pain, nausea and dizziness. These symptoms all became increasingly worse. I hadn't had a seizure since 2005, and in January, following the vaccine, I had one. My neurologist cannot determine the cause of this nor the migraines. My usual medication for my migraines do not work anymore. I have had to quit my job because I am a fall risk. I also must use a can to move around now to maintain my center of gravity.
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| 40 | 2021-06-07 | impaired work ability |
In march, I had a prescription to take Macrobid as a preventative for a UTI. I had taken it in the p...
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In march, I had a prescription to take Macrobid as a preventative for a UTI. I had taken it in the past with no problems. I took it on Saturday evening and in the morning I had a really bad cough, shortness of breath, body aches, fever. I had to call in sick to work, The next day on Monday, I felt completely better, I felt like I hadn't been sick at all. I took Macrobid again on the 16th of march and the same thing happened, I woke up the next morning on the 17th with shortness of breath and body aches this time was worse than the first. By the 18th I felt mostly back to normal. I was tested for Covid which came back negative on the 18th. My doctors said over the phone could have been an acute reaction to the Macrobid.
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| 40 | 2021-06-07 | loss of personal independence in daily activities |
Symptoms are ongoing 8+ weeks post vaccine. I have had two doctors visits and numerous blood tests. ...
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Symptoms are ongoing 8+ weeks post vaccine. I have had two doctors visits and numerous blood tests. All normal. I was perfectly healthy prior to this other than a vitamin D deficiency that is now within the normal range. No known prior COVID exposure/infection. Have been maintaining a small, strict family bubble since March 2020 - working from home, home schooling my son, no travel or even going into stores. I had the normal/expected next day reaction to the 2nd shot - extreme fatigue, body aches, headache. I rested for the full day on Saturday and felt better /normal by Sunday morning. However, by late Sunday afternoon, new symptoms came on. They started out on the left side of my body and then grew from there in the days that followed. First it was pain behind my left knee that radiated down to my ankle and later upward through my left thigh, hip, entire arm, and shoulder. From there, it progressed to all over pain in my joints on both side of my body and almost daily headaches - typically around the base of my skull. I am also experiencing prolonged periods (days and sometime weeks at a time) of constant muscle tension/soreness in both arms and legs and intermittent tightness in my chest. However, the pain has remained most intense/pronounced/persistent on my left side and a couple of different times in the last 8 weeks I've had bruising on my left foot and ankle. As a result of all of this, I am fatigued most days and it is all inhibiting my ability to function normally. I don't know whether it is related to the vaccine or not, but I know it isn't normal. My quality of life and ability to function as I typically have has decreased dramatically in the last 8 weeks and I am very worried and I don't know what to do. If someone can please contact me and advise whether they have received any similar reports and provided direction on some type of specialist or test that might be able to help, I would be forever grateful as I am scared and my primary care physician has basically just said I need to wait it out.
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| 40 | 2021-06-08 | feeling abnormal, excessive sleepiness |
I went to urgent care at 2:30 pm in the afternoon on 4/16 which was a Friday. I got my shot I was fi...
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I went to urgent care at 2:30 pm in the afternoon on 4/16 which was a Friday. I got my shot I was fine. Around 5pm - 6pm dinner time on Sat 4/17 I started to feel off. I was feeling weak and tired. I woke up on the morning of the 17th and I was horribly sick. I had a low grade fever a little over 100 to 101 degrees I had chills and shakes similar to flu symptoms. I had no appetite and did not want to drink anything. I slept the entire day I had a horrible headache I felt really crappy. I did vomit once but none after that. Monday morning the 19th I started to feel better I was still running a low fever in the 99-100 degree range. At that point I was able to get fluids in and eat and was able to keep everything down. I still had a headache and was feeling run down . Tuesday morning the 20th I was feeling much better I still had a headache but basically all other symptoms had subsided.
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| 40 | 2021-06-09 | nervousness |
dizziness; fever; chills; nervousness; Headache; sleepiness/drowsiness; shaking; diarrhea; This is a...
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dizziness; fever; chills; nervousness; Headache; sleepiness/drowsiness; shaking; diarrhea; This is a spontaneous report from a contactable consumer (the patient). A 40-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 06Mar2021 16:00 (Batch/Lot Number: Pfizer EL9267) as single dose for covid-19 immunisation (Age at vaccination 40 years) . Medical history included penicillin hypersensitivity. Concomitant medications included ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. On 13Feb2021 the patient received the first dose of BNT162B2 vaccine (Lot #Pfizer EN5318). The patient experienced dizziness on 07Mar2021 09:00 with outcome of recovering , fever on 07Mar2021 09:00 with outcome of recovering , chills on 07Mar2021 09:00 with outcome of recovering , nervousness on 07Mar2021 09:00 with outcome of recovering , headache on 07Mar2021 09:00 with outcome of recovering , sleepiness/drowsiness on 07Mar2021 09:00 with outcome of recovering , shaking on 07Mar2021 09:00 with outcome of recovering , diarrhea on 07Mar2021 09:00 with outcome of recovering. The patient received paracetamol (TYLENOL), increased fluid intake and bed rest as treatment of the events. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-01 | mental status changes |
Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and b...
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Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and balance was off and fell several times. Body aches and pain continued. 12/29/2020 at 8 pm had fever of 100. 12/30 fever 103f chills, slept almost all day loss of appetite. 12/31 no fever in the morning but acting different than normal. In after non could not tell my husband child?s name went to the ED where I was admitted for altered mental status. Discharge today with altered mental status, unspecified. Wife still has headache but normal level of consciousness.
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| 41 | 2021-01-01 | sleep disorder |
Heart palpitations and tachycardia. BPM 102. Lasted for at least 30 minutes. Drank 8 ounces of water...
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Heart palpitations and tachycardia. BPM 102. Lasted for at least 30 minutes. Drank 8 ounces of water, practiced deep breathing and went back to bed lying on left side. Eventually was able to fall asleep so unsure of total duration.
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| 41 | 2021-01-03 | abnormal dreams | Fever, Headache, Nausea, stomach cramping, vivid dreams |
| 41 | 2021-01-04 | anxiety |
15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patien...
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15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patient anxious with these symptoms, feet shaking, felt heart "beating out of chest." Vitals gradually improved after benadryl over one hour. Sent home in care of husband. Will call tomorrow to check on patient and work with allergist on follow up vaccine before receiving.
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| 41 | 2021-01-04 | feeling abnormal |
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ...
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Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
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| 41 | 2021-01-04 | impaired work ability | 4 days the vaccine I got a high fever, body aches and tonsils were severly swollen and couldnt work |
| 41 | 2021-01-05 | excessive sleepiness |
got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a conta...
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got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140/ELO140), via an unspecified route of administration, at the left arm on 30Dec2020 06:30 at a single dose for COVID-19 immunization at a hospital. Medical history included seasonal allergies and doesn't take medications. On the same day of 30Dec2020, about an hour after vaccination, patient got a very metallic taste in mouth, which lasted for about 12-18 hours and did sleep a lot, which she expected, but woke up about 11 at night and still had it and it was gone. Patient knew she slept longer than she normally does, went to bed at 1PM and slept until 11PM, which is not usually normal. Was up for about an hour or two and then went back to bed until 8AM of 31Dec2020. Patient was concern was if it was some type of reaction that it would mean she was going to have a stronger reaction to the second one and stated it was irritating but not a huge deal. Patient also felt tired and expected it as she worked five 12-hour shifts in a row. Patient was not sure if the metallic taste was connected to the COVID-19 vaccine. No prior vaccinations within 4 weeks. Outcome of the events was unknown.
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| 41 | 2021-01-06 | feeling abnormal, impaired work ability |
Sedation, Myalgia, Immediate post vaccine, employee reported feeling "funny" almost like she was int...
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Sedation, Myalgia, Immediate post vaccine, employee reported feeling "funny" almost like she was intoxicated. this passed after a few hours. Narrative: Employee missed greater than >1 days of work second to symptoms (aches and extreme fatigue)
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| 41 | 2021-01-06 | feeling abnormal |
Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine unt...
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Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine until about 3pm. Just typical arm pain. Moderate/Severe Fatigue set in around 3-6pm. Needed to nap from 4-5pm (extremely unsusual). Felt fine the next day. Moderate congestion in ears starting around the same time (6 hours after) and is persisting 30 hrs later. Feel like my ears will not pop and trying to yawn a lot. Also felt pretty bad sinus congestion starting at 7pm 12/21 (10 hrs after vaccine). Could not breathe through nostrils. Treated with sinus rinse and sudafed.
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| 41 | 2021-01-06 | insomnia | Insomnia lasting for 5 days at this time an continuing |
| 41 | 2021-01-06 | sleep disorder |
fatigue - onset about 1230, I usually don't take naps but I took a 4 hour nap that day headache - on...
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fatigue - onset about 1230, I usually don't take naps but I took a 4 hour nap that day headache - onset about 1230, lasted the rest of the day and intermittently the next few days injection site pain x 3 days - moderate, pain would wake me in my sleep if I rolled onto affected side
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| 41 | 2021-01-07 | impaired work ability |
Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, b...
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Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, body aches and 102.0 fever. Fever lasted until day 3. Day 3-5 weakness, SOB with any exertion, fatigue. Had to call off work on day 3.
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| 41 | 2021-01-07 | loss of personal independence in daily activities | Headache, Myalgia, extreme fatigue, joint pain unable to complete household work. Narrative: |
| 41 | 2021-01-08 | depression |
Depression, Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: On 12/28/20 continue...
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Depression, Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: On 12/28/20 continue with headache, abdominal malaise, Dizziness. But referred is improving.
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| 41 | 2021-01-08 | nervousness |
employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of h...
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employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of having lots of saliva. Did not get nauseated. Also experienced metallic taste in mouth. 5 minutes later felt dizzy, then 5 minutes later felt shaky BP was 159/93, HR 107 felt well enough to finish out shift, and went home. Following day felt lethargic, but recovered from that at home.
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| 41 | 2021-01-10 | impaired work ability |
I started with low-grade fever and chills about 12h after receiving my second dose of the Pfizer cov...
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I started with low-grade fever and chills about 12h after receiving my second dose of the Pfizer covid19 vaccine. Chills lasted for about 15min, they were of moderate intensity. Then I had low grade fever, body ache and tiredness for the entire next day (01/08/2021); it was bad enough to interfere with my regular activities of work and childcare. I ended up taking the day off. On the following day (01/09/2021), I woke up fully restored.
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| 41 | 2021-01-11 | confusional state |
Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue...
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Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm
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| 41 | 2021-01-11 | disorientation |
Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with rednes...
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Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .
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| 41 | 2021-01-11 | feeling abnormal |
I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which ...
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I developed a sharp pain on the back side of my left neck area; I developed a severe earache, which began to subside within about 2 days; my upper left molar started aching (toothache); I had a sharp intermittent pain in my left jugular/carotid neck area; felt a little "tipsy; I had intermittent numbness and tingling in my left jaw area; I had intermittent numbness and tingling in my left jaw area; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to Sulfa antibiotics. The patient's concomitant medications were not reported. The patient previously took meperidine (DEMEROL) and experienced allergies. Within an hour of receiving the vaccine, the patient had a sharp intermittent pain in her left jugular/carotid neck area and felt a little "tipsy". This continued for about one day. Then last week (approximately 28Dec2020), her upper left molar started aching (toothache). This subsided within about 2 days. Then on 30Dec2020, she developed a severe earache, which began to subside within about 2 days. Around 31Dec2020 through 04Jan2021, she had intermittent numbness and tingling in her left jaw area. Last night (05Jan2021), she developed a sharp pain on the back side of her left neck area. She went to the doctor on 04Jan2021, and no treatment was prescribed. She began self-medicating with an old prescription of prednisone on the evening of 04Jan2020 due to being fearful of developing Bell's Palsy. Most of her symptoms have now improved after beginning the prednisone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 41 | 2021-01-11 | feeling abnormal |
The left side of her face, it didn't go completely numb, but mostly; still can't chew on the side of...
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The left side of her face, it didn't go completely numb, but mostly; still can't chew on the side of the mouth; difficulty speaking; her eye socket, it didn't feel like her eye was there; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK923, expiration date: Apr2021), via unknown route of administration on 30Dec2020 at single dose (first dose by injection once to left upper arm, by the shoulder, a little down) for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medications were reported none. Her blood pressure was diagnosed years prior to the report, like 10+ years prior to the report, but she did not know if it had anything to do with it. The left side of her face, it didn't go completely numb on 30Dec2020, but mostly: stated her eye socket, it didn't feel like her eye was there, and her mouth, she had difficulty speaking, she still could not chew on the side of the mouth in Dec2020. Stated it felt like pulling, like something pulling, like a rope was tied and pulling backwards to the back of head and downward. States this lasted 2 days thankfully, and she did not regret getting it. She Provided weight as a lot of pounds, said she was joking. The vaccine was not prescribed by a doctor, her job offered it, she worked at a hospital, so it was voluntary and she took it. The event started maybe 6 hours after getting the vaccine, it was while she was sleeping, she woke up, she had slept, it was in the middle of the night, and was gone by Saturday for sure. This was her first dose. States site of administration was where she typically gets flu shots. The outcome of the event The left side of her face, it didn't go completely numb was recovered on 02Jan2021. The outcome of other events was unknown.
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| 41 | 2021-01-12 | feeling abnormal |
The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite ...
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The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite right and something may be wrong. She stated she was feeling all warm. She was complaining of mild heat or burning traveling from the vaccination arm, across her chest to the other arm and down her torso. Did not complain of any breathing difficulties or other symptoms. Her heart rate and respirations were normal. Upper extremities were examined for redness or hives - none found. The heat flash lasted about 2 minutes then she stated she felt normal. She was observed for another 20 minutes. She was examined again before leaving and no signs or symptoms were noted at that time. She felt normal before leaving the clinic.
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| 41 | 2021-01-12 | impaired work ability |
Sunday I had al little ache and pain. On the 21st I had to leave work with a fever 101.4 also had bo...
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Sunday I had al little ache and pain. On the 21st I had to leave work with a fever 101.4 also had body ache. It progressed from there then I tested positive for Covid. I went to a clinic to get tested was given Zpac, Zythrimac, steroids' .
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| 41 | 2021-01-12 | insomnia | 2 dose, feeling of being cold, not able to warm up, unable to sleep |
| 41 | 2021-01-13 | anxiety |
Shortness of breath; Anxious; Chest Heaviness; This is a Spontaneous report from a contactable pharm...
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Shortness of breath; Anxious; Chest Heaviness; This is a Spontaneous report from a contactable pharmacist. A 41-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284) via intramuscular route of administration on left arm at a single dose for COVID-19 immunization at a nursing home. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks, or any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced shortness of breath, anxious, and chest heaviness on 07Jan2021 11:00. The events were reported as non-serious but resulted in visit to the Emergency room/department or urgent care. Treatment and outcome of the events were unknown. The patient had not been tested for COVID-19 since the vaccination.
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| 41 | 2021-01-13 | confusional state, disorientation |
Narrative: PATIENT VACCINATED ON 12/23/2020, PRESENTED TODAY (01/13/2021) FOR 2ND VACCINE. SHE REPOR...
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Narrative: PATIENT VACCINATED ON 12/23/2020, PRESENTED TODAY (01/13/2021) FOR 2ND VACCINE. SHE REPORTED SYMPTOMS OF CONFUSION, DISORIENTATION, AND TASK WERE HARD TO COMPLETE, STATED SHE FELT LIKE SHE WAS DRUGGED. THESE ISSUES STARTED 2 HOURS AFTER SHE RECEIVED VACCINE.
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| 41 | 2021-01-13 | confusional state, feeling abnormal |
I was approached by a person in the center at approx 1000 stating she had an employee that received...
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I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.
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| 41 | 2021-01-13 | panic attack |
Employee stated that she experienced a panic attack while on duty the same day she received the vacc...
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Employee stated that she experienced a panic attack while on duty the same day she received the vaccine - approximately 12 hours after administration. She has a history of panic attacks, especially when she is fatigued - which she states she was that day. She also reported that her friends brought her a double expreso coffee approximately 1 1/2 hours before attack. She went to the ED where she was released home.
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| 41 | 2021-01-14 | anxiety |
became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED...
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became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED, discharged home
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| 41 | 2021-01-14 | anxiety | Slight tingling sensation on tongue and part of throat Heart rate increased with anxiety |
| 41 | 2021-01-14 | feeling abnormal, impaired work ability |
Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At app...
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Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At approximately 0400 + chills, HA, body aches, and nausea without emesis. + fever (Tmax 100.3), Patient reports yesterday took motrin/tylenol around the clock. Today (1/15), Patient reports no fever today but ?brain fog? and feelings of fatigue. Patient reports last dose of motrin 600 mg at 08:00. Patient reports she called off work yesterday due to not feeling well. Last day of work and shift - ?Tuesday, January 12th Home remedies? - Tylenol, motrin, rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the TCH Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she called out of work yesterday, next scheduled shift Monday (1/18). Patient educated to manage her RTW according to the TCH Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.
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| 41 | 2021-01-14 | sleep disorder |
Staff had 2nd vaccine yesterday 01/13/2021 at 11:20. At night 3 am woke up with bodyache, lower bac...
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Staff had 2nd vaccine yesterday 01/13/2021 at 11:20. At night 3 am woke up with bodyache, lower back pain, fever 103, could not sleep. Took Tylenol. Today at 12 noon staff feels chill, fever 102. Now ok. W
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| 41 | 2021-01-15 | impaired work ability |
I started itching while being monitored post vaccine administration within the 5 minutes of the vacc...
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I started itching while being monitored post vaccine administration within the 5 minutes of the vaccine being administered. The itching was everywhere including my tongue and throat, since this is my workplace and I was working I had to go home and was given Benadryl to take upon arrival, the Benadryl did not help so I did a virtual visit with a physician who recommended that I increase the dose of benadryl at the same time I called my PCP to inform them of the issue they ordered, Atarax 25 mg every 6 hours plus taking an over the counter antihistamine.
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| 41 | 2021-01-16 | emotional distress |
1/17/2021 2:42 pm gave vaccine 1/17/21 2:54 pm itchy throat on outside was upset and we opted fo...
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1/17/2021 2:42 pm gave vaccine 1/17/21 2:54 pm itchy throat on outside was upset and we opted for 25mg Benadryl as a precaution. BP 112/72. Reported itchy back. Checked back, unremarkable. 3:30, no issue ? she went home. F/u 4:30 - no issues
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| 41 | 2021-01-17 | feeling abnormal |
Teeth chattering but not cold or feverish Feeling there was movement within my head that a piece of ...
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Teeth chattering but not cold or feverish Feeling there was movement within my head that a piece of the brain was moving up and down like my mouth (not dizzy or felt like room spinning) Feeling there was darkness/stuffiness in my head (not congestion) Feeling like my brain was not in control of my body Feeling sluggish The chattering lasted less than a minute, the motion in the head has weakened but still present and the darkness in the head is gone.
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| 41 | 2021-01-17 | feeling abnormal |
Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went t...
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Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-17 | impaired work ability |
I became very weak, lethargic, vomiting, sore...flu like symptoms. Sent home. Lasted for two to thre...
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I became very weak, lethargic, vomiting, sore...flu like symptoms. Sent home. Lasted for two to three days. I was told that if symptoms got worse to go to ER, but they started getting better with time.
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| 41 | 2021-01-18 | feeling abnormal |
5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/...
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5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/o & talking w/friend. Over the course of 30 min cheeks feeling improved but felt that cheeks remained a bit numb. L eye puffiness gone. Left amb after 45 min HR 96, BP 112/70, pulse ox 99%.
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| 41 | 2021-01-18 | sensation of foreign body |
Patients states felt lump in throat, able to swallow, denied shortness of breath or difficulty in br...
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Patients states felt lump in throat, able to swallow, denied shortness of breath or difficulty in breathing. Able to manage secretions. , Respirations 24, heat rate 102, skin warn and dry. Diphenhydramine 50 mg IM left gluteus maximums. Monitored for 30 min. Husband arrived to escort home. Refused transport or advice to seek medical attention. States "I am a ER nurse, and I am OK now". Respirations 18 heart rate 84. Patient left with husband following.
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| 41 | 2021-01-20 | abnormal dreams |
Headache for the entire day; Malaise; Fatigue; Body aches; Vivid dreams (fever); Vivid dreams (fever...
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Headache for the entire day; Malaise; Fatigue; Body aches; Vivid dreams (fever); Vivid dreams (fever); This is a spontaneous report from a contactable nurse. This 41-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=Ej1685), via unspecified route at left arm on 17Dec2020 07:30 PM at single dose for COVID-19 immunization. Medical history included Insomnia and obesity. No known allergies. No other vaccine in four weeks. Concomitant medications included zolpidem tartrate (AMBIEN), acetaminophen, acetylsalicylic acid (ASPIRIN) and diphenhydramine. On 08Jan2021, patient experienced headache for the entire day, malaise and fatigue, body aches and vivid dreams (fever), all with outcome of recovered in Jan2021. No treatment was received. No COVID prior vaccination. No COVID tested post vaccination.
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| 41 | 2021-01-20 | feeling abnormal, restlessness |
hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakne...
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hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms. She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm. Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-20 | feeling abnormal |
general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spo...
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general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spontaneous report from a contactable consumer (patient's sister). A 41-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on Jan2021 at the age of 41-year-old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had no covid prior vaccination. Patient previously received first dose BNT162B2 on Dec2020 at single dose for covid-19 immunisation. She had received her second dose of vaccine and it "hit her like a bus", she experienced general body pain, migraine, nausea, and a low grade fever of 99 on Jan2021. Outcome of events was unknown. Information on lot/batch number has been requested.
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| 41 | 2021-01-20 | feeling abnormal |
tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is ...
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tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-01-20 | loss of personal independence in daily activities |
Employee developed muscle aches and pains, fever, extreme fatigue, called off work 4 days. Continue...
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Employee developed muscle aches and pains, fever, extreme fatigue, called off work 4 days. Continues to have moderate-severe leg pain as of 1/20/21. Tylenol brings pain from moderate to mild.
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| 41 | 2021-01-21 | feeling abnormal | Congestion, out of body experience (like a fog where you cannot think), headache, syncope |
| 41 | 2021-01-21 | feeling abnormal |
Immediate nausea and dizziness followed by increasing fatigue, brain fog and cognitive difficulties ...
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Immediate nausea and dizziness followed by increasing fatigue, brain fog and cognitive difficulties (I.e. driving and returning to work after) especially involving quick movements, tracking and concentrating. Moderate Arm soreness increased from the time of shot continuing beyond 24 hours and making it difficult to lift or move the arm
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| 41 | 2021-01-23 | sleep disorder |
Initially felt some anterior cervical lymphadenopathy Difficult to sleep that night due to muscle ac...
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Initially felt some anterior cervical lymphadenopathy Difficult to sleep that night due to muscle aches, had to continuously stretch in bed, headache, some nasal congestion (resolved quickly), muscle aches continued in the morning but worsened around 11:30am on 1/24 and developed fever to 100.9. Muscle aches and fever lasted until taking Tylenol a few hours later.
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| 41 | 2021-01-23 | sleep disorder |
L arm pain and swelling at injection site. Upper body aches unable to sleep. Lasted about 12-15 hour...
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L arm pain and swelling at injection site. Upper body aches unable to sleep. Lasted about 12-15 hours was gone about 27 hours after injection. Fatigue and feeling flush then chilled very mild. No fever
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| 41 | 2021-01-24 | feeling abnormal |
This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immun...
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This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.
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| 41 | 2021-01-24 | sensation of foreign body, anxiety, nervousness |
At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency ki...
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At 1:12 pm, RRT was called and 4 RNs responded to the scene. Stethoscope, pulse ox, and emergency kit brought to scene. Client reports feeling pins and needles in the back of her head. She feels that her tongue and neck are swollen but as assessed, they were not swollen. She also reports feeling tingling in her tongue and neck. She was AAOx4, in no acute distress, no SOB noted. Skin and lip color normal, cap refill <3 seconds. Heart and lung sounds normal. Vitals: BP: 128/80, HR: 90, O2: 99% on RA, RR: 18. She did not report any pain. EMS was not called at this time. It was decided by RRT team that client can be monitored for an additional 30 minutes. RN stayed with client throughout 30-minute monitoring period. RN stated that during monitoring period, client was fine but kept reporting that she felt a lump in her throat. Husband talking with RN revealed that client is not diagnosed with anxiety but does have it. At the end of her 30-minute monitoring period at 1:40 pm, RRT was called again. RN already with client and client reported that she felt tingling everywhere again all over her body and felt like she could not breathe. Additionally, she had that feeling of being embarrassed with the sudden rush of heat throughout her body. Additional RN's arrived to scene at 1:41 pm. Upon assessment, she was not SOB but had rapid breathing associated with anxiousness and nervousness, which she reported. RN noticed client's hands and arms were shaking and client stated it was because she was nervous. Client speaking in full sentences. At this point, RRT RNs decided that client needs 911 assistance which was activated by Fire Chief on site. RNs also assessed that client's tongue was swollen again. Heart and lungs sounds were normal. Vitals at 1:49 pm: HR: 102, BP: 144/70, O2: 95%, RR: 21. At this point, on the basis of the symptoms she was experiencing, RN's decided to administer Benadryl 50 mg IM that was in the emergency kit. When the decision was made, client was asked if it was okay to administer Benadryl IM. She was explained the purpose of Benadryl, the side effects, and risks and benefits. Client consented to receiving Benadryl IM. Benadryl 50 mg IM administered to RA by RN at 13:51. By 13:53, her tongue was not swollen anymore. At 13:58, she was not SOB anymore, talking in full sentences, no acute distress, tingling stopped. By 13:59, the same symptoms of tingling throughout her body, feeling a sudden heat rush throughout her body started again. HR: 65, RR: 21, O2 95%. At 14:01, EMS arrives, truck number 341, vitals stable on their end. At 14:04, client decided to go to RUHS via ambulance. One of the paramedics stated that client's hands were "cold as ice". At 14:07, report was given to paramedics/ambulance and client was in the ambulance. Care assumed by ambulance/paramedics.
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| 41 | 2021-01-25 | incoherent, abnormal dreams |
Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tma...
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Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tmax 100.4. Also states she had visual hallucinations, "wild" dreams, and seemed "incoherent" when talking with her husband. All symptoms have resolved but still has swollen lymph nodes in neck that wax and wane. Also c/o right side ear pain and right side sore throat x 2 days. Right side ear pain started on 1/24/21, 5 days after vaccine.
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| 41 | 2021-01-25 | sleep disorder |
My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in m...
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My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in my heart rate. I went from the 50's in a dead sleep to the 80's between 7-8am. Otherwise I had general lethargy, fatigue, and arm soreness. I did not have a fever.
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| 41 | 2021-01-26 | feeling abnormal, anxiety |
weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding...
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weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-27 | anxiety |
40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s....
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40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.
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| 41 | 2021-01-27 | feeling abnormal, insomnia |
Approx. at 2:30 1/8/21 started feeling out of sorts and fatigued, progressed throughout the afternoo...
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Approx. at 2:30 1/8/21 started feeling out of sorts and fatigued, progressed throughout the afternoon and by that evening was experiencing extreme fatigue, headache, body aches, chills, fever and difficulty sleeping. 800 mg of Ibuprofen was taken around 3am with some relief and was able to sleep, Saturday symptoms continued as Friday evening but slightly lessened in intensity. I am unsure how the fever was on Fri. night early Sat. morning as I was not feeling well enough to get up and check it but Sat. Night around 9pm, rested better but was drenched in sweat throughout the night, Sunday woke feeling better with most symptoms resolved.
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| 41 | 2021-01-27 | sleep disorder |
symptoms: exhausted/run-down, headache, some nausea, rash (red, itchy, sore) at injection site, not ...
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symptoms: exhausted/run-down, headache, some nausea, rash (red, itchy, sore) at injection site, not sleeping well treatment: resting, sleeping, acetaminophen, drinking fluids all symptoms started approximately 24 hours after the shot was administered. symptoms have not resolved as of typing this at 2117 28January 2021
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| 41 | 2021-01-28 | sensation of foreign body |
Full body rash; trouble clearing throat; felt like there was something stuck in throat; This is a sp...
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Full body rash; trouble clearing throat; felt like there was something stuck in throat; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249), intramuscular (right arm), on 13Jan2021 09:45, at single dose, for covid-19 immunization. Medical history included allergies: sea salt, hypothyroidism, anemia, asthma, and seizures (when younger). Concomitant medications were not reported. The patient previously took tramadol and hydrocodone and experienced allergies to both drugs. The patient experienced full body rash on 13Jan2021 10:15 (also reported as about 30 mins after vaccination). On 13Jan2021 10:15 (also reported as about an hour after receiving vaccination), the patient had trouble clearing throat and felt like there was something stuck in throat. The patient has been taking Benadryl and Motrin for these adverse events. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination and, had not been Covid-tested post vaccination. The outcome of the events was recovering.
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| 41 | 2021-01-29 | loss of personal independence in daily activities, impaired work ability |
Awoke on 1/29/21 with dizziness and fatigue, which interfered with daily functioning and led to some...
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Awoke on 1/29/21 with dizziness and fatigue, which interfered with daily functioning and led to some lost time at work. Ibuprofen taken, but no further treatment. Resolved by midday.
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| 41 | 2021-01-31 | disturbance in attention |
have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a ma...
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have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a major flare-up of my condition; low-grade fever (between 99-100); severe muscle & joint pain; severe muscle & joint pain; existing nerve impingement affecting the left (L) side of my body & both sides of my face; decreased concentration & executive functioning; GI upset; anticipated some inflammation response to the vaccine; feel sick; This is a spontaneous report from a contactable other-HCP (patient). A 41-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 30Dec2020 at 18:00 at single dose in right arm for covid-19 immunization. Medical history included Ehlers-Danlos syndrome hypermobility type, IgA deficiency, cervical radiculopathy, spondylosis of cervical region, chronic hypertension, fibromyalgia, androgenic alopecia, seasonal allergies, and known allergies: gold, nickel. The patient's concomitant medications were not reported. The patient previously took prednisone and experienced allergies. The patient reported that she anticipated some inflammation response to the vaccine from 04Jan2021. Briefly, she started to feel sick around 04Jan2021, by 10Jan2021 was experiencing a major flare-up of her condition requiring additional medication and time off from work. She had had a low-grade fever (between 99-100) from 04Jan2021 for 7 days, severe muscle and joint pain from 04Jan2021. She had existing nerve impingement affecting the left (L) side of her body and both sides of her face from 04Jan2021. Beginning 12Jan2021 she had limited use in her L hand, numbness down the L side of her body into her L foot. This was most likely due to significantly increased levels of inflammation as a result of the vaccine. She had also had GI upset, decreased concentration & executive functioning from 04Jan2021. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.
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| 41 | 2021-02-01 | feeling abnormal |
Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, pani...
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Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, panic attacks, or heart issues. She started saying her lips were feeling numb and kind of strange and her back hurting. 50mg of benadryl was given at 940am. Patient continued to decline. She complained of chills, chest pain, and n/v. She was visibly shaking. BP was 168/137 HR 99 and oxygen 96%. 911 was called at 9:45am. AMR arrived at 9:55am and took over. Patient was taken to ER.
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| 41 | 2021-02-02 | impaired work ability |
12/18 vaccination 12/19 Nausea started in afternoon. Fever off and on; comes and goes. Nausea, vomit...
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12/18 vaccination 12/19 Nausea started in afternoon. Fever off and on; comes and goes. Nausea, vomiting has consistently been present till present date. PCP,video chat; blood work and possible nausea meds is scheduled for 2/8/2021. *it is not all the time, it comes and goes. Some days better then others. I had to leave work on 4 occasions.
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| 41 | 2021-02-03 | anxiety |
Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating his...
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Client presented for 1st dose of Pfizer Covid Vaccine. Patient's history was reviewed indicating history of anaphylaxis to iodine. 30 minutes after vaccination, client reported she had numbness of her tongue (anterior 1/3), some numbness of her lower cheeks/jaw. No difficulty breathing. BP120/85; HR 80. After a few minutes was reassessed and vitals were unchanged. Client felt anxious. No rashes, no breathing issues but continued anxiety and symptoms of numbness continued. 911 called. EMS assessed and vitals unchanged. Numbness lessened to just tip of tongue. Normal speech. EMS did not transport and father arrived to pick her up at 12:15 pm.
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| 41 | 2021-02-03 | nightmare |
fever (highest 100.8), severe muscle pain, joint pain, jaundice (I have Gilbert's sydrome), axillary...
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fever (highest 100.8), severe muscle pain, joint pain, jaundice (I have Gilbert's sydrome), axillary and cervical lymphadenopathy on L side, headache, restless leg, nightmares
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| 41 | 2021-02-04 | feeling abnormal, sleep disorder |
I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was a...
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I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was about to pass out. I felt more comfortable staying at work where I could get immediate help. I had an extreme case of brain fog. That lasted about 3 hours. I started to have the feeling that you get when your limb is asleep. On day 4, I started to exhibit the symptoms again. I felt like I do when I have thyroid issues, so I went to see my endocrinologist, but he didn't do anything. I did have labs done. I started having blood pressure increases as well. I haven't been able to work out like usual since the vaccine and my sleep has been very poor. I wake up in the middle of the night and am unable to go back to sleep. I am now on heart medication, which is what I was taking previously for thyroid flare ups. I go back to see my endocrinologist in March.
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| 41 | 2021-02-04 | loss of personal independence in daily activities |
moderate intensity myalgias and arthralgias; moderate intensity myalgias and arthralgias; fatigue; h...
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moderate intensity myalgias and arthralgias; moderate intensity myalgias and arthralgias; fatigue; headache; I have been having difficulty with routine activities due to pain; I have been having difficulty with routine activities due to pain; pain at the lumbosacral area; ESR elevated; ANA is positive; This is a spontaneous report from a contactable physician (patient). A 41-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EL1283), on 05Jan2021 at single dose in left arm for COVID-19 immunisation at hospital. Medical history included rhinitis allergic and eczema. Concomitant medication included cetirizine hydrochloride (ZYRTEC) and ethinylestradiol, norgestimate (TRINESSA). The patient previously took ciprofloxacin hydrochloride (SPECTRA) and experienced drug hypersensitivity. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EH9899) on 16Dec2020 at 09:00 for COVID-19 immunisation in the left arm and experienced myalgia, arthralgia, fatigue and headache. After the second dose on unspecified date in Jan2021 the patient developed moderate intensity myalgias and arthralgias, also significant fatigue and headache. The patient waited the 2-3 days after vaccination to see if adverse reaction improved, and it improved at the third day, but unfortunately the same symptoms started again one week after second dose of vaccine and have no improved. The patient had symmetric polyarthralgias affecting her hands, wrist, knees, ankles. She had been having difficulty with routine activities due to pain. Also pain at the lumbosacral area. Also have myalgias and fatigue affecting her work and routine activities. The patient also had a mild HA. The patient underwent laboratories after symptoms began again and CBC, CMP, CK, RF, Anti-CCP and TSH are WNL. But, ANA was positive which in the past was negative and have a ESR borderline elevated for her age. The patient was going to see a rheumatologist, but all this that she was feeling coincides with the vaccination for COVID 19. The outcome of the events was not recovered, no treatment was performed.
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| 41 | 2021-02-04 | panic reaction | Systemic: Other- tachycardia, elevated bp, radiating sensation, panic-Severe |
| 41 | 2021-02-05 | nervousness |
0945 pulled into medical site @ clinic . States she received vaccine @ 9:25 an waited 15 minutes a...
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0945 pulled into medical site @ clinic . States she received vaccine @ 9:25 an waited 15 minutes after receiving the vaccine & was cleared to leave. After she left the site she started feeling hot, c/o itchy rash on left side of neck, and feeling hot and shaky. EMS on site to evaluate patient. 9:47 gave Benadryl 25 mgm PO 10:10 symptoms resolved. Doctor notified. Patient instructed to take Benadryl 25 mgm when she gets home and to notify her PCP regarding additional f/u. Patient left site @ 1020.
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| 41 | 2021-02-06 | feeling abnormal, anxiety |
1350 Feeling anxious and weird, HX seizures as a child, 1413 Zyrtec given laid down Semi Fowlers po...
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1350 Feeling anxious and weird, HX seizures as a child, 1413 Zyrtec given laid down Semi Fowlers position 1444 Report feeling nasal congestion throat swelling has improved. Vitals 124/84, P-79 SPO 97 % Exited and in stable condition.
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| 41 | 2021-02-06 | sleep disorder, feeling abnormal |
Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morn...
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Within hours after 1st dose, felt foggy, L arm & neck pain & bad headache. Felt better the next morning. 2nd dose, felt foggy, L arm pain & bad headache hours after. Fatigue the same night, had chills, couldn?t sleep and woke up with a temp of 100.3, sinus & ear pressure/pain, congestion & then a runny nose, headache, L arm & neck pain, felt like I was swallowing rocks, sore throat, diarrhea
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| 41 | 2021-02-07 | anxiety |
Headaches; Rigors; Extreme fatigue; left arm pain radiating up to neck and skull; left arm pain radi...
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Headaches; Rigors; Extreme fatigue; left arm pain radiating up to neck and skull; left arm pain radiating up to neck and skull; chest and back pain /stabbing pain in my left chest; chest and back pain; Nausea; heart palpitations; feeling of impending doom; This is a spontaneous report from a non-contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 18Jan2021 07:30 (at the age of 41-years) to as a single dose for Covid-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical vaccine data included that the patient received the first dose of BNT162B2 on 28Dec2020 at 07:15 (at the age of 41-years) in the left arm for Covid-19 immunization. There were no concomitant medications. On 18Jan2021 22:30, 15 hours after second injection the patient experienced symptoms which would best be described as a cardiac event. The patient elaborated that she woke from sleep with left arm pain radiating up to neck and skull, chest and back pain, nausea and stabbing pain in my left chest. This was associated with heart palpitations and a feeling of impending doom. The episode lasted 15 minutes and happened 4 times throughout the night. On 19Jan2021 at 07:30, 24 hours after injections the patient experienced headaches and rigors began with extreme fatigue. Unable to function type of fatigue. Fatigue persisted for 48 hours post injection. The patient was now 72 hours post injection and continued with headache and nausea. The patient did not receive any treatment for the events. The patient had not been tested post vaccination. The clinical outcome of event extreme fatigue, chest and back pain, heart palpitations feeling of impending doom, left arm pain radiating up to neck and skull and rigors was recovering. The outcome of events headaches and nausea was not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.
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| 41 | 2021-02-08 | anxiety |
Got second vaccine on Tuesday feb 2, by Wednesday evening I felt extremely tired and sore muscles. ...
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Got second vaccine on Tuesday feb 2, by Wednesday evening I felt extremely tired and sore muscles. By Thursday/Friday I noticed that it seemed as though the glands in my neck were swollen (slightly affecting my salivary glands especially on left side). My left armpit is very swollen and remains swollen to today. By Friday and into Saturday and currently I developed tinnitus in both ears. My ears feel stuffy, like I went up in an airplane and they need to pop. The tinnitus is really loud, especially at night and has triggered my anxiety. I?m so upset and scared I?ll have tinnitus for life now. I?m an avid bird watcher and I?ve also prided myself on excellent hearing, so I?m taking this hard. Very, VERY, scared.
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| 41 | 2021-02-08 | insomnia |
I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness a...
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I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.
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| 41 | 2021-02-09 | crying |
At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front ...
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At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front 4 teeth were in so much pain I cried. I took 100mg of Tylenol and the pain lessened in about 2 hours. At approximately 10am on 2/5/21, I became clammy with shivers yet I was feeling over heated. My temperature was 99.3 degrees. I did not take any medicine but instead took a nap. When I woke up, my temperature felt normal. I did feel dizzy until around 4:3pm that same day. I still get headaches in the front of my forehead since 2/5/21.
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| 41 | 2021-02-09 | feeling abnormal |
This 41 yo female received her first Pfizer COVID vaccine (Lot EL1284) on 1/7/2021. She reports be...
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This 41 yo female received her first Pfizer COVID vaccine (Lot EL1284) on 1/7/2021. She reports being in good health, had no illness exposures (does work in hospital with children), and had no recent travel. She reports following her Covid vaccination, she had a sore arm at vaccine site for 4-5 days with no other issues. On 1/31 (day24) while putting on lipstick to take a selfie to send to her friend she noticed the right side of her lower face (lip area) felt "weird"- tingled and the corner of her mouth would not smile symmetrically with left. Her friend commented something was off with this picture. The next day this droop worsened with loss of facial lines/wrinkles on right (nasolabial fold), had tingling/numbness to lips and corner of mouth and inability to smile on right. This prompted her husband to bring her to the ER on 2/1/2021. She denied any fever, headache, weakness to arms/legs, no SOB/CP, dysphagia or speech issues or trauma. ER providers exam noted normal CN evaluation but documented mild right sided decrease in nasolabial fold vs left and loss of taste to anterior right tongue. She had no involvement of eye or forehead. She was diagnosed with early Bell's Palsy and treated with oral steroids and anti-virals. AS of 2/10/2021 with use of medications, she advised her facial weakness/droop had resolved but still has tingling. Her smile is symmetrical at this time. No c/o on loss of taste. Has diagnosis of Bell's Palsy. IHD case 9967.
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| 41 | 2021-02-10 | insomnia, disturbance in attention |
I suddenly developed Tinnitus after receiving Pfizer COVID-19 vaccine dose #2. It's so loud, I have...
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I suddenly developed Tinnitus after receiving Pfizer COVID-19 vaccine dose #2. It's so loud, I have difficulty concentrating and sleeping. I happened to tell someone else about this and she reported that her Tinnitus was significantly worse following dose #2 of Pfizer vaccine.
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| 41 | 2021-02-11 | crying, anxiety |
Anxiety, crying, nausea. Watched 30 minutes. Comforted, provided juice and granola bar. No symptoms ...
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Anxiety, crying, nausea. Watched 30 minutes. Comforted, provided juice and granola bar. No symptoms after 15 minutes. checked back in with her after 4 hours and no other side effects.
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| 41 | 2021-02-12 | anxiety | Pfizer-BioNTech COVID-19 Vaccine EUA Rapid, racing heartbeat - anxious feeling for about 12 hours |
| 41 | 2021-02-12 | feeling abnormal |
7 minutes after vaccine, I felt my heart pounding heavily and checked my iwatch. It indicated that m...
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7 minutes after vaccine, I felt my heart pounding heavily and checked my iwatch. It indicated that my Heart rate went from 88 to 141 in the past 5 minutes while sitting. I then felt flushing throughout my body. I had the sensation of tingling on my face and lips and told the present employees that I felt weird. They retrieved the doc, who then took my pulse ox - registered at 96/97. Then they took my blood pressure and it was 180/100 (I typically have low blood pressure 98/60). I started to feel disequalibrium and nauseous and the doc to be back to a room. She administered a dose of IM EPI and IM benedryl and called EMS. My symptoms persisted and the doc told the EMS workers I had urticaria on my face during her case presentation. I was transported to the ED, where I was monitored. My symtoms had reduced following epi and benedryl but returned when I was in the ED. The doctor administered pepcid and solu-medrol and zofran. They also conducted and EKG- reportedly normal. These medications helped control my symptoms and my BP had returned to normal (120/70) following meds. discharged on a tapering dose of steriod and zofran prn.
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| 41 | 2021-02-16 | confusional state |
Became extremely confused and felt a pressure on my chest. Was not going away after 30 minutes. Vita...
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Became extremely confused and felt a pressure on my chest. Was not going away after 30 minutes. Vitals were erratic but within normal perimeters. Was sent to the ED to monitor. The second day was washed out and felt sick but nothing else was needed.
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| 41 | 2021-02-16 | sleep disorder, disturbance in attention, impaired work ability |
Tightness in the chest, throat, ears, and head with a feeling of dizziness started on the 4th day af...
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Tightness in the chest, throat, ears, and head with a feeling of dizziness started on the 4th day after receiving the vaccine. Feeling extremely fatigued and difficulty breathing. Falling asleep whenever and wherever. Rashes all over the body including the face that come and go. Burning pain and a feeling of flushing when the rash develops. Waking up in the nights with the rashes and itchiness that is unbearable. Experiencing difficulties staying focused and complete a single task. Off from work for a week now due to continuous dizziness.
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| 41 | 2021-02-17 | crying |
trouble lifting my arm; Pain in arm; Nauseous; Chills; Urge to cry; This is a spontaneous report fro...
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trouble lifting my arm; Pain in arm; Nauseous; Chills; Urge to cry; This is a spontaneous report from a contactable consumer who reported for herself . This 41-years-old no pregnant female patient received first dose of bnt162b2 (BNT162B2) from LOT# E19262, on 03Feb2021 17:30 on right arm at SINGLE DOSE for covid-19 immunisation .Age at vaccination:41 years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine . The patient received other medications within 2 weeks of vaccination .Medical history included :Allergy to adhesive, ADHD, high blood pressure (HBP), depression, anxiety, gerd. On 04Feb2021 20:00 the patient experienced chills, urge to cry, trouble lifting in arm , pain in arm and she was Nauseous. Events reported as non serious .No treatment received. Outcome was not recovered. Prior to vaccination the patient was not diagnosed with COVID-19Since the vaccination, the patient has not been tested for COVID-19
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| 41 | 2021-02-20 | agitation |
6 hr after injection, immediate onset of upset GI, diarrhea, within hour other symptoms on-set inclu...
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6 hr after injection, immediate onset of upset GI, diarrhea, within hour other symptoms on-set including nausea (no vomiting), extreme exhaustion/fatigue, agitated/moody, malaise. About 12-18 hr in severe headache, body ache, normal site soreness. Symptoms stayed thru Thursday late afternoon and started dissipating and not clearing until Friday morning.
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| 41 | 2021-02-22 | sleep disorder |
Started with achiness just before midnight (after having sore arm all day, but not troubling), woke ...
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Started with achiness just before midnight (after having sore arm all day, but not troubling), woke with fever/chills/headache about 1am and unable to sleep well 1-6am, slight nausea 4-8am, still ongoing achiness all over body and just ill-feeling and fatigue (currently 11am day-after vaccine)
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| 41 | 2021-02-23 | anxiety |
Client c/o hot flashes on and off; tingling sensation L finger; slight difficulty of breathing; sl...
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Client c/o hot flashes on and off; tingling sensation L finger; slight difficulty of breathing; slight dizziness and states " feels like having anxiety."
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| 41 | 2021-02-24 | feeling abnormal | COVID-19 Vaccine |
| 41 | 2021-02-24 | impaired work ability |
Took the shot on 2/18 and on 2/21 that night about 10:30 my arm started itching below where I got th...
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Took the shot on 2/18 and on 2/21 that night about 10:30 my arm started itching below where I got the shot on left arm. Wen to bed and woke up next morning it was broken out with blisters all over body, itching everywhere. I went to see my doctor and she hadn?t seen anything like this. I went to the dermatologist they took 3 biopsy?s and came back with a diagnosis of Sweets Syndrome which is an auto immune disorder, paperwork from dermatologist states that it would be favored more likely due to the vaccine. Now I have no job because I cannot work like this, it breaks out or flares up any my allergies flare up or anything that causes my white blood cells to go up.
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| 41 | 2021-02-28 | feeling abnormal |
fever (102.3), sore arm, sore arm pits, headache, brain fog, chills, body ache, food aversion, nause...
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fever (102.3), sore arm, sore arm pits, headache, brain fog, chills, body ache, food aversion, nausea, fatigue
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| 41 | 2021-02-28 | impaired work ability |
About 16 hours after shot some soreness/pain up my spine, still could do daily activities- took some...
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About 16 hours after shot some soreness/pain up my spine, still could do daily activities- took some ibuprofen as needed. But after 24 hours abdominal pain, still able to do daily activities but during that evening's sleep the pain went up and felt like the early stages of labor through till the morning-- then I took ibuprofen. This abdominal cramping was steady in the night and did not easy for many hours and caused me to vomit. Due to pain and vomiting I was not able to go in to work for the day but was able to recover by lunch time with ibuprofen and rest and so I could return to work the following day.
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| 41 | 2021-03-01 | anxiety |
S: 41 yo female c/o B/L arm redness from upper arm to finger tips, dizziness, mild throat tightness ...
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S: 41 yo female c/o B/L arm redness from upper arm to finger tips, dizziness, mild throat tightness and facial flushing after 16:10 after Pfizer vaccine that was given at 16:10. First dose of vaccine. No SOB. O: Pt flushed, arms reddened and feeling uneasy. B/P 130/100, Pulse 98. RA STATS 99%. RR 16. Lungs CTA. Benadryl 25 mg PO at 16:29, water and reassurance. B/P at 16:41 126/82, Pulse 94, SATS 100%, Lungs clear, B/L arms normal color. Hands remained chapped and reddened (too much hand washing per patient). A: Mild allergic reaction to Pfizer vaccine, first dose. P: 16:56, patient improved, refused further care, refusal form signed and instructions given for post care and worsening symptoms. Pt discharged to home via W/C to care. Instructed to F/U as noted.
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| 41 | 2021-03-02 | feeling abnormal |
headache; on and off chills; lethargic; nasal congestion; started feeling run down; This is a sponta...
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headache; on and off chills; lethargic; nasal congestion; started feeling run down; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received 2nd dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in left arm on 16Feb2021 12:00 at single dose for covid-19 immunisation. Medical history included nocturnal seizures, hypothyroid, sinus infections, seasonal allergies, allergies to sulfa drugs. Concomitant medication included lamotrigine (LAMICTAL), levothyroxine, glucosamine, naproxen sodium (ALEVE), cetirizine hydrochloride (ZYRTEC). The patient previously received 1st dose of bnt162b2 on 26Jan2021 at 11:00 in left arm for covid-19 immunisation. At about 11 pm after the vaccination (16Feb2021 23:00), started feeling run down. Woke up the next morning (17Feb2021) with headache, on and off chills, lethargic, with nasal congestion. No treatment received in response to the events. The outcome of events was recovering. This case was reported as non-serious. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 41 | 2021-03-02 | insomnia, mental impairment, sleep disorder, confusional state, feeling abnormal |
Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, l...
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Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, lymph node under arm - near breast on side of vaccination swollen for 4 days. Headache Onset of chills began at 1am. Around 5am I started shaking and nauseous and I had not been able to fall back to sleep. 5am 2/25 until I woke up for the day 2/26 at 6am, I had the nausea, chills, weak. Lymph node swollen stayed for 4 days. I felt very confused, like I couldn't hold a full thought. No reaction to 1st vaccine except a sore arm
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| 41 | 2021-03-02 | loss of personal independence in daily activities |
STARTED HAVING SHOULDER PAIN IN RIGHT ARM RIGHT AFTER VACCINE BUT PAIN DID NOT IMPROVE AND STARTED H...
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STARTED HAVING SHOULDER PAIN IN RIGHT ARM RIGHT AFTER VACCINE BUT PAIN DID NOT IMPROVE AND STARTED HAVING LIMITED MOBILITY WHICH KEPT GETTING WORSE. BY 3RD WEEK I WENT TO MY PCP AND SHE SAID I NOW NEED PHYSICAL THERAPY AND IS NOT SURE HOW LONG I WILL NEED TREATMENT. SHE COULD FEEL A LARGE LUMP ON MY RIGHT DELTOID WHERE THE VACCINE WAS GIVEN AND RECOMMENDED HEAT AND IBUPROFEN/TYLENOL, ALSO. I AM NOT ABLE TO WASH MY HAIR WITHOUT ARM PAIN, REACH BEHIND ME, LIFT OBJECTS LIKE MY PURSE OR A MILK UG, PICK UP MY WATER BOTTLE WHILE SITTING AT MY DESK, SLEEP WITH MY ARM STRETCHED OUT, AMONG OTHER DAILY THINGS.
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| 41 | 2021-03-02 | sleep disorder |
Reports symptoms began 6pm , 1 hour after receiving vaccination, headache and feeling bumps on her ...
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Reports symptoms began 6pm , 1 hour after receiving vaccination, headache and feeling bumps on her tongue and roof of mouth, taste was off. on 3/3/21 midnight was awakened from sleep from pain in all of her joints, back and neck. Experienced dizziness and fatique in the morning.
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| 41 | 2021-03-04 | sensation of foreign body |
About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nau...
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About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nausea, feeling faint, knot in throat, this last about 5-10 minutes then passed, had knot in throat x 2 days.
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| 41 | 2021-03-07 | anxiety |
o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief...
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o Complaint The patient is a 41 year(s) old Female complaining of allergic reaction, nausea. o Chief Complaint Quote Patient complained of allergic reaction that started about 45 mins ago. She got her 1st dose of Pfizer Covid vaccine yesterday morning. She complained of rash all over the body, swelling on the hands and face including eyes and lips. She denied chest pain, abdominal pain, fever, cough, vomiting and difficulty breathing. She complained of nausea that started 5 mins ago. She has not taken any meds yet for her symptoms. o Time Seen 02-18-2021 01:20 o Historian patient ADDITIONAL HPI: o Additional HPI Pt here with concerns of allergic reaction. Pt fell asleep on the couch approx 2200. She awoke 2 hours later with itching of her hands. Over the next hour she developed a full body rash, itching, and swelling of face. No wheezing, no difficulty swallowing. Upon arrival to ED pt started to feel nauseated. Pt had first dose of COVID vaccine approx 16 hours prior to onset of sxs. No h/o allergic reactions, no h/o asthma. Emergency Department Course and Clinical Decision Making: Patient presents with urticaria and swelling to her face eyes and lips. Shortly upon being roomed she started to feel very nauseated and started vomiting. No stridor or wheezing, no immediate airway compromise but given both cutaneous and GI symptoms, significant concern for anaphylaxis. Patient was immediately given epinephrine intramuscularly, 0.3 mg. An IV was placed and she was given Solu-Medrol, Benadryl, Pepcid, and Zofran. Patient's urticaria and swelling started to nearly immediately improved after the epinephrine. She is feeling much better though slightly anxious. To be reaction from the Pfizer vaccine, no other obvious triggers, patient has no history of allergic reactions or other sensitivities. We will observe in the emergency department in a monitored setting for several hours to assure no rebound symptoms, patient updated on plan. 0500 Pt has been resting. Urticaria resolved, swelling to face resolved. Discussed with pt reporting reaction to CDC, info provided. Also discussed the second dose of vaccine, recommended reaching out to Epi response team or PCP to get recommendations. Will give short course of prednisone, 4 days, Benadryl as needed, ED return precautions discussed, will dc home.
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| 41 | 2021-03-07 | anxiety |
Skin became hot, burning, difficulty swallowing, difficulty breathing, anxiety, dizziness, light hea...
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Skin became hot, burning, difficulty swallowing, difficulty breathing, anxiety, dizziness, light headed. Took benadryl po 50 mg. Was seen at ER. Received albuterol neb, steroids IV, and prevacid PO. Sent home with po steroids and benadryl. S/S improved after treatment.
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| 41 | 2021-03-07 | disturbance in attention |
1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body ache...
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1/9/21: second dose of vaccine administered at day 12 body chills, aches by 11pm 1/10/21: body aches, low grade fever, woke up early morning (6 or 7am) with nausea, weakness- husband had to help me to bed, headach by 4pm fever was getting higher, body aches and chills worsen. Called Telehealth for support and was advised to go to ER At ER arrived with high fever, full rigor, bones felt like they were breaking one by one so bad body aches, chills 1/12/21: First day of cognitive issues - sever fatigue, could not comprehend anything, could not work or do school 1/17/21: Realized the cognitive issues were bad and needed to see DR, dizziness, audio distorted, couldn't follow directions 1/18/21: First Dr apt at medical center Currently still in Dr's care 2/23/21: First Nuro apt with specialist
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| 41 | 2021-03-07 | feeling abnormal | Extreme fatigue. Brain fog. Muscle aches. Nausea. Mild fever |
| 41 | 2021-03-09 | anxiety, depression, nightmare, impaired work ability |
Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection s...
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Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021
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| 41 | 2021-03-10 | feeling abnormal |
Racing heart Numbness and tingling from mouth to toes Weak Dizzy/lightheaded Foggy Happened about 8...
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Racing heart Numbness and tingling from mouth to toes Weak Dizzy/lightheaded Foggy Happened about 8 times over 3 days
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| 41 | 2021-03-10 | sensation of foreign body | lips and tongue tingling, lump in throat. Evaluated by EMS-Cleared |
| 41 | 2021-03-11 | feeling abnormal |
Other than the normal symptoms of chills, body aches, feeling run down....the day after I had the se...
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Other than the normal symptoms of chills, body aches, feeling run down....the day after I had the second dose, I experienced a fainting episode and collapsed on the floor.
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| 41 | 2021-03-11 | impaired work ability, sleep disorder |
1/11/21- (24 hrs. after)- first vaccine, experienced mild body aches soreness in arm from injection ...
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1/11/21- (24 hrs. after)- first vaccine, experienced mild body aches soreness in arm from injection and slight fatigue. 2/1/21 (12hrs. after)- second vaccine experienced the following: chills/mild fever, body aches. (15-20 hrs. after) - visibly shaking with chills body aches comparable to the flu. Awoken by chills and shaking, fatigue. Fever broke, sweating 22 hrs. after receiving 2nd vaccine. Work in an office setting, was only able to stay 3 hours (0730-1030)due to exhaustion, body aches and generally feeling unwell. Day 2-6 sharp frequent headaches, and fatigue all other symptoms gone.
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| 41 | 2021-03-14 | depression |
1/13 vaccination About 6 hours later, I started to feel hot, feverish, to feel really sick. I didn't...
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1/13 vaccination About 6 hours later, I started to feel hot, feverish, to feel really sick. I didn't think much about it. I went to work, thought was a sinus infection. Went home, and felt horrible. 1/14 didn't feel great but went to beach for my birthday. It went downhill from there. I got really really sick really fast. 1/17 rapid test; positive. *still very fatigue, hard to describe the feeling. I get winded really easy. **it really did affect me; 'put me in a dark place' / the mental part is really worse then the body part.
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| 41 | 2021-03-14 | excessive sleepiness, impaired work ability |
Chills, Fever, (my normal temp is 97.4-97.8 daily for the past year) and after the shot, my temp ros...
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Chills, Fever, (my normal temp is 97.4-97.8 daily for the past year) and after the shot, my temp rose to 99, 100, 101.2 - from Sat., 3/6 - Sun., 3/7. I was exhausted and slept most of the night and day on Sun., 3/7. I then woke up thinking the worst was behind me - I ended up getting stomach pains and had diarrhea late Sun., 3/7 and into Mon., 3/8 followed by a throbbing headache and feeling super tired. The headache lasted through Thursday afternoon and is gone now. I am still pretty tired.
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| 41 | 2021-03-14 | insomnia |
Injection occurred at 1:30pm Friday Severe stabbing muscle pain around ribs starting in the back int...
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Injection occurred at 1:30pm Friday Severe stabbing muscle pain around ribs starting in the back intercostal muscles around 8pm Friday. Muscle spasms and pain increased and spread to back and front intercostals as well as upper back muscles making it painful lay down or walk most of the day Saturday. Muscle pain made sleeping difficult Friday and Saturday nights. By Saturday morning the pain started to subside and spasms were only affecting lower intercostal muscles. By the time I woke up at 6am Sunday all pain was gone.
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| 41 | 2021-03-15 | emotional distress |
Patient felt faint nearly immediately after but said she wasn't having problems breathing. She was...
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Patient felt faint nearly immediately after but said she wasn't having problems breathing. She was told to breath deeply and she quickly started feeling "a little better" so she was helped to a chair with arm rests in the room. She said she had an orange in her bag, so she started eating her orange. Just a minute later she said she was going to pass out, so the pharmacist caught her. He held her up in the chair and tried to revive her for a few moments but noticed that the blood was draining from her face and her lips were turning blue so yelled for one of his technicians to call 911 and the other to grab an epi pen. He then lowered her to the floor in case he needed to begin to resuscitate while the technician brought him the epipen. While lowering her she urinated on herself. As the pharmacist went to check her vitals before administering the epipen and beginning cpr if necessary the patient suddenly gasped once and her eyes opened widely, but not continue to breath. Upon inspection in her mouth there was a piece of orange near the bottom of the throat. The pharmacist asked if she was choking and she did not response at all, but did not start visibly breathing either. So the pharmacist swiped the piece of orange out quickly, in case it was either previously lodged or patient would have to be resuscitated. She did not seem to enjoy this and this seemed to wake her up and she quietly gasped not choking. She started to quickly improve and admitted that she was feeling better, and had passed out before after getting blood drawn but never after a shot so didn't mention this. While this was happening a police office was going through the drive through so the technician called him in for assistance and he arrived around this time. He asked her a few questions like "what's her name, who's president, how many quarters are in a dollar" which she was able to answer. She said she was mostly embarrassed and was feeling much better. She sat up in the chair again about the time the emts came in. The checked her out, but she didn't want to go to the Emergency Room. She was driven home by her father. I called her later around 6 pm that night and she said she was feeling totally fine and I advised her to please call her PCP and discuss this incident with him or her.
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| 41 | 2021-03-15 | feeling abnormal |
Within an hour of receving the vaccine, I became dizzy, had face tingling and arm tingling and felt ...
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Within an hour of receving the vaccine, I became dizzy, had face tingling and arm tingling and felt mentally foggy. As the day progressed, I felt a fullness in my throat and fatigue. Over the next week, the dizziness became worse, I experienced intense headaches and shortness of breath for several days. I had difficulty sleeping and vivid dreams. I have had thyroiditis twice in my life after giving birth to my 2 children with similar dizziness and throat fullness. I decided to contact my doctors and had my thyroid levels checked. My TSH was abnormal and my doctor thinks I could be having another episode of thyroiditis. My menstrual cycle arrived a week early. Following this, I continued to have dizziness, throat fullness, and intense headaches. I developed sore breasts and breast discharge as well as in increase in frequency of urination. I decided to postpone the second shot until I was feeling better as past episodes of thryoiditis took about 2 months to resolve. My next menstrual period was a week late, also accompanied by mood swings, breast tenderness and intense headaches. SIx weeks later, I continue to experience occasional dizziness and throat fullness and increased urination. Prior to the vaccine, I was feeling fine and it seems like the vaccine triggered some kind of hormone/endocrine response in my body. I have not had reactions to any vaccines prior to this. I am quite hesitant to receive the second vaccine and am wondering if I should wait a period of time and try something different such as the Johnson and Johnson one. I? not quite sure what in the Pfizer vaccine ( perhaps the mRNA?) could have triggered this reaction in my thyroid and endocrine system. and would appreciate guidance on what to do next as I would like to be fully protected from COVID-19 but do not want to endure these unusual side effects.
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| 41 | 2021-03-16 | disorientation |
I got my vaccination at 4pm, waited the 15 minutes at the united center waiting area and felt fine. ...
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I got my vaccination at 4pm, waited the 15 minutes at the united center waiting area and felt fine. I went home to pickup my daughter and at 6pm was back on the road driving and started to feel tired. I stopped at the light at foster and had just called my parents to tell them i had gotten the shot. I mentioned I was starting to feel tired and as I said it started to feel more tired. My mom responded maybe you should pull over and that was the last thing i remember as I fainted/blacked out immediately after. When I awoke my daughter (in the back seat along with my dog) explained that I had accelerated and hit the back of another car and then drove around that car, ending with both cars facing the direction of travel with my car in front of the car i had rear-ended. I was completely disoriented and had not recollection of hitting the gas or break much less driving. I was told two times that the driver in the other car was fine and was told when asked a third time that he did have some pain possibly and went in the ambulance to get checked out. I felt disoriented and jittery last night, took 2 Tylenol before bed and have felt fine today beyond feeling confused and horrible about what happen. My husband picked me up form the site and took me to my parents a few blocks north of the accident.
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| 41 | 2021-03-16 | feeling abnormal | Sore arm, tiredness, foggy, fever, nausea, racing heart, pulpultations, diarrhea |
| 41 | 2021-03-16 | insomnia |
It gets worse everyday, got vaccine on Sat morning and today is Wednesday- Headach, chills, stomach...
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It gets worse everyday, got vaccine on Sat morning and today is Wednesday- Headach, chills, stomach ach, night sweating, sleepless, shoulder ach
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| 41 | 2021-03-17 | fear, anxiety | Tingling in head, light headedness. Stated she is scared. Anxious. V/S 122/56, HR 72, O2 99%. |
| 41 | 2021-03-17 | feeling abnormal |
The injector could not get the shot in, and kept trying and finally after i heard a pop the shot go...
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The injector could not get the shot in, and kept trying and finally after i heard a pop the shot got in. Injection site is more towards side arm and shoulder. 3 hours after the second shot, I started to experience flu like symptoms, dizzy, achy, arm pain from awful injections, soar arm etc etc. The last 3 days I have experienced all symptoms that they say are normal, plus nerve pain running down my arm and across my chest to my other arm pit. Back pain, neck stiffness and just an overall feeling not good. I am concerned that there is damage from the injector not knowing what she was doing and now I am having a reaction to how she did the shot. Injection site is hot to the touch and bruised. My first vaccine I did experience dizziness and injection site looked like I was stung by a bee, very swollen but not hot to the touch like now. I have been on tylenol, which is doing anything so i switched to ibuprofen for pain, achinesss and overall just not feeling well. I cannot move my arm much, but can use my fingers. Today is day 4 of the same issues and at this point if my arm is not better by next week I will go see the doctor. My doctor has advised to report this, and ice areas and ibuprofen/tylenol. I am concerned I have nerve damage done at this point from whoever was the injector. I am hoping there is a way to find out who did mine. At the end of the appt, the injector did say sorry that was awful and I was so traumatized that I didn't even know what to do or say at the time. It was so bad my husband was getting his phone out to video but as soon as he did, she got it in deep where it was suppose to go????
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| 41 | 2021-03-18 | loss of personal independence in daily activities, impaired work ability |
Injured my back during vacuuming on Saturday 3/13. Went to ER on Sun 3/14 from back pain and limited...
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Injured my back during vacuuming on Saturday 3/13. Went to ER on Sun 3/14 from back pain and limited mobility. Received intravenous steroids and lidocaine patch and was prescribed muscle relaxers, lidocaine patches, and ibuprofen 600 to manage pain. Had two chiropractic adjustments on 3/15 and 3/17 for SI joint pain. Only worked 1 out of 5 days this week and still dealing with dull achey pain and limited mobility when sitting, transitioning from positions, and bending over. Had a follow up with an urgent care provider on 3/18 who advised me to continue to rest and take full dose of ibuprofen to mitigate SI joint inflammation.
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| 41 | 2021-03-19 | feeling abnormal, nervousness |
10:54 Throat thick, report feeling "funny"/ strange. BP 110/60 10:57 EPI administered, BP 110/80 Th...
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10:54 Throat thick, report feeling "funny"/ strange. BP 110/60 10:57 EPI administered, BP 110/80 Throat feels better. Shaky. 11:02 Transported
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| 41 | 2021-03-20 | sensation of foreign body |
Shortly after the vaccine was administered, pt endorsed feeling as if a "lump" was in her throat. Fe...
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Shortly after the vaccine was administered, pt endorsed feeling as if a "lump" was in her throat. Felt some tightness with swallowing. No SOB, wheezing, nausea/vomiting, urticaria. Normal vitals and exam, post oropharynx clear, no angioedema and no wheezing on exam. Pt given oral Benadryl, a nd observed in car for 30 minutes prior to discharge
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| 41 | 2021-03-21 | anxiety |
Pt received first dose of the Pfizer covid19 vaccine at 1014. Immediately after pt stated feeling a...
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Pt received first dose of the Pfizer covid19 vaccine at 1014. Immediately after pt stated feeling anxious, dizzy and like her heart was pounding. Pt was monitored, provided water and was released at 1140 after symptoms went away.
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| 41 | 2021-03-22 | amnesia, incoherent |
About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt ...
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About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt cloggd. Tachycardia, palpitations, nausea/vomitting, extreme Fatigue, weakness, headache, dizziness, and loss of memory. I had this type of episode 2-3 times over 5 days, lasting about 20-30 minutes, last one being at work, all of a sudden, same type of episode. Went to ER after Coworkers stated I was " in coherent " or in and out, my BP upon arrival to er was in the 160's/90's. They ran multiple lab tests, CT head, CXR and ECG. By the time I was dicharged my BP was normal I believe it was 116/81. Some side effects like nausea lasted a week, I was given an antinuasea prescription
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| 41 | 2021-03-22 | feeling abnormal |
Red swollen warm sensitive spot too the side of where the injection was. Felt horrid with an upset ...
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Red swollen warm sensitive spot too the side of where the injection was. Felt horrid with an upset stomach all day yesterday. Felt feverish.
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| 41 | 2021-03-23 | impaired work ability |
Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2,...
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Sore arm March 19-20 Fever began March 21 to present, ranging in 99 degree range daily. Lowest 99.2, highest 99.6. Also experiencing chills, lymphnode on left side of neck, little to no appetite, diarrhea, full body aches, dizziness, ringing in ears, knee pain, headache, nausea, sweating, tiredness. I have not been to work this week.
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| 41 | 2021-03-24 | anxiety, nightmare, depression |
Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder an...
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Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-03-24 | confusional state |
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / L...
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Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
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| 41 | 2021-03-24 | impaired work ability |
Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperatu...
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Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-03-25 | sensation of foreign body |
24 hours later, I developed issues with my throat. I have spasms that feel like my throat is tighte...
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24 hours later, I developed issues with my throat. I have spasms that feel like my throat is tightening up. This has been going on for 3 weeks. I have trouble swallowing and i constandly feel like something is stuck in my throat.
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| 41 | 2021-03-26 | anxiety, panic attack |
Pfizer COVID-19 Vaccine EUA 3/23: The patient presents with facial swelling and facial swelling. Pa...
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Pfizer COVID-19 Vaccine EUA 3/23: The patient presents with facial swelling and facial swelling. Patient a 41 y/o female with a history of HTN and anxiety presents to the Emergency Department with facial swelling in her left cheek that began today after she received her first dose of the Pfizer COVID-19 vaccine. She had a panic attack prior to getting vaccinated today. She was also feeling anxious while receiving the vaccine and states that she experienced a tingly sensation on the inside of her cheek as well as having a dry mouth. The patient denies trouble swallowing and eating, sinus pressure, shortness of breath, rashes, and dental issues. She notes that she has gone to the bathroom more frequently today but is not experiencing any diarrhea. Additionally, she has taken hydroxyzine for her symptoms. She is allergic to penicillin.. The onset was abrupt. The course/duration of symptoms is constant. Location: Left cheek. The character of symptoms is swelling. The degree at present is minimal. The exacerbating factor is none. The relieving factor is none. Risk factors consist of none. Prior episodes: none. Therapy today: prescription medications including hydroxizine. Associated symptoms: Dry mouth and tingly sensation on the inside of cheek. Associated injury none. She states she had a panic attack upon sitting down in the chair to receive her COVID shot in her left arm. She had to take her anxiety medication there and then later in the day. She states she felt as if the inside of her cheek was swollen and scratchy this made her very anxious and decided to come in to get checked out. She denies any hives any abdominal pain nausea vomiting shortness of breath chest pain or redness at the injection site. She feels mildly improved from an anxiety standpoint now compared to the onset but still mildly anxious. She has a very normal physical exam no neck tongue or lip swelling there is no redness at the injection site she has no hives abdomen is soft and tender or buccal mucosa is unremarkable ultimately patient reassured discussed it is important she get her 2nd COVID shot. She understands return precautions for signs of allergic reaction. She received no medications.
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| 41 | 2021-03-28 | nervousness |
Presented self with "H/A". no blurred vision or difficulty breathing. Stated she had just a "lil b...
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Presented self with "H/A". no blurred vision or difficulty breathing. Stated she had just a "lil blurred vision". Also stated had not eaten since breakfast. Came directly to get vaccine after work. Husband driving car, advised if HA worsens, pull over and dial 911. Stated feel better. she thinks it was just nervousness. Allowed to leave observation area.
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| 41 | 2021-03-29 | depression |
Fatigued, swellling and soreness in armpits for over a week, headache for two days, depression and m...
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Fatigued, swellling and soreness in armpits for over a week, headache for two days, depression and moodiness, lack of appetite for several days after the shot
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| 41 | 2021-03-30 | sensation of foreign body | lump in throat. Evaluated by EMS-Cleared |
| 41 | 2021-03-31 | feeling abnormal |
Pt received first dose Pfizer vaccine at 1528, at 1550, pt was in observation area and reported fee...
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Pt received first dose Pfizer vaccine at 1528, at 1550, pt was in observation area and reported feeling "strange" like her throat was tight. Pt has PMH of anaphylactic reaction to multiple medications and foods. Nurse encouraged pt to begin pursed lipped breathing. At 1552 pt became SOB and felt her throat "closing". Administered 0.3mg Epinephrine IM to L quadriceps muscle, applied O2 via mask running at 12L and called 911 for ER transport. BP 138/72, HR 100, O2 sat 99% temp 98.2. Paramedics arrived at 1558, pt was stabilized and transferred to higher level of care.
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| 41 | 2021-04-01 | anxiety |
Patient received 1st dose ofCovid vaccine & was anxious about receiving it. I gave the vaccine at 10...
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Patient received 1st dose ofCovid vaccine & was anxious about receiving it. I gave the vaccine at 10:40 & She started to have tingling in her hands about 15 mins after. I took her blood pressure at 11:00am because she was getting dizzy/lightheaded. It was 135/85 & her pulse was 85 so I believe she was getting more anxious. At 11:05 she stated that she was having trouble breathing, so I confirmed with her several times that she was having trouble breathing & gave EpiPen in left leg 0.3mg then called 911. She felt like she was breathing easier but was going to pass out so had her lay on her back with feet elevated until paramedics arrived.
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| 41 | 2021-04-01 | feeling abnormal |
Headache, nausea, foggy brain starting about 20 hours after vaccine, lasting up until around 32 hour...
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Headache, nausea, foggy brain starting about 20 hours after vaccine, lasting up until around 32 hours after vaccine. Staying very hydrated seemed to help minimize the nausea a bit.
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| 41 | 2021-04-01 | irritability |
My skin has been itchy in various places since the first dose. My stomachs (upper and lower), My che...
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My skin has been itchy in various places since the first dose. My stomachs (upper and lower), My chest especially in-between my boobs and under them and my chest has broken out into red bumps when I itch it. I have a sensation of lactation in my breath even though I haven't been pregnant since 2017. My breaststroke feel cystic and swollen but my period isn't due. Lots of extra sensation in my chest. I feel more irritable. The itching has been every since my first Pfizer shot. I am sweating abnormally in my chest area. Daily. Since first dose. Arm had more tenderness with the first dose than the second.
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| 41 | 2021-04-02 | anxiety |
Within 5 min of receiving the shot there was a minor itch such as a tag rubbing my neck. I am not a...
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Within 5 min of receiving the shot there was a minor itch such as a tag rubbing my neck. I am not an itchy person so I noticed it right away, but ignored it. Then with in the 10 minutes I felt an elevated breathing as if one were hyperventilating. I told myself that I was probably anxious any that too went away within 3+ minutes. The itch continued to increase after leaving the site, and by 6 pm it had become like an ?morphine drip? type itch . An itch that you get after a procedure in a hospital and they give you opioids. An annoyance but harmless. This has continued for 3 days. After the first day, I asked a pharmacist what would be recommended for the itch. She suggested benedryl. It worked for a short period of time 1 1/2 hours. Calamine lotion was also tried with a cool shower. After the 3 day I went to the urgent care where no testing was done, but I was prescribed hydroxyline
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| 41 | 2021-04-02 | panic reaction, abnormal dreams, hallucination |
2nd dose after 30 mins- dizziness after 3 hours- extreme fatigue after 8 hours for next 3 nights- ...
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2nd dose after 30 mins- dizziness after 3 hours- extreme fatigue after 8 hours for next 3 nights- severe headache, vivid dreams, hallucinations, out of body experience, panic, nausea
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| 41 | 2021-04-03 | feeling abnormal |
My joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and...
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My joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes) was at a 5. Usually, my joint is at a 2. My right ankle became swollen. Usually, my ankles don't swell. I've also had four migraines during this time -- I typically have migraines every two to three months. I experienced fatigue which caused me to take multiple naps throughout the day. I experienced multiple days of brain fog, lasting up to 5 days at a time. Typically, I have brain fog for 2 - 3 days. Basically, I feel like I'm having a prolonged fibromyalgia and Sjogren's episode. The symptoms are still persisting.
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| 41 | 2021-04-04 | confusional state |
Racing heart (160 BPM), sores in mouth, confusion, high fever (104F +), vomiting, and most concernin...
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Racing heart (160 BPM), sores in mouth, confusion, high fever (104F +), vomiting, and most concerning: I couldn't not figure out how to use my hands. I could move them, but not where I wanted to. For example, I couldn't 'find' my face or get my right hand to make contact with my left hand.
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| 41 | 2021-04-04 | feeling abnormal | Aches, Chills, constant sleep, throwing up, headache, foggy head, cold sores |
| 41 | 2021-04-05 | sleep disorder | extreme arm and shoulder soreness, painkillers ineffective, throbbing, unable to sleep due to pain |
| 41 | 2021-04-06 | amnesia |
Dizzy, lightheaded, pain, excessive fatigue, memory loss. After first shot it lasted for about 2 1/2...
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Dizzy, lightheaded, pain, excessive fatigue, memory loss. After first shot it lasted for about 2 1/2 weeks. After second shot, it has lasted a week so far.
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| 41 | 2021-04-07 | irritability |
Fatigue, migraine got worse, dizziness, irritability, lightheaded, blood pressure and heart rate wen...
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Fatigue, migraine got worse, dizziness, irritability, lightheaded, blood pressure and heart rate went up
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| 41 | 2021-04-08 | feeling abnormal, loss of personal independence in daily activities, confusional state |
migraine that lasted more than five hours, accompanied by confusion, and extreme lethargy. Lethargy,...
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migraine that lasted more than five hours, accompanied by confusion, and extreme lethargy. Lethargy, feeling faint, chills, and weakness continued for over 24 hours. Extreme fatigue and mental fogginess still persistent, impeding all day-to-day activities.
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| 41 | 2021-04-08 | feeling abnormal |
Pfizer-BioNTech COVID-19 Vaccine EUA first dose administered approximately 2:52pm. Reaction started ...
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Pfizer-BioNTech COVID-19 Vaccine EUA first dose administered approximately 2:52pm. Reaction started approximately 2:57pm after seated in observation area; sense of feeling "not right" then heart started racing, chest felt tight, vision got strange and I couldn't really move. Once this episode passed I got up and told a volunteer I thought I was having a reaction. Moved to secondary observation area, hooked up to machine that tracked heart rate and blood pressure. Next episode occurred at approximately 3:10pm; heart rate shot up to 160 (unsure of BP), same feelings of immobility accompanied with urge to pee/poop. These episodes continued for 4-5 rounds until approximately 4pm and lasted multiple minutes each time.
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| 41 | 2021-04-08 | sleep disorder |
Patient began feeling pain in her legs that woke her up several times at night and into the morning....
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Patient began feeling pain in her legs that woke her up several times at night and into the morning. Walking helped to prevent serious pain. Offered that she get electrolytes and magnesium and contact her doctor.
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| 41 | 2021-04-09 | anxiety | Anxiousness. |
| 41 | 2021-04-09 | anxiety | Anxiety, nausea, headache, racing heart 12:00pm-10:00pm day after vaccine |
| 41 | 2021-04-09 | confusional state |
Approx. 36 hours after the first shot, I noticed an intense ringing in my ears that has not gone awa...
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Approx. 36 hours after the first shot, I noticed an intense ringing in my ears that has not gone away. For the first 48 hours I also experienced dizziness, confusion, mood swings, and soreness in my arm. I still have occasional dizziness and mild vertigo.
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| 41 | 2021-04-09 | insomnia |
First dose, fever of 103.2 F; Chills; sweating; fatigue; headache; muscle pain; arm pain; insomnia; ...
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First dose, fever of 103.2 F; Chills; sweating; fatigue; headache; muscle pain; arm pain; insomnia; nausea; This is a spontaneous report received from a contactable other-HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number :UNKNOWN) via an unspecified route of administration in left arm on 17Feb2021 at 05:00 PM (at the age of 41-years-old) as single dose for covid-19 immunization. Facility type vaccine was Hospital. Patient medication history included severe preeclampsia, Patient allergic with penicillin and concomitant medications as ibuprofen (IBUPROFEN), Zolpidem tartarate (AMBIEN) and paracetamol (TYLENOL) were reported. AE resulted in: Doctor or other healthcare professional office/clinic visit. On 18Feb2021 at 03:30 am, the patient experienced fever of 103.2 F, Chills, sweating, fatigue, headache, muscle pain, arm pain, nausea, insomnia. Treatment was given for events. The outcome of the events was recovered. Information about lot/ batch number has been requested.
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| 41 | 2021-04-10 | anxiety |
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic:...
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Anxiety-Medium, Systemic: Hyperventilation-Mild, Additional Details: Patient was extremly anxious about getting the vaccine prior to the administration
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| 41 | 2021-04-11 | feeling abnormal |
At the time of the shot I felt the stuff going into my system and all the way down my whole right si...
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At the time of the shot I felt the stuff going into my system and all the way down my whole right side all the way down to my right leg. It wasn?t painful or anything I was just aware that something was just injected into my body. About an hour after my injection I had a pain go into my hand a few times and I had to keep moving it around to make it go away which it did. That night had neck pain. That night I woke up to a pain in my right calf muscle and I thought I was going to get a Charlie horse so I got up and walked it off. It never got as bad as a Charlie horse. So I went to sleep and not much longer I woke up to the same thing in my left calf muscle. So I got up and walked around. Next morning Same thing happened. So I called the place I got the shot and they suggested taking magnesium pills and electrolytes as well as did my Dr Office. So I did that. Two days later I was feeling a pain in my left back shoulder blade. It eventually went away. I was worried about blood clots, but idk what caused this? Had diarrhea for a few days. And sweats the next morning. I?m day 5 into the first shot of Pfizer right now. I?m worried if I should get the second shot because of the leg cramping.
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| 41 | 2021-04-12 | abnormal dreams |
Extremely persistent and vivid dreams on a nightly basis similar to those associated with Mefloquine...
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Extremely persistent and vivid dreams on a nightly basis similar to those associated with Mefloquine.
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| 41 | 2021-04-12 | confusional state, impaired work ability |
Within 20 minutes, my body felt like a sandbag with dizziness and my equilibrium was off balance fol...
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Within 20 minutes, my body felt like a sandbag with dizziness and my equilibrium was off balance followed by a sense of falling forward. Paramedic took my blood pressure and oxygen. He offered to get me ride to hospital. I declined. I decided to call my doctor, then I started to feel allergic reactions with tingling nose lips and tongue and also back of throat was itchy and scratchy. I felt out of control. Doctor asked me to come to office and get seen. Within an hour, my symptoms worsened. I had a hard time walking and the doctor assessed me. Looked at my throat and listened to my lungs. I was wheezing. I had to take high doses of Benadryl and a steroid. I was told if any symptoms worsen, I have to go to hospital. I had all symptoms for 48 hours before I felt a turnaround and things lessened. I was not able to do much at all and could not go to work. I have continued symptoms with asthma and some allergy reactions that are lingering.
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| 41 | 2021-04-12 | insomnia |
From an email received 08 April 2021-"My1st vaccination was on the 20th of March. On the 28th/29th (...
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From an email received 08 April 2021-"My1st vaccination was on the 20th of March. On the 28th/29th (I?m not entirely certain which night it began), I woke up in the middle of night experiencing a pins and needles sensation in my lower legs. It was mild enough that I assumed I had just slept in the wrong position. Over the course of the next several nights, the numbness and pins and needles sensation grew progressively worse. I was waking up several times throughout the night as a result and the numbness and tingling has spread to all four limbs (hips to toes, shoulders to fingers). The night of April 1st, the feeling had grown severe enough that I had trouble sleeping and was growing very worried about the symptoms. I didn?t have any symptoms during the day though, and that night the symptoms mostly went away. I still have the tiniest bit of mild tingling in my toes sometimes overnight, but otherwise I?m feeling just fine now."
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| 41 | 2021-04-13 | feeling abnormal |
*Lips tingled then went completely numb - started 30 minutes post shot and lasted for about 2 hours ...
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*Lips tingled then went completely numb - started 30 minutes post shot and lasted for about 2 hours *Burning flush feeling - like "niacin flush" - felt over face, neck and upper body starting about 45 minutes post shot and lasting for about an hour *Severe headache / migraine - started slowly about an hour after shot and built up to migraine at 2 hours post shot. Lasted for almost 2 days and then went away to dull headache on 2nd morning after shot. Took Tylenol starting 8 hours post shot and repeated every 6 to 8 hours. *Brain fog / inability to concentrate - started 3 to 4 hours after shot most severe 6 to 10 hours post shot. Slowly came back with 2nd night of sleep. *Dizziness - started 40 minutes post shot while driving home. Most severe about 2 hours post shot then lessening. Lasted a day and a half and then just went away. *Severe Arm pain - pain in injection site arm for so severe that I couldn't move the arm above chest level or touch it against anything for a day and a half. Woke up on 2nd morning after shot and pain is completely gone.
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| 41 | 2021-04-13 | feeling abnormal |
Pfizer-BioNTech COVID-19 Vaccine EUA. Shortly after injection, during the initial 15 minute waitin...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Shortly after injection, during the initial 15 minute waiting period until 5 or 6 hours later, there was a weird taste in my mouth and a tightness in the back of my throat, as though the glands were swollen and constricted my throat making it uncomfortable to swallow. There was no pain. Between a rating of 1 to 10, the discomfort level was about 5. I also felt weakness in my whole body and walking felt strange and lasted for the entire day. The injection site has mild soreness even 24 hours later.
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| 41 | 2021-04-13 | impaired work ability |
My lymph nodes in neck became very painful at 7 am and got worse through the day. I had to leave wor...
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My lymph nodes in neck became very painful at 7 am and got worse through the day. I had to leave work bc pain was so severe. I had bad wheezing and a terrible cough. I now three days later still have swollen lymph nodes, low temp, and hot sweats.
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| 41 | 2021-04-14 | feeling abnormal, amnesia, insomnia |
VERTIGO, VISUAL HALLUCINATIONS, RACING THOUGHTS, INSOMNIA, VISUAL DISTURBANCES (FLASHING LIGHTS, BLA...
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VERTIGO, VISUAL HALLUCINATIONS, RACING THOUGHTS, INSOMNIA, VISUAL DISTURBANCES (FLASHING LIGHTS, BLACK FLOATERS), SHORT TERM MEMORY LOSS, RINGING IN EARS, LONG LASTING BRAIN FOG NO EFFECTIVE TREATMENT AVAILABLE BRAIN FOG STILL CONTINUING- 4 WEEKS AFTER VACCINE FIRST ADMINISTERED
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| 41 | 2021-04-15 | crying, loss of personal independence in daily activities, anxiety |
he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp...
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he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp of 100.5. The shivering quickly changed to more of a convulsing and temp got up to 104.7F. When I woke the next morning, temp was back down to 101-102F and most of shakes were subsiding. But I noticed that I had a deep, cutaneous pain reaction from head to toe when I awoke on 3-5-21. I could not brush my hair because my scalp was too tender. I couldn't let anything touch me and put pressure against any part of my body. Then at 3:30 that afternoon, I went to bathroom and had a bowel movement. It was so excruciating that I truly though my colon might have come partially out. I was in too much pain to flush, so I crawled across the house to my bed and laid on my side for an hour, crying. When I was finally able to go back to the bathroom to flush, I was expecting a large BM. It was not. It was about 2" x 1" and soft. There was no blood. It just felt like it tore me up. ****Then at 7:30 PM on 3-5-21 was when things got very serious. I was sitting down watching TV after a light meal. Suddenly, I started noticing discomfort deep in my upper back, between my shoulder blades. Within 5 minutes, it was at its worst....I was have rated it 11/10 pain. The pain was just very deep, behind the spine, about palm sized radius and unrelenting. My first thought was "maybe this is musculoskeletal since I've been in bed a lot because of the pain today." So I looked in my medicine cabinet for what I had and took 5 mg of Oxycodone and 10 mg of Cyclobenzaprine. An hour later, these meds hadn't touched it. I was beginning to really worry about an MI, or aortic dissection or pulmonary embolism (though I had no SOB). Lying flat on my back on a hard surface seemed to provide the only relief (though minimal relief, 9/10 pain). I called another provider who was on call and told her. She said that I could try taking 800 mg of Ibuprofen, but if I wasn't relieved in 1 hour, I needed to call 911 or have someone take me to the ER. I was asleep in an hour. I took it easy the next two days but started feeling back to normal during the days. I continued to sweat throughout the nights and skin pain continued so much that I had to cut some of my hair out. That following Tuesday, the deep upper back pain returned.
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| 41 | 2021-04-15 | nervousness, disorientation |
symptoms of dizziness, slight "disorientation", shaky, nausea; notes very sensitive to meds. 1340 BP...
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symptoms of dizziness, slight "disorientation", shaky, nausea; notes very sensitive to meds. 1340 BP 158/100, pulse 99, p ox 99%. Able to drink water; no issues swallowing, able to breathe without issue. Still nausea, hot, shaky. Continued monitoring. Denies headache or vision changes. 1350 BP 136/100, pulse 99; complaints of heart racing, hot, comes and goes. No issues breathing. Wanting to go to bathroom; feels stable; accompanied by staff. 1400 BP 140/90, pulse 106. 1410 BP 138/90, pulse 95, p ox 99%. Feeling more herself; still some shakiness. Refused ED evaluation; feels comfortable going home. Brother accompanying; will drive.Aware if symptoms worsen/issues breathing, to seek medical attention; agreed.
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| 41 | 2021-04-16 | feeling abnormal |
Swelling and bruised feeling in arm pit and collar bone. Joints and tender points inflamed. Worse ...
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Swelling and bruised feeling in arm pit and collar bone. Joints and tender points inflamed. Worse on the left side of the body. Can not raise left arm up as stiffness and pain in underarm is intense. Expected, but tenderness, swelling, and pain at injection site. Feels like body was ramped up into a flare up (agin worse on the left side - same as injection side). Headaches.
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| 41 | 2021-04-16 | loss of personal independence in daily activities |
Severe whole body muscle aches limiting normal daily activities. Chills. Arm soreness in injection a...
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Severe whole body muscle aches limiting normal daily activities. Chills. Arm soreness in injection arm, swollen axillary lymph node in injection arm, swollen bump at injection site.
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| 41 | 2021-04-17 | delirium |
delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were ...
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delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were swollen all over; body and face were swollen all over; new onset of widespread bodily pain; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included hypersensitivity to iodine contrast, anaphylactic reaction, hypermobile Ehlers-Danlos Syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) being evaluated for mast cell activation syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, estrogens esterified/ methyltestosterone (ESTROGEN/METHYLTES), and other unspecified medication. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 10Mar2021 at 14:00 the patient experienced a fever up to 102.7, extreme shortness of breath on standing, coughing and wheezing, delirious and slurring, body and face were swollen all over. The patient called the doctor on call at her primary care physicians office and treated the symptoms with diphenhydramine (BENADRYL), paracetamol (TYLENOL) and mast cell stabilizers. The patient had a bad flare of ME/CFS symptoms, in Mar2021, for about 7 days. She also experienced a new onset of widespread bodily pain in Mar2021 which didn't go away until the second vaccination. The patient received the second dose of BNT162B2 (Lot: ER8730) in the left arm on 31Mar2021 and had a better experience. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of delirious, wheezing, fever up to 102.7, shortness of breath, coughing, slurring, body and face were swollen all over was resolved with sequel on Mar2021; pain was resolved on 31Mar2021; bad flare of ME/CFS symptoms for about 7 days was unknown.
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| 41 | 2021-04-17 | depression |
suicidal thoughts; depression; This is a spontaneous report from a contactable consumer (patient). A...
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suicidal thoughts; depression; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (age at vaccination was 41 years) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: ER2613) in left arm on 17Mar2021 17: 00 at a single dose for COVID-19 immunization. Vaccine Facility type was hospital. Medical history was none. Allergies to medications, food, or other products was no. Patient was not pregnant at the time of vaccination. Concomitant medications included celecoxib (CELAXA) and rosuvastatin calcium (CRESTOR). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that 2 days post shot on 19Mar2021 09:00, she began to have suicidal thoughts. She did suffer from depression, but she was not suicidal and have never been treated for this level of depression before. 2 1/2 weeks later her mood has improved. She did not harm herself. Events were considered non-serious. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19.
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| 41 | 2021-04-17 | feeling abnormal |
Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tin...
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Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; She felt panicky, because it felt like her throat was "closing"; very odd, uncomfortable feeling; This is a spontaneous report from a non-contactable consumer reported for herself. This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 in left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021, the patient experienced mouth & throat felt numb & tingly. She felt panicky, because it felt like her throat was "closing". It was a very odd, uncomfortable feeling that lasted roughly 1.5-2 hours. It scared her. No treatment received for events. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of events was recovered on unspecified date. No follow-up attempts are needed. No further information is expected.
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| 41 | 2021-04-17 | feeling abnormal |
4/18/21: Awakened with a loud, sharp ringing in my right ear. The ringing is consistent and botherso...
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4/18/21: Awakened with a loud, sharp ringing in my right ear. The ringing is consistent and bothersome and causes a feeling of being "off". 4/17/21: Nausea, headache, and mild fever
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| 41 | 2021-04-17 | feeling abnormal |
Sore arm after injection and bruising, woke up in a brain fog, started feeling bad with body aches a...
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Sore arm after injection and bruising, woke up in a brain fog, started feeling bad with body aches around 11:00 am, got very cold, pulse rate in 100s from 8:00 am until 9:00 pm then in the 90s, blood pressure 157/97 around 12:30 pm, had blotchy skin on neck and chest around 12:00 pm, still extremely tired with slight headache on 4/17/2021
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| 41 | 2021-04-17 | feeling abnormal |
a prolonged episode of her fibromyalgia and Sjogren's condition; a prolonged episode of her fibromya...
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a prolonged episode of her fibromyalgia and Sjogren's condition; a prolonged episode of her fibromyalgia and Sjogren's condition; right ankle became swollen; a prolonged episode of her fibromyalgia and Sjogren's condition; joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes); migraines; fatigue; multiple naps throughout the day; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 41 Years, at single dose on 17Mar2021 (Lot number EN6207) for COVID-19 immunisation. Medical history included fibromyalgia, Sjogrens syndrome and lactose intolerant. Concomitant medications included gabapentin, ciclosporin (RESTASIS), cevimeline all taken for an unspecified indication and start and stop date were not reported. The patient previously took celecoxib and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes) was at a 5. Usually, her joint was at a 2. Her right ankle became swollen. Usually, her ankles didn't swell. She also had four migraines during this time - she typically had migraines every two to three months. She experienced fatigue which caused me to take multiple naps throughout the day. She experienced multiple days of brain fog, lasting up to 5 days at a time. Typically, she had brain fog for 2-3 days. Basically, the patient felt like she was having a prolonged episode of her fibromyalgia and Sjogren's condition. The symptoms were still persisting. The patient reported above events was non-serious. It was reported that the adverse event result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". And she received treatments for the adverse events including ace bandage for ankles and further monitoring. The patient was not diagnosed with COVID-19 prior to vaccination and she did not test for COVID-19 since the vaccination. Events outcome was not recovered.
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| 41 | 2021-04-18 | anxiety |
Patient reported at 1213 tingling/numbness in her lips, right side of face and throat with redness a...
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Patient reported at 1213 tingling/numbness in her lips, right side of face and throat with redness and mild facial swelling of the right cheek. Pt. stated feeling "a sense of doom." She felt warm to the touch. Denied chest pain or dyspnea. 911 called at 1213. FD station is steps away from our site, so we rang their doorbell and they responded and were on site at 1216 with their 3 BLS supporting the 3 RN's on site mananging the event. Vitals #1: @1214 BP 180/100, P 100, RR 24, O2sat 98%. Vitals #2: @1219 BP 180/120, P 85, RR 22, O2sat 98%. ambulance arrived at 1220. Pt. remains with same and not worsening symptoms. Vitals #3: @1225 BP 150/120, P 98, RR 22, temp 100.1F. Pt. left in ambulance at 1230.
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| 41 | 2021-04-18 | confusional state | Increased heart rate, confusion, shaking/muscle twitch, increased breathing, weakness |
| 41 | 2021-04-18 | feeling abnormal |
1400 - Patient complaint of "feeling funny" and "my tongue feels weird." Patient taken to treatment...
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1400 - Patient complaint of "feeling funny" and "my tongue feels weird." Patient taken to treatment area to be assessed. She then stated that it "was hard to swallow." BP = 158/94, HR = 109, O2 Sat = 99% 1402 - Nurse assessed patient and implemented COVID vaccine reaction order set - patient given Benadryl 50mg PO. 1409 - Patient given Pepcid 20mg PO and monitored for 30 minutes after medication given. BP = 146/97, HR = 92, O2 Sat = 100% 1435 - Patient stated she feels fine and would like to leave. Recommended she follow-up with PCP to see if they recommend for her to receive 2nd dose when scheduled, and to inform staff if getting 2nd dose of previous reaction. BP = 152/93, HR = 95, O2 Sat = 100%
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| 41 | 2021-04-19 | insomnia, feeling abnormal, abnormal dreams |
Major symptoms are plugged/whooshing/ringing/popping ears. Pressure in my head. Dizziness, especial...
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Major symptoms are plugged/whooshing/ringing/popping ears. Pressure in my head. Dizziness, especially when I look up after looking down at my phone. My hands and feet get so cold they hurt. I can put my frozen feet by my space heater and they don?t warm up, they just hurt more. Inability to concentrate and foggy brain. During meetings I find myself starting sentences but I can?t finish them, it?s like I stop and wait for my friends/family/coworkers to finish my thoughts. Other symptoms that don?t bother me as much. Constant sinus drainage and occasional sneezing. Dehydration. Insomnia and vivid dreams.
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| 41 | 2021-04-21 | feeling abnormal |
COVID-19 SCREEN: Have you had close contact with a laboratory-confirmed COVID-19 patient within 14 d...
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COVID-19 SCREEN: Have you had close contact with a laboratory-confirmed COVID-19 patient within 14 days no Traveling in the last 14 days no Fever? no Body aches? no Cough? no Shortness of Breath/difficulty breathing? no sorethroat? no Loss of taste/smell? no headache? no Nausea no Vomiting no Diarrhea no _______________________________ 41 year old female presents with swelling and soreness to right shoulder, arm, axilla, and breast since Friday evening (3 days ago). She received 2nd dose of Pfizer covid19 vaccine to the right arm on day previous on Thursday at 3:40pm. Friday evening also started with the whole right arm feeling heavy and numbness to the right 2nd finger, fever 101F, fatigue, chills, and brain fogginess. Fever stopped the next day. 3/26/21 was first covid19 vaccine dose also to right arm, did not get any similar symptoms. Taking 200mg ibuprofen every 6 hours, Tylenol 325mg every 4 hours for soreness. Denies SOB, or pain or redness or rash at the injection site or redness at injection site. Denies fever or chills at this time. Deneis nausea, vomitng or diarrhea.
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| 41 | 2021-04-21 | nervousness |
I noticed a metallic taste in my mouth around April 12 and I still have it. It seems to have improve...
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I noticed a metallic taste in my mouth around April 12 and I still have it. It seems to have improved but I?m nervous now that it has lasted so long and I?m due for my second vaccine on April 27.
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| 41 | 2021-04-21 | sensation of foreign body |
41 y/o F w/ PMHx panic d/o presenting with difficulty talking, reporting ?feeling a lump in my throa...
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41 y/o F w/ PMHx panic d/o presenting with difficulty talking, reporting ?feeling a lump in my throat,? chest tightness/shortness of breath, hazy vision, and tingling in bilateral arms/hands 10 minutes after her first dose of Pfizer (given at 12:03 PM - symptom onset at 12:13 PM). Reports symptoms started suddenly with chest tightness and hazy vision which then resolved after approximately one minute. Reports symptoms then localized to her throat and she felt like she had to gag. After 2-3 minutes of having difficulty talking, she reports she feels like she can fully talk again. Reports her throat swelling sensation has resolved and only residual symptoms are a ?caffeine rush feeling? and tingling in her hands. She did not have water or breakfast today and endorsed feeling nervous prior to her vaccine today. Only medical hx includes panic d/o (occasional - last panic attack 1.5 yrs ago). Not on daily or prn medications and never has been; no h/o seeing psychiatry or therapy. Reports her current symptoms feel different than other panic attacks. No other chronic conditions or daily meds. Denies h/o serious allergic reaction to any medications (oral, intravenous, injections). Reports feeling dizzy with Excedrin PO 10 yrs ago. Never been given Epinephrine. H/o hay fever with weather changes - does not take medications. Pt denies swelling of the face, itching of the skin, rash, CP, dizziness, extremity weakness, HA, n/v, or abdominal pain.
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| 41 | 2021-04-22 | thinking abnormal |
Injection site pain, tiredness, headache, muscle & joint pain, chills, nausea, feeling unwell and cl...
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Injection site pain, tiredness, headache, muscle & joint pain, chills, nausea, feeling unwell and cloudy.
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| 41 | 2021-04-24 | feeling abnormal |
Fatigue and lightheaded within 3 hours of vaccine, lasted 3 full days. Headache within 12 hours of v...
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Fatigue and lightheaded within 3 hours of vaccine, lasted 3 full days. Headache within 12 hours of vaccine, lasted 24 hours. Muscle aches and restless legs within 18 hours of vaccine, lasted 36 hours. Dizziness within 24 hours of vaccine, lasted 72 hours. Mental fog within 3 hours of vaccine, lasted 36 hours.
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| 41 | 2021-04-24 | feeling abnormal |
Dizziness and Brain Fog. Tripped while at home on carpet and fractured left distal radius. Required ...
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Dizziness and Brain Fog. Tripped while at home on carpet and fractured left distal radius. Required emergency surgery and plates and screws.
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| 41 | 2021-04-25 | feeling abnormal |
I previously had COVID-19 early last August. I had all the symptoms and had a fever around 99-100 fo...
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I previously had COVID-19 early last August. I had all the symptoms and had a fever around 99-100 for many days in a row. I also got the coughing towards the end of Covid and then had Covid pneomonia and was hospitalized for 4 days as my body just needed oxygen. I was hoping to take the vaccine so I wouldn't get the full Covid illness again. I took my first dose of the vaccine Wednesday morning, 4/21. I only felt tired Thursday morning, 4/22 however by middle of the afternoon I began to have shivers and was very cold. As the night went I was feeling terrible and had first seen a 104 temp but thought I took it wrong. Later took my temp again and was 102.5. After taking some ibuprofen my temp went down to 99.8. I had terrible leg pain and restless legs and couldn't get comfortable the entire evening, full body was in pain. It was worse then having actual Covid, I've never had my body feel that bad before but very glad it was for a shorter time period. Very sore and stiff, almost as if I couldn't get up to use the restroom. I was sleeping in and out (trying atleast) and woke up with night sweats around 11pm. I do think my fever had finally broke around then. I was in communication that night with my friend who is a nurse and we both hoped I would be better by the next morning. Thankfully I did sleep the rest of the night and only felt very tired and exhausted Friday & Saturday. Friday, it was still hard to get out of bed, alot of soreness but glad the fever was done. Saturday was better just tired and started to feel almost back to normal again on Sunday (5 days post my 1st vaccine dose) just still tired even today on Monday, 4/26.
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| 41 | 2021-04-25 | hallucination |
24 hours after shot had hallucinations, then 3 days later started having sore throat, lost voice, an...
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24 hours after shot had hallucinations, then 3 days later started having sore throat, lost voice, and scratchy chest feeling. no fever, no cough, no sob.
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| 41 | 2021-04-26 | disorientation |
I was not having any side-effects today so decided to drive to town. A few minutes into driving I f...
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I was not having any side-effects today so decided to drive to town. A few minutes into driving I found myself very disoriented, unable to determine how fast I was going or differentiate between right and left and couldn't understand why other cars were signaling/honking to me. I kept finding myself in the wrong turn lanes and generally confused. I came home as quickly and safely as I could. I didn't see any warnings or adverse effects about disorientation or difficulty operating a motor vehicle so thought I should report this.
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| 41 | 2021-04-26 | disturbance in attention |
On 08-APR-2021 (1 day after first vaccine): experienced headache/fatigue/difficult concentrating On ...
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On 08-APR-2021 (1 day after first vaccine): experienced headache/fatigue/difficult concentrating On 16-APR-2021 (9 days after first vaccine): experienced a sudden reaction at the injection site. The area became swollen, red, hot to the touch, itchy, and painful. The affected area was approximately 4 inches in diameter, surrounding the injection site. Medical attention was not sought. Discomfort was treated with icing of the area. The symptoms resolved at approximately 24 hours after onset.
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| 41 | 2021-04-26 | insomnia |
Started having Stiff neck and Stiff shoulder since 4/22/2021. Unable to work or manage pain. Not abl...
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Started having Stiff neck and Stiff shoulder since 4/22/2021. Unable to work or manage pain. Not able to sleep because of pain and unable to find a posture that can help relive pain. Was taking Advil and Tylenol continuously, but of no use. Started taking the TiZANdine 2mg from 4/23/2021 but no change in pain. Been to Physician's office on 4/27/2021. Doctor tried to change prescription to GABAPENTIN 100mg.
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| 41 | 2021-04-27 | depression, feeling abnormal, anxiety |
A couple of hours later I had fatigue, cough, joint pain, muscle pain, change of appetited, brain fo...
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A couple of hours later I had fatigue, cough, joint pain, muscle pain, change of appetited, brain fog & lost of voice. I have not fully recovered from this symptoms. I seen several doctors. On 01/19/2021 I seen my doctor they tested me for covid & told me to rest & go back to work when I felt better. On 02/08/2021 got tested for covid again. On 02/26/2021 I was tested again for covid due to my cough and dry throat. On 03/02/2021, 03/9/2021, 03/15/2021 I was seen by raspatory doctor due to the symptoms that I was having. On 03/25/2021 continued cough anxiety and depression fatigue and pain. On 04/02/2021 I followed up with my pcp for my ongoing issues and she refer me with an ENT. On 04/26/2021 I was seen by ER because of migraines and I don't have a history for migraines. Today on 4/28/2021 I am seeing the ENT for the voice lost.
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| 41 | 2021-04-27 | feeling abnormal |
mental fog, severe fatigue, chest pain, elevated d-dimer, neg chest CT fatigue gradually improving t...
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mental fog, severe fatigue, chest pain, elevated d-dimer, neg chest CT fatigue gradually improving though not to baseline as of 4/28/2021
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| 41 | 2021-04-27 | sleep disorder | It?s made my tinnitus louder too point can?t ignore disrupts sleep and made my neck tighter. |
| 41 | 2021-04-28 | fear |
feeling of blood moving in arms/legs with cold sensation.; Face numbness.; SOB; Events of low blood ...
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feeling of blood moving in arms/legs with cold sensation.; Face numbness.; SOB; Events of low blood sugar (not diabetic); Dizziness; Clammy feet; Very scary; Thyroid was in rage during this event; This is a spontaneous report from a contactable health professional (patient). A 41-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 41-years-old), administered in Arm Left on 08Mar2021 10:00 (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included Hashimoto's. The patient had no known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced Face numbness, Dizziness, Events of low blood sugar (not diabetic), SOB, Clammy feet. Most importantly, feeling of blood moving in arms/legs with cold sensation. The patient was hospitalized for the events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The onset of events was 09Mar2021 07:00. The patient also reported that it was "Very scary" and "Thyroid was in rage during this event" on an unspecified date. Went to ER twice weeks apart. Lasted for 3 weeks. The patient underwent lab tests and procedures which included blood glucose: low on 09Mar2021. No treatment received for the adverse events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation) required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events "Very scary" and "Thyroid was in rage during this event" was unknown while for the rest of the events was recovered with sequelae (Recovered with lasting effects). Not diagnosed with COVID prior vaccination, not COVID tested post vaccination. No other vaccine in four weeks. No other medications in two weeks.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-04-28 | impaired work ability |
Severe headaches for at least 5 days Fatigue persisting for 1 month at least, first week in bed -los...
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Severe headaches for at least 5 days Fatigue persisting for 1 month at least, first week in bed -loss of work week on sick leave Muscular pain in body which had reduced over the weeks Pain in nerves-initiated in right side of my body and then became strongest in spinal cord which required me to go to hospital twice-Emergency Area March19, 2021 being released with medication March 20, 2021 ; then again March 21, 2021 in hospital being released with medication by March 22, 2021. Nervousness
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| 41 | 2021-04-28 | panic attack |
patient was given her 2nd dose of the Pfizer Covid-19 vaccine. 5 minutes after patient seemed to be ...
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patient was given her 2nd dose of the Pfizer Covid-19 vaccine. 5 minutes after patient seemed to be having symptoms of a panic attack. Patient stated that this has happened to her in the past and the symptoms were similar. Pulse was above 90 and blood pressure was 218/120. Blood pressure was rechecked after another 5 minutes and systolic pressure was still over 200. EMS was called and the patient was transported to Emergency Room.
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| 41 | 2021-04-29 | anxiety | Fever, back pain, sweating, chills, anxiety |
| 41 | 2021-04-29 | feeling abnormal |
Diagnosed with pityriasis rosea caused by covid vaccine. Rash lasted for 7 days. Fatigue, brain fog...
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Diagnosed with pityriasis rosea caused by covid vaccine. Rash lasted for 7 days. Fatigue, brain fog, sore throat and nasal congestion are still persisting. Per doctor?s directions I have been taking Benadryl every 6 hours since April 18. Also taking anti-inflammatory regularly and prescribed steroid cream.
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| 41 | 2021-04-29 | nervousness |
Pt asked to be observed . pt's spouse states pt had CoVid in December and was nervous. Pt stable g...
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Pt asked to be observed . pt's spouse states pt had CoVid in December and was nervous. Pt stable given water and snacks.
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| 41 | 2021-04-30 | feeling abnormal |
migraine; she felt like she had had her third back surgery; throwing up; diarrhea; stomach cramps; b...
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migraine; she felt like she had had her third back surgery; throwing up; diarrhea; stomach cramps; blood pressure has been so high/My blood pressure reached 200/198; I lost 30 pounds; I had a stroke; pulse high; in pain; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (lot number: not reported) as single dose for COVID-19 immunisation. Medical history included pain, anxiety, two back surgeries previously, and smoke all the time. Concomitant medications included clonazepam (KLONOPIN); and pain medications for her back and anxiety medications (unspecified). She got her first dose of the Pfizer COVID vaccine 36 days ago (11Mar2021) and within 5 minutes, she had the worst migraine of her life. She has had two back surgeries previously and after the COVID vaccine, she felt like she had had her third back surgery that night (11Mar2021). That night, she was also throwing up, had diarrhea and was having horrible stomach cramps. Since then (Mar2021), her blood pressure had been so high that they were afraid that she was going to have a stroke at any minute. For her migraine, she had been to the hospital 4 times for it and they had given her three doses each time of the migraine cocktail and that hadn't touched her migraine. She went back to the doctor and her blood pressure and her pulse were both still high (2021) and with the migraine she was ready to jump off of the dock because it hurts so bad. She was on 4 medicines to try and combat what this vaccine had done to her. She can no longer function. She needed to know an antidote or something to get this out of her system. She stated that she "is going to die from this". She didn't know what to do. They said she was going to have a stroke. She can't work and no one knows what to do because there were no studies on this because it is so new. She wanted it out of her body. Her life literally has turned into her just lying in bed and moaning in pain. She was in the emergency room (due to migraine), there were 3 people in there who had complained from the Pfizer vaccine (unspecified). She was calling because she got her first shot of COVID vaccine and she had a stroke (unspecified date in 2021) and she was going to die. She needed an antidote to get it out of her system because she been to the hospital 5 times now. She had migraine that is so bad that they gave her 4 doses of Topamax, it didn't touch it, she threw up everything she eats, she lost 30 pounds (2021) & her blood pressure reached 200/198 and she smoked all the time, they said she had stroke. She had bad migraine and nothing helped at all. She had doctor appointment, and nobody can give her answer. Regarding second dose, that was 21 days after, but she was not going to get it (second shot) and they said she was 80 % vaccinated. At hospital, when she was in emergency room (for migraine), where they do lab tests (2021), they were fine. She was not getting better, getting worse (not clarified for all events). Date of hospitalization: the day after she got the vaccine and next was two days ago, 3 different times (further details unknown). She further stated that she was driving to doctor. She lost her life because she can't work, this drug had ruined her life (as reported). The outcome of the event migraine was not recovered. The outcome of other events was unknown. Information about lot and batch number was requested.
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| 41 | 2021-05-02 | feeling abnormal |
On April 4 (throughout the day) -- began to show symptoms of feeling abnormal / off-center (beginnin...
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On April 4 (throughout the day) -- began to show symptoms of feeling abnormal / off-center (beginning around 10am). by 5pm -- became uncoordinated / unbalanced (couldn't access phone, put on clothes, etc.). Advised by Neurologist to seek ER treatment and directed to local hospital. Initially, diagnosed as showing symptoms of a Stroke. Upon further analysis, hospital determined it was a MS Flare Up. Since April 4 -- patient lost use of left side (hands, legs). Right Side brain also affected. Currently in acute rehab (Since April 17) to regain functionality. As of May 3 -- still unable to walk on her own or use left hand. Still experiencing visual issues. Acute Rehab facility believes recovery may take up to a year. Patient's normal Neurologist was puzzled by diagnosis because the symptoms as well as the duration and acuteness of the episode is inconsistent with her MS condition. Patient was originally diagnosed with MS in 2009 and there have no MS flare-ups since the initial diagnosis. The normal Neurologist noted that the symptoms are inconsistent with her history. Believe it was proper to notify, given the recent vaccination. Can provide full medical records, if helpful
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| 41 | 2021-05-03 | feeling abnormal |
La segunda dosis de la vacuna casi 8 horas luego de administrada comenzó a darme mucho dolor de cab...
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La segunda dosis de la vacuna casi 8 horas luego de administrada comenzó a darme mucho dolor de cabeza. Ya cumplida las 10 horas de administrada comencé con vómitos durante toda esa noche hasta la mañana siguiente vomité 7 veces. A las 11 horas de administrada comencé con movimientos involuntarios, a temblar mucho. Me dió fiebre de 40 grados. Al día siguiente no podía levantarme. dolor de cuerpo, me mareaba de solo caminar, y no podía orinar, tenía dolor en area de ovarios y pelvis. Ese día que fue el siguiente continúe con los vómitos y no pude levantarme de la cama. Me administraron un suero de solución salina para la deshidratación, y tomé phenergan 50 mg para los vómitos. 36 horas despues me dolían las caderas y espalda y piernas. A Las 48 horas me comenzaron diarreas las cuales al día de hoy continúo con las mismas (ya van 5 dias de la vacuna) . Luego de 5 dias de la vacuna sigo con diarreas, las he controlado con imodium y probioticos, tengo el cuerpo debil, me mareo por momentos, y continúo con dolor área de ovarios como de menstruación que al momento no se supone sea pq estuve en menstruación justo 3 días antes de la vacuna. Mi cuerpo lo siento extraño , aun me duelen las caderas, espalda y cabeza, y contiúo con dolor de estómago, nauseas y diarreas. Los medicamentos fueron administrados en casa.
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| 41 | 2021-05-03 | insomnia, loss of personal independence in daily activities |
About 15 mins after vaccine I felt a sudden onset of lightheadedness and feeling as if i would pass ...
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About 15 mins after vaccine I felt a sudden onset of lightheadedness and feeling as if i would pass out, told the nurse I was going to throw up. I was given zofran and Dr monitored Vs. I continued to experience waves of dizzyness, nausea, abdominal pain. Shaking followed (I felt so cold), along with frequent need to urinate and urgency to have a BM (loose) for several hours. I was given fluids and monitored. They gave Ativan 0.5mg 2.5 hrs later? I was discharged home at 8:45p.m. by Dr and told not to get the 2nd Vaccine. Symptoms continued and worsened on day 3 with Shortness of breath, chest pain and tingling in my arms that spread to my legs, back and neck. The first week I could barley walk and was seen in the ER 2 times for chest pain, shortness of breath, dizzyness, tingling, heart racing, diarrhea, nausea, muscle weakness, insomnia due to shortness of breath (gasping) with heart racing, & unable to control my body temperature. Given Prednisone 40mg which exasperated symptoms. 1/13/21 In ER and given Benadryl 3 bags of fluids, potassium and sodium. Postural tachycardia was noticed. Referral to Neurologist.High D-dimer at ER on 1/16/21 CT scan performed to rule out blood clot in lungs. Reffered to Cardiologist. Metoprolol and Colchicine was started in Jan by Cardiologist Dr . Weekly visits with Dr for the first couple months. More meds started to decrease inflammation. Furthur referrals to Immunologist, infectious disease, and Rheumotology. At 3 months worsening of tingling in my neck and headaches/burning that felt like shocks and shooting down neck and ears. Neurologist performed 3 view MRI to rule out transverse Myelitis. In ER early April for new onset of Petechiae, CBC labs normal. Immunologist states he felt i experienced an allergic reaction followed by secondary anaphalaxis. He is testing me for Mast cell activation syndrome (not diagnosed yet). Now almost 4 months later still unable to work. Waiting results to rule out POTS. Currently battle daily fatigue, chest pressure/pain, lung SOB, heavyness/pressure, with any exertion. I am limited with daily walking/normal activities. Symptoms that come and go are tingling, nausea, diarrhea, flushing of frequent urination, neck pain, regulating temperature.
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| 41 | 2021-05-07 | depressed mood, loss of personal independence in daily activities |
This is a spontaneous report from a contactable consumer reporting for the daughter. A 41-year-old...
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This is a spontaneous report from a contactable consumer reporting for the daughter. A 41-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose maybe the right arm (reporter was unsure) at the age of 41-year-old for COVID-19 immunisation, administered through hospital. Medical history was none. There were no concomitant medications. In Apr2201 the patient experienced she can't hear right now and it won't go away, ringing in ears, she is extremely stressed out and this is affecting her life, she was so upset. The course of events was as follows: She has had ringing in her ears from this, started some time after the shot. She was extremely stressed out and this was affecting her life. She can't live like this. She recently divorced with 2 kids and trying to work. Went to the doctor twice and they sent her to ENT department. This is destroying her life. It was very stressful. Patient was having a severe problem. She had been to the doctor twice, including this week in Apr2021 and once the end of last week in Apr2021. They looked at her medications and sent her to counseling, to therapy. She had definitely not gotten better, has been persistent. She did not know on like a graph scale where it was. She received no treatment for ringing in ears. She was trying to take something for stress because this was horrible. She cannot hear right now and it won't go away. This is a serious problem. Reporter did not want her daughter to go deaf. She received a message from hospital, regarding her being scheduled for the second vaccine on Saturday and she said she was not going for that she wished she had not gotten the first one. Reporter stated she has a good friend who's daughter was a PA whom she has been corresponding to about this and she sent them links of how the Covid vaccine is linked to tinnitus. She has never had anyone report this. She sent it to her daughter and her daughter said can't read this, there is blogs with responses and she just said she can't read this, she was so upset that she can't hear right because of this with this ringing that won't go away. She had gotten a call from the Hospital Department stating that she was ready for the second shot. She was not getting the second shot and was sorry that she got the first one. The outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 41 | 2021-05-12 | insomnia | Insomnia, joint aches, low-grade fever |
| 41 | 2021-05-17 | insomnia, anxiety |
Really bad anxiety and now insomnia. I conceived week of vaccine. Exact date unknown. I miscarrie...
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Really bad anxiety and now insomnia. I conceived week of vaccine. Exact date unknown. I miscarried Jan 25,2021 and got pregnant again week of this vaccine
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| 41 | 2021-05-18 | sleep disorder, loss of personal independence in daily activities |
Right wrist swelling; Noticed decrease in gross motor function; Severe neck pain; Numbness, tingling...
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Right wrist swelling; Noticed decrease in gross motor function; Severe neck pain; Numbness, tingling, pins and needles in right arm and severe pain 10/10 in hand/same symptoms in left hand; Numbness, tingling, pins and needles in right arm and severe pain 10/10 in hand/same symptoms in left hand; Numbness, tingling, pins and needles in right arm and severe pain 10/10 in hand/same symptoms in left hand; Severe lower back pain 8 to 10/10; Disrupted sleep; Unable to bend over and tie shoes and to stand up straight / Unable to sleep sidelying on either side with neck turned since that resulted in pins and needles in arm and hand; This is a spontaneous report received from a contactable consumer other healthcare professional (The consumer reported for self) A 41-years-old (non pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8733, Expiration date: UNKNOWN), via an unspecified route of administration in Right arm on 03Apr2021 03:45 PM as single for COVID-19 immunisation. Medical history included anaemia, Extremely low ferritin levels, Arthritis of the cervical vertebrae. Known allergies to Kiwi, Tomatoes, nightshades from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. On April 5th to April 11th the patient experienced Severe lower backpain 8 to 10/10 which disrupted sleep and caused me to be unable to bend over and tie shoes and to stand up straight. Resolved with ATC Tylenol and Motrin after 6 days. On April 19th the patient Began noticing severe neck pain with concomitant numbness, tingling, pins and needles in right arm and severe pain 10/10 in hand. Adverse event start date: 19Apr2021. On April 20th the patient noticed the same symptoms in left hand. Unable to sleep side lying on either side with neck turned since that resulted in pins and needles in arm and hand. Pain 8 to 10/10 unrelieved by Tylenol and Motrin. Patient was only able to sleep on back with head in midline position. Patient noticed decrease in gross motor function, was unable to open doors with right hand, unable to make a fist with right hand. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient received Treatment for the adverse events which includes, 6 day course of steroid (Steroid taper 6days and started Neurontin 100mg TI) ordered by PMD resolved neck pain but still have numbness, tingling in both hands with daily continuous pain of 7 to 10 at any time. On April 28th: Right wrist swelling noted after steroid completion. Pain still persisting. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Sars-cov-2 test (COVID test name: PCR Test; Test type: Nasal Swab): Negative on 24Apr2021. Outcome of the event Severe lower back pain 8 to 10/10, Disrupted sleep, unable to bend over and tie shoes and to stand up straight, Severe neck pain had recovered on 11Apr2021; the remaining events were reported as not recovered. ; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-05-20 | sleep disorder |
headache with visual sensitivity, headache, hard to hear for a second, speech was impaired for a sec...
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headache with visual sensitivity, headache, hard to hear for a second, speech was impaired for a second, difficult to find words for a second, felts as if she had a fever and kept coming in flashes, pain went down leg, but then quickly went away, index knuckle on left hand felt burning, but went away,2nd day- tiredness, hot flashes, thirsty, 3rd day sleep disturbances, night sweats on each day since vaccine, throat dry on second day, 3rd day throaty dry, lymph nodes swelling, tired, this morning pain in right axillary area, neck still sore, dizziness this afternoon, abdominal upset this morning, hot flashes today
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| 41 | 2021-05-23 | feeling abnormal, anxiety |
Patient reported dizziness, lightheadedness, ascending warmth/tingling, tunnel vision, and that she ...
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Patient reported dizziness, lightheadedness, ascending warmth/tingling, tunnel vision, and that she "couldn't feel her hands" shortly after receiving her vaccine. She was highly anxious and stated "I never should have done this". On arrival to med obvs, her hands were in a contracted position and her arms/legs were shaking. Patient repeatedly asked if she was going to be paralyzed. The patient began to feel better after several deep, relaxed breaths. Patient was given water, apple juice, and crackers. Pt requested to use the restroom around 11:10. She was transferred there via wheelchair where she was able to urinate, and reported feeling better after doing so. On discharge, patient reported slight light headedness and "off" feeling, but was otherwise better. Vitals as follows: 10:50- BP 151/84, HR 144, RR 22, O2 97 10:52- BP 146/78, HR 144, RR 22, O2 97 11:00- BP 148/85, HR 125, RR 20, O2 100 11:07- BP 139/78, HR 116, RR 20, O2 100 11:26 (sitting)- BP 135/70, HR 104, RR 18, O2 100 11:36 (sitting)- BP 128/73, HR 98, RR 18, O2 100
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| 41 | 2021-05-25 | sensation of foreign body |
5/14/21: Approx. 4-5 hours after 2nd dose, developed full body hives, headache, fatigue, body aches,...
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5/14/21: Approx. 4-5 hours after 2nd dose, developed full body hives, headache, fatigue, body aches, lump in throat. Treated with Tylenol and Benadryl. On 5/15/21, at 6pm called Pharmacy and instructed to go to ER. ER administered epi-pen, prednisone, Benadryl, Pepcid and Tylenol. 5/17/21: Appointment w/ Allergist and advised to take Zyrtec, Allegra, Singular, and Pepcid, until symptoms resolve. If still symptomatic after 6-weeks, call Allergist back and re-evaluate.
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| 41 | 2021-05-26 | feeling abnormal |
Patient described reaction to first dose as follows: almost immediately after her first Pfizer COVI...
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Patient described reaction to first dose as follows: almost immediately after her first Pfizer COVID injection, she states that she felt nauseous and short of breath, then vomited. Per pt, EMS said her blood pressure was ?through the roof? (no exact vitals given). She was observed for 30 minutes, stated she felt much better and went home voluntarily. At no time was epi administered per patient. Today, patient gave her vaccination history from 4/14/2021, stated that she felt fine today and that she wanted to proceed with her second Pfizer dose. It was determined that there was no contraindication and the vaccine was given at 3pm. Within 3 minutes, patient stated that she was having difficulty breathing and was nauseous. EMS arrived immediately, pt coughed up some sputum, vitals as follows: 144/97 105 98% initial temp 101.7, but pt was in the back of a car with engine off and the warehouse was a little warm. EMS repeated vitals 140/88 100 98%. Pt was able to ambulated out of the car to a chair, eyes closed, but at no time did she appear SOB or in any distress, RR remained 16-18 bpm. Final by 128/88.HR 99 SaO2 99%., blood glucose 140, repeated temperature out of the car 99.1. EMS stated that she appeared to be stable, but pt insisted that she did not feel good, was nauseous and SOB, and that she wanted to be transported to a hospital. Pt taken to Arizona General by ambulance, with stable VS and in NAD, AOx3.
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| 41 | 2021-05-28 | anxiety |
Immediately after injection felt suddenly a hot sensation throughout body, heart started pounding ra...
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Immediately after injection felt suddenly a hot sensation throughout body, heart started pounding rapidly and uncontrollably, especially on left side of chest, entire left arm started tingling and becoming numb down to my fingertips. I felt like impending doom and windpipe felt like it was starting to close up. I dialed 911 and took two puffs of my inhaler to open up my lungs.
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| 41 | 2021-05-28 | feeling abnormal |
Stinging whelps and hives on injection; Stinging whelps and hives on injection; bump arose 3 inches ...
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Stinging whelps and hives on injection; Stinging whelps and hives on injection; bump arose 3 inches approximately from injection; throat swelling; nausea; diarrhea; itching; headaches; chills; dizziness; weakness; congestion; exhaustion; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 12B3) via intramuscular route of administration in left arm on 14Jan2021 at 12:00 PM as single dose for COVID-19 immunization. The patient medical history included hypothyroidism, hypertension, allergies year round and allergies ciprofloxacin, penicillin, peaches, bananas, strawberry, cockroaches, trees, grass, dander, dust, mold, cats and dogs. The patient did not receive any other vaccine within 4 weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included, levothyroxine, amlodipine, setraline, losartan and women multivitamin. On 14Jan2021 at 12:15 PM, the patient experienced stinging whelps and hives on injection site with swelling, bump arose 3 inches approximately from injection, throat swelling, nausea, diarrhea, itching, headaches, chills, dizziness, congestion, weakness and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl. The case was considered as non-serious by the reporter. Since the vaccination, the patient had been tested for COVID-19 including nasal swab test on 15Jan2021 with result: negative and throat swab test on 29Jan2021 with result: negative. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-05-29 | impaired work ability |
On 4/03/2021 awoke with sharp under scapula pain with loss of power to left serratus anterior that m...
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On 4/03/2021 awoke with sharp under scapula pain with loss of power to left serratus anterior that manifested over the next weeks into severe axillary anterior and posterior spasms with tingling down left arm thumb, index and middle finger. Numbness to fingers thereafter and then significant loss of strength came after that especially to tricep, teres major and hand. Started dropping stuff on the floor and am unable to perform my full job duties at this time. Treatment and pain/weakness/tingling symptoms are ongoing
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| 41 | 2021-05-31 | anxiety |
The day after I received dose 2, 04/13/2021, I started having pain behind my eyes. I was feeling ver...
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The day after I received dose 2, 04/13/2021, I started having pain behind my eyes. I was feeling very fatigued. I had to take painkillers to help get through the day. I had a lasting headache for a whole week. My right armpit became swollen and sore. On 04/15/2021, I felt tingling on the left side of my body with mild dizziness and anxiety. I had a virtual visit with Dr. on 04/16/2021. I also had knee pain which is unusual for me. During my virtual visit, Dr. informed me that she felt fatigue for the week after she received her vaccine too. I was told that if my symptoms continue to follow up with the doctor. As of today, 06/01/2021, I can still see where I received the vaccination. I have a red bump there. It does not hurt, but it is noticeable.
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| 41 | 2021-06-01 | anxiety |
This is a spontaneous report from a contactable consumer or other non healthcare professional (HCP)....
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This is a spontaneous report from a contactable consumer or other non healthcare professional (HCP). The patient reported for self. A 41-years-old (non-pregnant) female patient received BNT162b2 (Formulation: Solution for injection; Lot Number and Expiration date: UNKNOWN) , via intramuscular route of administration on, Solution for injection) (reason for unknown Lot number: Unable to locate or read the details), via an unspecified route of administration on 30Apr2021 (at 41-years-old) as single dose for COVID-19 immunisation. Patient medical history included known allergies to Penicillin, Sulfa from an unknown date and unknown if ongoing. Concomitant medication (other medications the patient received within 2 weeks of vaccination) included estradiol (.025mg patch) taken for an unspecified indication, start and stop date were not reported. No other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 02-May2021 the patient experienced Bruising of legs, calf area. Severe throbbing in both legs, numbness and tingling in both feet and toes. No distal pulse in right foot. Anxiety, due to worry of health after the vaccine. The patient had been tested for COVID-19, underwent lab tests and procedures which included Nasal Swab test (sars-cov-2 test) result was negative on 06May2021. Patient underwent venous and arterial ultrasounds of unknown results. Therapeutic measures were taken for the events occurred. Events were reported as non-serious. The outcome of the events was reported as recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 41 | 2021-06-01 | feeling abnormal |
Severe dizziness ( started at around 15 minutes after injection), cold followed by hot burning sens...
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Severe dizziness ( started at around 15 minutes after injection), cold followed by hot burning sensation on upper parts of both arms. Numbness in both hands, low back pain (sciatica flare up, especially on right side). Right side of right leg (calf into foot) numbness, with constant "nerve zaps". Entire right arm and right leg experience complete numbness (and the sensation of sharp "pins and needles"). This has been going on now for over a week (started night one after receiving shot). Deep muscular pain on underside of right leg. Dizziness is recurrent and random. Random itchiness throughout body (hives appeared once on right foot). Pain and tightness of chest (pain occurred 3 days after shot, tightness immediately when reactions occurred).
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| 41 | 2021-06-01 | feeling drunk, disorientation |
Immediately developed a metallic taste in her mouth that lasted for 4 days. Within 15-20 minutes of...
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Immediately developed a metallic taste in her mouth that lasted for 4 days. Within 15-20 minutes of receiving vaccine she developed tingling of her face and numbness of her tongue - this persisted for 10-15 minutes. She reports feeling drunk and disoriented for 3-4 days after vaccination.
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| 41 | 2021-06-01 | nervousness |
She got her vaccine, she had no reactions at all. On 5/12/21, she woke up 2 days with ankle and fee...
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She got her vaccine, she had no reactions at all. On 5/12/21, she woke up 2 days with ankle and feet swelling, hand and face swelling, eyelid swelling. She had a fever up to 100.5. Her swelling has not gone down on any of the locations. She cannot even take her wedding bands off. Her feet are extremely cramped in her shoes. Her allergies have gone tremendously. She has been throwing up and have been nauseous a lot. She has not been taking anything but Benadryl for the reactions. She also has gained 7# since the vaccine. Her hands have also been shaky. She has not notified her doctor of any of these symptoms.
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| 41 | 2021-06-03 | feeling abnormal, anxiety |
Rash still after almost 2 weeks, spreading, very itchy.; Felt run down; Stomach issues; Anxiety; Thi...
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Rash still after almost 2 weeks, spreading, very itchy.; Felt run down; Stomach issues; Anxiety; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) via an unspecified route of administration on 20May2021 at 10:30 in right arm as a single dose for COVID-19 immunization. Medical history was not reported. The patient previously took naproxen for allergies. The patient did not received any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Concomitant medications included Alprazolam, Zoloft and Atenolol. On 21May2021, the patient experienced Rash still after almost 2 weeks, spreading, very itchy. Felt run down and having stomach issues and anxiety. The patient did not receive any treatment medication. The outcome of all events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-06-03 | feeling abnormal |
Tingling in face and feet; elevated blood pressure; elevated heart rate; Dizziness; Brain fog; This ...
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Tingling in face and feet; elevated blood pressure; elevated heart rate; Dizziness; Brain fog; This is spontaneous report from a contactable consumer, the patient. A 41-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 10:45 (at the age of 41-years-old) as a single dose for Covid-19 immunisation. The patient medical history included asthma, reflux and migraine from unknown date. Allergies to medications, food, or other products was reported to cats. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included meloxicam, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), all for unknown indication from unknown date. The patient experienced tingling in face and feet, elevated blood pressure, elevated heart rate, dizziness and brain fog on 17Mar2021 at 10:45. The patient did not receive treatment for the reported events. The clinical outcome of the tingling sensation, elevated blood pressure, heart rate increased, dizziness and foggy feeling in head was recovering. No follow-up attempts are possible, information about batch number cannot be obtained.
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| 41 | 2021-06-04 | insomnia |
lost feeling in legs; nausea; Dehydration; insomnia; This is a spontaneous report received from COVA...
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lost feeling in legs; nausea; Dehydration; insomnia; This is a spontaneous report received from COVAES from a contactable consumer (patient). A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 14:30 at the age of 41-years-old (Batch/Lot Number: ER2613) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no any other medications the patient received within 2 weeks of vaccination. The patient experienced lost feeling in legs 10 days after 2nd vaccine (as reported), extreme nausea, dehydration and extreme insomnia on 15May2021 04:00 with outcome of recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 41 | 2021-06-06 | loss of personal independence in daily activities |
Day 3 I received severe vertigo which cause vomiting due to the motion and was completely down for t...
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Day 3 I received severe vertigo which cause vomiting due to the motion and was completely down for two days. Now it is day 6 and I still have dizzy so bad that I can?t drive!
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| 41 | 2021-06-07 | amnesia |
Sudden onset short term memory loss. Testing has included MRI, CT, EEG, extensive blood tests, inclu...
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Sudden onset short term memory loss. Testing has included MRI, CT, EEG, extensive blood tests, including Lab (rare neurological disorders). All are normal. SARS test was negative with disclaimer that it didn't eliminate the possibility of her having Covid. Currently receiving high dosage of Prednisone for "encephalopathy" diagnosis. She is not responding. This has been going on for 3 months.
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| 41 | 2021-06-08 | feeling abnormal |
About a month and 20 days after my second vaccine I had trouble breathing. I work in the hospital, s...
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About a month and 20 days after my second vaccine I had trouble breathing. I work in the hospital, so I thought maybe it was bronchitis, the mask made it harder to breathe. I had the weekend off and decided by Monday I would go to the doctor if not better. I woke up on Sunday, still achy, not wanting to move, couldn't really eat, I was just mostly drinking water. I woke up Monday and came back to bed, moved the blanket and then could barely breathe. My skin got very clamy, feeling scared and unsure if it was a heart attack. I called 911 and was taken to hospital to a shock trauma. I am only back to work 4 hour days, and working with a pulmonologist.
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| 41 | 2021-06-08 | feeling drunk |
Coughing, sneezing, runny nose, congested, bodyaches, teeth pain, jaw pain, neck pain, headache, che...
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Coughing, sneezing, runny nose, congested, bodyaches, teeth pain, jaw pain, neck pain, headache, chest pain, fever, chills/sweats, loss of appetite, fatigue????, sore throat, painful swallowing? All symptoms started approximately five hours after receiving the vaccine, after receiving the vaccine within seconds I got incredibly lightheaded and dizzy, almost like a drunk feeling?
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| 41 | 2021-06-08 | impaired work ability |
Ongoing, worsening pain in L arm for 4 weeks after injection. Pain radiates to wrist and to scapula....
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Ongoing, worsening pain in L arm for 4 weeks after injection. Pain radiates to wrist and to scapula. Causing patient to miss work. Has tried ice, heat, ibuprofen, hydrocodone, and lidocaine patches with limited benefit. Imaging work-up and physical therapy eval pending.
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| 41 | 2021-06-08 | nervousness, anxiety |
Pt was very nervous about the injection. It was determined that she had anxiety related to the injec...
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Pt was very nervous about the injection. It was determined that she had anxiety related to the injection. She passed out and was unresponsive at times, cold sweats, limp. There were no signs of swelling or throat closing. and airways were clear. All vitals were normal following the event, 911 was called and arrived within 5-10 minutes and check vitals again then administered oxygen and she became more responsive. Blood sugar was also checked with a hand-held device and finger stick blood sample. It was determined that she should go top the hospital for additional care and tests.
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| 42 | 2021-01-01 | anxiety |
@ 1525 Pt stated to this nurse that her throat felt like it was "burning a little". Denies s/s of ...
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@ 1525 Pt stated to this nurse that her throat felt like it was "burning a little". Denies s/s of any breathing issues. Water was given to her by this nurse. @ 1528 she stated that it felt more like "an itchy feeling in her throat/chest". Expressed to this nurse around 1533 that the issues had slightly resolved, and that she felt anxious upon receiving the vaccine. This nurse gave Pt a Benadryl 25mg @ 1539. States that her s/s are better. Pt states she takes the following medications, Allegra po once daily, Flonase daily, and Flovent. Does voice that she has chronic allergies/asthma. Pt is still in observation @ present time 1552. Left observation @ 1554, states that her s/s had improved.
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| 42 | 2021-01-01 | feeling abnormal, irritability |
pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy n...
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pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy nose, body aches, fever and chills but no actual fever- body just felt really warm. problems breathing at times (like a panic attack), headache, stiff neck, fatigue-- I fell asleep in my car because I was so tired. sore arm, irritability, When trying to lie down, I could not get comfortable, I found myself lying on the floor since it was cold, this is not normal behavior. i felt super sick. I was crawling on the floor because of how dizzy and tired i felt. It felt like a really bad drunk or hangover. noises were too loud, it felt horrible. I don't know if it is done.
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| 42 | 2021-01-01 | feeling abnormal |
Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue s...
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Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site
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| 42 | 2021-01-03 | anxiety, panic attack |
Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for...
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Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for right deltoid after first dose. Hemodynamically stable and afebrile. Differential diagnosis includes but is not limited to allergic reaction, anxiety, panic attack, asthma attack, sequelae of hyperthyroidism. After resting comfortably in the room for approximately 15 minutes, she reported that her symptoms were starting to subside. She happily excepted diphenhydramine (dose not documented). She was observed for 2.5 hours and had no worsening of symptoms. Her vital signs were stable and she had appropriate SPO2 on room air throughout her stay in the emergency department. We discussed strict return precautions for evidence of allergic reaction, chest pain, worsening shortness of breath, altered mental status or fever. She will follow-up with her primary care doctor. Discharged in stable condition to the care of her husband.
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| 42 | 2021-01-03 | feeling abnormal |
began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had fin...
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began to feel foggy/slow, arm too paintful to move within two hours and by 11:20 my tongue I had finally noticed was swollen. EMS was called and I was sent to the ER.I was given benedryll by ems, at ER I was given a steroid, Claritin and another medication for the reaction. Discharged with epi pens, a round of steroids, benedryl initially which was changed to Claritin by follow up dr.
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| 42 | 2021-01-03 | impaired work ability |
Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50m...
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Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50mg q4 x 3 doses, took albuterol every 2 hrs for 8 hrs. Had EpiPen nearby (a family member's, not mine), but did not use. Felt fine the next morning, 24 hrs afterwards. Just mild headache for a few days (not unusual for me)
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| 42 | 2021-01-04 | feeling abnormal |
arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills ...
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arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision
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| 42 | 2021-01-06 | agitation, depression, crying |
Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, "I did experience the sor...
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Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, "I did experience the sore arm, though mine lasted about a week. I received my vaccine the morning of the 21st and by the evening I was experiencing what I have been called "tantrum moodiness". Short fuse, unreasonably angry, felt like crying, yelling, arguing. By the next day some general malaise that led to aching, especially it seemed in connective tissue. More moodiness, crying, some yelling. By Wednesday it seemed to resolve."
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| 42 | 2021-01-06 | amnesia, confusional state |
I had visual aura with migraine which is a normal event for me. This time, however, it was accompani...
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I had visual aura with migraine which is a normal event for me. This time, however, it was accompanied by confusion and memory loss that lasted about 15 minutes. I couldn?t say names of people known to me or read a list on my counter. In 25 years of migraines I have never had these symptoms with my migraine. I took an over the counter migraines medicine which resolved the symptoms.
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| 42 | 2021-01-06 | feeling abnormal |
About 1 hr post vaccination, patient developed jittery feeling (like she chugged espresso), cold fee...
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About 1 hr post vaccination, patient developed jittery feeling (like she chugged espresso), cold feeling in the chest. Pt reported eating breakfast and being adequately hydrated. Patient returned to vaccine clinic, remained seated for about 30 minutes, drank water, and feeling dissipated.
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| 42 | 2021-01-06 | nervousness |
Diarrhea left arm pain; abdominal pain 12/22 - vaccinated 12/23 onset of left arm pain and couldn't ...
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Diarrhea left arm pain; abdominal pain 12/22 - vaccinated 12/23 onset of left arm pain and couldn't lift her arm. 12/24 arm pain improved. 12/25 felt normal and healthy 12/26 stomach sharp pain, diarrhea and felt shaky. 12/30 tested negative for COVID-19. 12/31 - symptoms persisted through today and have improved for the first time today. Left with only mild abdominal ache. Not sure the abdominal symptoms are related to the vaccine. She was advised to seek medical care if symptoms persist or worsen.
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| 42 | 2021-01-06 | sensation of foreign body |
About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of m...
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About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of minutes and then passed. Then about 45 minutes after I started to feel a heaviness/ache in my upper chest. This feeling continued for days. Around day four I began to have a feeling of great pressure in my throat, particularly when swallowing. I noticed that my heartrate was elevated, but that might have been because the feeling was very stressful. The feeling would increase when I turned my head to the side or put my chin down.This feeling persisted for 3 days. After three days the feeling changed slightly and started feeling more like the sensation one gets when you have food stuck in your throat. As I type this, it is 8 days after the vaccine and I still feel this sensation in my throat.
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| 42 | 2021-01-07 | feeling abnormal, impaired work ability |
Headache Fatigue Narrative: 24 hours after vaccine administration onset of headache, malaise, feelin...
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Headache Fatigue Narrative: 24 hours after vaccine administration onset of headache, malaise, feeling poorly - subsequently missed work 12/22 in order to rest; resolved by 12/23
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| 42 | 2021-01-07 | insomnia |
Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asth...
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Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-01-07 | nightmare |
Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable othe...
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Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable other hcp, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number EL3246), intramuscularly on 02Jan2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. Prior to the vaccination, the patient had been diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On 02Jan2021, the patient experienced headache, chills, bad dreams and excessive thirst. No therapeutic measures were taken as a result of the events. The clinical outcome of headache, chills, bad dreams and excessive thirst was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 42 | 2021-01-08 | sleep disorder |
The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the ...
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The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the night with pain. The day after: moderate to severe pain on the left arm that radiates to the neck and back. Took Ibuprofen in the morning. Pain was getting better as the day pass. At night, around 6 pm started to feel that something is not OK. I am not the same as before. My legs are not very strong (feeling it, not a problem that I can?t walk - it feels like). Feeling dizzy at times. Went to bed and pain on the left arm is much better. Two days after the vaccine: woke up with body aches, feeling dizzy at times, weak, nauseous. Not feeling OK. It is now around11:30 am two day after the vaccine and I am starting to get worried. Please contact me for advise. Thanks
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| 42 | 2021-01-09 | impaired work ability, confusional state |
Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions an...
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Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.
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| 42 | 2021-01-10 | impaired work ability | muscle aches, low fever. called in sick to work. |
| 42 | 2021-01-10 | impaired work ability |
I was really fatigue, and I felt feverish. I checked my temp and it was greater than 104, I was unab...
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I was really fatigue, and I felt feverish. I checked my temp and it was greater than 104, I was unable to go to work. My hips hurt and some body ache and taking aspirin.
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| 42 | 2021-01-11 | feeling abnormal, loss of personal independence in daily activities |
1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things w...
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1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.
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| 42 | 2021-01-11 | impaired work ability |
The day after the vaccine was given, 01/07/2021, I had a headache and nausea around 10:00am. I had ...
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The day after the vaccine was given, 01/07/2021, I had a headache and nausea around 10:00am. I had to leave work early. I fainted when I got home on Thursday. Felt very tired. So I rested the remainder of the day and that night. On Friday 01/08/2021, I felt very tired and had a temperature of 100.6. I slept most of the day. Friday night I fainted again around 8:00pm. Slept all night. Felt much better on Saturday. Felt normal from Sunday on.
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| 42 | 2021-01-11 | impaired work ability |
Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling and pain occurring still 4 days post vaccin...
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Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling and pain occurring still 4 days post vaccine, visit with PCP who prescriped 800mg ibuprofen 3x/day and rest, no work. Symptoms began 7am on 1/9/21. Fever, chills, headaches, body aches . symptoms began 9am on 1/9/21 and lasted 24 hours. utilized tylenol to control fever. Low grade fever until 3pm on 1/10/21 - more than 24 hours after symptoms began
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| 42 | 2021-01-12 | anxiety, sleep disorder |
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep chok...
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2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
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| 42 | 2021-01-12 | feeling abnormal |
Sore arm -24 hours Extreme fatigue 8 hours Brain fog Difficulty forming words physically Difficul...
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Sore arm -24 hours Extreme fatigue 8 hours Brain fog Difficulty forming words physically Difficulty coming up with words to use Exhaustion
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| 42 | 2021-01-12 | feeling abnormal |
Headache; Mental foggy; body aches; tired; This is a spontaneous report from a contactable Nurse (pa...
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Headache; Mental foggy; body aches; tired; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in right arm on 06Jan2021 H 05:00 PM at single dose for COVID-19 immunization, lot number: EL3246. Medical history was reported as none. Patient had no known allergies and had no COVID prior vaccination. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included Antibiotic. On 07Jan2021 at 09:00 AM patient experienced headache, mental foggy, body aches and tired. She was not treated for the events. Patient had not been tested for COVID-19 post vaccination. Patient was recovering from the events at the time of the report. No follow up attempts are possible. No further information is expected.
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| 42 | 2021-01-12 | insomnia |
Insomnia, I was not able to sleep after my 12hr shift which is highly unusual for me. I was awake fo...
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Insomnia, I was not able to sleep after my 12hr shift which is highly unusual for me. I was awake for a total of 45-50hrs before I could fall asleep. I finally took Benadryl 50mg and Melatonin 40mg and was able to fall asleep.
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| 42 | 2021-01-13 | anxiety |
headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this o...
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headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-13 | feeling abnormal |
Received the second dose of the COVID vaccine on 1/8/2021. She had some side effects including inje...
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Received the second dose of the COVID vaccine on 1/8/2021. She had some side effects including injection site soreness, chills, and fatigue over the weekend following the vaccine. The fatigue has been present all week and got worse last night (1/13). Her temperature has been fairly normal since the second dose, but today (1/14), her temperature went up to 100.1 and has been fluctuating throughout the day, staying mostly at about 99.4. States she does not feel sick, but reports feeling "off." Reporting the symptoms because it feels like they are continuing well after receiving the vaccine. Also reports that her arm was a little itchy over the weekend around the area where she received the injection
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| 42 | 2021-01-13 | impaired work ability | body ache, headache. called in sick to work. |
| 42 | 2021-01-13 | impaired work ability |
Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when g...
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Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when going to bed. Overnight, I started to experience chills followed by extreme perspiration and weakness to the point that I struggled to open a bottle of water I had by my bed. Tuesday, 1/12/2021: Headache, weak and tired but attempted to work. I had to leave shortly after arriving because my symptoms were becoming progressively worse to the point I almost passed out from standing. Upon arriving home, I started to experience nausea and vomiting x 3. Intense chills followed by the extreme perspiration still existed. Most of these symptoms subsided by 9:30p that evening. Wednesday, 1/13/2021: Intense headache, weakness and dizziness. Of note, my left underarm/armpit (the arm where the vaccine was administered) is sensitive to touch.
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| 42 | 2021-01-13 | insomnia | Body aches, insomnia |
| 42 | 2021-01-13 | sensation of foreign body |
Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a st...
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Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.
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| 42 | 2021-01-14 | impaired work ability |
Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Contin...
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Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Continued into Saturday. Sunday, Monday and most of Tuesday felt normal. Tuesday evening started to fell worse and Wednesday 1.13.21, 6 days after shot, headache, nauseous, very tired, could not go to work. Called Doctors office and spoke to two different nurses who advised these were normal reactions although maybe delayed. By end of day headache and nausea were gone but still felt unwell. 1.14.21 well enough to work, mostly normal. Took blood pressure and it was elevated by 20 points! BP is still elevated on 1.15.21.
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| 42 | 2021-01-16 | feeling abnormal |
"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I...
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"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I awoke with chills and sweats. No fever. Felt crummy all day. Today I have left shoulder and arm pain, swelling in my left armpit and under my arm. I also have some numbness and tingling through my arm down to my hand. I have a hard knot at the injection site but its not red. I also continue to have occasional chills."
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| 42 | 2021-01-16 | insomnia |
1/11/21Insomnia - Went to bed by 9pm (woke up 11:30 pm and did not sleep through the night) 1/12/202...
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1/11/21Insomnia - Went to bed by 9pm (woke up 11:30 pm and did not sleep through the night) 1/12/2021 Muscle spams (neck) - body ached, lethargy - Took Tylenol 1/12/2021 Headache (sinus pressure) started fading at around 8 pm 1/13/2021 Lightheaded 1/14/2021 Lightheaded 1/14/2021 back to normal
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| 42 | 2021-01-17 | memory impairment, feeling abnormal |
couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind...
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couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind eyes/eyes hurt; icreamed; Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off; Whole body still weak; sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips; Twitching of face when do certain movements; brain zaps and brain buzzing began; numbness to right side of face to neck/made its way to left side; Horrible headache; fatigue; felt pressure behind her right eye; felt in a fog; forgetful mid conversation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, EL0140), intramuscular on 23Dec2020 08:00 at single dose at right arm for COVID-19 immunization; prednisone via an unspecified route of administration from an unspecified date to an unspecified date (for 4 days) at 50 mg for an unspecified indication. Medical history included Known allergis: latex, contrast dye. Concomitant medication included the first dose of influenza vaccine (FLU) on 30Nov2020 at single dose at right arm for immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Day 1: on 23Dec2020 08:15, the patient felt pressure behind her right eye after shot, felt in a fog, forgetful mid conversation. Day 2. (24Dec2020) Horrible headache started, fatigue. Day 3 (25Dec2020) brain zaps and brain buzzing began, headache, fatigue, numbness to right side of face to neck. By day 5 (27Dec2020) made its way to left side. Twitching of face when do certain movements. Her Dr gave her Prednisone and she took 50 mg for 4 days and stopped because she couldn't differentiate the tingling in hands and feet from shot or from that. Still brain zaps, newest issue sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips. Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off. Whole body still weak, eyes hurt. Head a lot better than a day ago but still having buzzing and twitching. Today was day 18. She was awaiting an MRI with contrast on Friday hoping it got moved sooner as she was scared to what was going on. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included CT/MRI/Optic Nerve Scan/Pain Shot/Meds for Zaps. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 28Dec2020. The action taken in response to the events for prednisone was permanently withdrawn on an unspecified date. The outcome of the events reported as not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all these reported serious events might not be fully excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-17 | mental impairment |
difficulty thinking; Extreme fatigue; dizziness; This is a spontaneous report from a contactable nur...
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difficulty thinking; Extreme fatigue; dizziness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received her second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 11:15 at single dose at Arm Right for COVID-19 immunisation. Medical history included hypothyroidism, thyroid cancer, hypertension from an unknown date and ongoing, Known allergies: Latex, aluminium, nickel.The patient was not pregnant. Concomitant medication included gabapentin, propranolol, levothyroxine sodium (SYNTHROID), and pantoprazole. The patient has previously received her first dose of BNT162B2 on 20Dec2020 08:45 PM for COVID-19 immunisation at Arm left. There was no any other vaccines within 4 weeks prior to the COVID vaccine.The patient experienced difficulty thinking, extreme fatigue and dizziness resulted in Doctor or other healthcare professional office/clinic visit. All the events occurred on 11Jan2021 09:00 with outcome of recovering. No treatment was received. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.The events were considered as non-serious. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the mental impairment and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-18 | feeling abnormal |
Feel bad; Bad headache; Nausea; Dizzy happens when I move around and change position; Dizzy happens ...
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Feel bad; Bad headache; Nausea; Dizzy happens when I move around and change position; Dizzy happens when I move around and change position; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported) on the left arm on 06Jan2021 (15:00) at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included ibuprofen. On 07Jan2021 (12:30 AM), the patient had felt bad; bad headache; nausea; and was dizzy which happened when she moved around and changed position. The patient had received paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as treatment for the reported adverse events. The outcome of the events, 'felt bad', 'bad headache', 'nausea' and 'dizzy which happened when she moved around and changed position', was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested since the vaccination. The patient had COVID-19 test which was negative on 08Jan2021.
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| 42 | 2021-01-18 | feeling abnormal |
Body aches, joint pain, fever (tmax 101F), Mentally fog, fatigue Left sided Headache, dizziness, a...
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Body aches, joint pain, fever (tmax 101F), Mentally fog, fatigue Left sided Headache, dizziness, and I couldn?t hear out of my left ear. These symptoms peaked approximately 12 hours after the vaccine. They lasted for 24 hours. The next day, the fever was gone and the only symptom I had was fatigue. 48 hours after the vaccine all my symptoms had resolved.
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| 42 | 2021-01-18 | hallucination | Body aches, headache, fever, chills, hallucinations |
| 42 | 2021-01-19 | feeling abnormal |
within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all ov...
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within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all over & I asked for Benadryl. I was taken to the ED dept. I was given zofran 4mg and Meclizine for vertigo and IV after 4 hrs. I Was told to go home and sleep it off. I've home with joint pain, muscle aches, nausea, abdominal pain, foggy mind, tiredness, weakness. Saw my PCP today. Rest, zofran and meclizine PRN hydration and rest.
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| 42 | 2021-01-19 | insomnia |
About 12 hours after injection I went to bed. No side effects noted during the day. During the nigh...
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About 12 hours after injection I went to bed. No side effects noted during the day. During the night I had insomnia for the entire night. Also noted excessive itching to entire body. No hives or welts. Still itching this morning
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| 42 | 2021-01-20 | impaired work ability |
14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120....
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14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120. I went home from work and became itchy to my neck and arms . At about 20 hours later I became short of breathe and pulse standing would go up to 140. I rested and continued taking Motrin and Tylenol as suggested . I ate minimally despite nausea . I messaged my Dr the next AM. By that time my glucose was settling down to normal and my Bp and pulse . The headache got worse and I had a pain in my axilla on the same arm I received the vaccine. I developed ?lymphadema? in that area which is sore to touch or move my arm. I reached out to infectious disease Dr at the hospital I work at and he suggested to continue Tylenol and Motrin and wait a week as this is due to vaccine. It is now Day 3 following vaccine and I am yet unable to work. My arm and axilla area is sore and I can?t lift my arm without pain, I have headaches and nausea as well.
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| 42 | 2021-01-21 | feeling abnormal | Chills joint pain headache fever just felt generally bad this all lasted for 24 hours |
| 42 | 2021-01-21 | insomnia |
12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client ...
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12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client improved that evening. 1/20/2021 Four hours after second vaccine dose - Body aches, intense headache over right eye, The evening of the same day - Heaviness to left arm, increased pain to left arm radiating to hands, tightness to the left arm with a feeling of "electricity" in the arm. The pain increased in intensity to the left arm during the night. Unable to sleep due to intense pain to the left arm and axilla. 1/21/2021 In the morning, client experienced abdominal pain and diarrhea once (loose stool). She noted swelling to the left axilla, intense pain, swelling below the left jawline. 1/22/2021 Early morning nausea without emesis, itching of the right forearm and nape of the neck, throbbing pain to left axilla with itching, throbbing to the left ear, which has not been sensitive to pain due to deafness.
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| 42 | 2021-01-22 | anxiety | dizziness, nausea, slight shortness of breath/anxiety |
| 42 | 2021-01-22 | confusional state | Headache, chills, nausea, diarrhea, extreme fatigue, body aches, mild confusion |
| 42 | 2021-01-23 | disorientation |
Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, ...
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Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.
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| 42 | 2021-01-24 | crying, insomnia, impaired work ability |
Timeline reported by patient as follows. Monday: 1-4-2021 Cold feeling down my arm, within 30 mins ...
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Timeline reported by patient as follows. Monday: 1-4-2021 Cold feeling down my arm, within 30 mins felt nauseous- got something to eat since didn't eat before- felt better throughout the day until around 3 pm. That is when my arm was very sore and pain down my right leg. This pain increased throughout the evening and other joints were affected including hips shoulders sternum, knees and ankles- overall body aches. Difficulty sleeping due to pain. Low grade fever of 99.9. Tuesday: 1-5-2021 Very sore arm but went away by midafternoon. about 5:30pm started having stabbing stomach pains that came and went throughout the night. Heat applied to help a little bit. Low grade fever 99.6 Wednesday: 1-6-2021 Woke up with some stomach pain but not stabbing. Still had body aches and still not able to sleep through the night (this is uncommon for me- i sleep hard through the night)- Keft work early due to not feeling well. Temp 99.9 Thursday: 1-7-2021 Tired, body aches, still some stomach issues, not able to sleep through the night Friday:1-9-2021 Tired, stomach feels unsettled, body aches, up again throughout the night Saturday: 1/10/2021 Tired, no energy, stomach feel nauseous at times, body aches still present- tried to get some sleep during the day as well Sunday: 1-11-12021 Tired, still not restful sleep, bodys aches, chills, temp 99.9 Monday: 1-12-2021 Woke up in pain throughout body, some nausea, fever comes and go with high of 99.9 and low of 97.8. Chills with the higher temp., Emotional unable to stop crying for no reason (maybe because I'm not getting sleep?) Took 1/2 day of PTO due to not feeling well. headache Tuesday: 1-13-2021 Took PTO all day Pain throughout the body, nausea, exhausted, still not able to sleep all the way through the night- up multiple times for multiple hours, trying to get sleep thoughtout the day but still not getting a lot. Wedensday: 1-14-2021 Took PTO, continued body aches, stomach issues, no fever Thursday: 1-14-2021 Body aches, stomach pain and issues, no fever as of yet, headache,
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| 42 | 2021-01-24 | feeling abnormal |
left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left j...
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left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-24 | feeling abnormal | Felt miserable, collapsed, blacked out for unknown length of time, diarrhea, sweating, hot flashes. |
| 42 | 2021-01-24 | panic attack, feeling abnormal |
About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, ...
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About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.
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| 42 | 2021-01-25 | feeling abnormal |
My initial reaction was headache, body aches, and brain fog, lasted about a day and half. Then abou...
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My initial reaction was headache, body aches, and brain fog, lasted about a day and half. Then about a week later i started just itching on my for arms and torso. I have little bumps and they itch. It comes and goes.
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| 42 | 2021-01-25 | sleep disorder |
At the time of injection, after 5 minutes she had muscle pain from what she thought was the vaccine....
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At the time of injection, after 5 minutes she had muscle pain from what she thought was the vaccine. By noon, she could not move her arm. That did not subside until 4 days later. Day 5 it still hurt but was getting better. She reports she is still not sleeping well at night. She said she can barely put her sports bra on or pull up her pants without it hurting. She did try Motrin, and it helped with the throbbing pain but not with her range of motion. Ice does help a little bit.
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| 42 | 2021-01-26 | excessive sleepiness |
Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept fo...
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Exhaustion Migraine Pain at injection site My lips went numb My hands went numb Nauseous I slept for 16 hours
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| 42 | 2021-01-26 | impaired work ability |
Less than an hr after the vaccine I suffered a gushing bloody nose. About 10pm I started having at ...
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Less than an hr after the vaccine I suffered a gushing bloody nose. About 10pm I started having at gurgling, discomfort feeling in my stomach which had me in the restroom all night followed by fever and diarrhea. On 12/31 I was sent for a COVID test and results on 1/1 showed that I was positive resulting in me being out of work for a total of 3 weeks. And as of today I am still experience mild COVID like symptoms
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| 42 | 2021-01-27 | anxiety |
Patient developed itching in throat minutes after receiving the covid 19 vaccine. BP 180/100, P 94-1...
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Patient developed itching in throat minutes after receiving the covid 19 vaccine. BP 180/100, P 94-107, RR 16 O2sat 98. Physician notified and requested a medical evaluation. Given Claritin 10 mg po at 12:00 pm and monitored patient for 40 min. Patient continues to feel itching in throat and becoming anxious. Physician called for transport to have patient taken to medical center for assessment on observation.
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| 42 | 2021-01-27 | insomnia |
Fever of 38 C for 3 days. Been feverish since then. Generalized Myalgia and arthralgia that not impr...
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Fever of 38 C for 3 days. Been feverish since then. Generalized Myalgia and arthralgia that not improves with NSAID. Tachycardia, headache, insomnia, fatigue, chest pressure.
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| 42 | 2021-01-28 | impaired work ability | fever. called in sick to work. |
| 42 | 2021-01-30 | poor quality sleep |
12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area...
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12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose
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| 42 | 2021-01-31 | feeling abnormal |
Pain at injection; headache; fatigue; nausea; chills; brain fog; diarrhea; joint pain; This is a spo...
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Pain at injection; headache; fatigue; nausea; chills; brain fog; diarrhea; joint pain; This is a spontaneous report from a contactable other healthcare professional (hcp). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), intramuscular on 18Dec2020 16:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included depression, anxiety, and known allergies to IVP dye. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications (reported as other medications in two weeks) included bupropion hydrochloride (WELLBUTRIN), sertraline hydrochloride (ZOLOFT) and unspecified multivitamin. The patient had no other vaccine in four weeks. The patient previously took cefalexin (KEFLEX) but had known allergies. On 19Dec2020 08:00 AM, the patient experienced pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain. No treatment received in response to the events. The patient was not tested for COVID post vaccination. The outcome of the events pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain was recovered on an unknown date. Information on the Lot/Batch Number has been requested.
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| 42 | 2021-01-31 | nervousness | light headedness, shaky; gave juice. |
| 42 | 2021-02-01 | delirium |
13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache,...
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13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache, ear pain and upset stomach. All of Saturday these symptoms went on and I had a tightness in my throat, not pain. I was very delirious and speaking jibberish when awake. Sunday the fever lessened and I felt more alert, but a large swelling started in my armpit in the left arm. Monday the fever was gone but I still had major joint pain, off and on headache and overall sick feeling. Today I woke and have a very upset stomach and achy feeling all over. The lump in my arm pit has gotten smaller but is still painful and visible.
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| 42 | 2021-02-02 | feeling abnormal, disturbance in attention |
1/29/21 Friday night: Muscle in upper arm knotted up so bad it pinched the nerve and my arm was use...
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1/29/21 Friday night: Muscle in upper arm knotted up so bad it pinched the nerve and my arm was useless. I had muscle weakness and joint pain down to my wrist. I had to do old physical therapy exercises, ice pack on upper arm, and took tylenol (really wanted to take advil). Saturday evening: I discovered my lymph gland was swollen and very sore under my left arm. Took a hot shower and it helped. As long as I don't wear a regular bra it's ok. Sore to touch or if I moved my arm a lot. Tylenol (again with the advil)and heating pad. Still sore today. Creeps me out. I also, slept all day Saturday. Took a long nap Sunday. Went to the clinic on Monday, back to another clinic on Tuesday-Tuesday was when I had the extreme exhaustion. I napped for 3 hours in the afternoon and was so tired and woozy when I woke up. I had brain fog. Couldn't concentrate or care about much for awhile. Today, I slept in, and feel fineat the moment. Waiting to see if I have that nap exhaustion thing. I plan to walk some and go pick up some Vitamin C and Zinc supplements today.
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| 42 | 2021-02-03 | feeling abnormal |
severe body aches; site of injection severely sore; low grade fever; nausea; joint pains; felt terri...
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severe body aches; site of injection severely sore; low grade fever; nausea; joint pains; felt terrible like hit by a truck; This is a spontaneous report from a contactable other healthcare professional reporting for a patient. A 42-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the right arm on 19Jan2021 14:30 at single dose for Covid-19 immunization in a hospital. Medical history was none. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included first dose of BNT162B2 via unspecified route of administration at the left arm on 31Dec2020 for Covid-19 Immunization and experienced had small joint pain on unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 16:45 (within 3 hours of getting the 2nd shot), the patient experienced severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck. The patient has not been tested for COVID-19 since the vaccination. The patient took Tylenol and didn't work. The outcome of the events severe body aches, site of injection severely sore, low grade fever, nausea, joint pains, felt terrible like hit by a truck was not recovered. The events were considered non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.
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| 42 | 2021-02-03 | feeling abnormal |
Exhaustion started 2 hours after injection, the next day I had a fever of 101.4, chills, my skin hur...
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Exhaustion started 2 hours after injection, the next day I had a fever of 101.4, chills, my skin hurt, and no appetite. The fever broke over night. The following day I had hardly any appetite, brain fog, and exhaustion.
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| 42 | 2021-02-03 | poor quality sleep |
I have had hot flashes two days after my vaccination.; I have them every night since and have not be...
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I have had hot flashes two days after my vaccination.; I have them every night since and have not been sleeping well due to them; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 05Jan2021 15:30 at single dose for covid-19 immunisation. The patient's medical history included Known allergies: PCN, latex, eggs. The patient was not pregnant at time of vaccination. There were no concomitant medications. On 07Jan2021 22:00, the patient has had hot flashes two days after vaccination. The patient has never had hot flashes before. The patient have them every night since and have not been sleeping well due to them. The patient did not received treatment for the events. The outcome of the events was not recovered.
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| 42 | 2021-02-06 | excessive sleepiness |
Headache, Chills, Nausea, Fatigue, Muscle Aches. I slept for approximately 18 hours with really bad...
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Headache, Chills, Nausea, Fatigue, Muscle Aches. I slept for approximately 18 hours with really bad chills.
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| 42 | 2021-02-07 | disorientation, confusional state |
Patient returned at 9:36am after receiving first dose at 8:41 complaining of nausea and dizziness. ...
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Patient returned at 9:36am after receiving first dose at 8:41 complaining of nausea and dizziness. Vital signs taken and assessment determined Benadryl needed. Patient was given 0.4mL =(20mg) . Patients vitals checked every 5 minutes. At 10:16 patient felt better and reposted symptoms better and no dizzy spells. Pt released at 10:38. Patient called for update on 2/5/21. Patient reported feeling better this day but reports that nausea returned with cramping and lasted until 2:30 pm day of shot. Dizziness and confusion lasted until 9:00pm day of injection, disoriented until 6pm day of injection and diarrhea that lasted until 4pm day of injection. Per medical director, Dr, patient should not get second dose of Pfizer vaccine.
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| 42 | 2021-02-07 | feeling abnormal |
Client reports that she was feeling weird and was not a panic attack as she has had them before. Sh...
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Client reports that she was feeling weird and was not a panic attack as she has had them before. She states that she was lightheaded, dizzy and that her tongue started to well and she couldn't swallow. Client reports that she received Benadryl, and anti nausea medication. Client was transported to the local hospital. Client states that she could still breath through her nose and that she was only in the ER for approximately 2.5 hours.
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| 42 | 2021-02-07 | feeling abnormal |
Temp between 99.5 to 100.5 degrees Fahrenheit; Achy; Headache; Injection site pain; Difficulty lifti...
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Temp between 99.5 to 100.5 degrees Fahrenheit; Achy; Headache; Injection site pain; Difficulty lifting arm; stiff neck; Feeling of having the flu; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via intramuscular route of administration, on 13Jan2021 at 09:15 AM (at the age of 42 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included gastritis, and COVID-19. The patient had known allergies to Bactrim. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included omeprazole 20mg daily, cetirizine hydrochloride (ZYRTEC) 10mg daily, vitamin D3 200 IU daily, and bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10) 20 billion live probiotic cultures. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021 at 10:30 PM, the patient experienced temperature between 99.5 to 100.5 degrees Fahrenheit, achy, headache, injection site pain and difficulty lifting arm, stiff neck and feeling of having the flu. All symptoms lasting 48 hours. The events were reported as non-serious. The patient did not receive any treatment for these events. The outcome of the events temperature between 99.5 to 100.5 degrees Fahrenheit, achy, headache, injection site pain and difficulty lifting arm, stiff neck and feeling of having the flu was recovered on an unspecified date in Jan2021. Since the vaccination, the patient had been tested for COVID-19 which included a blood test on 21Jan2021 which was negative.
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| 42 | 2021-02-08 | depression |
About 24 hours after receiving the vaccine she had sudden onset of moderate to severe depression. Pr...
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About 24 hours after receiving the vaccine she had sudden onset of moderate to severe depression. Prior to the vaccine she had been in remission and felt better than she had in years. The depression is persistent as of 3 weeks after vaccine.
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| 42 | 2021-02-09 | anxiety |
15 minutes after received COVID 19 vaccine, developed shortness of breath, dry mouth and throat dysp...
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15 minutes after received COVID 19 vaccine, developed shortness of breath, dry mouth and throat dysphagia, high blood pressure and anxiety.
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| 42 | 2021-02-09 | feeling abnormal, anxiety |
I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minute...
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I have been really brain fogged; weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness/ same sensation in my arms, in arm that I got shot in and it came with hand weakness; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; I had a weird like feeling in my legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety; Lethargy; Very tired; My heart kind of feel like it is pounding out from the chest like off and on throughout the day; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Jan2021 as a single dose, for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided. Patient got the vaccine on 17Jan2021 and she had been really brain fogged and on Tuesday and Wednesday she had a weird like feeling in her legs and it hardly lasted for five minutes but it came with weakness and it felt like a short of energy or anxiety and then Friday evening, patient had the same sensation in her arms, in arm that she got shot in and it lasted for about ten minutes and it came with hand weakness and then she had no muscle pain necessarily but lethargy, very tired and her heart kind of feel like it was pounding out from the chest like off and on throughout the day, events occurred on unknown date in Jan2021. Patient called the doctor and he said to wait but it is kind of there now, so she had an appointment on Wednesday. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 42 | 2021-02-09 | feeling abnormal |
I started feeling off within a few hours of receiving the vaccine, but not bad enough to keep me in ...
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I started feeling off within a few hours of receiving the vaccine, but not bad enough to keep me in bed. This lasted the first couple days, along with being more tired, a sore throat, and injection site soreness. But I have continued to have a headache and felt lethargic since. Again, I am functioning, just not feeling good.
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| 42 | 2021-02-12 | insomnia |
Received vaccine at 1:48pm at PODsite. Initially, no reaction. By following morning, 2/11, woke with...
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Received vaccine at 1:48pm at PODsite. Initially, no reaction. By following morning, 2/11, woke with sore arm, slightly stiff neck, and heart palpitations that persisted throughout the day. Had trouble sleeping as palpitations continued throughout the night and varied in degree from a flutter to a thump. No chest pain, no chest pressure and no breathing issues. By morning of 2/12, symptoms were still present and numbness in both arms from elbow to finger tips occurred. Called my healthcare nurse's line for advice to determine if I should see my doctor or go to ER. I was advised to visit the ER. Arrived at ER at approximately 12:56pm where I was immediately admitted and assigned to doctor. After my first 30-60 mins of observation, I was informed that my heart rate and blood pressure were high. I informed doctor that I have never had high blood pressure, so that is unusual. Was discharged around 4pm and instructed to submit an adverse reaction report and to see my general practitioner in 2 days. I was informed the following: no evidence of an acute cardiopulmonary process. Heart size and contours are normal.
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| 42 | 2021-02-15 | anxiety, panic attack |
I noticed on Thursday afternoon - Petechiae - rash on both legs, one area on arm and abdomen. I wen...
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I noticed on Thursday afternoon - Petechiae - rash on both legs, one area on arm and abdomen. I went to Clinic - walk-in care and was seen - the day of the 7th and I went back on the 9th (because more areas popped up). I developed extreme anxiety. The extreme anxiety lasted for about a week. I was seen in ER - twice (Jan 14 and 15)- I was treated with anxiety medicine for anxiety and panic attacks- Essoxer and Xanex. Petechiae rash is still there - lightened up but it's still there some. Did not get the second vaccine per doctor's advice.
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| 42 | 2021-02-15 | sensation of foreign body, feeling abnormal, confusional state |
I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vom...
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I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vomited forcefully several times. My neck and upper back became stiff and painful. Then came chills, shaking, and more nausea. My throat felt like there was a lump in it that was closing me off. I felt very weak and easily fatigued. I started to have visual issues, confusion, and was unable to focus. Neck pain continued to be severe. The next morning I woke feeling good, but within 2 hour again I went downhill. Symptoms are only about half as bad as the day before. Very very tired.
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| 42 | 2021-02-16 | panic attack | Panic attack |
| 42 | 2021-02-17 | crying, insomnia, hallucination, feeling abnormal |
smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had ...
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smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.
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| 42 | 2021-02-17 | feeling abnormal |
Itching and feeling off over a week post second dose. The following day I was extremely tired and we...
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Itching and feeling off over a week post second dose. The following day I was extremely tired and weak. By that evening, day 9 or 10, I began vomiting followed by horrible diarrhea that lasted about 12 hours. I never thought it was related to the vaccine until I heard from others that had the same symptoms days after their vaccine.
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| 42 | 2021-02-18 | feeling abnormal, sleep disorder |
About 3 hours after the afternoon shot, I noticed I began to feel bad. Not in any specific way, just...
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About 3 hours after the afternoon shot, I noticed I began to feel bad. Not in any specific way, just bad. That evening, I noticed chills, pressure at the top of my head, sensitivity to sounds, and aching body. That night, I had trouble sleeping due to all of this. The next day, an additional thing I noticed was how much my lymph nodes hurt, especially in the throat and armpits. The left armpit in particular was more swollen and painful than at any other time in my life. I could not put my arm down without pain. The day after that, the feelings subsided. This 3rd day after the shot, my left armpit lymph node is a little sore, but I am able to do my daily activities. I took children's chewable aspirin tablets the first evening, day and 2nd evening.
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| 42 | 2021-02-18 | feeling abnormal |
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ...
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could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
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| 42 | 2021-02-21 | feeling abnormal |
Two days after the 2nd injection I started to have chest pain and not feel right. I went to the Stat...
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Two days after the 2nd injection I started to have chest pain and not feel right. I went to the Station where I volunteer. I did and EKG which showed Anterior Infarct. I went to the ER. They gave me 4 baby aspirin to take and some blood work. I was told the blood work showed elevated levels consistent with a blood clot as well. I had a CT scan to rule out a clot in my heart or lungs. Which it was negative. I was released and told to see a cardiologist in the next few days. I saw the cardiologist two days later who said I ended up with Pericarditis and that it should resolve on its own. I was feeling better until two days ago when I developed chest pain again. I again went to my fire station I volunteer for and did an EKG which showed Anterior Infarct. I am currently waiting for treatment from my cardiologist.
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| 42 | 2021-02-22 | disturbance in attention |
Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, ...
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Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, increased HR and BP. Given Benadryl, was monitored and released. She felt normal from 2/15 to 2/18. Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED. Had normal labs. Vitals normalized. Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril. Her HR improved to 119 and her BP improved to 161/98.
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| 42 | 2021-02-24 | excessive sleepiness |
tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appet...
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tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-24 | sleep disorder | Body aches, chills, headache, unable to sleep |
| 42 | 2021-02-25 | mental impairment, feeling abnormal |
felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; diff...
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felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient) A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room. The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.
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| 42 | 2021-02-26 | feeling abnormal |
extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very...
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extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very strong have had it all week intermittently. Shaky, racing heart, high BP all intermittent, gastrointestinal upset, headache, feeling run down, trouble breathing but lungs fine Disruptive to working, thinking daily life feel very weird on and off
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| 42 | 2021-02-26 | impaired work ability |
I had the injection at 1000 am. At 8pm, I had chills, fever (Tmax 101), body aches, bone pain, fatig...
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I had the injection at 1000 am. At 8pm, I had chills, fever (Tmax 101), body aches, bone pain, fatigue, and swollen lymph node under my right arm. For about 4 hours, I could barely move because I was in so much pain. These symptoms continued, but after the four hours, was a little better. I still had significant symptoms for another day and a half. The symptoms slowly decreased until gone. I was off of work for 3 days. No treatment outside of OTC Tylenol, Aleve, ice pack, and rest.
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| 42 | 2021-02-28 | nervousness, confusional state, sensation of foreign body |
Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thou...
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Within 5 minutes of getting the vaccine, felt HR going up. Walked straight for the door as she thought fresh air might help. Felt shaky and cold sweats. Was very itchy. No visible rash. Felt a lump in her throat and tightness in her chest. Paramedics sat with her outside. Dizzy and confused and had to sit for an hour before feeling comfortable driving home. Then slept for the entire day. Felt heart palpitations throughout the day. HR was up to 128 at home. 2 days later started to feel better. Felt normal 4 days later.
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| 42 | 2021-03-01 | feeling abnormal |
About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic we...
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About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic were normal. No respiratory distress. After 30 minutes of observation, I left back to my work unit within the hospital and walking back I became dizzy, felt faint and weak. Developed a headache and felt mentally foggy. It lasted about 2-4 hours. No further medical attention seeked at that time. 3 days later at rest at home about 6/7pm, I experienced dizziness, headache, pain to base of neck R side, pain down my spine and lateral back. Numbness to R cheek bone. Twitching to L hand. Numbness, tingling and weakness to L arm. Tightness to chest and back. Emergency department diagnosed degenerative cervical disk disease. Negative on neuro exam.
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| 42 | 2021-03-03 | anxiety |
nausea, no vomiting. feeling flush, shakey, and anxious. No SOB, pruritis. Moved to a quiet room. ...
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nausea, no vomiting. feeling flush, shakey, and anxious. No SOB, pruritis. Moved to a quiet room. Lay down for 45 minutes and observed. symptoms spontaneously subsided.
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| 42 | 2021-03-03 | disturbance in attention |
Light headed and very dizzy. I had came back to work. I got severely tired. I went home to bed. For ...
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Light headed and very dizzy. I had came back to work. I got severely tired. I went home to bed. For the next 2 days I was weak, headache, light headed, dizzy, couldn't concentrate. Nausated. I had covid in November 2020 and it was some of the symptoms I had then. I am very worried about the second shot
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| 42 | 2021-03-03 | sleep disorder, feeling abnormal |
3/2/21: Shot about 7:30 am I. Arm. 2ish feeling tired and sluggish but not too bad. 4pm low gra...
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3/2/21: Shot about 7:30 am I. Arm. 2ish feeling tired and sluggish but not too bad. 4pm low grade fever and tired. 6:30 high fever 103 fever chills, shaking from chills. Lasted about 4 hours. No meds taken to offset. About 11 hot and tired. Hot with fever about 99-100.5. Up and down all night from being sore and not able to get comfortable. As well as feeling hot. Thirsty. Mental fog. 3/3/21: very tired. Wore out by simple tasks. Slept most of day. Achy body. A few slight fever times but not bad. Slept 18 of 24 hours. Times awake we?re just sitting. Mental fog. Even hearing someone else talk would wear me out. Went to bed at 6:30 pm. Was very tired but trouble falling asleep because could not get comfortable so took an Advil pm. Slept until 5:50 only getting up once to use bathroom. Did wake up in puddle of sweat when we to bathroom. 3/4/21: still tired feeling but feel much better. Mental fog way better. No fever. Feel alert and awake. Not feelingwore out by simple tasks. Location of injection: and arm response. Vaccine 1 given was about 2-3 inches down from shoulder joint. Very sore arm for 5 days. 3 days could raise arm or move without it hurting. Vaccine 2 given was no more than 1 inch down from shoulder joint. I was asked to pull T-shirt sleeve up further before getting it. It was much higher in arm than vaccine #1. 2 hours after vaccine arm was very sore. By 4 hours after arm hurt and not able to move it without pain. Did not use arm for even small normal tasks like taking a drink. By time fever broke around 11 pm, Arm felt much better. Sore but no pain to move it or use it for normal activities.
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| 42 | 2021-03-04 | poor quality sleep |
chills; increased heart rate; poor sleep; fatigued; This is a spontaneous report from a contactable ...
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chills; increased heart rate; poor sleep; fatigued; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247), via an unspecified route of administration in the right arm on 25Jan2021, at 12:15 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, at 12:15 the patient experienced chills, increased heart rate, poor sleep, and fatigued, which were non-serious. The patient underwent lab tests and procedures which included heart rate: increased on 26Jan2021. Details were as follows: hours after injection (just after midnight), the patient had chills, increased heart rate and poor sleep; next day she was fatigued and side effects subsided 24 hours after onset (midnight). The outcome of chills, increased heart rate, poor sleep, and fatigued was recovered in Jan2021, with no treatment No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-03-06 | disorientation |
Twelve minutes after second vaccination patient C/O Headache, Dizziness, slow to respond and "Fellin...
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Twelve minutes after second vaccination patient C/O Headache, Dizziness, slow to respond and "Felling disoriented" per patients husband. Pt encouraged to lie down on stretcher to see if conditions would improve. Concerns for anxiety versus reaction. Patient was oriented to name, day of week, year, and current President. Per patient's Husband, patient has a history of POTS, and under the care of a cardiologist, and is on a beta-blocker. Per physician on duty it was recommendation to call EMS and pt transport to ER for further evaluation. Pt treated and released from ER at 1505
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| 42 | 2021-03-07 | feeling abnormal |
Patient received Pfizer COVID vaccine and after 15 minutes felt like she was having an "acid" trip. ...
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Patient received Pfizer COVID vaccine and after 15 minutes felt like she was having an "acid" trip. Felt dizzy and foggy. We took her blood pressure reading. Observed her for an additional 15 minutes and still felt the same. At that time, we called EMTs who responded to her. EMT's told us that she refused services and left.
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| 42 | 2021-03-07 | panic reaction |
10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feel...
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10 minutes after the injection mouth tasted like metal, heart racing, body shakes, cold limbs, feeling of being hot and cold, sheer panic. Symptoms were very strong for the first few hours after injection. Jittery, shaky, uneasy feeling persisted for about 48 hours.
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| 42 | 2021-03-09 | abnormal dreams, anxiety |
Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensi...
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Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensitivity. Going on a week now This was my first vaccine.
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| 42 | 2021-03-09 | sensation of foreign body |
sensation that something was stuck in her throat (similar to when a tonsil stone is present); Stiffn...
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sensation that something was stuck in her throat (similar to when a tonsil stone is present); Stiffness at injection site; Itching; Sore muscle; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL6269), via an unspecified route of administration in the right arm on 06Feb2021 08:15 at a single dose for COVID-19 immunization. The patient's medical history included sulfa allergy. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced sore muscle on 06Feb2021 23:15, stiffness at injection site on 07Feb2021 04:15, itching on 07Feb2021 04:15, and sensation that something was stuck in her throat (similar to when a tonsil stone is present) on 07Feb2021 08:15. No treatment was received for the adverse events. Outcome of the events was recovering.
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| 42 | 2021-03-11 | feeling abnormal |
Fever >102; chills; dizziness - lasted 6 hours loss of consciousness - passed out about 2AM for just...
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Fever >102; chills; dizziness - lasted 6 hours loss of consciousness - passed out about 2AM for just about 30 seconds swollen lymph node under right arm - persisting on day 3 post injection brain fog - lasted 2 days
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| 42 | 2021-03-13 | feeling abnormal | SEVERE fatigue, foggy brain, low grade nausea for 9 days + |
| 42 | 2021-03-13 | feeling abnormal |
Hypertension of 162/118 with heart rate of 130 being at 1335. Normal blood pressure is around 120/80...
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Hypertension of 162/118 with heart rate of 130 being at 1335. Normal blood pressure is around 120/80 & resting heart rate of 70. Swimmy headed. But laughing and joking. Observed for 10 minutes, transferred to ER from vaccine site on campus. Triage bp was 145/100, hr of 112. Time elapsed between vitals taken was 17 minutes. EKG performed. Was not informed of results. Monitored for next several hours. Was asked to drink approximately 32 oz of apple and water. Given crackers to eat. Discharged from ER at approximately 1800. Bad headache same night into next day.
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| 42 | 2021-03-13 | memory impairment |
sharpening to the brain in the waiting area the first 15 minutes and a sharp using to the left hip i...
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sharpening to the brain in the waiting area the first 15 minutes and a sharp using to the left hip in the waiting area in the first 15 minutes but I wasn?t too worried about that. Uncontrollable laughter 11:45 AM the next morning. Forgetting where I was going on day two at 2 PM when I went to pick up lunch for the family totally got the wrong lunch. Again with uncontrollable laughter for 8-10 minutes. Sharp pain 05/14/2021 in the ovary area where I have a cyst in my ovary. Words messing up all the time. Right upper chest pain, freezing cold nose and nose tip feels like it?s freezing and has numbness and a runny suddenly on day 3.
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| 42 | 2021-03-14 | anxiety |
10 minutes after receiving second Covid vaccine, tongue and mouth felt tingly and scratchy. denies ...
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10 minutes after receiving second Covid vaccine, tongue and mouth felt tingly and scratchy. denies difficulty breathing or throat closing. Had similar symptoms with the first vaccine., Discussed with her PCP who gave her a note to have her second Covid vaccine but to take Benadryl 50 mg po one hour prior to shot which she did. Denies any drowsiness, stating she takes benadryl on a regular basis frequently. Ambulated with staff to med: Appears somewhat anxious, oropharynx patent, pink, moist mucus membranes, BP 128/62, T 98.6, Chest: CTA. RRR, HR 64. AAOx3, clear in conversation, ambulatory without difficulty. Declined transport to the ED or urgent care for continued care/follow up, although symptoms are not worsening but stable, and her anxiety decreased, during her 40 minute stay after the vaccine. Again, denied drowsiness and symptoms abating. She then left the unit for home at 2:40pm
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| 42 | 2021-03-14 | anxiety |
Client received her first dose of Pfizer vaccine and during the post-vaccination wait period, she co...
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Client received her first dose of Pfizer vaccine and during the post-vaccination wait period, she complained of chest pain/tightness. She described the pain as dull. She stated that she has a history of allergy to penicillin. She also has high blood pressure, but missed a dose today. She takes medication for anxiety as well. She was immediately evaluated by EMT personnel on site, and ?911? was called. She was evaluated by the emergency personnel for 30 minutes inside the ambulance and then transferred to the hospital
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| 42 | 2021-03-16 | disorientation, feeling abnormal, excessive sleepiness |
Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept f...
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Sore arm, joint pain, nausea, fever. But later that afternoon EXTREME fatigue set in. I have slept for the majority of the last 3 days. I wake up foggy and disoriented. Takes a while to focus and become alert. I use the restroom and maybe I'm able to be active for 15- 20 minutes then I'm back asleep, or too tired to keep my eyes open. Today is the first day I have been able to stay awake more than an hour. I had energy for about an hour and then felt like I was unplugged I'm just too tired to function. All I can do is go back to bed.
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| 42 | 2021-03-18 | feeling abnormal |
I?ve been running a fever of 100.2 to 100.8 since the night I received my vaccine. I have also exper...
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I?ve been running a fever of 100.2 to 100.8 since the night I received my vaccine. I have also experienced severe lethargy/exhaustion, mental fuzziness, headaches, body aches and chills. The fever has persisted and is going on 48 hours.
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| 42 | 2021-03-18 | feeling abnormal |
I have a big brain head aches from the outside in; Feel like I?m walking slanted when I?m walking st...
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I have a big brain head aches from the outside in; Feel like I?m walking slanted when I?m walking straight, can?t think in depth (it?s challenging to write graduate level papers); have to absolutely sleep 8-12 hours a night otherwise, I cannot function well with multi tasking as I did before the vaccine; Thirsty a lot more than usual, coughing sore throat (maybe this is normal w/the vaccine, I?m not sure). Today at 9:00pm, I realized that I lost my sense of taste. I ate a pizza and could not taste it. I am able to taste really sweet juice with my taste buds near the back of my tongue. This was something different today which is why I wanted to report. It does not feel like it is life threatening. Just uncomfortable to deal with. I?m so glad that I received the vaccine. If this is all that happens to me then , I am thankful for being alive and just having to deal with these discomforts while the vaccine is working through my system. Just note the symptoms maybe this is something in common with other people too.
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| 42 | 2021-03-19 | feeling abnormal |
Immediately after injection patient was light headed, drowsy, nauseous. Patient was given water and ...
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Immediately after injection patient was light headed, drowsy, nauseous. Patient was given water and glucose tabs (potential low blood sugar) and rested with head down. Even after rest patient still complained head was "fuzzy" and seemed dazed. EMTs were called and patient was taken to local hospital for follow up care.
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| 42 | 2021-03-21 | anxiety |
Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All ...
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Progress Notes PA-C (Physician Assistant) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/22/2021 Date: 3/22/2021 Subjective Patient is a 42 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience racing heart and face tingling. She denied rash, difficulty breathing, difficulty swallowing, throat tightness and facial swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, rash, hives, dizziness and headaches +facial tingling: Previous Reactions: Denies Objective Vitals Vitals: 03/22/21 0811 03/22/21 0819 03/22/21 0834 BP: (!) 153/90 134/87 118/85 Pulse: 87 80 80 SpO2: 98% 100% 99% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) Her symptoms completely resolved prior to discharge. PA-C Electronically Signed 3/22/2021 9:02 AM
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| 42 | 2021-03-21 | feeling abnormal, sleep disorder |
lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, ...
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lymph nodes hurt extremely, esp in throat and armpits; Left armpit node was so swollen and painful, it was difficult to put my arm down; feeling bad in a non-descript way; sensitive to sounds; feeling pressure in my head at the top third of it; chills; body aches; Couldn't sleep due to discomfort; discomfort; This is a spontaneous report from a contactable healthcare professional (patient). This 42-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 16Feb2021 at 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included endometriosis, depression, anxiety, thoracic scoliosis, and a herniated disc at L4-L5. The patient was not pregnant at the time of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included bupropion, citalopram, and tramadol from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EL9261) on 28Jan2021 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 16Feb2021 at 17:00, a few hours after the vaccine the patient noticed feeling bad in a non-descript way. Soon after in the evening she was sensitive to sounds, felt pressure at the top third of her head, chills, and body aches. She could not sleep that evening due to discomfort. On 17Feb2021 lymph nodes hurt extremely especially In the throat and arm pits. The patient's left armpit node was so swollen and painful it was difficult to put her arm down. The second day the symptoms were the same but lessened. The third day only the left armpit node hurt a little. The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with children's chewable aspirin in the evening of 16Feb2021 and the day and evening of 17Feb2021. The outcomes of feeling bad in a non-descript way, sensitive to sounds, pressure at the top third of the head, chills, body aches, couldn't sleep due to discomfort, lymph nodes hurt, and left armpit node swollen and painful were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-03-21 | sleep disorder |
Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the...
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Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the next day. Extreme body aches that started in the middle of the night that continued into the next day. Extreme headache which made me nausea until 5PM the next day. Felt 100 percent better on Sunday at 1PM. Vaccine was given on Friday at 1PM.
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| 42 | 2021-03-22 | anxiety | anxiety due to previous shot 10 years ago 140/70 92 16 Alert and oriented x4 |
| 42 | 2021-03-22 | insomnia |
I started with a headache at 10pm the day of the vaccine. Throughout the evening I had arm pain, chi...
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I started with a headache at 10pm the day of the vaccine. Throughout the evening I had arm pain, chills, sweats, insomnia, joint and muscle pain. All of those things have lasted through today 3/23 and have not improved at all. I feel like I was hit by a truck.
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| 42 | 2021-03-22 | insomnia |
Vaccine admin. At 8:38 am at Vaccine Clinic. The nurse (I?ve forgotten her name - boomer aged, shor...
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Vaccine admin. At 8:38 am at Vaccine Clinic. The nurse (I?ve forgotten her name - boomer aged, short gray hair) was standing when she administered the vaccine, and I remember making a note of the whole situation because it was the first time that a nurse did NOT say, ?Relax your arm.? I thought that was odd. I felt nauseous and dizzy within 1-2 min., but after my 15 min. Waiting period was up, I was no longer feeling dizzy or nauseous so I left. Within 10 min. I felt an ache in my arm, deep in the bone, and different then the regular shot-site pain. This is a dull ache that is barely tolerable. A few hours later, my shoulders and neck were experiencing very extreme, sharp pain, and I can barely move my arm, neck, and head. It hurts to hold my head up straight. This pain continues for another 2 days. It is a very intense, throbbing ache, and worse after a fitful night of rest, due to the constant pain in my left arm and neck. 48 hours later, still in intense pain and got a massage. Helped briefly but pain returned within minutes. On day 3, I got another more targeted massage on my shoulders and neck, with only a brief amount of time free from the pain. Day 4, the pain is so intense and I can barely handle it. I make an appointment with a APRN. She does not mention SIRVA but prescribes 800mg of Ibuprofen every 4 hours as needed for pain, and Flexeril, a muscle relaxer. She also gave me a shot of Toradol for the pain. The Flexeril makes me drowsy, and the ibuprofen takes the sharp edge of the pain away, but does nothing to mask the dull, deep ache in my left arm and shoulder. Day 5, 6, 7 all the same. On day 7, a new tingling sensation and numbness in my left hand and fingers start. Contacted office again to request a referral for physical therapy, and also to make a note of SIRVA in my file. Got a prescription for a stronger pain medication; neurontin to hopefully make the pain more manageable.
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| 42 | 2021-03-23 | anxiety |
Date: 3/24/2021 ...
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Date: 3/24/2021 Subjective Patient is a 42 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality and rapid progression of symptoms. PMH: asthma r/t seasonal allergies ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches + lightheaded: Previous Reactions: none that she is aware of. Had dizziness/lightheaded with ear piercing. Objective Vitals Vitals: 03/24/21 0951 03/24/21 0955 03/24/21 0959 BP: (!) 166/111 (!) 150/100 (!) 142/72 Pulse: 66 57 63 Resp: 18 14 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: Speaking full sentences Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious (slight). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Improved with rest/reclined. Pt able to sit up and stand w/o dizziness/lightheadedness. Assessment/Plan Treatment included: water and close monitoring Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Anxiety mixed with pseudo mild vasovagal syndrome. Pt improved and did well. Pt aware of option of getting her vaccine done here in the bay next time if she would like. Recommend 30 minute observation. F/up with pcp otherwise. 3/24/2021 9:48 AM
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| 42 | 2021-03-25 | anxiety |
After shot #1 on 3/5/21: tenderness at injection site lasted for weeks. Fatigue on 3/6/21 only. Inte...
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After shot #1 on 3/5/21: tenderness at injection site lasted for weeks. Fatigue on 3/6/21 only. Intermittent heart racing. After shot #2 on 3/25/21: pain at injection site. Severe depression and anxiety lasting the day of injection. Intermittent racing heart. Chills, fatigue, overall malaise starting 3/26/21. Moderate headaches starting 3/26/21. Numbness/tingling in tips of fingers on right hand starting 3/26/21.
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| 42 | 2021-03-25 | feeling abnormal |
I am 5 days out from the 2nd dose. I had to make an urgent care visit because of shortness of breath...
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I am 5 days out from the 2nd dose. I had to make an urgent care visit because of shortness of breath, blurred vision, light headedness, brain fog, nausea, fatigue, feeling of fainting and tightness in throat. These symptoms have been present and overwhelming for over 3 days presented themselves after day 2 of vaccine. The original symptoms of headache, body aches and chills subsided by day 3.
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| 42 | 2021-03-25 | feeling abnormal |
Feeling nausea, weak, dizzy. Had a brain banana since yesterday. HR 60 reg. BP 106/81, O2 Sat 100...
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Feeling nausea, weak, dizzy. Had a brain banana since yesterday. HR 60 reg. BP 106/81, O2 Sat 100%.
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| 42 | 2021-03-25 | memory impairment |
Fainted after getting up to use the restroom in the middle of the night. Fainting resulted in injury...
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Fainted after getting up to use the restroom in the middle of the night. Fainting resulted in injury to my chin and head. Had to get 7 stitches in chin from falling into dresser. I have no memory of falling. Only remember using restroom and be woken up from the floor by my husband.
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| 42 | 2021-03-27 | feeling abnormal |
I have been experiencing fatigue, muscle pain and weakness, fogginess, dizziness, headaches, a sligh...
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I have been experiencing fatigue, muscle pain and weakness, fogginess, dizziness, headaches, a slight sore throat, light coughing. I started experiencing these symptoms a day after the second dose.
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| 42 | 2021-03-28 | panic attack |
itching in the arm, high blood pressure (114/99 mmHg) 107 , headache, pulse 107, panic attack, fa...
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itching in the arm, high blood pressure (114/99 mmHg) 107 , headache, pulse 107, panic attack, fainting
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| 42 | 2021-03-29 | anxiety, panic attack, feeling abnormal |
I am having anxiety sense the fourth day of the vaccine and it only was the first one. I can?t sleep...
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I am having anxiety sense the fourth day of the vaccine and it only was the first one. I can?t sleep or eat and I feel this panic attacks and are awful.
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| 42 | 2021-03-29 | feeling abnormal |
About ten minutes after the vaccine I had a strange feeling that something wasn?t right. Vaccine arm...
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About ten minutes after the vaccine I had a strange feeling that something wasn?t right. Vaccine arm started going numb with tingling. That hand then became completely numb. Then my throat went numb and face was tingling and couldn?t swallow properly. Found nurse at the vaccination site and reported not feeling well. She immediately noticed I was bright red and breaking out in hives. Nurse gave me an antihistamine shot and an oral antihistamine for an allergic reaction. I?ve never had an allergic reaction before or ever experienced any of these symptoms before. After a few minutes the symptoms started going away. I was advised to not drive myself home. About an hour later some milder symptoms came back, such as slight tingling of face and lips. Went away again gradually. Fell asleep (not sure how long) and woke up with swollen and numb lips so I took some more antihistamine. No more allergy symptoms after that.
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| 42 | 2021-03-29 | impaired work ability, loss of personal independence in daily activities |
On Mar, 25th , around 4.30 pm I got vaccinated. I went back home. I ate my summer and Took Tyelenol ...
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On Mar, 25th , around 4.30 pm I got vaccinated. I went back home. I ate my summer and Took Tyelenol as I was tired and arm was little sore. I slept around 7.30 pm and got up at 7 am. I felt weakness and after I had my break fast , my body pains started. Every muscle ached and every joint ached. I had weakness and lethargy. I took tyelenol extra strength so the pain was subsiding . I had temperature 100.3 since Fri , Mar 25th. When the tyelenol was wearing off the pains used to become horrible. I was not able to move and I was on my bed bed most of the time. On 28th I even tried Ibuprofen as Tyelenol was not helping a lot with pains but Ibuprofen did not work at all. I sent messages to my dr who thought these side effects are expected. On Mon she replied if the side effects did not resolve I can go to Immediate Care. My arm was sore but that soreness was nothing compared to body aches I had. I called off from work on Fri and Sat. My employer wanted return to work clearance. I went to discuss with Immediate care doctor as I had same weakness and tiredness and little walking was making me breathe heavily. As it was almost the end of 4th day after I got my vaccine they tested me for Covid and my results were negative. I still have to be in quarantine for 7 days from yesterday. I was tested Covid positive in Mar 2020 around mar 24th. I had same horrible pains but had high temperature like 1049.8 and with tyelenol it was 102.5. I am scared to take the second dose that might trigger same reaction. I suffered a lot like people suffered after 2nd dose. First dose is sensitizing dose but I showed such reaction that means my body recognized the threat and began to fight in first dose then what is the need of second dose that is actually a booster dose. My main concern is I might feel the same way how I felt now. I am still weak and cannot perform my daily activities like cooking and I have 4 kids aged 7- 12 yrs age.
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| 42 | 2021-03-29 | impaired work ability |
Employee began to feel ill at 2am the night following the vaccine. Suffered from weakness, fever/chi...
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Employee began to feel ill at 2am the night following the vaccine. Suffered from weakness, fever/chills, nausea, body aches, headache, sweats. Employee missed 3 work days but returned to work once symptoms subsided.
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| 42 | 2021-03-30 | abnormal dreams, nightmare |
Metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not w...
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Metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not with food; very vivid dreams every night-sometimes nightmares, usually don't remember dreaming at all; very vivid dreams every night-sometimes nightmares, usually don't remember dreaming at all; This is a spontaneous report from a contactable Other-HCP (patient reported herself). A 42-year-old non-pregnant female patient received BNT162B2 (COVID-19, Pfizer, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration on 29Jan2021 12:00 PM at single dose to her left arm for Covid-19 immunization. She was allergic to Sulfa-thrush. No Covid was tested prior or post vaccination. Concomitant medications included (BENADRYL) every night and paracetamol (TYLENOL) 1-2 times a week bef. On 29Jan2021, the patient experienced metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not with food, very vivid dreams every night-sometimes nightmares, usually did not remember dreaming at all. She did not take any treatment in response to the events. Outcome of the events was not recovered.
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| 42 | 2021-03-30 | anxiety |
42 yo female with c/o itching to neck/throat, sensation of throat swelling/SOB, dizziness ~1:43 pm. ...
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42 yo female with c/o itching to neck/throat, sensation of throat swelling/SOB, dizziness ~1:43 pm. She has prior h/o anaphylaxis to IV contrast and appeared to be very anxious. Pt was given Benadryl 25 mg PO, water, and rested in a recliner. BP 140/80, HR 88, o2 sat 100%. 911 was called as pt's symptoms were not improving and she had travelled to vaccination clinic alone by bus. She remained A&Ox3, was speaking in full sentences, and no swelling or erythema to throat visualized.
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| 42 | 2021-03-31 | feeling abnormal, insomnia |
I was fine for about 10 hours after the vaccine. Then started with sleeplessness, traveling pain in ...
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I was fine for about 10 hours after the vaccine. Then started with sleeplessness, traveling pain in my joints, hip, neck, and back. That pain persisted for 24 hours. The pain all over my body and in my joints resolved, but I started with an intense stabbing pain that started in my lower back any time I'd bend over or extend my torso. The pain traveled up my back until the evening when it settled between my shoulder blades and the base of my neck. The next day, my back and neck were stiff and painful. I called the doctor and he said it was likely that the spine was inflamed and should go away by day 5. The pain receded, but last night I noticed a very distended and bloated belly. I'm petite and it is not usual for me. I now also have a mental fog that is concerning me. When driving carpool for my son's soccer practice (a route I do ever week), I made several wrong turns and only was made aware I was going in the right direction when the kids told me. I still have stiffness in my neck and back and a headache. None of these symptoms did I experience before the second vaccine shot.
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| 42 | 2021-03-31 | feeling abnormal | Extreme fatigue, nausea, upset stomach, brain fog for 7 days |
| 42 | 2021-03-31 | impaired work ability |
This may be within the normal bounds but wanted to make sure that I reported this as continued resea...
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This may be within the normal bounds but wanted to make sure that I reported this as continued research is ongoing with the Covid-19 vaccines. I received the Pfizer vaccine 2nd dose on March 29 around 12:15 pm. At the injection site I developed a light bumpy rash. My upper arm also was swollen -- the best way to describe the feeling is as if someone stitched a small ball into my skin and took a bat to it. Made it very difficult to work (typing), and lifting/using arm. I also had a mild sore throat for 48 hours post vaccination.
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| 42 | 2021-04-01 | feeling abnormal |
Sore arm for a couple days after shot 1. Sore arm for a few days after shot 2. Body aches, tired, a...
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Sore arm for a couple days after shot 1. Sore arm for a few days after shot 2. Body aches, tired, a little fuzzy headed the following day. Sometime in the past few weeks (I'm not sure when) I've developed pulsatile tinnitus in my left ear. It comes and goes. It's not very bad and usually only happens when I'm lying down in bed in the evenings. It feels like there's a little extra ear wax or cotton or something in that ear all the time though. I've never had tinnitus prior to this.
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| 42 | 2021-04-01 | feeling abnormal |
Ten days after the vaccine was administered I woke up feeling like something was wrong. I just didn?...
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Ten days after the vaccine was administered I woke up feeling like something was wrong. I just didn?t feel right. I tried to lay down to see if I could feel better but this did not help. Even while in a relaxed state my blood pressure was up to 170/97 and heart rate of 220. I was very dizzy and felt like fainting but did not lose consciousness. I had a terrible pressure in my chest, in the left side of my neck and along the inside of my left arm. Also notable my vision was blurred. Called 911 ambulance took me to the Hospital ER and the ekg they performed was abnormal and also notable when they drew my blood my sodium level was below the normal threshold. I had taken 3 nitroglycerin tablets and my symptoms subsided enough for them to let me go home. Since coming home my bp has remained elevated much higher than normal at around 135/85. I continue to feel not quite normal and have the pressure in my left side of neck, chest and left arm. I feel very certain this is all due to the covid vaccine I received.
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| 42 | 2021-04-02 | confusional state |
like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like bl...
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like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like blurry vision and then she lost her senses/loss of consciousness (fainting); tachycardia; mental confusion; loss of sphincter control (urinary incontinence)/pissed on herself; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 15Mar2021 13:15 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the pharmacy. Medical history was not reported. There were no concomitant medications. The patient was not pregnant (including at the time of vaccination). On 16Mar2021 13:15, she came around to feeling really something bad in her body. She described this as she had loss of consciousness (fainting) which started to feel like blurry vision and then she lost her senses. She then passed out for 5-8 minutes and she had loss of sphincter control (urinary incontinence) as she pissed on herself. She also had tachycardia and mental confusion by that time. They called an ambulance and she was brought to the emergency or urgency department/room. The events [loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion] were considered as serious (medically significant). She also had several diarrhea (noted in 2021) episodes during one week. She had no COVID prior vaccination and not tested post vaccination. She would like to know if the reaction that she had with first dose vaccination was normal as she was afraid of the second one. The patient did not receive any treatment for the events of loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion. Outcome of the event of diarrhea was unknown while recovering for the remaining events. Information on the lot/ batch number has been requested.
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| 42 | 2021-04-02 | loss of personal independence in daily activities |
Fatigue. Could hardly get out of bed in the (next/second) morning. It was bad. Was a bit better by a...
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Fatigue. Could hardly get out of bed in the (next/second) morning. It was bad. Was a bit better by afternoon. I was at 90% by the third morning, and not quite 100% at the third evening but progressively recovering. Included muscle aches - all muscles as far as I could tell. Very mild headache. Started same day as vaccine. Was also present second day. Gone by third day. Mild arm soreness at injection site after both 1st and 2nd doses.
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| 42 | 2021-04-04 | anxiety, panic attack |
Day 1 (4:30 pm vaccination day). Clammy hands and metal taste for 15 minutes, dizzy feeling for 1 m...
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Day 1 (4:30 pm vaccination day). Clammy hands and metal taste for 15 minutes, dizzy feeling for 1 minute. Later that day, overall feeling of unwell, short lived muscle weakness, tired, sore arm, anxiety, loss of appetite, odd, bubbling sensation in left leg, slight itchy skin mostly in legs and at injection site. Day two. Unwell, nausea, loose stool in morning, anxiety, tired, slight sore arm, odd bubbling sensation in left leg, slight itchy skin, loss of appetite, red eyes, red itchy chin, slight itchy skin in legs and at injection site Day three. Unwell, nausea, very slight sore arm, loose stool in morning, panic, tired, itchy red eyes, nausea, red itchy chin, slight itchy skin mostly in legs and at injection site, no appetite. Day 4. Loose stool in morning, more energy but still tired, itching continue slightly on chin and injection site and legs, appetite returning, slightly tired, very slight sore arm. Day 5. Woke up with indigestion, feeling unwell and tired, laid in bed and felt a jolt by means of noise in my head which only happened once and was quickly over, very slight sore arm, itchy at injection site, weird metal taste, upset stomach, leg and arm vein fullness Day 6. Woke up tired with overall feeling of slight unwell but gained a good bit of energy as the day progressed, leg and arm vein fullness. Day 7:. Leg and arm vein fullness Day 8:. Non localized Itchy skin Side note:. I'm beyond worried to get the second vaccination.
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| 42 | 2021-04-05 | anxiety | Anxiety. Xanax 5mg. 1/2 tab. 8:00am 4/5/21. |
| 42 | 2021-04-05 | feeling abnormal | Brain fog, tiredness, headache, stomach upset, fever |
| 42 | 2021-04-05 | feeling abnormal |
Brain fog a few hours post-injection 12 hrs to 36 hrs post-injection: Headache, muscle aches, stabbi...
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Brain fog a few hours post-injection 12 hrs to 36 hrs post-injection: Headache, muscle aches, stabbing and burning pains in most muscles, severe fatigue, dry mouth/ cracked lips not relieved by fluids, temp of 99.5, cold sweats, chills 36 to 48 hrs: fatigue, residual muscle aches, headache, nausea & belching
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| 42 | 2021-04-05 | insomnia, feeling abnormal |
Initially (24 hours) I had fever 100.5, chills, aches. These resolved by 3/20. Arm was very sore f...
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Initially (24 hours) I had fever 100.5, chills, aches. These resolved by 3/20. Arm was very sore for about 3 days, but took almost a week to completely feel better. On 3/21 more concerning symptoms started to develop. Brain fog, spacenesses, trouble looking at books, computer tv. Very strange sensation. This resolved by 3/25. Other symptoms that developed beginning 3/21 were GI upset (diarrhea, stomach churning) as well as insomnia - very short and broken sleep all night with dreams and waking up each time after brief sleep with bad/sour taste in mouth. The insomnia has gotten progressively worse and unlike anything I've had before. I do not have a history of insomnia ( I sleep very well) . For the last week, I do not sleep more than a hour or two at a time and have the broken sleep, with dreams, not a good deep sleep at all, and sour/bad taste in the mouth. I also don't have any history of GI problems. I have been eating a bland diet to try and help with the stomach issues, which have improved somewhat but are still not resolved. The insomnia is very troubling. Also occurring is heat sensation in the right hand (this actually developed after my first shot which was 2/23) that would occur a few times a day where my knuckles are. In the last several days (starting 4/3) my right forearm and bicep have been feeling of weakness and numbness, almost like someone has been sitting on it. Not pins and needles feeling, but weak and numb. This is somewhat transient, and happens for a few hours each day. It seems to have improved as of today 4/6. My physician feels I could have had some kind of neurological response to the vaccine. I would like to know if this could be the case, or if there is any data showing these symptoms will go away, as I am obviously upset by them.
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| 42 | 2021-04-06 | anxiety, depression, nervousness |
I broke out in Hives over my whole body and my throat was swelling a bit. Got dizzy and shaky. I was...
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I broke out in Hives over my whole body and my throat was swelling a bit. Got dizzy and shaky. I was given 2 shots in Hips and a steroid.
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| 42 | 2021-04-06 | excessive sleepiness |
Sore arm injection site, extreme fatigue still ongoing, severe nausea, rash on left side of ribs app...
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Sore arm injection site, extreme fatigue still ongoing, severe nausea, rash on left side of ribs approx palm size, chills, sleeping excessively with bouts of sweating and chills alternately.
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| 42 | 2021-04-07 | anxiety |
Patient provided information regarding history of asthma, previous allergic reations to animal, perf...
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Patient provided information regarding history of asthma, previous allergic reations to animal, perfume, dust, pollen. Also, reported anxiety when she see needle or syringe. When staff asked patient whether she is comfortable to complete her vaccination, patient replied that as long as she do not see the procedure she will be fine. After vaccine administration patient reported discomfort in her throat. Dr. and EMT team were notified. Patient's vital signs were BP 116/72 HR 103 O2 98% RR 18. Patient was monitored for forty minutes, no medications were administered. Patient left in stable condition (vita signs BP 121/70, HR 95, O2 99% RR 18). No hospitalization required.
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| 42 | 2021-04-07 | disturbance in attention |
Chills, feverish, rash, spams in arm, hand trembling. possible diarrheas, headache, fatigue, blurred...
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Chills, feverish, rash, spams in arm, hand trembling. possible diarrheas, headache, fatigue, blurred vision, loss of focus, general malaise and body pain.
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| 42 | 2021-04-07 | feeling abnormal, mental impairment |
About 8 minutes after the shot I started to feel "off" which progressed into lightheadedness and tho...
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About 8 minutes after the shot I started to feel "off" which progressed into lightheadedness and thought I was going to pass out. I alerted the pharmacy team right about the 10-minute mark when they increased instead of getting better. Had to sit down, hard to form thoughts, hard to talk without feeling nauseous. Got very hot, had to remove the top layer I was wearing, and put my head down in my hands bc I felt like I was going to get sick. Then around 11:05, the hot flashes turned into a cold sweat, still with the pass out/nausea feeling. Around 11:08 my lower back and hands felt like they were shaking but they weren't. Was given a small bottle of water. At 11:14 the nausea and sweats had passed but it felt like my hands were shaking so badly as if holding a jackhammer. It also felt that my hand muscles were trying to stretch my fingers flat and up, while I was actively trying to cusp my knees. The shaking started to appear in my lower calves but then everything subsided and I was OK to stand up/leave around 11:20. I had some slight brain fog for a few hours and was tired, but was fine come Sunday (aside from site injection swelling and sensitivity that cleared up by Monday).
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| 42 | 2021-04-07 | insomnia |
Major headache starting just few hours after the vaccine. It was difficult to sleep. Treated with Ty...
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Major headache starting just few hours after the vaccine. It was difficult to sleep. Treated with Tylenol the next morning. Mild tinnitus in both ears. It's been almost 2 weeks post 1st vaccine and the ringing/humming/ shushing is still here....luckily it isn't unbearable but noticeable where I get to easily pay attention to it. I'm not sure if I should get the 2nd shot. I read reports of people's tinnitus getting worse after the 2nd shot. The headache also keeps coming and going, a lot more often than my normal range.
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| 42 | 2021-04-08 | crying |
heart rate was noted to be high in the 146-150 range.The patient was able to talk and respond to que...
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heart rate was noted to be high in the 146-150 range.The patient was able to talk and respond to questions but kept her eyes closed and was crying. She started heaving but was not vomiting. Benadryl and Solumedrol IM he was alert and coherent but kept her eyes closed and said ?she could not open them?. She started to have rigors at 2:40pm, her pulse ox dropped to 89%, heart rate again climbed to the 150?s. Taken to the ED
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| 42 | 2021-04-09 | feeling abnormal |
-Recieved shot about 3pm -During the 15 min waiting period my eyes felt kind of dry and "weird". I ...
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-Recieved shot about 3pm -During the 15 min waiting period my eyes felt kind of dry and "weird". I honestly didn't even consider it could be a reaction, I thought the way I was breathing through my mask must have been drying my eyes out. -Left clinic after 15 mins, only symptom at this point was dry eyes -about 5 mins in to our drive home my face was feeling very funny and kind of numb. I was feeling worse and worse. -looked in mirror and noticed face was bright red and swelling up. Also my throat was fire red. -it was getting worse and worse, also was starting to get itchy. -My entire face was bright red -Stopped at Sister-in-law's house (cause it was on the way home and she is a nurse) and took two benadryl. Was observed for another 20 mins there and the reaction started to calm down. The redness was still there, but the swelling seemed to have stopped. -went home and kept a close eye on it the rest of the night. -became itchy, but no rash. The bright redness went away after about 20 mins, but my face stayed red (like a sunburn) most of the evening. Throat was red as well. -felt fine when waking up on 4/9 and no other instances of these symptoms -sore arm 4/8-4/10
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| 42 | 2021-04-10 | anxiety |
I was find after the 15 minute waiting period. By the time I had pulled out of the complex in my ca...
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I was find after the 15 minute waiting period. By the time I had pulled out of the complex in my car my cheeks were bright red and it continued down my neck. My right side of neck felt tight/stiff. By the time I got home I had a hive above the right clavicle. Right hand felt numb. Heart rate accelerated, face became puffy. Lips and gums felt numb, throat got red and swollen, hive on right gum and back of throat felt itchy. Never lost ability to breath or swallow. High anxiety, felt extremely uncomfortable in my body. Took Histaminum hydrochloricum via bioAllers Pollen Hayfever treatment several times between 6:30pm and 10pm. Took Skullcap via tea between 7pm and 8pm. Reaction started to calm down around 8:45pm, and I felt back in my body by 10pm. It took until about 2:30am until my heart beat regulated. I will see a PCP hopefully today (Sunday) if not tomorrow.
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| 42 | 2021-04-10 | crying |
42 y/o female, hx of fainting ?when getting shots?. c/o SOB, stated ?I feel numb on my face from nos...
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42 y/o female, hx of fainting ?when getting shots?. c/o SOB, stated ?I feel numb on my face from nose down to my mouth?. Also stated ?I feel like my throat is closing and having hard time swallowing?. Pt is hyperventilating, crying. Paramedics V/S taken HR 95, BP 149/88, O2 Sat 100%. Educated on calming and deep breathing techniques, given po fluids tolerating well. Pt now more calm and sent home without s/s acute distress.
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| 42 | 2021-04-10 | excessive sleepiness |
Blackout; Sleeping a lot; This is a spontaneous report from a contactable consumer (patient). A 42-y...
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Blackout; Sleeping a lot; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Batch/Lot Number: EN6204) at the age of 42-years-old as single dose for covid-19 immunisation. Medical history included seizure from 1994 to an unknown date (it is been happening since the patient was a teenager), epileptic from an unknown date and unknown if ongoing. Concomitant medication included levetiracetam taken for seizure from an unspecified start date and ongoing. The patient reported that she had like blackout from, assuming the vaccine the next day on 23Mar2021. It was kind of later in the day and then next day, 23Mar2021, she was just having kind of had a blackout and she was sleeping a lot and may have had a seizure, she was not really sure as she was sleeping a lot and may had a seizure; she was not sure and she was epileptic. The patient was grateful that she got the vaccine. The patient underwent lab test and procedures which included blood test: unknown on an unspecified date. The patient was recovering from the events. Information on the lot/batch number has been requested
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| 42 | 2021-04-10 | loss of personal independence in daily activities, insomnia |
Injury to left shoulder, pain in left shoulder and arm, weakness in left hand and arm, and numbness/...
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Injury to left shoulder, pain in left shoulder and arm, weakness in left hand and arm, and numbness/tingling/pins & needles sensation in left hand for more than 2 weeks after receiving my second vaccine shot. Pain has made it difficult to sleep, drive, sit up, etc. Also experiencing pain in back of lower neck due to pain posture. Just started physical therapy and was prescribed high-strength ibuprofen to deal with the pain. Experienced no pain when I received my first Covid shot, but when the vaccine administrator gave me my 2nd shot, it hurt very badly going into my arm, and it seemed like she injected me in a location that was different from my first shot.
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| 42 | 2021-04-11 | anxiety, feeling abnormal |
Patient began feeling anxious like her heart was working harder. She has a neurologic condition that...
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Patient began feeling anxious like her heart was working harder. She has a neurologic condition that causes her to have syncope with left arm parthesias. Patient felt overall off.
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| 42 | 2021-04-11 | impaired work ability |
04/08/21 - Pain at injection site, Fever (100.4*F), Fatigue 04/09/21 - Pain at injection site and ar...
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04/08/21 - Pain at injection site, Fever (100.4*F), Fatigue 04/09/21 - Pain at injection site and arm, Fever (100.0*F), EXTREME Fatigue, Joint Pain, Body Aches, Dizziness (Did not go to work) 04/10/21 - Dizziness, No fever, Fatigue, Joint Pain, Nausea 04/11/21 - Large Joint Pain, Fatigue, Pain in Left Shoulder near injection site 04/12/21 - Large Joint Pain, Fatigue, Pain in Left Shoulder near injection site
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| 42 | 2021-04-11 | sleep disorder, insomnia |
The night of the vaccination I began having fevers night sweats and radiating severe Right neck pain...
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The night of the vaccination I began having fevers night sweats and radiating severe Right neck pain that radiates from my neck to my right ear up my R scalp and R front and to the top of my head causing severe chronic headaches constantly. So far it has last for seven days with minimal relief and it is worse at night when I try to sleep causing me insomnia due to pain. Pressure in my head feels like my brain is about to explode and I feel it in my neck and back of my ear on the right side.
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| 42 | 2021-04-12 | anxiety |
Prior Hx of anaphylaxis. Tingly feeling bilateral of face/jaw described as moving up and down. Patie...
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Prior Hx of anaphylaxis. Tingly feeling bilateral of face/jaw described as moving up and down. Patient visibly anxious before and after vaccine administration. Vital Signs: BP 151/121 HR 93 Resp 18 O2Sat 94 Skin Signs: Other - flush A/Ox4 Circulation: Cap refill <2sec Respiratory: Diminished bilateral Initial Treatment: Observation. Family doctor: Dr. (local) 1:19 PM Vital Signs: BP 136/90 HR 98 Resp 12 O2sat 96 Skin Signs: Other - flush, dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: Continue observation. Patient visibly more calm. Hx of hives with influenza vaccine. A/Ox4. No obvious distress, No increased resp effort. Advised patient to have discussion with family doctor before second dose. Tingling reduced by 1:28 PM. 1:31 PM Vital Signs: BP 132/102 HR 88 Resp 12 O2Sat 96 Skin Signs: Warm and dry Respiratory: Breath sound clear bilaterally Follow up Treatment: 'Tingly' feeling moved to lower jaw and decreased in intensity at 1:34 PM. Notes: 1:43 PM call placed to Dr. - Related patients vitals to RN. 1:48 PM patient denies 'tingly' feeling. No SOB or difficulty swallowing. Stated she feels 'normal again'. Disposition: Home with husband at 1:57 PM.
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| 42 | 2021-04-12 | crying, feeling abnormal, loss of personal independence in daily activities, restlessness, anxiety, sleep disorder |
Shot #1- Rushes of very intense anxiety, massive headache, extreme light sensitivity, loss of taste ...
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Shot #1- Rushes of very intense anxiety, massive headache, extreme light sensitivity, loss of taste & strange feelings in mouth, intense inability to rest, chills and then soaking my bedding with sweat, and then a crippling multi-day depressive bout which was extremely atypical for me. Shot #2- similar schedule, several hours after my shot I began to feel intense rushes of anxiety, a bit of a sore throat this time, this find the anxiety just completely took over in the night and I was writhing and thrashing, freezing cold but sweated through FIVE pairs of pajamas straight, absolutely could not get any rest or relief. Dizziness upon standing. The next day so utterly depressed and unable to move. No headache, no fever, but a very alarming ?cloud? or fog in my brain. Unable to communicate, dropping things, couldn?t complete a simple task, very frustrated and would burst into tears unprovoked. NOT AT ALL typical behavior for me. This went on for three days and I have not felt so low since the 90s when I was a pubescent teenager.
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| 42 | 2021-04-12 | impaired work ability, feeling abnormal |
4/9/21, just a sore arm and tired the same day Day 2-2.5: tired and little headache, sore arm, some...
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4/9/21, just a sore arm and tired the same day Day 2-2.5: tired and little headache, sore arm, some body aches Monday &Tuesday (4/12/21 --4/13/21) Had to miss work. Temp 99 on 4/13. VERY fatigued. Unable to regulate body temp. Hot and cold. Joint pain., body aches, excessive thirst, brain fog.
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| 42 | 2021-04-12 | sleep disorder |
Next day: mild chills, mild fever, strong headache (throbbing), by evening 2 lymph nodes near collar...
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Next day: mild chills, mild fever, strong headache (throbbing), by evening 2 lymph nodes near collarbone on left side (same as vaccine) were swollen and painful. The pain from the lymph nodes kept me awake some of next night. Minor pain and redness around injection site but similar to first dose. Following day: neck lymph nodes still very swollen but also one in the armpit region (also on left side) becomes swollen and painful so it became uncomfortable to use my left arm. Back pain and general pain around the rib cage (seemed to be muscular). The redness around the injection site grew larger (almost 10cm across); chills are gone, headache is gone, very mild fever a couple of instances during the day.
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| 42 | 2021-04-13 | anxiety, confusional state |
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic:...
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Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported anxiety with needles, blood work, vaccines. She experienced lightheadedness, dizziness, and needed to lie down. Bendaryl was given 50 mg and patient recovered. Cold packs applied to back of neck, water given. Likely an axiety induced response.
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| 42 | 2021-04-13 | anxiety |
Patient received first dose of Pfizer COVID-19 vaccine. Patient started to feel nauseous and dizzy. ...
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Patient received first dose of Pfizer COVID-19 vaccine. Patient started to feel nauseous and dizzy. EMT was called and stated patient was anxious but checked out cleared and patient refused services.
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| 42 | 2021-04-14 | crying, restlessness |
itchy skin, then sudden intense restlessness and hyperactivity sensation--I guess like I'm on meth (...
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itchy skin, then sudden intense restlessness and hyperactivity sensation--I guess like I'm on meth (so I'm told). can't sit still, intense need to fidget/move, can't focus, feel very tired but also like I'm overdosing on caffeine/sugar. was randomly and for no reason at all emotional. when trying to research this reaction, I started involuntarily crying. feels like maybe the shot impacted the inflammation I normally have, then intensified whatever imbalance or whatever that is going on with my hormones. started to subside at 3:30pm on 4/15/21. now I feel exhausted.
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| 42 | 2021-04-14 | disorientation |
The patient said they felt disoriented. They continued to wait and still felt disoriented so an EMT ...
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The patient said they felt disoriented. They continued to wait and still felt disoriented so an EMT was called and they checked vitals.
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| 42 | 2021-04-15 | feeling abnormal |
itchy face, R arm and legs high BP: 146/100 fatigue, general unwell feeling light-headed/dizziness w...
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itchy face, R arm and legs high BP: 146/100 fatigue, general unwell feeling light-headed/dizziness while and immediately after urinating brain fog
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| 42 | 2021-04-16 | anxiety | Feels heart racing, dizziness and anxiety |
| 42 | 2021-04-16 | feeling abnormal |
dizziness; brain fog; vision issues; balance issues; This is a spontaneous report from a contactable...
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dizziness; brain fog; vision issues; balance issues; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 10Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included migraine from an unknown date and unknown if ongoing, kidney stones from an unknown date and unknown if ongoing. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included tizanidine hydrochloride (ZANAFLEX); amitriptilina [amitriptyline] (AMITRIPTILINA); and topiramate (TOPAMAX), all taken for an unspecified indication, start and stop date were not reported. Tizanidine, amitriptyline, and topiramate were taken within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 on 10Feb2021 at 12:00 (at the age of 42-years-old) for COVID-19 immunisation. On an unknown date after the second vaccination, the patient experienced dizziness, brain fog, vision issues, balance issues. Therapeutic measures were taken as a result of dizziness, brain fog, vision issues, balance issues included anti-inflammatory steroid. Clinical outcome of the events dizziness, brain fog, vision issues, balance issues was not recovered. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021284020 same reporter/ patient, different drug dose/ AE.
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| 42 | 2021-04-17 | impaired work ability |
Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly ...
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Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly started a couple weeks after the vaccine and eventually worsened to the point of not being able to open my mouth. Symptoms included facial paralysis, Muscle weakness, fatigue, vision issues, Neuropathy issues. I was transfused with multiple doses of Immunoglobulin and IV steroids. Still currently in Physical therapy I have lost 3 months of not being able to work. Also had a blood clot
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| 42 | 2021-04-17 | sensation of foreign body |
lump in throat/numbness to tongue, redness to face, dry mouth, pressure under eyes, evaluated by EMS...
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lump in throat/numbness to tongue, redness to face, dry mouth, pressure under eyes, evaluated by EMS, symptoms improved, pt. refused transport.
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| 42 | 2021-04-18 | feeling abnormal |
Immediately after injection i became nauseous followed by dry heaving, head fog, and aggressive cors...
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Immediately after injection i became nauseous followed by dry heaving, head fog, and aggressive corse tremors
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| 42 | 2021-04-19 | anxiety, feeling abnormal |
Vertigo/ dizzy/ floating feeling happening 24 hours a day. This feeling is creating major anxiety, ...
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Vertigo/ dizzy/ floating feeling happening 24 hours a day. This feeling is creating major anxiety, had to take a medical leave.
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| 42 | 2021-04-19 | feeling abnormal |
The next morning my eyes were sensitive to light and then I became more exhausted by the hour. Full ...
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The next morning my eyes were sensitive to light and then I became more exhausted by the hour. Full body Aches set in, foggy head, headache. By around two I began running a light fever. By about 3 pm I felt overall horrible. By four-five I became incredibly nauseated and began vomiting about an hour later. I kept vomiting throughout the night until it was only acidic bile left. During this time I was burning up if I had even a sheet on my skin, but freezing if I didn?t. I was sweating late into the night. Vomiting stopped around 3 am. The next two days I managed rice, bananas and teaspoons of water but was always nauseated. Fever was gone, but headache and exhaustion remained. Daily nausea finally began to wane and was replaced by heartburn and gross feeling in my throat for about two days. About a week and half after the shot I finally regained my energy and had no stomach issues. Two weeks after injection today- The injection site still is bruised and burns/itches from time to time lightly.
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| 42 | 2021-04-19 | irritability |
Nausea within 30 minutes, sleepiness within 1 hour, after 3 hour nap woke up with scratchy throat an...
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Nausea within 30 minutes, sleepiness within 1 hour, after 3 hour nap woke up with scratchy throat and eyes & muscle weakness. Chills, sweats, fatigue, nausea, muscle weakness, loss of appetite, and irritability lasted 2 days. Day 3 woke up with swollen toes on my left foot still irritable but less fatigued. Took Aleve, drank lots of fluids. No formal treatment sought at this time.
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| 42 | 2021-04-19 | loss of personal independence in daily activities |
Left shoulder (arm where vaccine was administered) pain started on Monday morning, two days after va...
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Left shoulder (arm where vaccine was administered) pain started on Monday morning, two days after vaccine administration. Today is just more than four weeks since onset of pain. I have lost range of motion in my shoulder and cannot zip/unzip my clothes, put on coats, or make a full circle with my arm.
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| 42 | 2021-04-20 | agitation, insomnia |
Vaccine administered 3/30/21. On 4/1/21, rash developed on buttocks right of tailbone. Feelings of f...
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Vaccine administered 3/30/21. On 4/1/21, rash developed on buttocks right of tailbone. Feelings of fatigue, generally unwell. Originally misdiagnosed as HSV-2 outbreak on 4/3/21. Prescribed Acyclovir. Neurological issues including numbness and tingling in legs, buttocks, and arms/hands, as well as continued fatigue/feeling unwell. On 4/12/21 discontinued acyclovir, and on 4/13/21 developed diarrhea, insomnia, agitation, stomach cramping, and tremors/shaking in legs, back, and shoulders. Visit to emergency room on 4/16/21 for diarrhea and shaking. Administered 1 L fluids; various test performed including chest XRay, EKG, and blood labs. All looked normal. On 4/16/21 follow up visit with Primary Care Provider diagnosed with shingles. Restarted acyclovir on 4/14/21 and instructed to continue by PCP. As of 4/21/21 symptoms have improved on acyclovir, but not resolved. Continued tingling in backs of legs. Fatigue and feeling unwell continues.
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| 42 | 2021-04-20 | feeling abnormal | " Brain Fog" No Respiratory Distress No rash |
| 42 | 2021-04-20 | impaired work ability, insomnia |
I started having severe muscle ache and chills from 4/9/21 and I went to see doctor on 4/11/21. They...
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I started having severe muscle ache and chills from 4/9/21 and I went to see doctor on 4/11/21. They tested for COVID but it came out negative on 4/12/21. I kept taking Tylenol since 4/9/21 every 6 hours. It got worst on 4/15/21. I could not sit down or lie down. I went to see doctor again on 4/16/21. Dr said my lower back is inflamed and it could be from vaccine and gave me Meloxicam 15mg 1 per day and Cyclobenzaprine 5mg 3 per day. I stopped taking tylenol during this time. It was still miserable and I could not get any sleep. I went to see doctor again on 4/19/21. Dr told me to start taking Tylenol every 6 hours. I can bear the pain with Tylenol. I still have severe muscle pain and chills. It's hard to sit down and work or drive.
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| 42 | 2021-04-21 | anxiety, abnormal behaviour |
Patient developed anxiety after first shot (3/7/2021) and then had worsening of anxiety to point of ...
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Patient developed anxiety after first shot (3/7/2021) and then had worsening of anxiety to point of possible manic episode/psychotic break after second dose (3/28/2021). Patient had to be hospitalized due to bizarre behavior and concern of threat of harm to self or others. No history of manic episodes before this event, though patient has a reported history of depression.
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| 42 | 2021-04-22 | feeling abnormal |
Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart p...
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Delayed onset (day 4): headache, dizziness and vertigo, brain fog, chest pressure, increased heart palpitations, tinnitus
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| 42 | 2021-04-24 | feeling abnormal |
feeling Dizzy; she felt like "garbage" and felt like she was going to throw up; she felt like "garba...
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feeling Dizzy; she felt like "garbage" and felt like she was going to throw up; she felt like "garbage" and felt like she was going to throw up; This is spontaneous report from a contactable nurse reported for slef. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose (lot: ER8732) in left arm on 01Apr2021 09:30 AM for COVID-19 immunisation. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included allergies to dairy and eggs. Concomitant medications were not reported. The patient got her first vaccine on 01Apr2021 (Thursday morning). About an hour and a half after she got her vaccine, she started feeling "super dizzy" that got worse throughout the day because she was driving. She felt like "garbage" and felt like she was going to throw up. By the time she got home that day it was a little better, but she had to lay down, and any time she got up or moved too fast she experienced the dizziness. The next day she felt it again when she was in the car and then reported that by that night she felt better. She started feeling dizzy and it didn't go away until Friday evening, no treatment received for the adverse event. The patient wanted to know if she should get the second vaccine. She is due to get her second dose next week on Thursday and is concerned if it is safe for her to do so. She is worried how bad her reaction is going to be after the second dose. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-04-24 | insomnia |
main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick succ...
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main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise; has kept her up nights three nights; vision was double; fatigue; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Mar2021 (at the age of 42-years-old; not pregnant), at 10:00 AM (Lot Number: ER2613) as a single dose in the left arm for COVID-19 immunisation. Medical history included eosinophilic oesophagitis and known allergies: sulfa drugs both from an unknown date and unknown if ongoing. Concomitant medications included finasteride (PROPECIA), lorazepam (ATIVAN) and fluticasone propionate (FLOVENT (reported as FLOVENT 200)); all taken from an unspecified date for an unspecified indication. On 18Mar2021 at 5:00 PM, the patient reported that the main issue was hearing/ear discomfort. The patient's hearing swells and subsides, in 3- 4 quick successions. It makes sort of a vibration noise and has kept her up nights three nights since vaccine. After the dose, the patient's vision was double, but she thought it was just because of fatigue. Patient also reported that arm soreness was going away. No treatment was received by the patient for the reported adverse events. Post vaccination COVID test: polymerase chain reaction (PCR) COVID test/ nasal swab was conducted on 18Mar2021 and the result was negative. The outcome of the event "arm soreness" was recovering and not recovered for all other events. No follow up attempts are needed. No further information is expected.
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| 42 | 2021-04-24 | irritability |
Myself: sore arm, night sweats, headache. Next day some body aches and chills. My 2.5 month old: 2...
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Myself: sore arm, night sweats, headache. Next day some body aches and chills. My 2.5 month old: 2nd dose irritable and horrible time with bowl movements. In a lot of pain as a result.. diarrhea. Lasted about two-three days. First shot bowl movements turned green for a week with an extreme sulfur line odor.
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| 42 | 2021-04-25 | anxiety, panic attack |
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient received 2nd Pfizer dose and asked for med...
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Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient received 2nd Pfizer dose and asked for medical assistance in the observation area. Heart rate was 100 then up to 120. No medical intervention by onsite EMS. The patient did request an ambulance and was transported to the hospital. She presented to the ED with a panic attack/anxiety. Patient was discharged to home.
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| 42 | 2021-04-26 | anxiety |
4/27/2021 Pt was observed post Covid-19 immunization for 15 minutes . During the observation peri...
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4/27/2021 Pt was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: itching to face and neck. Assessment : Time of assessment Alert and oriented, Anxious and itching to face and neck. No rash seen by this writer Actions taken: Vitals sign taken VAERS form obtained and completed by RN. VS taken at 1532- BP- 129/85, P- 73, O2- 100%, Water given. Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1532. Administered by RN. Famotidine (Pepcid) 20 mg by mouth. Time: 1532. Administered by RN. Disposition: Reports no further symptoms of adverse reaction after observation for 40 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the CDC system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/27/2021 3:13 PM
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| 42 | 2021-04-27 | crying, feeling abnormal |
neuropathy in her left foot/ numb like tingling, a lot of tingling feeling/feel it every now and the...
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neuropathy in her left foot/ numb like tingling, a lot of tingling feeling/feel it every now and then throughout her body; numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body; numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body; felt weird; Iinterfering with her brain; makes her "like I want to cry."; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 01Apr2021 (lot number: ER8737) as single dose (at the age of 42-years-old) for COVID-19 immunisation. Medical history included temporomandibular joint syndrome (TMJ), headache and clench my teeth; from an unknown date and unknown if ongoing. Concomitant medication included butalbital, caffeine, paracetamol (BUTALBITAL, ACETAMINOPHEN & CAFFEINE) taken for "clench my teeth", start and stop date were not reported; the patient was also taking unspecified vitamins, supplements and an unspecified headache medication. The patient received the first shot of BNT162B2 for Covid-19 immunisation on an unspecified date. The patient had both the shots and was wondering because she was left with like this neuropathy in her left foot, it was kind of numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body. It was like setting on her left foot and she got the shot on her left side. She got the last second shot and got it on Thursday (01Apr2021). She told her doctor right away the she saw this only after the last shot. She told the guy it was weird, it felt weird and then he said, you know it was a kind off to the side and was just "mental". But it has not gone away, it was like neuropathy, she doesn't remember if it was with the first shot because it was so quick in between. She wanted this to go away, it was really annoying. It was interfering with her brain, it was not good, it makes her "like I want to cry." The patient had a lab work done on Thursday morning (08Apr2021) and stated that her blood work was fine. They did a thyroid check, did her blood sugar and everything was fine; and her B12 to make sure her B12 wasn't low but everything was fine. The patient does not know the name of the tests. The patient wanted to know if the side effects she was experiencing was normal and was it going away. The outcome of the events was unknown.
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| 42 | 2021-04-27 | feeling abnormal |
At about 2:30 started feeling funny. Thought I was possibly hypoglycemic but my blood sugars were 12...
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At about 2:30 started feeling funny. Thought I was possibly hypoglycemic but my blood sugars were 123. Then about 3:00 tasted feeling tingling in my arm and finger tips and legs. 3:30 my legs felt like they were swollen but the weren't. Noticed I was coughing more to clear my throat. And felt a little itchy on different parts of my body. Around 4:30 my husband noticed I had something on my face. Turned out to be hives. My throat area velt wierd a little numb but not completely. I felt big lumps on both sides of my neck. I then started to feel tingling on my nose and left side of my tongue. I noticed it felt a little uncomfortable to swallow almost like a sore throat but without pain. I did not feel short of breath at any time. I took 50mg of benadryl at 6pm. The symptoms started to subside. Still had occasional itching. By the morning I felt better. Throat felt better and itching was gone. I did end up taking more benadryl at about 8pm because I noticed my throat feeling swollen again. By the morning I was back to normal again.
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| 42 | 2021-04-27 | feeling abnormal |
Patient reported lightheadedness, minor throat swelling, "foggy" feeling. Reported some dizziness. A...
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Patient reported lightheadedness, minor throat swelling, "foggy" feeling. Reported some dizziness. Advised patient to lay down and monitored them. Offered snacks and drinks. Patient reported feeling better after an hour and left on own will with no symptoms.
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| 42 | 2021-04-28 | feeling abnormal |
At about 3:50 PM client was given vaccine. 10 min or so later reported lips feeling fuzzy. No troubl...
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At about 3:50 PM client was given vaccine. 10 min or so later reported lips feeling fuzzy. No trouble with breathing. At 1610 B/P 130/94 P 80. At 4:16 PM 911 was called. About 4:20 PM client reported something is happening to me. Client brought up both hands to head & stated feeling pressure behind both ears & in both ears. Pulse not racing. 2nd nurse speaking with client to support, calm, said she was having trouble finding words. EMS assessed & had client walk with them to the ambulance. RN
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| 42 | 2021-04-28 | loss of personal independence in daily activities |
After 30 minutes receiving the vaccine pt felt itching of the tongue, feeling flushed & itching of b...
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After 30 minutes receiving the vaccine pt felt itching of the tongue, feeling flushed & itching of both cheeks, after an hour, slight difficulty swallowing & talking, tongue felt thick & funny, also itching of whole body no rashes, Took liquid Benadryl & Liquid Zyrtec per instructions of immunologist with some relief.
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| 42 | 2021-04-29 | sensation of foreign body |
Arm pain, swelling of the arm, shoulder, neck and a ball under the arm. Headache, sweating, itching ...
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Arm pain, swelling of the arm, shoulder, neck and a ball under the arm. Headache, sweating, itching all over the body and muscle aches. I feel like a lump in my throat and I feel very tired.
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| 42 | 2021-04-30 | feeling abnormal |
Patient called and reported sudden symptoms that "felt like a nerve thing" and a sudden facial droop...
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Patient called and reported sudden symptoms that "felt like a nerve thing" and a sudden facial drooping on one side. The symptoms subsided after a few minutes. I instructed the patient to report any additional symptoms and to seek guidance from her MD if symptoms return. We also discussed the possibility of Bell's Palsy after COVID vaccines.
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| 42 | 2021-04-30 | feeling abnormal |
Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the mid...
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Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs; Dizziness; At the time she was given her COVID-19 Vaccine shot, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back; dry eyes; she was coughing more; the increase in coughing had made her voice huskier sounding; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 08:45 Arm Left (Lot Number: EP6955, Expiration Date: 30Jun2021) single dose for covid-19 immunisation. Medical history included ongoing Crohn's disease from 1999, ongoing Hidradenitis suppurativa at the end of 2019, ongoing Small Fiber Peripheral Neuropathy diagnosed at the end of 2019. She said her doctor was not sure of the Small Fiber Peripheral Neuropathy's cause, or if the Small Fiber Peripheral Neuropathy was associated with any of her other medical conditions. She said she had symptoms for sometime, and was diagnosed with a lot of things at the end of 2019 because she was finally able to see a specialist. Concomitant medications included adalimumab (HUMIRA AC) from in Feb2020 at 40mg injection pen once a week for her Crohn's disease. Reported she has had no reactions to flu or pneumonia vaccines for immunisation in the past. She said she had her first COVID-19 Vaccine dose on Thursday, 18Mar2021. She said on Saturday morning (20Mar2021), she had shortness of breath, dizziness, and chest pressure. She said her shortness of breath, dizziness, and chest pressure has been lasting for 20-something days, and she doesn't know why. She said she had taken two (different) week long prescriptions of Prednisone. She said she had 2 EKGs, 2 chest x-rays, and blood work, which were all normal on 13Apr2021 and 2021. She said her doctors don't know why she was having the shortness of breath, dizziness, and chest pressure. She said she was using inhalers, medications, and everything, and still had her symptoms. She asked if what she was experiencing was a side effect of the COVID-19 Vaccine, or due to her 2 autoimmune diseases because her doctors were grasping at straws at this point. Reported she had so many medical conditions, and was taking so many different medications. Reported she has had shortness of breath and chest pressure every day, but the dizziness wasn't constant, and had lessened. She said she has never had the shortness of breath and chest pressure before. She said she has never had anything last that long either. She said she was wondering if her shortness of breath and chest pressure were caused by the COVID-19 Vaccine. Clarified the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, saying it was an odd feeling. Reported she was coughing more, and she believed the increase in coughing had made her voice huskier sounding in 2021. She said she had a cough associated with outdoor allergies, but the cough she had now didn't feel like her normal allergy cough. She said she had no mucus. She said she was not sneezing, or coughing out anything. She said the cough she had now was different. Reported at the time she was given her COVID-19 Vaccine shot 18Mar2021, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her fingertips. She said the warmth feeling also went to the left side of her back. She said she was kept longer after she got her COVID-19 Vaccine for monitoring. She said the warmth feeling in her left arm, left fingertips, and left back didn't last long, and went away. Reported she had gone to the Emergency Room on Tuesday, 13Apr2021, because she had palpitations, and a weird feeling under her skin. She said while at the Emergency Room, she had an EKG, chest x-ray, and blood work. She said the doctor was looking for a blood clot. She said all her testing came back negative for a blood clot. She said earlier that day (13Apr2021) was her 3rd visit to her doctor since her symptoms had started. Reported she had started Restasis on 19Mar2021, the day after her first COVID-19 Vaccine. She said she was prescribed Restasis for dry eyes, and didn't have the dose, NDC, Lot, and Expiration Date because she was not at home. AEs require a visit to Emergency Room and Physician Office. Treatment included Stated she had taken 2 different week long doses of Prednisone to treat her symptoms. She said she first took Prednisone 40mg, once a day, for 7 days. She said she was off the Prednisone 40mg for 2 days, and had instructions to call her doctor if she wasn't feeling better. She said she went back to her doctor, and was prescribed Prednisone 60mg for 3 days, then Prednisone 40mg for 3 days, and then Prednisone 20mg for 3 days. She said she did not have the 2 Prednisone prescription NDC, Lot, and Expiration Dates. She said she was also put on a 10-day Azithromycin 250mg tablet prescription. She said she took a Azithromycin 500mg (2-250mg tablets) dose the first day, and then Azithromycin 250mg, once a day, for the next 9 days. She said she did not have the Azithromycin 250mg tablet NDC, Lot, and Expiration Date. She said she was also prescribed an Albuterol (90mcg per actuation) inhaler, providing: NDC Number: 66993-019-68, Lot Number: A63H, Expiration Date: Jan2022. She said she didn't feel like the Albuterol inhaler was doing the rescue part, and that she could take the Albuterol inhaler every half hour. Reported she was prescribed an Albuterol inhaler (90mcg per actuation) for shortness of breath. Outcome of the event Shortness of breath, the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, coughing more, the increase in coughing had made her voice huskier sounding was not recovered. Outcome of the event Palpitations, a weird feeling under her skin was unknown. Outcome of the event Dizziness was recovering. Outcome of the event had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back was recovered on 18Mar2021. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-05-07 | insomnia |
14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, ...
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14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; Not sleeping at night; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; This is a spontaneous report from contactable consumer. A 41year old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8735), via an unspecified route of administration administered on Left arm at 24Apr2021 12:30 PM (at the age of 41 years) as a single dose for covid-19 immunisation. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8734), via an unspecified route of administration administered on Left arm at 03Apr2021 04:30 PM as a single dose for covid-19 immunisation. The patient's medical history included asthma and premature ventricular contractions. Patient's past drug included aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zyrtec, Lexapro 5mg, sprintec (birth c) and Vit C. On 25-APR-2021 02:30 Patient stated that not sleeping at night, 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Treatment was received for the adverse event Ems came checked pulse and blood pressure gave plan. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were resolving. Information on Lot/Batch number was available. Additional information has been requested.
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| 42 | 2021-05-07 | nervousness |
She could even barely make it to give herself to go pee, she was completely immobilized.; Migraine/l...
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She could even barely make it to give herself to go pee, she was completely immobilized.; Migraine/light sensitive/nausea/headache; Extremely dizzy; Painful and scary; scary; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the 1st of 2 reports. A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) (at the age of 42-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she woke up at 6:00 in the morning (on 17Apr2021), there were on migraine, light sensitive, extremely nauseous and extremely dizzy. She could even barely make it to give herself to go pee, she was completely immobilized. She was that nauseous and that dizzy, she was staying in the bed she could not do anything else; she could not get in the kitchen or get something to drink. She took a MOTRIN (as a treatment) around 3 after, she was still felling the symptoms, migraine got disappeared, she was able to move around but eventually got better headache. She was painful and scary. The patient outcome of migraine was recovered and the outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) :PFIZER INC-2021479302 same reporter, drug, different patient and event
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| 42 | 2021-05-14 | feeling abnormal, insomnia |
fainting; Extreme fatigue; chills; headache; insomnia; elevated resting heart rate; nausea; brain fo...
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fainting; Extreme fatigue; chills; headache; insomnia; elevated resting heart rate; nausea; brain fog; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0162), via an unspecified route of administration, administered in right arm on 23Apr2021 08:15 as 2nd dose, single for COVID-19 immunization. The patient's medical history included allergic to chocolate. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), in the right arm on 02Apr2021 08:15 AM for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 was administered was clinic (Public Health Clinic/Veterans Administration facility). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. There were no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme fatigue, chills, headache, insomnia, elevated resting heart rate, nausea, fainting, brain fog, all on 23Apr2021 at 13:00. These started about 5 hours after injection, worsened for about 35 hours, then improved over the next 48 hours. No treatment was received for the events. The outcome of the events were recovered on an unspecified date. Follow-up attempts are needed. Information about lot/batch number is available.
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| 42 | 2021-05-14 | panic attack, confusional state, amnesia |
didn't know who her fiancee was and didn't recognize the house; panic attack; wasn't feeling well; c...
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didn't know who her fiancee was and didn't recognize the house; panic attack; wasn't feeling well; confused; This is a spontaneous report from a contactable consumer (reporters fiancee). A 42 years old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID 19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 28Apr2021 at 17:32 (at the age of 42 years old) (Batch/Lot number was not reported) as SINGLE DOSE for covid 19 immunization. Medical history included hypertension( high blood pressure; had it for more than 10 years). The patient concomitant medications includes blood pressure medication taken daily (details not provided). Historical Vaccine BNT162B2 was received on 07Apr2021 Dose 1, first dose was received 21 days before second dose. The patient experienced panic attack, wasnt feeling well, confused on 29Apr2021, didnt know who her fiance was and didnt recognize the house on 29Apr2021 at 10:30. The clinical outcome of the events was unknown. The clinical course was as follows His fiancee went to get second vaccine shot yesterday. Today she woke up and said she wasn't feeling well. She had a bad reaction. She didn't know who her fiancee was and didnt recognize the house. The ambulance came and she had a panic attack. She did not want to be touched by anyone. Patient didn't recognize caller or her daughter. The ambulance only checked her vitals. They did not take her to the hospital. The adverse events did not require an emergency room visit or physician office visit. She is home right now and is laying down, so reporter is not sure if she is still confused. He states that she didn't have any memory issues prior to the application of the vaccines second dose. He would like to know if this reaction was caused by the product. The clinical outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 42 | 2021-05-17 | loss of personal independence in daily activities |
Numbness and Pain in Left Hand following Second Pfizer Shot. Joints at Left Pointer and Middle Fing...
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Numbness and Pain in Left Hand following Second Pfizer Shot. Joints at Left Pointer and Middle Finger Red, "on fire".....Left Hand Swollen. I cannot lift, type, open doors, hold a coffee cup, tie my shoes, put earrings in, etc.
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| 42 | 2021-05-18 | depression |
Neurological issues of shaking and tremors mostly in her leg; Intermittent tremors or involuntary mu...
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Neurological issues of shaking and tremors mostly in her leg; Intermittent tremors or involuntary muscle contractions; Pulsating heaviness in her legs; Severe diarrhea; Loss of appetite; Constipated with no normal bowel movements; Nauseated; Felt run down and fatigued; Pain on the right side of her tail bone and upper right buttocks; Pain on the right side of her tail bone and upper right buttocks; Rash on right of tailbone and upper buttocks that progressed into blistering; Tingling in her hands, low back, and tailbone area; Depression; Original rash was shingles; Herpes simplex virus could have attacked her gastrointestinal system; Mild GI symptoms; This is a spontaneous report from a contactable consumer (patient who is a registered dietician). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 30Mar2021 (Lot Number: ER8732) at the age of 42 years, as first dose, single, for COVID-19 immunization. The patient's medical history included herpes simplex virus (HSV) from 12 years ago (2009) and she has not had any problems with this in a very long time (her lesions would be limited to her vulva area and she has never had an outbreak on her buttocks before). There were no concomitant medications. The patient was experiencing symptoms post COVID-19 vaccine that she wanted to report. She is seeking guidance for treatment or a provider that could help. The patient received the vaccine on 30Mar2021 and then felt run down and fatigued and developed pain on the right side of her tail bone and upper right buttocks on 01Apr2021. On 01Apr2021, she had developed a rash on right of tailbone and upper buttocks that progressed into blistering (rash in that area which then blistered). The patient had tingling in her hands, low back, and tailbone area from 01Apr2021. The patient went to urgent care (physician visit) on 03Apr2021 and was prescribed acyclovir for the symptoms above. The patient saw her primary care provider for this new onset blistered rash and given her history, she was prescribed acyclovir, she took an 8 day course of that but then started to become constipated with no normal bowel movements and started feeling nauseated on 09Apr2021. The patient took that for eight days and felt not 100%; felt bad run down. She stopped Acyclovir on Monday (12Apr2021) and was off it for two days temporarily because she was experiencing nausea and mild gastrointestinal (GI) symptoms in Apr2021. For those two days off it, the patient developed severe diarrhea with a loss of appetite starting on Tuesday (13Apr2021). The patient also had neurological issues of shaking and tremors mostly in her legs and pulsating heaviness in her legs and tingling in hands on 14Apr2021; fatigued; and depression on 01Apr2021 that worsened. She saw her primary care doctor yesterday (15Apr2021) and was prescribed more acyclovir and was started back on it. The doctor told her that herpes simplex virus could have attacked her gastrointestinal system in Apr2021. She has this shaking that feels like it starts in the back of her body that has not subsided, describes the shaking as intermittent tremors or involuntary muscle contractions. Last night (15Apr2021), she also had loss of appetite and diarrhea. The patient went to the emergency room (ER) this morning (16Apr2021) because she woke up at 3:30 and experienced same tremors from night before that went away. The patient went to the ER on 16Apr2021, they did a full work up, did not find anything. The patient was given liter of fluid for shaking and had electrocardiogram (EKG), blood work and chest X-ray that came clear (16Apr2021). She had pictures of rash when first developed on 01Apr2021 and the physician stated that it looked like shingles. The ER provider said she felt like the original rash was shingles instead of herpes simplex virus based on the pictures that the patient showed her. The doctor stated that they had heard of others developing post vaccination shingles. The patient has another follow-up with her primary care physician today (16Apr2021) for further guidance after her ER visit. The patient would like to know if Pfizer has any recommendations for treatment in this situation. The patient wanted someone to shed some light on shingles and treatment; for the first dose. The patient was recovering from "Rash on right of tailbone and upper buttocks that progressed into blistering", "Tingling in her hands, low back, and tailbone area", and "Constipated with no normal bowel movements". The outcome of "Herpes simplex virus could have attacked her gastrointestinal system" and "Pulsating heaviness in her legs" was unknown. The patient had not recovered from the remaining events. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-05-24 | anxiety | Anxiety. Had a headache PTA. |
| 42 | 2021-05-24 | feeling abnormal, agitation, poor quality sleep, insomnia |
Patient reports receiving Pfizer vaccine 5/21/2021 and insomnia since receiving vaccine and feeling ...
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Patient reports receiving Pfizer vaccine 5/21/2021 and insomnia since receiving vaccine and feeling "electricity" throughout body. Per patient, went to urgent care on 5/24/21 in PM, had normal vital signs, and was given hydroxyzine and Flexeril and was able to sleep for 2 hours overnight, but it was not a restful sleep. When I spoke with patient on the phone, patient was agitated, and had pressured speech, and appeared to be in pain. I prescribed Lunesta 3 mg and told patient if unable to sleep, to go to Emergency Department for further evaluation.
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| 42 | 2021-05-24 | insomnia |
dose 1: 05Jan2021; dose 2: 22Jan2021; dose 1: 05Jan2021; dose 2: 22Jan2021; ear ache; Cough; congest...
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dose 1: 05Jan2021; dose 2: 22Jan2021; dose 1: 05Jan2021; dose 2: 22Jan2021; ear ache; Cough; congestion; loss of appetite; Headaches; fatigue; right axillary lymph node swollen; Dizziness; Room spinning; nausea; body and face tingling; chills; body aches; insomnia; This is a spontaneous report from a contactable nurse reporting for herself. This 42-year-old female nurse (Patient) reported that: A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 22Jan2021 11:00 AM (Batch/Lot Number: EL3249) as SINGLE DOSE for COVID-19 immunization. Patient also received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 05Jan2021 09:30 AM, (Batch/Lot Number: EK9231) as SINGLE DOSE for COVID-19 immunization (time interval between two doses: 18 days). Medical history included drug hypersensitivity, to Penicillin, tetracycline. Concomitant medication included cetirizine hydrochloride (ZYRTEC) 1x/day and Multivitamins. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 22Jan2021 10:00 PM, the patient experienced dizziness, room spinning, nausea, body and face tingling, chills, body aches and insomnia. Also, it was reported that, the patient had fatigue, right axillary lymph node swollen on 23Jan2021, on 24Jan2021: dizziness had nausea. On 26Jan2021: Dizziness, nausea, loss of appetite, tingling face and body and headache. On 27Jan2021: Dizziness, nausea, tingling face and body, cough, congestion and on 28Jan2021: Cough, congestion, earache. On 29Jan2021, the patient presented with dizziness, tingling face and body, cough congestion, and headache. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for adverse events. The patient was recovering from all the event at time of reporting. Follow-up attempts are completed. No further information is expected.
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| 42 | 2021-05-25 | feeling abnormal |
MY EYE BROWS SWELLED; DIZZINESS; CRAVED BLACK LICORICE LIKE MAD; MASSIVE EYE TEARING; HAD A RIGHT SI...
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MY EYE BROWS SWELLED; DIZZINESS; CRAVED BLACK LICORICE LIKE MAD; MASSIVE EYE TEARING; HAD A RIGHT SIDED FRONTAL HEADACHE; POST NASAL DRIP; I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS.; This is a spontaneous report from a non-contactable non-health care professional. A 42-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine) (Lot/batch no: EN6199) dose number 1 via unspecified route of administration on left arm as a single dose for COVID-19 immunisation on 04Mar2021 at 06:30 PM (at the age of 42-year-old). Medical history included allergy to gold. Concomitant medication was not provided. Reported patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced dizziness within the first 15 minutes. Within the first hour her eye brows swelled and she had a right sided frontal headache. 2 hours later she felt like she was at high altitude which lasted for 36-48 hours. The swelling broke during the night with massive eye tearing and post nasal drip. She craved for black licorice like mad on 04Mar2021. The action taken was not applicable. Therapeutic measures were taken as a result of events and included self-treatment with ice pack, tylenol, and clairitin from an unknown date. The patients recovered from the events dizziness, eye brows swelled, frontal headache, massive eye tearing and post nasal drip was recovered. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-05-26 | anxiety |
Charge nurse called to attend to patient after receiving her second Pfizer vaccine. Family members r...
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Charge nurse called to attend to patient after receiving her second Pfizer vaccine. Family members reported she was anxious since yesterday about receiving her second Pfizer vaccine today. It was reported by patient that she had symptoms of nausea, dizziness and anxiousness today. As per her family same thing occurred with her 1st Pfizer vaccine. She denied any significant Medical hx , other than decreased vision, which she does not take any medication for. Charge nurse and vaccinating nurse, moved her to a private tent to vaccinate her and to be monitored. Charge nurse and myself elevated her feet, and had her take sips of water. Wet cool cloth was applied to the back of her neck. She confirmed she felt better after the cloth. She was left in stable condition with vaccinating nurse. I was called back at 1330, because she felt with SOB and more anxious. She did not have any emesis at any point while she was at vaccination site, and no syncope occurred. She was more relaxed after breathing exercises. She was walked over in stable condition closer to EMT to be monitored closely. Vitals were taken. At this time, she was more relaxed and denied any nausea, headaches, SOB or any other symptoms. Family members continued to give her water and she was able to sustain without any emesis. Pt left with family members at 1400, in stable condition.
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| 42 | 2021-05-26 | feeling abnormal |
My blood pressure dropped, started getting heart palpitations, feeling short of breath at times, bod...
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My blood pressure dropped, started getting heart palpitations, feeling short of breath at times, body (arms/legs) would go numb easy. Would see "stars" at times. Lasted for a good 10-14 days and still don't feel 100% back to normal, but most has subsided.
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| 42 | 2021-05-26 | loss of personal independence in daily activities |
I started to get a upset stomach, fever, headache, fatigue, then extreme arm pain through out my arm...
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I started to get a upset stomach, fever, headache, fatigue, then extreme arm pain through out my arm into my shoulder and neck. I also experience numbness down my arm into my wrist and fingers. At this same time I got muscle pain all over. Next day I still had the extreme arm pain and numbness as well as fever and muscle pain . I let my physician know about my issues. Two days after and my arm still hurts but am still having air pain, but its more the arm numbness running from my shoulder down to my fingers. Its becoming a problem to be able to do daily activity.
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| 42 | 2021-05-28 | anxiety |
Patient received COVID vaccine at 1550 and immediately started feeling throat tightness/anxiety/sob....
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Patient received COVID vaccine at 1550 and immediately started feeling throat tightness/anxiety/sob. Brought over here by clinic staff. A/Ox4/airway patent/sat 100%. Given IM epi. Given Benadryl, Solu-Medrol, will add on Pepcid continue to monitor on cardiac monitor. Discharge tachycardia noted, secondary to epinephrine. No repeat epinephrine required during ED course. Patient is on daily steroid, we will not add steroid on top of this. Prescribed EpiPen if symptoms were to significantly worsen.
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| 42 | 2021-05-28 | feeling abnormal |
Systemic: Hypertension-Severe, Additional Details: Approx 90 min post injection pt returned with "sw...
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Systemic: Hypertension-Severe, Additional Details: Approx 90 min post injection pt returned with "swimmy feeling" in head; dz;difficulty in walking. In staff EMT recorded bp 120/110; advised er or clinic. Pt went to er and was told injection prob not the cause given med and released. I spoke to pt following day and she said hospital thought vaccination not the primary cause and advised pt to see family physician.
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| 42 | 2021-05-28 | panic attack |
Pt felt dizzy, took slow deep breaths, then fell asleep onto husband's shoulder in chair for 30 seco...
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Pt felt dizzy, took slow deep breaths, then fell asleep onto husband's shoulder in chair for 30 seconds. Pt awoke and said she was cold and shivering, pt admits to some "chest pain", pt's vital signs were: 126/80 mmHg, 91 bpm pulse, 99% O2 sat on room air. Pt stated she has had a panic attack 4 years ago, she stated this episode "felt similar to last time". Pt given candy by staff, warm water, and emotional support by staff and spouse. Pt reported some abdominal pain after the panic attack, but improvement in other symptoms following being given warm water. No medications were administered.
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| 42 | 2021-05-29 | anxiety, insomnia |
Fatigue, headaches and unusual sensations in head/scalp/neck area (pressure, numbness, tingling) sta...
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Fatigue, headaches and unusual sensations in head/scalp/neck area (pressure, numbness, tingling) started day after shot and continued for weeks before finally seeking medical help two weeks post vaccination. Have since experienced blood pressure fluctuations, anxiety, vertigo, nausea, light-headedness, heart palpitations, ear pressure/throbbing, chest pain and sensations of weakness/numbness on left side of face/head/neck/chest/arm. Two weeks post-vaccine (on 5/11) I met with my endocrinologist to check on my Hashimoto's condition and thyroid/iron bloodwork since I was still feeling fatigued and generally unwell post vaccine.
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| 42 | 2021-05-30 | sensation of foreign body |
Allergic reaction. Itchiness all over, rash in part of face and chest. Feeling very groggy, felt lu...
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Allergic reaction. Itchiness all over, rash in part of face and chest. Feeling very groggy, felt lump in my throat, felt like I couldn't breathe possible panic attack.
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| 42 | 2021-05-31 | depressed mood |
same as previously reported via completed VAERs. Now mensus has started again, more than 10 days ear...
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same as previously reported via completed VAERs. Now mensus has started again, more than 10 days early. This is now twice since vaccination. Heavy bleeding, severe cramping and bloating along with pain in joints. Fatigue & melancoly.
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| 42 | 2021-05-31 | feeling abnormal |
but I was dizzy/weak; but I was dizzy/weak; weak from lack of appetite and fever; weak from lack of ...
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but I was dizzy/weak; but I was dizzy/weak; weak from lack of appetite and fever; weak from lack of appetite and fever; headache; had chills and shivering and couldn't get warm; had chills and shivering and couldn't get warm; My temp started to climb overnight Friday; It felt like my face was going to explode; This is a spontaneous report from a contactable other hcp. A 42-years-old female patient reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch number and expiry date were not reported) via an unspecified route of administration, administered in Arm Left on 29Jan2021 07:00 as single dose for covid-19 immunisation. The patiently previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch number and expiry date were not reported) via an unspecified route of administration, administered in Arm Left on 08Jan2021 11:00 as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. It was reported that the patient got second dose Friday morning, 29Jan2021, at 07:00. By 4 pm on Friday she had chills and shivering, and couldn't get warm. By 6pm on Friday, a headache started. The headache got progressively worse overnight Friday, the worst headache she had ever experienced. It felt like her face was going to explode. Her temperature started to climb overnight Friday. Got up to 101.5 by early Saturday morning. By noon on Saturday, headache started easing up, but was dizzy/weak. By 4:00 pm Saturday she was feeling a lot better, just weak from lack of appetite and fever. The patient underwent lab tests and procedures which included body temperature: started to climb on 29Jan2021, body temperature: 101.5 on 30Jan2021. On an unspecified date, the outcome of the events was resolved. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
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| 42 | 2021-06-02 | feeling abnormal |
About 12 hours the first vaccine: body ache, chills, low grad fever (99.1), exhaustion. These sympto...
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About 12 hours the first vaccine: body ache, chills, low grad fever (99.1), exhaustion. These symptoms went away in about 48 hours. A few days after the first does, swelling of both lymph nodes in left and right arm pits and inflammation in the palm of my hand under the middle finger. The lymph node swelling went away in about one week. The hand inflammation is still present. About 12 hours after the second vaccine: body ache and extreme exhaustion and brain fog. These symptoms went away after 24 hours. A few days after the second does, swelling of both lymph nodes in left and right arm pits. The swelling symptoms went away after about one week.
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| 42 | 2021-06-03 | nervousness |
Tired feeling; Joint pain; Vomiting; Shaky feeling; Migraine; Stiff neck; Slight headache; This is a...
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Tired feeling; Joint pain; Vomiting; Shaky feeling; Migraine; Stiff neck; Slight headache; This is a spontaneous report received from a contactable healthcare professional, the patient. A 42-year-old non pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the left arm on 17Mar2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, hypothyroidism, tension headache (on 16Mar2021) and allergic to mold. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included SYNTHROID, ZYRTEC and MIDNITES, all for an unspecified indication, initiated on unknown date. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient previously took aspirin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, immediately after the vaccination, the patient experienced a bit of a stiff neck and still had a slight headache. Over the course of about 5 hours at 19:00, the headache turned into a migraine with splitting head pain, shaky feeling and vomiting. The patient was self-treated with two TYLENOL rapid release, but only managed to throw them back up. She went to sleep and by about midnight she was feeling mostly better, with only a slight headache and tired feeling lingering. She felt fatigued and had some minor joint pain at the time of the report. The clinical outcome of the events stiff neck, migraine, vomiting and shaky feelings were recovering; tired and headache was not recovered and the outcome of joint pain was unknown. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-06-08 | feeling abnormal, loss of personal independence in daily activities, impaired work ability, insomnia |
Within 24 hours of my 2nd Pfizer shot, I had some moderate level dizziness, lightheadedness and brai...
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Within 24 hours of my 2nd Pfizer shot, I had some moderate level dizziness, lightheadedness and brain fog. Then on May 8th, I woke with debilitating vertigo. I was unable to walk without help, and over the next two weeks, I had severe dizziness, brain fog, cognitive decline, and was unable to work, drive or watch my kids. After about two weeks, I noticed I was experiencing ringing in my ears, which I learned was tinnitus. The tinnitus has steadily increased in volume/intensity, and now I have insomnia because the noise is so bad. The vertigo, dizziness and brain fog have since gone away, but the tinnitus has not. I strongly believe that my tinnitus is related to the covid vaccine.
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| 42 | 2021-06-08 | feeling abnormal |
This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient ...
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This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiration date: unknown), via intramuscular route, administered in upper left arm on 19Mar2021 (at the age of 42-year-old) as 1st dose, single dose for COVID-19 immunisation. She was given vaccine between 15:00 pm and 16:00 pm. The patient medical history includes asthma, gastroesophageal reflux disease, covid -19 and migraine. Concomitant medications included Breo, Singulair, Flonase and Azelastine. The hospital advised to stop taking Flonase. She had rabies vaccine for work, and she must be checked every 2 years for titers. There was no family history. She was not HIV positive or syphilis positive. The patient experienced within 15 minutes of receiving the vaccine, her left side of face went numb, and the left arm went heavy. By the next day, the thumb and pinky on left hand were numb and had pain in left arm pit. The patient experienced migraines on 18May2021. The inside of her mouth has been persisting on left side of face. The rest of her face was getting better, but then 2 weeks ago she had another full episode, and it went back numb again on the left side of her face and has been numb since. Now it has traveled into left eye up towards the eyebrow, towards her ear, down to her chin, and straight up the middle. Half of her tongue feels tingly numb, and the other half was fine. Her lips are numb. It was like when you get dental work, get home, and the Novocaine wears off. And that was what the whole left side of her face feels like. Did not feel as heavy as the first couple of days, but she feels like she cannot use her arm because it was weak. Left thumb and pinky were numb was on and off. Since she relapsed 2 weeks ago, it has been numb ever since. The left-hand grip was weak. Numbness of left thumb and pinky has gotten worse. Her left-hand grip has gradually worsened as time has went on. She had pain every once in a while, but pain was not constant like it was. She was been having headaches since she got Covid. Asthma, reflux, and Covid that should be all of her medical conditions. The patient saw on a group to call this number if she had a reaction to the Pfizer vaccine. She did VAERS online reporting back in Mar. She states people are like they never heard of what happened to her before. The patient was 216 or 218 pounds. She had been waiting since Mar since the adverse reaction. She stated it takes about a month to get her fully on the medication. She just started on medications and was told it will take about 2-3 months before she starts feeling better if medications works. She saw EMTs at site and told her if face was still numb next day to go to the ER. She woke up and more of her face was numb, pinky and thumb were numb, and her arm pit was hurting. She went to the ER on 20Mar2021. She was discharged the next day on 21Mar2021 with no diagnosis and told to follow-up with neurologist. On 11May2021 while at work, she had a weird feeling come over her body. She went clammy and was weak, she could barely stand. The numbing of the face was just in her mouth but that night, her whole face went numb on left side. She could barely walk; it was super weird. They did head CT, cervical CT, and bloodwork, but they could not really find anything. She was admitted back into the hospital on 12May2021, and they did more brain MRIs and bloodwork. She was discharged on 14 May with really no diagnosis and to follow-up with the neurologist. Lab test included Covid negative on 13Jan2021 and 4 brain MRIs. Two were regular MRIs, a brain MRI with contrast, and she thinks it was a MRA where they looked at the blood vessels flow in and out of the brain. She also had brain CT, cervical spine CT, and a ton of blood work. She was hospitalized twice. And they still do not know what was wrong with her. She will 2 more brain MRIs and a cervical MRI left to go in 2 more weeks, Covid 19 Test (positive in Dec2020 and negative in 13Jan2021). The outcome of the events left side face went numb and left thumb and pinkie numbness was not recovered/resolved. Left arm heaviness and axillary pain was recovering /resolving. The outcome of feeling abnormal, difficulty in standing, Tingling tongue, Numb lips, migraine, cold sweat(clammy) and asthenia was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 42 | 2021-06-08 | sleep disorder |
I was breathless and extremely exhausted for several weeks prior to the most extreme symptoms presen...
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I was breathless and extremely exhausted for several weeks prior to the most extreme symptoms presented. I started feeling excruciating chest pain so much so that I thought I was having a heart attack, could not sleep at night because the pain grew increasingly worse, radiating pain down my arms, and it was extremely difficult to even complete sentences I was so winded. As these symptoms progressed I thought they were an injury from yard work and wrote it off as costochondritis and suffered. Eventually I was at work and could not even get a sentence out without extreme pain and breathlessness. I was taken to urgent care where they instructed me to go to the emergency room at hospital. There I was given a series of tests. I believe I had a echocardiogram where all my findings were normal. Then they did a blood test where they look for clotting as they were concerned about a blood clot. That was a slightly elevated number which then brought me to a CT scan with contrast. This is where they found that it was not a blood clot but pericarditis. They followed up with a ultrasound of my heart where they saw the sack around my heart inflamed with fluid. The first question I asked the doctor is could this be related to my vaccine which I just completed. The more I learned about pericarditis, the longer I realize how long I have been suffering with breathlessness. I dismissed it for such a long time because I had recently had another baby and was doing a lot of heavy lifting carrying her around as well as mask wearing as a teacher. Because of the mask I dismiss my breathlessness and ignored it for a long time.
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| 42 | 2021-06-09 | feeling abnormal |
sore arm; both arms go numb all the way to pinky, heavy feeling that she can't describe in any other...
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sore arm; both arms go numb all the way to pinky, heavy feeling that she can't describe in any other way; headache; nausea; stomach pain; dark circles under her eyes; heart rate was elevated; so foggy the first day; diarrhea; extreme fatugue; both arms go numb all the way to pinky, heavy feeling that she can't describe in any other way; This is a spontaneous report from a contactable consumer (patient) or other non hcp from an Agent Team. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for Injection, Batch/Lot Number: EW0177) via an unspecified route of administration, administered in arm left on 20May2021 08:57 (at the age of 42-year-old) as 1st dose, single dose for covid-19 immunisation. Medical history included vasovagal syncope (Verbatim: vasovagal syncope), overheated, fearful, or not feeling well, she faints. Caller states if she has an illness, she will throw up and pass out. Reporter states when she faints, she stops breathing. The patient's concomitant medications were not reported. Patient previously took vaccine included Titanus (she got was 11 years ago and that was the tetanus DDAP or TDAP). On an unspecified date the patient experienced sore arm, on 20May2021 the patient experienced extreme fatigue, both arms go numb all the way to pinky, heavy feeling that she can't describe in any other way, diarrhea, heart rate was elevated, so foggy the first day, on 21May2021 the patient experienced headache, nausea, stomach pain, dark circles under her eyes, on an unspecified date in Jun2021 the patient experienced both arms go numb all the way to pinky, heavy feeling that she can't describe in any other way. patient having symptoms from the Covid vaccine that she got about 14 days ago and she's due for her second dose Thursday. Transferring agent states the caller doesn't want to, s patient having concerns that patient going to experience the same thing patient having if she gets the second dose and if she is, patient doesn't want to go through with the second dose. Patient states basically 14 days after having the first dose, which patient had on 20May2021 at 0850. patient states she still having some side effects 14 days later and from asking around and reading up, most people aren't still having side effects 14 days later. Patient states she was concerned about whether she should get the second dose or not. she can't take SSRIs, NSAIDS, can't have caffeine. Patient states she been having headaches every single day since the first dose. she was extremely fatigued. Patient states starting a few days ago, her arms go numb. Patient states yesterday they were numb all afternoon into the evening, there was nothing she could do, she tried to stretch and move each arm. Patient states her pinky's are numb on each hand, which is new, that's never happened before. Patient states just based on all that, she did have some pretty strong symptoms for the first 48 hours after vaccine. Patient states within first 15 minutes, her heart rate was elevated her normal resting heart rate is in the 50s and 60s and even some-times at night while she's sleeping, it goes into the 40s and after the vaccine it went up to the 90s. Patient states her blood pressure last time at the doctor was 97/60. Caller states her blood pressure is usually really low. Patient took her blood pressure 15 minutes after the first dose, she thinks it was 122/80 something, which is normal for most people, but for her its really high. Patient states her cardiologist said she had a little bit of inflammation and said to check with her primary care provider so she messaged her all that information but her primary care doctor is supposed to be leaving for her vacation, so she might not have a chance to look at it. the first 48 hours, she felt incredibly heavy, she could get up and walk around, she just didn't feel right. Patient states anytime her significant other went over a bump in the car on the way home, she just doesn't know how to describe it, it wasn't motion sickness, she thought oh my gosh don't go over anymore bumps, it intensified the heavy feeling. Patient states had nausea and stomach pain but that's mostly gone away now. she also had diarrhea for the first 24 hours. Patient states other family members who had Moderna were very sick after their second dose. Patient states there was a report that came out. Patient states her daughter and significant other also got their first dose and her daughter is 13, they had no reaction other than a sore arm and a little fatigue the first day. Headache: Patient states she had a headache within 24 hours, it's more of an after effect, definitely a lingering one. Caller states it's not constant, they come and go but for someone who never usually gets headaches unless severely ill is weird. Fatigue: Patient states fatigue started that day, 20May2021, it was definitely worse the first several days after, and hasn't completely gotten better, its still lingering. Patient states she thinks its improved, she's trying to exercise more. Caller states the days she does exercise, she feels less fatigued. Patient states she has been exercising more since 01Jun2021. Arms go numb; pinkies are numb on each hand: the numbness started within the last few days. Patient states it's from her scapula down to her pinky, its weird. Heaving feeling: Patient states she got a heavy feeling within 5 or 10 minutes of getting the shot then it kind of worsened through out the day, it was weird. Patient states she would get to the point where she needs to lay down but if she laid down for a long time she would feel worse and then she would start moving around but then if she kept doing stuff she would get to the point where she had to lay down again. Diarrhea began right after shot when she got home within an hour and it was just the next 24 hours. Nausea; stomach pain, the nausea and stomach pain lingered. she does have to follow a GERD diet to prevent stomach ulcers so when she sticks to that she doesn't have any stomach pain but if she has a tomato or onion here or there it will start to come back. she was so foggy the first day. dark circles, she had been sleeping up to 8 hours a night and before she was only sleeping 6 hours a night so she would think it wouldn't be that way. Went with Pfizer because a family member had zero reaction to either dose whereas those who took Moderna were very sick after the second. The immediate members of Patient household were completely fine after their first Pfizer dose. patient underwent lab tests and procedures which included blood pressure measurement: 122/80 (122/80 something), heart rate: 90 on 20May2021.The outcome of the event headache was not resolved, outcome of the event extreme fatigue, both arms go numb all the way to pinky, heavy feeling that she can't describe in any other way, heart rate was elevated, so foggy the first day, sore arm was unknown, outcome of the event nausea, stomach pain, dark circles under her eyes was resolving, outcome of the event both arms go numb all the way to pinky, heavy feeling that she can't describe in any other way was resolved on an unspecified date in 2021, outcome of the event diarrhea was resolved on 22May2021.
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| 42 | 2021-06-09 | sleep disorder |
A couple weeks after the 2nd shot I had blurriness of vision and had bouts of light headed dizzine...
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A couple weeks after the 2nd shot I had blurriness of vision and had bouts of light headed dizziness . 4 weeks after the shot I began getting non-stop tinnitus in both ears. It is non-stop and cannot sleep
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| 43 | 2021-01-04 | abnormal dreams |
sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I cou...
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sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I could barely keep my eyes open for three days; mild headache; menstrual cramps; diarrhea; I had bizarre dreams like being attacked by zombies for three days; chills; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration at Left arm on 23Dec2020 17:45 at single dose for covid-19 immunization. Patient known allergies included Imitrex, beef, grass, weeds, trees, Cats. Other medical history included Asthma, allergies, migraine, Premenstrual syndrome (PMS), overweight. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications in two weeks. The COVID-19 vaccine was administered at Hospital. The patient experienced extreme fatigue. Her arms felt like lead for three days, and she felt so sleepy. She felt like she could barely keep her eyes open for three days. She had a mild headache. It triggered menstrual cramps and diarrhea for three days. She had bizarre dreams like being attacked by zombies for three days. She had chills for a few hours. She had a sore arm for a couple of days. Adverse events start date was 23Dec2020 10:00 PM. Treatment included Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of chills was recovered on 24Dec2020, of headache, chills, fatigue and sore arm was recovered in Dec2020, of other events was recovered on 26Dec2020.
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| 43 | 2021-01-04 | feeling abnormal |
fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was ...
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fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4°F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.
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| 43 | 2021-01-05 | impaired work ability |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable physician reporting for a nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A 43-year-old female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. The physician was reporting that a nurse received the vaccine and had a headache after receiving it. She also tested positive for Covid 6 days after getting the vaccine (on 28Dec2020). He was asking if there was any connection with getting the first shot and testing positive. She was very keen with social distancing and wearing a mask. The physician is a medical oncologist. He was reporting on one of the nurses that worked at the hospital. She also developed nasopharyngeal congestion 4-5 days later. The nurse was at work today. She was disappointed because she had to go home. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 28Dec2020. The outcome of the events was unknown. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
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| 43 | 2021-01-06 | impaired work ability, feeling abnormal | Body aches and chills, no fever. Felt poorly. Sent home from her shift. |
| 43 | 2021-01-06 | insomnia |
First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mil...
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First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mild pain arm. 12/17-12/18 arm pain got worse every day. 12/19 couldn't sleep at night. 12/20 limited motion in arm. Called doctor12/21. Took 400mg ibuprofen. Took Medrol for shoulder pain. 12/22 not able to sleep. Dr. wrote rx for Flexerol. Continued to take meds. Went back to work 12/23 with some pain. By 12/26 much better.
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| 43 | 2021-01-07 | anxiety |
Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "le...
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Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "left eye feels funny, like twitching and my blood pressure feels high" Narrative: Pt reports high anxiety along with stated symptoms.
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| 43 | 2021-01-10 | sleep disorder |
I received the vaccine on Friday evening at 6:45 p.m. . Starting early morning on Saturday around 3:...
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I received the vaccine on Friday evening at 6:45 p.m. . Starting early morning on Saturday around 3:00 in the morning I begin to have extreme body aches causing me to wake up and my whole body was aching and I was shivering and it was difficult to move my right arm, which is the arm that took the injection. I was barely able to prop myself up to take Advil. I was down for the rest of the weekend in bed in pain. On Sunday the 10th of January the pain was less but it was more focused as a headache and I was extremely fatigued and slept the whole weekend.
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| 43 | 2021-01-11 | disorientation |
I almost blacked out around 8:30 AM the morning after my vaccination. I took my dogs outside and sta...
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I almost blacked out around 8:30 AM the morning after my vaccination. I took my dogs outside and started feeling woozy and seeing spots. By the time I got back into my house, I had tunnel vision and could not see directly in front of me. I went to lay down, but ran into a piece of furniture because I was so disoriented and hit my shin on it. I collapsed on my bed. I stayed there for few hours and then I was ok. I had severe, flu-like symptoms for most of the day - fever, chills, low energy, joint pain (specifically back and hip) - that waxed and waned. I finally felt almost back to normal approximately 50 hours after the injection.
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| 43 | 2021-01-11 | sleep disorder |
I had had minor intermittent teeth pain off and on for several weeks. With in a day of getting the v...
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I had had minor intermittent teeth pain off and on for several weeks. With in a day of getting the vaccine the pain began increasing to the whole left side of my face and neck and increasing in intensity. I was unable to sleep 12/24 and 12/25 and ended up going to urgent care on 12/26. Despite not having sinus fullness/drainage they diagnosed it a sinus infection and gave me antibiotics. At the end of the 5 day course my symptoms had improved some but were not gone and I was still requiring frequent Tylenol for pain so the course of antibiotics were extended. I do not know if this was caused by the vaccine, but it coincided with the vaccine.
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| 43 | 2021-01-12 | anxiety | HYPERtension chest pain (mild), anxiety |
| 43 | 2021-01-12 | feeling abnormal |
The night after the injection, I was very lethargic, my mind was "cloudy" I couldn't form coherent s...
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The night after the injection, I was very lethargic, my mind was "cloudy" I couldn't form coherent sentences. Took Tyelenol before bed because my arm was very sore. Next morning, my whole body ached and had a severe tension headache, my jaw was very tense also. I was still very lethargic and my mind still "cloudy". Took Tylenol again after dinner, that night I started to feel relief from aches, headache and my mind can think more clearly.
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| 43 | 2021-01-12 | excessive sleepiness |
I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I w...
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I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I was tired, and had no smell and slept all weekend. My arm was very, very sore. The rash lasted until 12/23/2020.
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| 43 | 2021-01-12 | sleep disorder |
sob, headache, fatigue, joint /muscle pain, fever. Worst part is the right shoulder joint/muscle pai...
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sob, headache, fatigue, joint /muscle pain, fever. Worst part is the right shoulder joint/muscle pain. This pain is very bad it has kept me up for 2 night and pain still present
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| 43 | 2021-01-13 | feeling abnormal, impaired work ability, impaired work ability, feeling abnormal |
We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on...
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We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on her arms that progressed to her legs and torso. The rash it itchy and burns. She still has the rash today. The next day after vaccination she experienced headache and aching that subsided within 3 days. This employee has a history of Lupus and breaking out in a rash is not uncommon for her, it is actually sort of common. When asked if this is the same sort of rash she experiences after too much sun exposure or stress (due to the Lupus) she says she would describe it as the same. She did miss one day of work due to the headache, aching, and just being miserable with the rash on top of it. She did not experience hives, trouble breathing, or swelling.
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| 43 | 2021-01-13 | feeling abnormal |
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne...
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arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-13 | feeling abnormal |
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, prog...
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Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
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| 43 | 2021-01-13 | irritability |
She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried ...
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She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried for a long time; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# either GL0140 or EL0140, Expiry date and NDC number were not written), via an unspecified route of administration in left arm on 23Dec2020 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient pregnant: No. She has had No positive test for covid before the vaccine, and No Antibody test before the vaccine either. She has had No issues with vaccines in the past. The patient had the vaccine on 23Dec2020 and then on 01Jan2021 she began to experience eye twitching and it hasn't gone away and it's very bothersome. It's still happening. Her first dose was on 23Dec2020. The eye twitching began on 01Jan2021, it's just the left eye, she can see the eye lid moving when it twitches, she felt it, like the eyeball itself was twitching or spasming. There were no issues with the vision in that eye. She did feel she was getting sleep, she was conscious about seeing if she was tired, both eyes felt as if she had cried for a long time but she had not cried at all and the eye that was twitching she felt it more in. She thought it was getting better in the morning because at that time she didn't feel it, but by mid-afternoon it was consistent. The twitching happened often sporadically every couple of minutes, and she was annoyed of it. Investigation Assessment: No. The outcome of the event left eye twitching was not recovered, outcome of other events was unknown.
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| 43 | 2021-01-13 | nervousness |
Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beat...
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Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beating fast. She also said that arms and feet felt "tingly". Patient felt this immediately after injection upon standing. Patient was escorted to chair for assessment. She was given water and pulse was normal. Patient said that she was feeling a bit better after a couple of minutes but then started experiencing chest heaviness and shakiness again. Patient alert, oriented, pulse normal, respirations normal. ER called and nurse came to clinic for assessment. Pulse was still normal upon his assessment but offered to take patient to ER via wheelchair for further assessment and patient agreed. Patient left clinic at approximately 8:55am to go to ER.
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| 43 | 2021-01-13 | sleep disorder |
I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a...
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I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a fungal infection of the nail, however it had felt fine until it woke me up in the night. I thought I had developed cellulitis. However by the next morning it was completely gone back to how it was which is a little painful and irritated but not bad at all.
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| 43 | 2021-01-14 | feeling abnormal |
Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Co...
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Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Covid vaccine here at the hospital where she works about 8:30 AM. About 10:00 she started having shakes and a headache and just not feeling right. She has had some periods of palpitations and feeling like her heart is racing as well. She called employee health and was referred in to see us. At this time she says she still has some headache and overall feels weird but no other new symptoms. No chest pain or shortness of breath or palpitations at this time. No trouble breathing. No fever. No visual changes but the light does bother her eyes. She does have a history of migraine headaches that are like this at times. The pain is in her forehead, not globally or in her neck. She has no neck pain or stiffness. She did not have much of reaction after her first vaccination. She does have a history of hypertension but has been taken off her medication because her blood pressures have been well controlled. She states that she does check them regularly at home and they have been okay. She denies any other recent sick symptoms. No other significant chronic underlying medical problems. Medications administered in the ED included ibuprofen 600mg and diphenhydramine 25mg orally at 1415, and acetaminophen 1000mg orally at 1000mg. Headache was better at 1540, blood pressure was lower at 139/90, no shaking. Pt discharged home.
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| 43 | 2021-01-14 | impaired work ability, feeling abnormal |
12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, ...
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12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, and the feeling of dizziness or fogginess for 36 hours. Writer missed 2 days of work due to symptoms. Continued symptom - injection site is swollen, red, firm, tender to touch, arm sore to lift, and pain noted in arm pit.
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| 43 | 2021-01-14 | impaired work ability |
Sore throat with white patches in back of throat started 2 days after vaccine. Missed work (work at ...
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Sore throat with white patches in back of throat started 2 days after vaccine. Missed work (work at hospital) the next day and went to urgent care. Tested negative for strep. Sore throat resolved that evening.
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| 43 | 2021-01-14 | insomnia |
Insomnia; Racing thoughts; This is a spontaneous report from a contactable consumer (patient herself...
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Insomnia; Racing thoughts; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 05Jan2021 at 13:00 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included chronic migraines, high blood pressure, and known allergies to tree nuts. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jan2021 at 16:00, the patient experienced insomnia and racing thoughts, which were assessed as non-serious. The patient did not receive any treatment for the adverse events (AE). The patient recovered from both the events on an unspecified date in Jan2021. Information on the batch/lot number has been requested.
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| 43 | 2021-01-17 | insomnia, feeling abnormal |
Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred per...
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Within 30 minutes of shot-Fleeting itching in both ears, fingertips, and soles of feet. Blurred peripheral vision in left eye only. Dizziness, wooziness. All resolved with 35 minutes of injection, initially. Within 4 hours of shot-Exponential increase in pain from waist down, including lower back pain. Took Motrin 600 mgs which resolved pain within 1 hour of taking it. Felt off/not myself-Felt foggy-headed-pressure in head and ears was not normal. 2100-0000 (Evening of shot)-Moderate sporadic dizziness that became moderate constant dizziness-Took 1 25 mg chewable Meclizine with 1 cup of water. Pain increased and Motrin wore off. Fatigue grew worse. 1/13/21-1/14/21-SEVERE back pain. Intense pain in legs and hips. Upper respiratory symptoms-Nasal congestion, ear pressure, sinus pain/pressure, chest and upper back discomfort, chest congestion, irritation, and aching. Cheeks and nose looked puffy/swollen. Eye pain, headache on and off. Fatigue, dragging. Felt feverish but no actual fever. Body aches-sides, legs-front, back, and sides, lower back, and glutes. Felt like arthritis from waist down, including lower back. Took nighttime cold syrup, etc. to be able to sleep and/or at least dull the pain. Also used heating massage pad to assist with pain relief. 1/15/21-1/16/21-Pain lessened in terms of intensity. Had longer spells of less intense pain. Also less pain with movement after resting/lying down. However, pain still intense at this point. Meds more helpful with the pain at this point as well. On Sat, felt dizzy and unwell all day, including extra tired. Hot, sweaty on Sat. Racing heart, chest tightness. Used inhaler and Metoprolol. 1/17/21-Felt unwell-intense pain still, dizziness, fatigue. Took Meclizine 25 mg that morning. Also took another 25 mg Meclizine later that afternoon. Nausea, dry heaving to the point I almost vomited 2x. After napping, nausea returned slightly but immediately went away. Felt very tired remainder of the evening. 1/18/21-Went to MD to get clearance to return to work. Dizziness prior to visit and took 1/2 25 mg Meclizine. Felt better until I got to doctor's office. While waiting to be called back, dizziness started up again and got severe. While waiting on MD to come in and talk to me, I got nauseated and felt like I might dry heave/vomit. I took another 1/2 Meclizine 25 mg and sucked on a mentholated cough drop to help with nausea, which did subside. Dizziness continued to be severe. MD took blood pressure, pulse ox, checked my ears, checked my pupils, listened to me breathe, asked me about my symptoms, return to work, and advised on safety of taking 2nd COVID injection when it is time but leaving it up to me in terms of if I feel benefits outweigh possible side effects of 2nd injection. He prescribed anti-nausea meds, pain meds, and stated he wants to see me for a follow-up visit in 1 week. He also prescribed steroid and pain med injections to be administered in office immediately, steroid injection sometimes contains Benadryl and based on how I felt after the shot, there may have been Benadryl in this one. He also requested I message him later in the day to let him know how I was feeling. Injections did GREATLY assist with pain and dizziness/foggy-headed feeling, once they kicked in. I did message him letting him know how I was feeling after napping. 1/18/21 evening-I am still feeling weak and tired and having stinging like pain in both legs along with minor lower back pain. Some chest and throat irritation as well as stomach discomfort. Going to take a gentle laxative as well as some of the nighttime cold medicine I purchased. Still also having dizziness on and off. I plan to return to work tentatively, on 1/19/21, per my return to work note from MD. I will keep my MD notified of how I feel between now and next Monday's follow-up.
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| 43 | 2021-01-17 | memory impairment, confusional state |
Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachyc...
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Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachycardic and hypertensive. I was taken to the Emergency room . 48 hours after exam I had extreme periods of confusion and extreme forgetfulness.
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| 43 | 2021-01-18 | feeling abnormal |
These symptoms began the morning after I received the second vaccine (4:30 pm). Symptoms started at ...
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These symptoms began the morning after I received the second vaccine (4:30 pm). Symptoms started at 0630 the next morning: Fatigue, chills, headache, foggy brain, heavy feeling. This is how I feel right before a fever with the flu.
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| 43 | 2021-01-19 | anxiety |
Patient received 2nd dose Pfizer @ 1549, after 10 minutes of monitoring patient c/o of tightness & f...
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Patient received 2nd dose Pfizer @ 1549, after 10 minutes of monitoring patient c/o of tightness & felt "slow swelling" in her throat. Also reporting "slow swallowing sensation" Patient brought out to back triage area, vitals stable, NO SOB, no wheezing, no lip or tongue swelling noted. 167/95, 63, 99% RA. Reporting feeling anxious. Only allergy or similar event patient reports is medication, ephedrine during delivery which was treated w/ O2 during her delivery Repeat vitals 134/90, 59, 99% Allergy MD on call notified of event, per MD continue to monitor for additional 30 minutes and call back w/ any further symptoms 136/93, 60 & 99% After 30 minutes, patients vitals stable, sensation has resolved & felt well enough to go home 127/92, 59 & 99%
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| 43 | 2021-01-19 | insomnia |
back ache; intense achy; rigors and chill; Could not sleep; second dose of BNT162B2 on 08Jan2021, fi...
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back ache; intense achy; rigors and chill; Could not sleep; second dose of BNT162B2 on 08Jan2021, first dose was given on 19Dec2020; This is a spontaneous report from a contactable physician (reported for herself). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3249), via an unspecified route of administration (left arm) on 08Jan2021 (10:00 AM) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 19Dec2020 (10:00 AM). Medical history included Celiac disease and allergies to medications, food, or other products: Latex, salicylate, wheat (celiac). Concomitant medication included melatonin (MELATONIN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that at around 30 hours after second vaccine dose (09Jan2021, 05:00 PM), the patient experienced back ache. At 36 hours post vaccine she developed intense achy and rigors and chill that lasts about 6 hours. The patient could not sleep during that time (10pm-330am). The patient took Tylenol at 1:30am. The symptoms abruptly stopped and felt perfectly fine after. There was a treatment received for the adverse event. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
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| 43 | 2021-01-19 | sleep disorder |
near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observat...
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near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observation increased heart rate, light headed, orthostatic after vaccine continued w/ rapid heart rate, light headed and orthostatic for 3 days day 2 severe body aches, chills, fatigue and headache,, arm pain only at injection site, swollen lymph nodes- Tylenol taken but barely touched pain day 3 still joint aches and headache, fatigue and chills, slight arm pain only at injection site, swollen lymph nodes- Tylenol and rest day 4 felt better, rash began on torso and spread to arms, groin , neck, swollen lymph nodes day 4 rash which began to itch lasting day 4,5,6,7,8- took Benadryl so I could sleep, swollen lymph nodes Continue w/ intermittent chills, body aches, headache and light headed for day s 4,5,6,7,8 Continue w/ swollen lymph nodes under left and right arm and today is day 14
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| 43 | 2021-01-20 | insomnia |
Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 h...
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Red, swelling and itching at injection site. Started 15 hours after injection and still present 57 hours after injection. Swelling of lymph nodes and pain in lymph node region in the same arm. Unable to turn a steering wheel due to pain or pick up objects with right hand. Reaction has followed the same time line as the arm. Pain is so severe that it prevents sleep.
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| 43 | 2021-01-21 | anxiety | Lightheaded, pale, rapid pulse, chest pain, anxiety, clammy. |
| 43 | 2021-01-21 | feeling abnormal, nervousness |
Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pal...
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Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pale and diaphoretic. Seen in the ED and was given fluids and monitored a couple hours and released. On 1/21/20 she continued to feel poorly with dizziness and ringing in her ears. She was seen by her physician and given a steroid injection and a meclizine prescription. Physician believes her symptoms are a continued reaction to the vaccine.
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| 43 | 2021-01-21 | impaired work ability | 101.2 fever. called in sick to work. |
| 43 | 2021-01-21 | sensation of foreign body |
Client had vaccine around 5:55pm and was instructed to wait in the lobby for 30 minutes after vaccin...
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Client had vaccine around 5:55pm and was instructed to wait in the lobby for 30 minutes after vaccine to monitor for reaction. Around 6:30 pm she went out to her car and came back into the clinic stating that she had pressure in her chest and a lump in her throat. 911 was called and client when to the emergency room where it was determined that she had an allergic reaction to the vaccine. We have called client to follow up but she has not returned our voicemail.
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| 43 | 2021-01-22 | feeling abnormal |
About 14 hours post-injection, I began to have onset of mild chills and mild ?yucky? feeling that yo...
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About 14 hours post-injection, I began to have onset of mild chills and mild ?yucky? feeling that you get when you are ill. This lasted about 24 hours, and then completely disappeared. No fever. I took ibuprofen 400mg which helped initially, but repeat dosing of this did not assist as well that evening.
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| 43 | 2021-01-23 | anxiety |
shortly after immunization complained of itchy throat and anxiety. She received 10 mg of loratidine....
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shortly after immunization complained of itchy throat and anxiety. She received 10 mg of loratidine. Approximately 30 minutes later she stated improvement in symptoms and left (it was 15:28). At 16:44 she returned to clinic complaining of worsening symptoms. She was escorted to the Emergency department for further care.
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| 43 | 2021-01-24 | fear, anxiety, feeling abnormal |
Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hemato...
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Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hematocrit were slightly low; fluttering in chest; Rash on left side of face and neck; skin started burning; Anxiety and fear; Anxiety and fear; Racing heart beat; Dizziness/Lightheadedness; Headache; Nausea; Has been on her period for three weeks/Is premenopausal/Was bleeding at time of vaccination; This is a spontaneous report from a contactable Nurse reporting for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at right arm on 06Jan2021 15:22 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, No agency site. Medical history reported included breast implants, She was healthy and had no medical diagnoses. The patient's concomitant medications was reported as none, She took no medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to report a possible reaction to the COVID Vaccine. Has been to the ER three times. Had a racing heart beat, dizziness, lightheadedness, and nausea on 08Jan2021. Developed a rash and skin started burning on 11Jan2021. The rash was on the left side of her face and neck. Racing heart beat started first. Then dizziness, headache, lightheadedness, and nausea began. She also had anxiety and fear. All symptoms began on 08Jan2021. Went to the ER on 08Jan2021. Was discharged from the Emergency room. Last night, 11Jan2021, she felt fluttering in chest, but it wasn't as severe as two nights ago. Her EKG was normal. Patient Hoped nothing occurs today. Took three Benadryl last night. Racing heart beat, rash, dizziness, headache, lightheadedness, nausea were all ongoing. The patient was wearing a Halter monitor until 12Jan2021 at 15:00, total duration for Halter monitor is 24 hours. Seriousness: Definitely disabling. Sunday night she thought she might not wake up Monday. She was fearful of all of the weird. Investigations: The patient was advised her labs were ok. Red blood cells are a little low. Hemoglobin and hematocrit were slightly low. Thought hemoglobin was 10.7. EKG was normal, Chest X-Ray was negative. The patient was just trying to figure out why reaction occurred. She Had been on her period for three weeks, was pre-menopausal. Was bleeding at time of vaccination on 06Jan2021. She did have breast implants, and didn't know if that was related or not. The patient Would not be getting the second injection. The nurse assessed the events of Racing heart beat, Anxiety and fear and Rash on left side of face and neck as related. The outcome of the event fluttering in chest was recovering, the outcome of the events Racing heart beat, rash, dizziness/ lightheadedness, headache, and nausea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac flutter, palpitations, headache, dizziness and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-01-24 | nervousness, confusional state |
Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper b...
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Sensation of fullness in back of throat, progressing to tingling sensation of mouth/face and upper body, and then tachycardia. Became very nervous with the strange sensation and took pulse which was initially in normal range. This however progressed to a rapid heart rate. Overall symptoms lasted 3-4 minutes. Pulled over and exited a busy highway. Called 911 (2:22 pm) during symptoms and they said they could only call an ambulance. Had some confusion when speaking to operator, as I couldn't tell them which exit I was at although I know the exit. Ultimately, drove myself to the hospital parking lot (about 4-5 min away) as heart rate had started to return to normal. Heart rate was in normal range when I rechecked in hospital parking lot. Sat in car for about 5 minutes before deciding to drive back to vaccine clinic to report my symptoms. Clinic about 3-4 minutes away. Pulse ox was normal x 2. BP was actually elevated x 2. Waited 30 minutes before being released home.
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| 43 | 2021-01-24 | sleep disorder |
Severe pain in arm, shoulder, and neck. Limited range of motion for 4 days. I could not pick thing...
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Severe pain in arm, shoulder, and neck. Limited range of motion for 4 days. I could not pick things up with my left arm or turn the steering wheel on my vehicle. Had difficulty sleeping because of pain. Feels almost back to normal as of today, 1/25, but still slight discomfort.
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| 43 | 2021-01-25 | feeling abnormal |
headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; T...
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headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female non-pregnant patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL3249; expiration date: unknown), intramuscular right arm on 08Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included exercise induced asthma. The patient has no known allergies. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient was not diagnosed with Covid prior to vaccination. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EJ1685) intramuscular left arm on 19Dec2020 10:00 at a single dose for covid-19 immunization but she had zero side effects. The patient reported that on her second dose, she had sore arm, fatigue, body ache, muscle ache, migraine and fogginess beginning 24 hours after receiving injection and lasting 72 hours. Slight linger of achiness and headache on the fourth day (12Jan2021) but able to work again. No treatment was received for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
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| 43 | 2021-01-25 | memory impairment, feeling abnormal |
Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't ta...
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Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; generalized body pain/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; swollen lymph nodes in her left arm pit/couldn't move her arm; This is a spontaneous report from a contactable nurse reporting for herself. A 43-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 on unspecified date for COVID-19 immunization and her arm was inflamed, and so swollen, she couldn't move it. Caller was instructed to call after getting the COVID vaccine. She had a reaction after the vaccine. Her doctor said to call Pfizer. It was after she received the 2nd dose of the vaccine, Saturday (09Jan2021). She had a reaction. She developed a headache and fatigue. She had had these side effects since Saturday. They have lasted Sunday, Monday, and today/Tuesday. She was very tired, and she has generalized body pain. The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back. Literally, her whole body was so painful. She had been taken Ibuprofen 800mg and Tylenol 1g. She had been taking those every 8 hours. She took them together. When she took them, her headache and body pain was maybe a 5-6/10. If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain. She also had swollen lymph nodes in her left arm pit. Which is the arm they injected the vaccine into. She just noticed it Saturday night. She couldn't move her arm. Now, after the second, she had a swollen lymph node the size of a quarter. It had been the same size since Saturday. She was wondering if it would go away? She was also becoming forgetful. Her brain was foggy-ongoing. Like she forgot her doctors appointment today. The outcome of event "brain was foggy" was not resolved while outcome of other events were unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-01-26 | anxiety |
hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her...
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hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side; dizzy; Heart racing; Her arm was very sore- it was difficult to lift it; Her arm was very sore- it was difficult to lift it; She did feel a little out of it, as it produced a little bit of anxiety; A mild allergic reaction; This is a spontaneous report from a contactable Other Health Professional (patient). A 43 years old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248, Expiration Date: Apr2021), via an unspecified route of administration on 12Jan2021 at 13:22 at single dose on right arm for covid-19 immunisation. Medical history included vasovagal (she did have a history of vasovagal. She talked to her doctor about this prior to the vaccine. At first when she had it her previous doctor felt a little confused. She was unsure if it was vasovagal or a blood clot in her lungs. She did get it checked out with a cat scan and there was no clot. They had to have tested her for anaphylaxis at that time. It was not a clear diagnose. Then she saw a cardiologist. She was diagnosed with vasovagal at that time. It lasted only a few months and she was fully recovered). Concomitant medications included ongoing ergocalciferol (VIT D) and ongoing vitamins NOS (MULTIVITAMIN). Patient received the vaccine on Tuesday, 12Jan2021. Her appointment was at 12:54, but she got the vaccine at 13:22. She was looking at her phone to re-schedule her second dose. She felt totally fine. At 13:27 she had this weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side. She looked up from her phone and was very dizzy. She stood up and as she did her heart started to race. It was a really weird feeling that she has never felt. She was a little out of it. She had no trouble breathing. Within 30 seconds she was completely fine. She did feel a little out of it, as it produced a little bit of anxiety. She had no other symptoms. She stayed at the facility for 30 minutes. As she was leaving one person asked how she felt and she was told to let the EMTs know. She let them know what happened. One woman working there said it could have been an anxiety attack. She did not have a lot of anxiety but she did have some. It did not feel like that. She had never had the warm sensations or heart racing. She was totally fine when talking to the EMTs. They did not seem concerned and they let her schedule her second shot. She read on Pfizer about allergic reactions. She was assuming this was what happened. A mild allergic reaction. She had no breathing issues or hives. Her arm was very sore- it was difficult to lift it. She had also never had this type of soreness with vaccines. Dizziness: She has had the dizziness a couple of times. Twice now. One when she had gotten home. It was very mild and nothing compared to what she had when she got the vaccine. Then another last night at bedtime. It was a woosh of dizziness. Arm soreness: very improved now. felt like she would normally have after getting a vaccine. The first day was intense but after a few hours was less. The next day she woke up and it was pretty much gone. She still had a little but it has mostly improved. Caller stated she would still like to get the second dose but she was a little nervous. She had it maybe once or twice since then and it has been mild with no extreme pressure drops. They thought maybe it was a virus that affected her. Her reaction to the vaccine was different. The difference was pretty significant. Vasovagal felt like her heart will stop and she will pass out. After the vaccine she felt dizzy but didn't feel faint, and had a racing heart. Nobody seemed concerned about her reaction and getting the second dose. But she read that Pfizer does not recommend getting the second dose even if you had a mild reaction. She was wondering what she should do. Her second dose is scheduled for 02Feb2021. Outcome of hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side and heart racing was resolved on 12Jan2021, dizzy was resolved on 13Jan2021, outcome of anxiety was unknown, outcome of her arm was very sore- it was difficult to lift it and a mild allergic reaction was resolving.
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| 43 | 2021-01-26 | feeling abnormal, impaired work ability, sleep disorder |
Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick...
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Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick. within 30 minutes of then end escalating over the next hour, I had a severe headache, bilateral, occipital, pressure in entire head and neck. The headache as also in my eyes and in my ears. Back was also painful - not as bad as neck, but i can't explain how horribly a hope a massage could fix me. There was no comfortable position to alleviate any of that. I also got the chills, constantly, suddenly switching from shivering cold to so hot i needed to take blankets off - but soon as i took the blankets off I'd be freezing cold again. I was also super nauseous, though i didn't vomit. I pretty much couldn't get out of bed much for 24-36 hours. During that time, i was unable to sleep as well, i think mostly due to the chills, constantly having to move about to keep warm or cool off, but not sure. I did take acetaminophen around 10pm 1/26 (36 hours after injection)- i felt like I knew you're not supposed to, but I couldn't take it any more and it might have less anti-inflammatory impact than ibuprofen. It dulled the pains some, but didn't make it stop. the chills and nausea mostly stopped and was able to sleep more the second night, last night. I'm now up and trying to work today (1/27). Head still has pressure headache throughout. Neck is still sore, like a pressure headache. I feel generally foggy and heavy.
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| 43 | 2021-01-26 | insomnia |
1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, j...
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1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-27 | insomnia |
Vertigo/dizzy/room spins starting; dizzy/room spins starting; Fatigue; Sore body; HA (headache); Nau...
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Vertigo/dizzy/room spins starting; dizzy/room spins starting; Fatigue; Sore body; HA (headache); Nausea; Racing thoughts; trouble sleeping; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 10Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies, anxiety, depression, high cholesterol, tinnitus and GERD; all from an unknown date and unknown if ongoing. Concomitant medication included valaciclovir hydrochloride (VALTREX), omeprazole magnesium (PRILOSEC), iron, atorvastatin (LIPITOR), melatonin and BCP. The patient was previously vaccinated with first dose of BNT162B2 via unspecified route in left arm on 20Dec2020 15:00 for COVID-19 immunization and experienced vertigo/dizzy/room spins starting on 08Jan2021 23:30. The patient was not pregnant. The experienced vertigo/dizzy/room spins starting 1-2 days prior to 2nd vaccine 10Jan2021 then it was worsened in Jan2021 after 2nd vaccine. The patient experienced fatigue, sore body, HA (headache), nausea, racing thoughts and trouble sleeping in Jan2021. No treatment was given to the patient for the events. The outcome of the events was not recovered. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 43 | 2021-01-27 | restlessness |
Fever, chills, migraine, entire body aches, muscle pain, weakness , fatigue and restlessness for a f...
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Fever, chills, migraine, entire body aches, muscle pain, weakness , fatigue and restlessness for a full 24 hours
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| 43 | 2021-01-27 | sleep disorder |
Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccin...
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Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccination clinic. I took an Aler-Tec pill and felt better 20 minutes after. My arm was sore for 2 days after and couldn?t sleep on Right side, arm hurt. Injection site was purple and bruised one week later but no pain.
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| 43 | 2021-01-28 | feeling abnormal |
Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit ...
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Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit on 1/21 for chest pressure, lightheadedness, dizzy. Cardiac work up- negative. Discharged. Still lightheaded and dizzy 1/22 - 1/24. On 1/25 sharp chest pains went to see my PCP. She prescribed a steroid pack. 1/26 at 3:30 pm felt weak, felt like I was going to black out. Went back to the ER- full cardiac work up, head CT, admitted to the hospital for observation. Stress test on 1/27. Everything normal. Follow up with PCP on 1/29 still very lightheaded. Ordered a 48 hour heart monitor and Neurology consult.
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| 43 | 2021-01-28 | impaired work ability |
Starting on the 18th I started having pain and numbness in my limbs and chest. I ended up going to t...
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Starting on the 18th I started having pain and numbness in my limbs and chest. I ended up going to the ER where they tested me for Covid and checked my heart. Everything came back negative. The next day I started having severe muscle weakness to where I couldn't stand for more than 5 or 10 mins without feeling like I was going to fall over. I couldn't hold anything up for long without my arms giving out. I started having muscle twitching all over including in my face. I would also have what I would describe as electrical shock nerve pain all over. I went to the ER again and everything came back okay again. I went to Urgent Care and my MD. My doctor stated after looking at the results from the ER that it was related to the vaccine. I was put on high doses of vitamins to see if it would help my body fight the reaction to the vaccine. I was taken out of work for the week because I literally couldn't do anything. I took the vitamins for 5 days before I started finally feeling better. I'm okay now for the most part. I still am having muscle twitching and nerve pain, but it is far more tolerable than it was.
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| 43 | 2021-01-28 | impaired work ability | chills, body aches, nausea, swelling under left arm pit Had to take off work 01/28/21 no doctor |
| 43 | 2021-01-28 | loss of personal independence in daily activities |
About 24 hours post 2nd COVID vaccine by Pfizer, experiencing increasing fatigue, chills and body ac...
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About 24 hours post 2nd COVID vaccine by Pfizer, experiencing increasing fatigue, chills and body aches impairing my ability to work.
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| 43 | 2021-01-30 | sleep disorder |
Around 8:00am, I started to feel tired and weak. Through the course of the day, I ran a fever of 102...
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Around 8:00am, I started to feel tired and weak. Through the course of the day, I ran a fever of 102.4. I had chills, a headache, very sore injection site, and the skin on my arms hurt. I was exhausted, but couldn't sleep. I took Tylenol, but it didn't seem to help much. I didn't have much of an appetite. Around 7:00pm, I no longer had chills but instead was very hot. About 2:00am, I woke up drenched in sweat, but felt so much better.
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| 43 | 2021-01-31 | impaired work ability, confusional state, feeling abnormal, disorientation |
01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout t...
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01/29/2021 930 noticed an itch on left thigh, like I wanted to hive - on various spots throughout the day. 01/30/2021 very tired (to be expected), noticed I had burning in what feels like my gall bladder and developed an ?odd? stomach ache later in the day. Thought it had to do with something I ate, but consumed nothing out of the ordinary. Went to bed early, felt like I wanted to fever but never did. decided to take a tsp of children?s Allegra because I still felt ? itchy? at times. 01/31/2021 woke up to what felt like pressure on my chest, like someone was squeezing me. Thought that was odd and thought it was perhaps the way I slept. Was still tired (4AM) went back to sleep. Woke up again feeling more rested and the same feeling. It was an awful feeling. Grabbed my pulse oximeter and my oxygen was about 96 laying down. Called an. ER, thought maybe I had Covid or something as I have never felt that way before. Receptionist told me she felt the same way after she got the shot. I ate, felt better but then developed a horrific headache akin to a migraine that was so sensitive to any movement I made. Felt like someone was shaking my head, it was so painful and I became disoriented. Like. I would get confused in my thoughts. Became very sensitive to light and movement. Looking at Facebook, I had to stop because I felt like I was going to seizure. Had to really rest. Ate lunch and took a multivitamin to see if that helped. Eventually I felt better but had to be careful, take it easy. 02/01/2021 woke up this morning still tired, like my body is fighting something. And I could fell the headache coming on and noticed I was getting confused in my thoughts. I decided to stay home from work. The morning was very bad as I felt as though I wanted to seizure. Could not get a hold of my doctor. My head still hurts, not as bad, but after I eat, I get confused and can?t hold two thoughts at once if that makes sense. Head seems very sensitive to eye movement like yesterday. It?s a gross feeling, even in absence of the pain.
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| 43 | 2021-01-31 | impaired work ability |
A couple of hours after receiving the vaccine a co-worker said my eyes were very low and red. I star...
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A couple of hours after receiving the vaccine a co-worker said my eyes were very low and red. I started feeling extremely exhausted and even slept on my shift on my desk. My supervisor told me to go home for the day. I went home and slept through the day and night until next morning. I then started feeling myself again.
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| 43 | 2021-02-01 | emotional distress |
20-30 minutes after vaccine patient returned to observation center complaining of difficulty breathi...
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20-30 minutes after vaccine patient returned to observation center complaining of difficulty breathing and constriction in throat. Vitals stable, pulse ox 100%, pharynx clear without edema and no wheezing. However she was quite distressed, becoming diphoretic, and stating that breathing and throat constriction was worsening. She was treated with 0.3 mg epinephrine IM left thigh and 25mg Benadryl left deltoid. After treatment breathing improved, throat constriction resolved, and she felt a rapid heart rate and dizziness. These also gradually improved and she was discharge home with her husband, with prescriptions for famotidine, loratadine, to not take metformin today, and strict ED precautions for recurrence of breathing or throat constriction symptoms.
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| 43 | 2021-02-02 | anxiety |
Immediate tingling to left side of face, followed by tachycardia & palpitations, flushing from chest...
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Immediate tingling to left side of face, followed by tachycardia & palpitations, flushing from chest & back up to the scalp. Taken straight to the ED, evaluated by MD, found to be very anxious & hypertensive (BP 203/128, P 110). Treated with IV Benadryl & Pepcid.
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| 43 | 2021-02-02 | feeling abnormal, disorientation |
I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sid...
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I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sided chest pain at around 8 minutes after administration. Then flagged down a nurse. They checked my blood pressure at 196/110 (first one may have been 210/110)- I was sort of disoriented. Sat there for about an hour with repeated blood pressure checks, until my pulse went from 118 down to 90. They let me go home at 170/100. I do t have hypertension. Then went and laid down in my office nearby and my left upper arm turned bright red and became painful and slightly swollen. Took five hours for my blood pressure to drop to 118/80- my normal is 114/78. Still have weird chest pain and some SOB with exertion (not normal for me).
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| 43 | 2021-02-02 | feeling abnormal |
This is a spontaneous report from a contactable healthcare professional. A 43-year-old female patien...
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This is a spontaneous report from a contactable healthcare professional. A 43-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EK9231; expiration date not provided), via an unspecified route of administration on 15Jan2021 07:40 at a single dose for COVID-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Concomitant medications were not reported. The patient reported that she was having some side effects from the second dose of the Covid vaccine. On 15Jan2021, within 1 hour, the patient started having a low-grade fever and very nauseous. Also, the patient stated that she "feels awful". She didn't experience this with my first dose. The outcome of the event feels awful was unknown, while the outcome of low-grade fever and very nauseous was not recovered.
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| 43 | 2021-02-02 | feeling abnormal | headache, fatigue, body aches, brain fog, joint pain and chest congestion |
| 43 | 2021-02-03 | impaired work ability |
Woke up with fatigue the next day. On Jan 1, 2021 I started running a temperature - it got up to 102...
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Woke up with fatigue the next day. On Jan 1, 2021 I started running a temperature - it got up to 102.1 - had temperature all weekend and tried to bring it down with Tylenol. Went to work on Monday, Jan. 4, and was sent right home after taking a COVID test (result was negative). Follow up with my Doctor on Thursday, the 7th, and had another COVID test was a positive result. Friday, the 8th, my family went to clinic to test and so I tested again that day and my result was negative for that test. My symptoms were body aches, headaches, lost sense of taste and smell and fatigue. These lasted 5-6 days.
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| 43 | 2021-02-06 | feeling abnormal |
Small redness around injection site then large red area 2-3 inches below injection site that is cont...
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Small redness around injection site then large red area 2-3 inches below injection site that is continuing to grow. Area is red warm and hard/swollen. Scratchy throat, rash on abdomen and back with no itch. Feel crappy.
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| 43 | 2021-02-07 | anxiety |
Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:9...
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Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:97 Six minutes after: dose, lethargic, sleepy, eyes dropped (look tired) & dizzy & c/o anxiety. Friend P/U to take her to ER. BP 144/92
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| 43 | 2021-02-08 | restlessness |
Woke up at 1:30 am with fever. Muscles spasming, took an Advil, didn't help. Took another Advil 30 m...
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Woke up at 1:30 am with fever. Muscles spasming, took an Advil, didn't help. Took another Advil 30 min later, restless, can?t stay still, moaning. Muscle cramping getting worse in abdomen. Get up to get more water and urinate, starting to salivate as if going to throw up. Lean over toilet for 20 min, burning hot , weak, throw cold water around face and neck. Take another Advil, lay back down in bed, muscle convulsions for next 20 min, slowly dissipating. Entire episode took 3 hours. Felt like worst period cramping with fever on top of food poisoning. Next day was mildly nausea and sore, tired.
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| 43 | 2021-02-09 | anxiety, thinking abnormal |
Approximately 45 minutes after the vaccine began to have dizziness, increased anxiety, and wheezing....
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Approximately 45 minutes after the vaccine began to have dizziness, increased anxiety, and wheezing. Progressed to difficulty breathing/shortness of air and unclear thinking. Related hypoxia occurred. Treated at home with antihistamines and albuterol. Epi-pen was not used, but should have been.
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| 43 | 2021-02-09 | feeling abnormal |
Arm was extremely sore; Felt very fatigued and achy; Felt very fatigued and achy; Stomach is still u...
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Arm was extremely sore; Felt very fatigued and achy; Felt very fatigued and achy; Stomach is still upset; Haven't felt like doing anything; Nausea; Abdominal pain; Threw up twice; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the right arm on 20Jan2021 (16:00) at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), spironolactone, fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC) and desogestrel, ethinylestradiol (MIRCETTE). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 30Dec2020 (when the patient was 43 years old) on the left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On the day of the vaccination, the patient was fine. The following day, 21Jan2021 (16:30), the patient's arm was extremely sore; she had felt very fatigued and achy; stomach was upset; and had not felt like doing anything. On 21Jan2021, at night, the patient had nausea, abdominal pain, and had threw up twice. The patient did not receive any treatment for the events. The outcome of the events, 'arm was extremely sore', 'felt very fatigued and achy', 'stomach was upset', 'had not felt like doing anything', 'nausea', 'abdominal pain' and 'threw up', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination. Information on the lot/batch number has been requested.
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| 43 | 2021-02-09 | sleep disorder |
Terrible headache/lingering headache; Body ache; Fatigue/tiredness; Slept on and off all day; sore a...
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Terrible headache/lingering headache; Body ache; Fatigue/tiredness; Slept on and off all day; sore arm at injection site with warmth, swelling and tenderness; sore arm at injection site with warmth, swelling and tenderness; sore arm at injection site with warmth, swelling and tenderness; This is a spontaneous report from a contactable nurse reported for herself. This 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Right arm), via an unspecified route of administration on 19Jan2021 10:15 at single dose for COVID-19 immunisation. Medical history included Hypothyroid. No known allergies. Patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID) and multivitamin 4 x week. The patient previously received first dose of BNT162B2 (lot number=EL0140, vaccine location=Right arm) on 29Dec2020 at 12:15 PM at single dose for COVID-19 immunisation. On 19Jan2021 06:00 PM (8 hours after injection until 36 hours), patient experienced terrible headache, body ache, fatigue, tiredness, slept on and off all day, sore arm at injection site with warmth, swelling and tenderness. 36-72 hours: back to baseline except lingering headache. No treatment received for events. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of events was recovered.
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| 43 | 2021-02-10 | confusional state |
SEVERE ACHING IN MUSCLES AND JOINTS. FEVER UP TO 102 X 2 DAYS. POINT TENDERNESS TO ENTIRE BODY. C...
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SEVERE ACHING IN MUSCLES AND JOINTS. FEVER UP TO 102 X 2 DAYS. POINT TENDERNESS TO ENTIRE BODY. COULD NOT WALK FOR 6 HOURS (MUSCLE WEAKNESS), CONFUSION, DIZZYNESS, HEADACHE, ABDOMINAL PAIN, CHEST PAIN, SHORTNESS OF BREATH.
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| 43 | 2021-02-11 | excessive sleepiness |
After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling gre...
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After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling great, Thursday evening I developed burning and itchy hives all over my neck chest and face, my face appeared swollen, I also had a smaller outbreak on my legs I took benedryl which seemed to calm the reaction some when I woke up the following morning, and another dose seemed to calm it some more
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| 43 | 2021-02-11 | impaired work ability |
2/10 vaccinator went to give vaccine and some amount leaked out onto clothing; unknown amount admini...
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2/10 vaccinator went to give vaccine and some amount leaked out onto clothing; unknown amount administered to patient. Upon inspection, it appear Vanishpoint syringe from OWS was cracked and vaccine must have leaked through crack rather than being injected Infection Control connected with Department of Health who advised second attempt as first dose 2/11 first dose administered (as stated in item 17) 2/12 employee felt unwell and called out sick from work
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| 43 | 2021-02-16 | sensation of foreign body |
pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongu...
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pt presented with erythema & swelling of face & periorbital regions C/O feeling fullness in tongue & throat & some difficulty swallowing approx 30 - 45 min following vaccine Had also eaten a english muffin with plain cream cheese just prior to symptom onset She was noted to have mild swelling of her tongue & very sl lower lip She was administered 50 mg of diphenhydramine, 20 mg famotidine & 60 mg Prednisone & cold compress to face Was able to take all orally with water & had no difficulty -- after approx 30 minutes her s/s had much improved & her facial erythema & swelling had reduced no resp distress and O2 sat was 99%
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| 43 | 2021-02-17 | disorientation |
Dose #2 pfizer; Pt reported onset of chest pain and SOB within 5 min of vaccine. Followed by nausea,...
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Dose #2 pfizer; Pt reported onset of chest pain and SOB within 5 min of vaccine. Followed by nausea, vomiting, and feeling of swelling of lips, . Pt used her own albuterol, 2 puffs. RRT called. BP 166/99, HR 90, pulse ox 100, airway intact, lungs clear, cardio tachy but regular, skin warm and dry with no diaphoresis. Concern for anaphylaxis as pt symptoms continued and some increase in disorientation Epi Pen administered, O2 via NC. IV access attempted but unable to obtain. EMS called. Pt monitored with resolution of CP, SOB, nausea, lips swelling and disorientation. Pt continued to have feelings of swelling of tongue and transported to ED
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| 43 | 2021-02-17 | hallucination |
Vominting within 1 hr of vaccine. Extream arm pain. Temp of 102. Hallucination with extream chills a...
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Vominting within 1 hr of vaccine. Extream arm pain. Temp of 102. Hallucination with extream chills and body aches.
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| 43 | 2021-02-19 | agitation | Tachycardia, agitation, hive on site of injection, |
| 43 | 2021-02-21 | feeling abnormal, impaired work ability |
On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on...
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On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on the tissue. This happened a second time and then it was finished. I felt really tired and not myself. Then later that night my arm began to hurt so bad that I could not lift it. I began to rub the area that was hurting and noticed that I now had a nice size lump there . I took a Tylenol 500mg and a hot shower. When I woke up the next morning my arm was still hurting but not as bad. When I went to use the bathroom I had began to start spotting again. This continued throughout the day and now I am bleeding as if I was having my period. I am super tired. It is to the point that i cant function at work.
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| 43 | 2021-02-25 | irritability |
swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't co...
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swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't comprehend conversations (needing to ask the person talking to me to repeat 2 times); getting snappy almost because they repeated it; Felt a few times while standing/walking I could all the sudden fall asleep; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiry date unknown), via an unspecified route of administration on the left arm, on 09Feb2021, at single dose, for COVID-19 immunisation, at a nursing home. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC), budesonide, formoterol fumarate (SYMBICORT), and ethinylestradiol, norethisterone (ALYACEN). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV3247, expiry date: unknown) received at age 49 years, via an unspecified route of administration on the left arm, on 19Jan2021 10:30, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 11Feb2021 at 08:00, the patient experienced "swollen lymph node the size of an egg under my left arm, I had a temp of 100.8, chills and body aches. I have felt like I can't comprehend conversations (needing to ask the person talking to me to repeat 2 times, then getting snappy almost because they repeated it) and felt a few times while standing/walking I could all the sudden fall asleep but then few minutes later I feel normal and alert again." The patient had no headache or foggy head feelings. No treatment was given for the events. The outcome of somnolence was resolved, outcome for the rest events was not resolved. The reporter assessed the events as non-serious.
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| 43 | 2021-02-27 | feeling abnormal |
Although I felt nothing during the first dose, I DID feel a prick for my second dose. It was followe...
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Although I felt nothing during the first dose, I DID feel a prick for my second dose. It was followed by a little itch, but nothing unusual. I made sure to rub my arm and keep it moving until I went to bed a couple of hours later. The next day, I woke up with no issues, just a slight tenderness at the injection site that only really hurt if I touched it. At about 9:30 am, almost 12 hours after the second dose, I became a bit tired, had a little chill, and was a tiny bit achy. I took two Tylenol, and continued to hydrate. I could feel myself getting more uncomfortable as the day went on. By 3:00 pm, I was freezing, could not get warm, and running a fever of 100. I took more Tylenol, and got bundled up and took a nap. At 4:00 pm, I woke up and was even colder, and had a fever of 102.4. At this point, I got into bed and had continued to hydrate and take ibuprofen (I had run out of Tylenol) every four hours. The fever broke at some point in the night, as I woke up and was soaking wet, but by the time I woke up the fever had returned and was 101. I took more Ibuprofen and the fever dropped back to normal around noon on February 18. By far, the worst feeling, aside from the fever, was the extremely severe joint pain I had in my ankles, knees, hips, arms, and hands. It was painful to stand and to walk. By Friday, I felt better, but was weak. I felt back to 100% on Saturday morning.
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| 43 | 2021-02-28 | feeling abnormal |
Patient stated eyes were itchy and throat itchy. Stated she felt funny. Given 25mg oral Benadryl. R...
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Patient stated eyes were itchy and throat itchy. Stated she felt funny. Given 25mg oral Benadryl. Resolution of symptoms before leaving vaccine site
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| 43 | 2021-02-28 | feeling abnormal | Swollen lymph nodes in R armpit, generalized fatigue, 'fuzzy headedness' |
| 43 | 2021-02-28 | panic reaction |
she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have...
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she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; left arm soreness; she felt ugh, like she was getting sick; sensation like she was going to pass out; Headache; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EM9810, intramuscular on left deltoid on 04Feb2021 as single dose (at the age of 43 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Pacemaker in Jun2019 and ongoing, sick sinus syndrome, and pre-existing cardiac arrhythmia ongoing. Historical vaccine included Tetanus, Tetanus made her arm sore, the soreness from tetanus was worse than the soreness from COVID vaccine since it lasted a week with tetanus, no lot number reported. No concomitant medication was reported. The patient experienced she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems on 05Feb2021 considered medically significant with outcome of not recovered, Within 15 minutes after receiving the vaccine she felt like she was going to pass out three times on 04Feb2021 considered medically significant and recovered on 04Feb2021, she may have been panicked on unspecified date with outcome of unknown, left arm soreness on 05Feb2021 with outcome of recovered on Feb2021, and she felt ugh, like she was getting sick on 05Feb2021 with outcome of unknown. The patient did not receive treatment for events. She stayed an extra 30 minutes to be monitored after the initial waiting of 15 minutes since she had to drive home, then she felt better. She has not called her cardiologist since she has the history of arrhythmias. She had the more arrhythmias start on the evening of the 05Feb2021, states it was weird because it seems to happen more in the evening between 6 and 9pm, sometimes as late as 10pm. However, 'yesterday' it started happening during the day, and it is more frequent, not constant, it just happens. States it is hard not think about it when her heart is having hiccups since that is what it feels like. She knows what it feels like because when her pacemaker goes off ventricularly she can feel it. She had arrhythmias before the vaccine but has not had issues with arrhythmias continuously. She was diagnosed with sick sinus syndrome and they do not know if it is cardiology or neurology, states it has been an issue for her for the last two years (2019). Lab data included weight of 284-286. She is asking if there is any data that supports her getting the second dose on 25Feb2021. She has read that some people tend to have more side effects with the second dose. The patient had no prior vaccinations (within 4 weeks).; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events worsening arrhythmia and pre-syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-03-01 | feeling abnormal |
I received shot 1 of the Pfizer-BioNTech mRNA vaccine on 2/17/2021. IMMEDIATELY afterward, I had a ...
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I received shot 1 of the Pfizer-BioNTech mRNA vaccine on 2/17/2021. IMMEDIATELY afterward, I had a headache and dizziness and brain fog (including trouble forming sentances and forgetting words). These symptoms have persisted every day since the vaccine. These symptoms have diminished slooooooowly over the past 14 days but are still present today.
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| 43 | 2021-03-01 | nervousness |
Lightheaded, blurred vision, flushed feeling, shaky, tightness in neck, diaphoretic. Evaluated by E...
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Lightheaded, blurred vision, flushed feeling, shaky, tightness in neck, diaphoretic. Evaluated by EMS. 1:09PM -Jaw slightly tight. 1:20 pm pain, stiffness traveling to mid back. 1:25 pm neck feeling better, no nausea, tinling in hands, no change in sensation in legs. 1:30pm remains lightheaded, vision remains blurry, c/o left sided chest discomfort when pressure applied, pain and stiffness in neck returning. 1:42 pm transported to Hospital by rescue squad.
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| 43 | 2021-03-04 | feeling abnormal |
Severely elevated liver function tests following 2nd dose of vaccine. Have fallen nearly back to b...
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Severely elevated liver function tests following 2nd dose of vaccine. Have fallen nearly back to baseline over 2 week coarse.
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| 43 | 2021-03-09 | impaired work ability |
1/12 vaccination 6:30 I felt nauseous. Vertigo. Started to get chills and HA. Progressively got wors...
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1/12 vaccination 6:30 I felt nauseous. Vertigo. Started to get chills and HA. Progressively got worse. 103 temp middle of night. Asthma was bothering me. Took my nebulizer, tylenol and motril. Called employee health; COVID test/negative, Symptoms lasted 2 days. PCP ONLINE; prescribed prednisone *Irritated my asthma for 2 weeks which was very unusual for me. Couldn't work because I couldn't breath with the 2 masks required. I would start to wheeze really bad just walking up flight of stairs.
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| 43 | 2021-03-10 | feeling abnormal | "3/6/21 9 pm, had shakes, chills, fever, brain fog, fatigue." |
| 43 | 2021-03-11 | impaired work ability |
Already suffer from migraines. Friday started as headache turned migraines and continued to today. O...
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Already suffer from migraines. Friday started as headache turned migraines and continued to today. On Wednesday stomach started hurting, by Thursday left work early due to severe stomach pains that stayed for long time then went away & returned. Today tummy still hurts, pooping often but not diarrhea, and head is pinging
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| 43 | 2021-03-13 | loss of personal independence in daily activities |
Developed reactive arthritis. Beginning four days after the shot, my joints started to severely ache...
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Developed reactive arthritis. Beginning four days after the shot, my joints started to severely ache. Within another week my ankle swelled up. My wrists, ankles, knee, and shoulder are all still sore. I?ve been unable to do my normal activities. My doctor prescribed me a course of prednisone on 3/12/21 and agreed I should not get the second shot.
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| 43 | 2021-03-13 | nervousness | shaky, heaviness. Evaluated by EMS-Cleared |
| 43 | 2021-03-15 | anxiety |
Notes Expand AllCollapse All Patient: ...
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Notes Expand AllCollapse All Patient: DOB: 6/11/1977 Date: 3/15/2021 MRN: Subjective Patient is a 43 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and "head rush", feeling dizzy and had a metallic taste in mouth (shortly resolved). Sensation of chest tightness as reported upon her arrival to bay. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Medical hx includes asthma and allergies, pvcs and IgG deficiency ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded) Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain and headaches R arm pain where injection site is. Ice pack given for site.: Previous Reactions: flu vaccine 20 years ago. She's done well with flu vaccines since then. Objective Vitals Vitals: 03/15/21 1244 03/15/21 1254 03/15/21 1310 BP: 128/85 122/65 Pulse: 86 86 86 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear airway Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: Hyperventilating upon arrival to bay. Pt improves with deep breathing. Pt did take her levalbuterol as well during her stay which did help her chest tightness. No wheezing heard pre/post administration. O2 sats 100% Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) R arm pain; injection R arm. Ice pack placed. Anxiety: hyperventilating, relieved with instructed deep breathing and removal of mask for short time. Lightheaded/dizzy: related to anxiety and systemic stress response. She reponded well to zyrtec, water and snack. Pt able to recover and stand w/o symptoms. She was ambulated out to the front w/o difficulty accompanied by this provider. She's to follow up with pcp/allergist. Pt voiced appreciation of care today.
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| 43 | 2021-03-15 | impaired work ability |
signs/symptoms, not sure if true adverse event: had a taste in my mouth immediately after receiving...
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signs/symptoms, not sure if true adverse event: had a taste in my mouth immediately after receiving first dose. Two days after first dose: heart rate increased to 130's resting, systolic blood pressure increased to 140's resting, (usual heart rate 70's-90's, usual systolic blood pressure 110's-120's), dizziness, headaches, very weak, temperature up to 99F. Symptoms lasted about two days. One day after 2nd dose: temperature up to 99F, heart rate increased to 130's resting (lasted about an hour), systolic blood pressure to 140's resting (lasted about an hour), felt flushed in the face, headaches, weak, temperature up to 99F, no dizziness. Symptoms lasted about one day.
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| 43 | 2021-03-16 | feeling abnormal, confusional state, disturbance in attention |
First 20 minutes fine. Next hour-extreme energy/adrenaline. More than ever experienced. Next 3-4 ho...
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First 20 minutes fine. Next hour-extreme energy/adrenaline. More than ever experienced. Next 3-4 hours- Severe brain fog, confusion, lack of concentration and mental dysfunction. Lack of clarity, rational thinking and precise understanding. Felt like an inability to talk, make sound decisions or focus. Also feelings of eyes bulging and short temporary numb bottom lip. Feelings of brain abnormality and being drugged. Hour to two after-Feelings of coming down from days of an extreme caffeine high with no sleep. Worried, is mildly putting my reaction to the vaccine reaction/side effects. It was terrifying. I thought, I may not return from the negative adverse effects I was having. Something was certainly not right. It is something, I?m not sure I can go through again. Especially, with the second shot being stronger than the first. I was incapable of doing anything!
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| 43 | 2021-03-16 | feeling abnormal | Fatigue, fuzzy brain, extreme chills |
| 43 | 2021-03-18 | anxiety |
Received the vaccine and waited 15 minutes. When it was time to go the patient got up and fell dizz...
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Received the vaccine and waited 15 minutes. When it was time to go the patient got up and fell dizzy, vertigo and heart starting beating really fast. I then called the pharmacist and he tried to check her pressure but was unable because there machine wasn?t working. He then said to wait a little longer, after waiting another 15 minutes they tried to check her pressure with a portable machine that was collected from the pharmacy aisle . Didn?t seem like they could use that on either so they called paramedics. The whole time the patient felt anxiety because of her heart beating. Paramedics took the patient to the ER where they checked her heart beats and it recorded 140bpm then was given fluids and later discharged. 2 days later patient returned to the ER for the same symptoms.
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| 43 | 2021-03-19 | loss of personal independence in daily activities |
Shortly after receiving my second dose my shoulder pain began and I had limited mobility in that arm...
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Shortly after receiving my second dose my shoulder pain began and I had limited mobility in that arm. This was not a typical injection sight pain, it was in my shoulder joint. I feel the injection site was high almost near the top of my shoulder and my injury resulted because of this. It took over a week before I could get dressed on my own. I still have shoulder pain with certain movements of my arm.
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| 43 | 2021-03-19 | sleep disorder | Strong, dull pain at injection site 12 hours after injection. Enough pain to wake from sleep. |
| 43 | 2021-03-20 | confusional state, disorientation |
On the second day after vaccine, about 25 hours later, I threw up, became disoriented, sleepy, and w...
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On the second day after vaccine, about 25 hours later, I threw up, became disoriented, sleepy, and was slurring my words. I have little recollection of the 2-3 hour period following throwing up and was in and out of consciousness, almost as if I had a concussion. I continued with my day, not knowing that I was not making sense, and had professional interactions with coworkers and clients, who later reported that I sounded confused, sleepy, and disoriented. I drove my car and received a parking ticket during that time. Since I did not have flu-like symptoms and felt fine for 24 hours directly following the vaccine, I thought I was fine. It actually scares me that I drove my car and that this could happen to others. I was back to normal 4-5 hours after symptoms started, and still had hazy to no recollection of the afternoon. I had to piece together the conversations and interactions the following day. I had a headache the following day and was tired.
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| 43 | 2021-03-20 | feeling abnormal |
After first vaccine which was done on a Monday I became sick on Friday, by Sunday I was at the walk...
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After first vaccine which was done on a Monday I became sick on Friday, by Sunday I was at the walk-in clinic getting tested for Covid. Results were negative, but I was put on antibiotic for bilateral ear infections. My symptoms were congestion, headache, ear pain, cough. After my second vaccine I had terrible body aches, headache and fatigue. After receiving the vaccines I have had a strange new pain in the muscles of my neck and upper back/ shoulder area. It comes and goes, but is unlike any pain I have ever had, and be a quick severe pain that takes my breathe away.
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| 43 | 2021-03-21 | feeling abnormal |
Pt said she felt dizzy and "off" and that she needed to lie down. Brought into medical bay via wheel...
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Pt said she felt dizzy and "off" and that she needed to lie down. Brought into medical bay via wheelchair, (she was already in one) Laid down. Reported felt cold, blankets given, vitals taken and stable. Pt was shakey at times but reported she felt fine. Vitals remained stable. Shakiness subsided within 10 mins. Then pt rested comfortably for about 20 mins. sat up. VS stable. Left in her wheel chair at 11:20, felt much better.
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| 43 | 2021-03-22 | feeling abnormal |
Extreme dizziness and a whirlwind feeling 10 minutes after injection. Slight dizziness and headache ...
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Extreme dizziness and a whirlwind feeling 10 minutes after injection. Slight dizziness and headache for 2 days following. Beginning Monday 3/1 - rapid heart rate, hard palpitations, extreme dizziness, nausea, high BP, squeezing feeling in left chest, shooting pain thru underside of left arm and across collar bone lasting thru 3/6.
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| 43 | 2021-03-22 | insomnia | sore throat, congestion, body aches, fatigue and insomnia. |
| 43 | 2021-03-24 | feeling abnormal |
5 minutes after injection started to feel dizzy. Not room spinning dizzy. More like a fogginess. Had...
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5 minutes after injection started to feel dizzy. Not room spinning dizzy. More like a fogginess. Had a hard time comprehending. Trying to use my brain made the dizziness worse. Was unable to drive. 90 minutes after injection started feeling winded while laying down. Took 25mg of Benadryl at 2hr mark after injection.
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| 43 | 2021-03-24 | impaired work ability |
Patient called clinic with complaints of possible reactions to the second dose of the vaccine today....
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Patient called clinic with complaints of possible reactions to the second dose of the vaccine today. States that after she was observed for 15 minutes following the second dose of the Pfizer vaccine, she went home and noticed some slight tongue tingling that lasted for a few minutes then went away. She had her second dose today at 0945. Denies any reactions after her first dose. States now she has bumps on her skin similar to a skin rash with some pruritus. Denies wheezing, dyspnea, SOB, lip/tongue swelling, throat tightness, dysphagia, chest pain, nausea, vomiting. States she did take Zyrtec 10 mg this morning which is normal for her as she has allergies. She was currently at work when calling. Advised Pt of the following for treatment: 1. Topical hydrocortisone 1% cream to affected areas for the itch. Cool compresses for swelling and the itch. 2. OTC Zyrtec-- advised her to take a second dose of 10 mg tonight when going to bed. Also advised her to take Benadryl 25 - 50 mg every 4-8 hours as needed, max 300mg daily. Can be sedating, do not take with driving or operating machinery. Decided it would probably be best for her to leave work and go home in case she gets sleepy. She denied needing a work note at this time. 3. Advised to call 911 if signs and symptoms worsen at any time. Advised Pt not to follow up at \center if having any red flag symptoms but rather go to the ED immediately. Red flag symptoms: SOB, wheezing, lip/tongue swelling, throat tightness, chest pain. Discussed reaction with collaborating physician who was also the clinical observer for the vaccines today. Also made clinic manager aware
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| 43 | 2021-03-24 | insomnia |
The day after my second dose I started having lower back pain and pain in my thighs. As days pass t...
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The day after my second dose I started having lower back pain and pain in my thighs. As days pass the pain has only intensified. I've had tingling, numbness, extreme sensitivity and a deep dull pain in my thighs. I use lidocaine patches for my back. But the pain in my legs does not go away. It intensifies in the evenings and at night. I have not been able to sleep since the pain started.
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| 43 | 2021-03-24 | panic reaction | Felt Faint, flushed, panicky |
| 43 | 2021-03-26 | feeling abnormal |
Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills,...
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Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills, Stomach and Chest Pains, Reflux and Heartburn, Flushing, Swelling/Edema, Dizzy, Lethargy, Brain-Fog// I?ve been trying to get diagnosed- have had some of these symptoms since September, but a couple/ few hours after the shot, I have been having all of those symptoms throughout the day and the ones I?ve had have been very-exacerbated; I?ve finally been able to hold down food.
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| 43 | 2021-03-26 | feeling abnormal | not feeling self, tingling |
| 43 | 2021-03-26 | sleep disorder |
Grade 3, swelling at injection site, arm pain after injection on Friday and today, Saturday after se...
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Grade 3, swelling at injection site, arm pain after injection on Friday and today, Saturday after second dose with LVN. The nurse LVN may not have injected it correctly. I struggled to do dishes after dinner. My arm pain kept me awake last night. I didn't have any arm pain or swelling at injection site with the first Pfizer dose with nurse. No Pain or side effects whatsoever with the first Pfizer vaccine. Vaccine may be fine. It might be the way the nurse injected it.
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| 43 | 2021-03-27 | anxiety, feeling abnormal |
Patient seemed slightly apprehensive, but stable after 20 minute observation period following immuni...
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Patient seemed slightly apprehensive, but stable after 20 minute observation period following immunization with COVID19 vaccine at 6:55. Patient requested to leave the store to check her blood sugar in her car, but shortly returned after (approximately 5 minutes), feeling stuffy and reporting that she was experiencing shortness of breath/difficulty breathing to the front store manager. Patient appeared diaphoretic, tearful, and having trouble breathing. PharmD felt for patient's pulse; felt thready and hard to palpate. PharmD administered epinephrine 0.3 mg via Epic-Pen into patient's left thigh, laterally, at 6:03 pm. Patient still appeared unwell, though conscious and breathing - pulse was difficult to palpate. 911 dialed and EMTs arrived within 3 minutes and took patient to the nearest hospital. Patient's family was present and sharing medical history with EMTs.
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| 43 | 2021-03-28 | feeling abnormal |
About 18 minutes after receiving the vaccine, I started to feel a little numb on the right side of m...
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About 18 minutes after receiving the vaccine, I started to feel a little numb on the right side of my collar bone and then a tingling in my right pinky toe and finally under my right eye. We had already left the vaccine site so I told my daughter who was driving that I felt a little funny and would let her know if she needed to take me to the hospital. I had not eaten yet that day, only coffee in the morning so we ran a couple of errands and then grabbed lunch. Around 3:30pm on the same day (3/28/2021) I started to feel better and the only side effect I currently have is tenderness in my arm where I received the shot. I did not seek medical treatment as it went away within a couple of hours.
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| 43 | 2021-03-28 | sensation of foreign body, anxiety |
43 year old female with a past medical history significant for asthma, anxiety, DM, migraines, thyro...
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43 year old female with a past medical history significant for asthma, anxiety, DM, migraines, thyroid papillary carcinoma who is presenting to the ED with an allergic reaction. She received her COVID vaccination at 1700. At approximately 1715 she felt a lump in her throat. Shortly after she felt as if her tongue/lips were tingling/becoming swollen and then she developed nausea. No rash or abdominal pain. No dyspnea or chest pain. All symptoms are consistent with prior episodes of anaphylaxis. She has had anaphylaxis to vaccinations in the past but was advised by her allergist to get the COVID vaccine today. On arrival patient is quite anxious. Vital signs are stable. Her tongue is enlarged/mildly edematous, additionally appreciated mild lip/perioral swelling. There is no stridor or wheezing, no evidence of respiratory distress. Given examination findings, symptom description, findings concerning for anaphylaxis. As such, epinephrine promptly administered as well as solumedrol, famotidine, and benadryl. Shortly after the epinephrine she endorsed improvement in her swelling, though during benadryl administration she endorsed a sudden onset of subjective throat swelling/felt as if she could not breathe. Patient was reassessed, no change in initial examination findings, within a few minutes she felt her symptoms improve without intervention.A short while later she again felt as if her throat swelling was worsening, as such epinephrine dose re administered. Following a 2.5 hour period of observation she endorsed continued improvement in her allergic symptoms, requested discharge home though continued observation offered. A course of prednisone prescribed, patient already with epi pen. Patient discharged home.
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| 43 | 2021-03-29 | insomnia, excessive sleepiness |
I had normal seasonal allergy congestion on Sat and Sun... took Claritin D for them (as usual) after...
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I had normal seasonal allergy congestion on Sat and Sun... took Claritin D for them (as usual) after I had the shot on Sat. Sat night couldn't sleep, then Sunday morning awoke with really bad congestion and a rash all over my chest, back, face & arms... and slept all day/night (~22 hours).
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| 43 | 2021-03-29 | insomnia |
After injection, felt mild to modeate pain on the arm. By the next day, I started to feel pain in my...
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After injection, felt mild to modeate pain on the arm. By the next day, I started to feel pain in my shoulder up to the neck area and stiffness. The pain has caused difficulty with my sleep. Used acetaminophen the next day, then changed to ibuprophen since the third day. Used ice on shoulder/neck and massage area with pain ointments since the third day. The symptoms have not yet resolved.
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| 43 | 2021-03-30 | disorientation |
Four hours after the vaccine, I started to experience a metal taste in my mouth. This lasted for abo...
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Four hours after the vaccine, I started to experience a metal taste in my mouth. This lasted for about 2 days. The day after the vaccine I started smelling a burning smell. However, nothing was burning. It is 4 weeks later and I still experience this. Today, I am in day 2 of smelling something like burnt toast. It drives me a little crazy and it is disorientating.
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| 43 | 2021-03-30 | nervousness |
muscle/joint aches; Shakey/jittery; jittery; rapid heart rate; Fever of 103.8; Chills; muscle/joint ...
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muscle/joint aches; Shakey/jittery; jittery; rapid heart rate; Fever of 103.8; Chills; muscle/joint aches; This is a spontaneous report from a contactable female nurse reported for herself (Non pregnant). A 43-year-old female patient(nurse) received second dose of BNT162B2 (Solution for injection, lot number: unknown) via left arm on 28Jan2021, 15:00 PM, single dose for COVID-19 Immunization. Patients receive other vaccines within 4 weeks prior to the COVID vaccine the patient took other historical vaccine included first dose BNT162B2 (lot number: Unknown) on 07Jan2021, at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient received other vaccines within 4 weeks prior to the COVID. Patient had allergies to medications Bactrim.
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| 43 | 2021-03-30 | sensation of foreign body |
Patient reported dizziness 15 mins following COVID vaccine. Assessed by EMS & Dr. At 1545, BP#1 138/...
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Patient reported dizziness 15 mins following COVID vaccine. Assessed by EMS & Dr. At 1545, BP#1 138/97 P 97 R 20 O2 Sat 97% RA. At 1600, BP#2 141/86 P 92 R 20 O2 Sat 97% RA. Pt reported no improvement at 30 min post vaccine and now c/o new symptoms: nausea, gen. itchiness, lump in throat Dr and EMS with patient. Pt stated she experienced dizziness with 1st dose of COVID vaccine on 03/09/2021. Pt transported by Rescue at 4:15PM.
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| 43 | 2021-04-01 | anxiety |
My right arm was sore and I had difficulty lifting it consistently until 48 hrs later. 12 hours late...
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My right arm was sore and I had difficulty lifting it consistently until 48 hrs later. 12 hours later I had soreness in my right leg and my shoulder and upper back on the right, as well as a side stitch in my right side. I had slight redness at injection site until 48 hrs later.. At 24 hours later, I noticed some 2-3 painful lumps on the back of my head at the base of my skull in my hair, they felt like they were bruises but they had no redness or marks, warmth to touch, or itchiness/irritation. They were mostly sensitive to touch but ached slightly on the Monday (29th) following the injection. On Tuesday and most of Wednesday the lumps were still apparent but were not tender to the touch. On Wednesday night the lumps started throbbing and became much more sensitive to touch again. I couldn't lay on my back to sleep and even bending my neck a bit to sleep on my side made them throb intensely. I was unable to sleep much at all. I took ibuprofen to help the pain and it didn't help. Upon waking Thursday they were throbbing quite intensely and I was beginning to have muscular spasms in my scalp on the back of my head - which is also for me an anxiety reaction, which I was also feeling. I didn't have a headache per se, but the back of my head hurt. If I applied any pressure to the back of my neck on the right I had intense shooting pains from the neck up to the lumps on my skull. I do have pinched nerves in my neck but I have never experienced any pain like that before in that part of my neck nor into my skull. It was very sharp. On Friday morning the neck shooting pains subsided but the lumps remain painful to touch.
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| 43 | 2021-04-01 | feeling abnormal |
APPROXIMATLEY 10 MINS AFTER GETTING THE VACCINE, PT COMPLAINED THAT HER THROAT WAS NUMB AND FELT DIF...
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APPROXIMATLEY 10 MINS AFTER GETTING THE VACCINE, PT COMPLAINED THAT HER THROAT WAS NUMB AND FELT DIFFERENT. WE GAVIE HER 50MG OF DIPHENHYDRAMINE AND HAD HER SIT FOR ANOTHER 20MINS. WE FREQUENTLY CHECKED ON HER AND SHE SAID HER SYMPTOMS WERE A LITTLE BIT BETTER, NOT GETTING WORST. CONSULTED PT TO TAKE BENADRYL OTC Q 6 HOURS FOR THE REST OF THE DAY AND TO FOLLOW UP WITH PCP. SHE WAS ADVISE TO CALL 911 OR SEE EMERGENCY HELP IF SYMPTOMS WORSEN. WE TRIED TO CALL SEVERAL HRS TO CHECK ON HER BUT SHE DID NOT PICK UP. THE NEXT DAY WE CALLED AGAIN AND PT STATED HER THROAT/SYMPTOMS WERE BETTER AND THAT SHE HAD FOLLOWED UP WITH PER PCP.
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| 43 | 2021-04-02 | anxiety |
Following post vaccine patient felt a pain across he forehead , had throbbing pain and patient was e...
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Following post vaccine patient felt a pain across he forehead , had throbbing pain and patient was extremely anxious, rapid pulse--patient was taken to medical observation and vital signs obtained , bp was 134/95 pulse 108 @ 11:40 then at 113/78 pulse 94 @ 11:50 patient was able to leave via the site they were transported to the exit via wheelchair
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| 43 | 2021-04-02 | anxiety | Felt faint, anxious, BP 93/59 (pulse 77), O2 sat 100%. Water given. F/u BP 98/56. |
| 43 | 2021-04-02 | sleep disorder, loss of personal independence in daily activities |
I received my first vaccine around 9:45 am on Tuesday March 30, 2021. My arm was sore at the site b...
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I received my first vaccine around 9:45 am on Tuesday March 30, 2021. My arm was sore at the site but by the next night it was painful to rotate my arm to get undressed around 8 or 9 pm. It was painful to lay on but I thought that was normal. By Thursday April 1, 2021 it had gotten more sore and more painful to move and rotate my shoulder to get dressed, do my hair, hold my children and just do normal everyday activities. Friday April 2, it got worse to where I did not even want to move it and could not reach my arm past my side to reach around and sleeping that night was horrible. Every time I would move the pain would radiate through the joint in my shoulder and I would have to try to brace it to move. I looked up shoulder pain after vaccine this morning April 3, 2021 and realized this was not normal. I also discussed my husbands reaction since he got his the day after mine. He said soreness at site but nothing in his actual shoulder and moving it. So now I reporting the pain as an adverse reaction and I will be making a doctor appointment today to have it looked at.
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| 43 | 2021-04-04 | insomnia |
I received my second Pfizer vaccine at about 8:05 Friday morning. The first 12 hours post second sh...
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I received my second Pfizer vaccine at about 8:05 Friday morning. The first 12 hours post second shot were uneventful. Then, much like my first shot, the pain in my shoulder started to drastically intensify. Around hour 13, I started to get chills. Intense chills that lasted throughout that night. I had a temperature between 100 and 101. Chills, sweating, and slept fitfully, up and down all throughout the night. Then I woke up the (Saturday) morning after my second dose, and I began to have very intense stomach cramping that was very debilitating. It felt like an awful kind of heartburn. The chills are gone. I still had pain in my shoulder. I was curled up in a ball, then stretching out my body, just trying really to not be in intense, intense pain. Finally, beginning around 1:30 PM on Saturday the pain started to very slowly lessen. By about 5 PM I could say the stomach cramping/heartburn kind of pain was almost fully gone. I woke up on Easter Sunday feeling still like my shoulder hurt, but all the other very very intense pain and symptoms seem to be almost entirely gone ? Well, except the headache that I really hadn?t cared much about while my stomach was cramping. But the headache had been present all day Saturday as well. Saturday and all day Sunday, I had but one of my girlfriends describes as a ?hangover headache.? I would say it?s something like when you have a couple glasses of wine where the tannins don?t agree with you. That lasted all this two days. Sunday evening my shoulder pain started to increase and really really started affecting the muscle connecting my neck to my shoulder, I think it?s called the trapezius. As it intensified, I started feeling numbness in my fingers as we were trying to rub it away. I?ve had really bad knots in that muscle in the past, so the numbness didn?t scare me. The muscles in my left arm continued to cramp and just really hurt. All the way from my trapezius and the side of my neck on that side down through my bicep. And when I say cramping muscles and feeling like they?re knotted, the only way I can think to describe it is to say that they were SCREAMING. I tried everything I could think of, but nothing helped. Finally I used an ice pack which worked for about 20 to 30 minutes and then I used a heating pad which also worked but not for very long. At this point I was just hoping I could sleep. Around 12:30 AM, I was finally able to somewhat drift to sleep after getting in a manageable position, I guess. I woke up every hour or two in screaming muscle pain. And I woke up for good just before 6 AM today, Monday. I've been at work today with strong, but not debilitating, pain in the muscles in my left arm and returned, more mild, heartburn pain in my stomach.
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| 43 | 2021-04-04 | sleep disorder, impaired work ability |
Every single side effect on the sheet - began with muscle soreness about 2 hours after the shot, whi...
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Every single side effect on the sheet - began with muscle soreness about 2 hours after the shot, which lasted about 1 week. Around 2:30am the morning after the shot, I was awakened from a deep sleep by chills and sweats, which lasted for about 36 hours from that moment. These were moderate to severe, such that these symptoms alone would have prevented me from making it through the workday. However, things got worse. Due to chills and sweats, I took my temperate, which was about 99F at that time. Over the course of the next 10 hours the temperature spiked to 100.4F oral. I tried to go back to sleep at 2:30am, but I could only toss and turn due to the chills. Perhaps due to lack of sleep, perhaps due to vaccine, I developed a head ache and some nausea - both of these are extremely rare symptoms for me, as I rarely have a headache more than once a year. By 5am, with climbing temp, sore arm, headache, upset stomach, chills, sweats, muscle aches and exhaustion, I consulted my boss - a 20 yr clinical pharmacist - who advised me this would end after 24 hours. Therefore, I took no meds and waited it out. Soon after 12:30pm, when the fever reached 100.4F, I felt the temperature break. It was almost 24hrs to the moment, and after that the symptoms began rapidly resolving. The temperature subsided completely by about 7pm that evening. Chills and sweats the next morning. Some fleeting headache and nausea the following day. A lot of dizziness and faintness over the next week or so, which I am unsure about - but it could be some sort of backup/accumulation of high dose Mg for my back, in the presence of the vaccine and/or immune response. I say below that I visited the doctor because, if my boss were not a clinical pharmacist, I would absolutely have made a doctor's appointment. Because I get COVID19 tested at work, I had no need to make an MD appt. I got COVID tested, and I consulted with a clinical COVID19 expert - better than a doctor's visit given how long it takes to get in to see my PCP and how little he knows about COVID19 vaccine responses.
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| 43 | 2021-04-05 | agitation |
About 5 hours after receiving the covid vaccine I started to feel flustered. My chin felt hot and a...
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About 5 hours after receiving the covid vaccine I started to feel flustered. My chin felt hot and a little itchy. When I looked in the mirror my chest from shoulder to shoulder was red and it looked almost like a prickly heat rash and was slightly itchy. About an hour later it wasn't as red on my chest. My chin still is red and feels irritated (like sunburn). I don't know how else to describe it. I tried calling Pfizer and no one answered. I called CDC but the agent was of no help and didn't have any info that I didn't already have.
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| 43 | 2021-04-05 | impaired work ability |
Joint pain beginning the morning after my second vaccine. Later in the day additional joint aching, ...
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Joint pain beginning the morning after my second vaccine. Later in the day additional joint aching, chills, fever, and a headache. Side effects required a day off of work. 2nd day after vaccine most aching was gone except for less severe aching in hips and knees. Day 3 all side effects gone. No pain at injection site at any point. Mild bruising at injection site. No symptoms or pain after 1st vaccine.
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| 43 | 2021-04-05 | sleep disorder |
Itching, all over body. Not extreme where I can't function. but causes multiple pauses during each w...
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Itching, all over body. Not extreme where I can't function. but causes multiple pauses during each waking hour and did not sleep well last night. Feels like something is touching / crawling all over me. especially hips, shoulders, neck, and stomach. Started last night 05-APR-2021
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| 43 | 2021-04-06 | anxiety |
pt complaining of numbness; arm same as injection 3 numb lasting 20 minutes two fingers back to norm...
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pt complaining of numbness; arm same as injection 3 numb lasting 20 minutes two fingers back to normal; pinky still feeling funny and itchy; pt becoming anxious now; c/o of feeling very tired; seen by MD to be transferred to ER accompanied by nurse and physician
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| 43 | 2021-04-06 | insomnia |
At time of shot, felt stinging pain in the elbow and wrist of left arm, later 5 mins. At some point...
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At time of shot, felt stinging pain in the elbow and wrist of left arm, later 5 mins. At some point the next day, I developed Spinal pain. Pain in SI joins, several distinct spots along the spine and the base of my skull, spinal stiffness, difficulty touching knees or putting chin to chest. Lasted 2 days. Night of 3/292021, I woke up with tooth pain in multiple teeth on both upper and lower and right and left sids of mouth. Pain great enough to wake me up and caused difficulty returning to sleep, after 600 mg ibuprofen, able to get to sleep and completely gone in the am. Starting 3/30, pain along nerve paths in upper right side back around scapula, felt like burning, intermittent. Now resolved to tingling / numb feeling and some tingling / decreased sensation in upper lip left side and under eye left side
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| 43 | 2021-04-06 | sleep disorder |
On 4/4 at 2am, awoke to chest, arm, neck discomfort, naseau, dizziness, sweating, and chills. Resolv...
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On 4/4 at 2am, awoke to chest, arm, neck discomfort, naseau, dizziness, sweating, and chills. Resolved with Tylenol. Fatigue lasted through the day, and by evening body aches returned. On 4/5, peach pit-sized lymph node appeared above collar bone, pain in armpit and neck on right side, fatigue, and aches, along with continues and visible spasms in the neck. 4/7, symptoms still persist, with more swelling spreading across collar bone and into neck.
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| 43 | 2021-04-07 | irritability |
Gastrointestinal issues including upset stomach, abdominal pain and diarrhea w some loose stools.. A...
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Gastrointestinal issues including upset stomach, abdominal pain and diarrhea w some loose stools.. Also had irritability, chills. Lasted 48 hrs... was sever for the first 24 hrs.
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| 43 | 2021-04-08 | feeling abnormal, disturbance in attention, excessive sleepiness |
The night of Monday April 5 I started to feel like I was fighting off a cold. That night I slept alm...
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The night of Monday April 5 I started to feel like I was fighting off a cold. That night I slept almost 11 hours, abnormal for me and woke up with heavy brain fog which has not gone away. I feel cloudy, unclear, slow, it is sometimes hard to finish sentences and complete thoughts.
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| 43 | 2021-04-08 | impaired work ability |
Covid vaccines pfizer 1st Dec 20,2020 , 2nd Jan 7th, 2021. April 5th, 2021 Went to ER after numerou...
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Covid vaccines pfizer 1st Dec 20,2020 , 2nd Jan 7th, 2021. April 5th, 2021 Went to ER after numerous tests for stroke. DX: Bells Palsy Facial Paralysis TX: very expensive CT scan, Blood Work, EKG, medications, loss of work, acupuncture. Still have it.
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| 43 | 2021-04-08 | insomnia, loss of personal independence in daily activities |
Insomnia for first two days. However, the dizziness began the day after and has not stopped (Curren...
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Insomnia for first two days. However, the dizziness began the day after and has not stopped (Currently on Day 12). Have had ulnar nerve pain in side of injection, resulting in numbness and tingling in hand. Visited a doctor who performed basic check ups, and just told me to wait it out. Have also had weakness in muscles and lowered stamina for simple things like walking. Used to walk 2+ miles per day, can barely manage 15 minutes now.
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| 43 | 2021-04-09 | sleep disorder |
lower back pain; pain in my thighs/deep dull pain in my legs; I had tingling, numbness and extreme s...
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lower back pain; pain in my thighs/deep dull pain in my legs; I had tingling, numbness and extreme sensitivity in my thighs; I had tingling, numbness and extreme sensitivity in my thighs; muscle pain; my thighs feel like they are burning; I do not sleep at nights; This is a spontaneous report from a contactable Physician. A 44-years-old (non-pregnant) female patient received second dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EN6205), via intramuscular on 10Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history included Juvenile rheumatoid arthritis, bilateral hip replacement (both hips) and psoriasis. Allergies were none. Concomitant medications included naproxen sodium, zinc, calcium carbonate, colecalciferol, ascorbic acid. The patient received first dose bnt162b2 (COMIRNATY Batch/Lot Number: EC3247), intramuscular on 09Feb201 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COIVD-19 prior or since the vaccination. On 11Mar2021, after vaccination the patient experienced lower back pain, "deep dull pain in my legs", "her thighs felt like they are burning", muscle pain and tingling, numbness, extreme sensitivity and pain in thighs. Clinical course of the evet was as follows: After the second dose, patient started having lower back pain and pain in thighs. As days passed intensity was increased, tingling, numbness and extreme sensitivity in thighs. She had used ice and heat to help muscle pain, but nothing worked. She also had deep dull pain in legs and sometimes her thighs felt like they are burning. Till two weeks since the second dose her pain had not gone away. Patient could not sleep due to pain. On an unspecified date patient had seen physician who has prescribed medicine included toradol shot but that does not help. She had gone to the ER and they gave her a cortisone shot however that had not helped either. Treatment medications included Cortisone, Hydrocone, Ondansetron, Tramadol and omepr, lidocaine patch on back to help. Outcome of events was not resolved. Additional information has been requested.
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| 43 | 2021-04-12 | impaired work ability |
I presented to the medical shot clinic event for my second COVID-19 injection on schedule. My inject...
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I presented to the medical shot clinic event for my second COVID-19 injection on schedule. My injection was given by a nurse at the Hospital and while I did not watch the needle enter into my shoulder, I quickly developed the symptoms of adhesive capsulitis to my right shoulder within a few hours. Initially I did not realize why I was in such extreme pain but did notice that the injection site and bandage placed over top seemed very high. The next day I could not move my shoulder in any direction without severe pain. Regardless of this I still presented to work as I had no one to cover my shift but wasn't able to continue working due to the amount of pain and inability to use my right arm. My coworker is a family medicine Doctor who reached out to a local orthopedic surgeon and fortunately I was able to get a same day visit with the orthopedist. He diagnosed frozen shoulder on January 26, 2021 citing improper placement of the vaccine and I was prescribed a variety of medications including muscle relaxers and anti-inflammatory medicine. He offered to give me a shoulder joint injection however I was concerned about a corticosteroid affecting the efficacy of the Covid vaccine that I had just received. After only minimal relief with the medications that were prescribed hi was in directed by the orthopedic surgeon to start physical therapy which I did. Physical therapy sessions were only partially helpful, and I was still having limitations with my work duties as well as activities of daily living in my home (Such as being able to trust myself, wash my hair, use a blow dryer, doing light housework with my right arm well-being right hand dominant etc.). Finally, after eight weeks of conservative treatment not helping and daily pain I opted for a right shoulder joint corticosteroid injection at orthopedic office. Just a day after the steroid joint injection in my right shoulder I was significantly improved and for a few weeks I was actually pain-free. Unfortunately, a few days ago my shoulder pain started to recur and I have been advised by my orthopedic surgeon that the next step is an MRI and potentially more invasive treatments. I have no way of knowing the name of the nurse at the Hospital who administered my vaccine, and no reporting channels as I am not an employee of that facility. I was able to get the vaccine without being an employee because of my company's relationship with that facility. I have reported this to my employer however, as well as through the V-safe check ins. I am discouraged and concerned that this may be happening to other patients going through that service for their vaccine.
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| 43 | 2021-04-12 | insomnia |
pt. states that since vaccination 3/31/2021, she has had more sx of temperature regulation issues, ...
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pt. states that since vaccination 3/31/2021, she has had more sx of temperature regulation issues, chest pains, palpitations, gi symptoms, headaches, fatigue, insomnia and dizziness
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| 43 | 2021-04-12 | loss of personal independence in daily activities, insomnia |
Continuous arm/muscle pain beggining from injection site to upper left shoulder. Can no longer full...
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Continuous arm/muscle pain beggining from injection site to upper left shoulder. Can no longer fully lift or hold heavy items with left arm painlessly. Pain is throbbing and worse at night making it difficult to sleep. Anti-inflammatory over the counter medicine, salon pass and lidocaine rubs do not help with pain.
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| 43 | 2021-04-12 | nervousness |
After the vaccine: 10 minutes - small headache started 30 minutes - swollen throat, pale color 40 mi...
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After the vaccine: 10 minutes - small headache started 30 minutes - swollen throat, pale color 40 minutes - shaky legs was administred two pills of benadryl following day, 9h30am - area around right eye swollen and rugged (consistent with previous allergy case - 10 years ago) tooke 1 pill of Cetirizine Hydrochloride 10mg
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| 43 | 2021-04-12 | sleep disorder |
Day 1-3 severe headache, fever, fatigue, body aches I was in the bed for 2.5 days. Day 5 - severe ch...
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Day 1-3 severe headache, fever, fatigue, body aches I was in the bed for 2.5 days. Day 5 - severe chest pain landed me in the ER at Hospital - pericarditis caused by the vaccine. Day 21- finally got into see a cardiologist, started colchicine to try to reduce the inflammation around my heart and prevent it from coming back. An echocardiogram is going to be performed on 4/14/21. Also, right upper quadrant pain when taking a deep breath, a ct scan is being scheduled. Ive not been able to sleep laying down since day 5 following the vaccine. Chest pain, shortness of breath and right upper quadrant pain are all a result of the vaccine.
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| 43 | 2021-04-12 | sleep disorder |
Pain in left arm where shot was administered. Began the morning after received the vaccine. Migrain...
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Pain in left arm where shot was administered. Began the morning after received the vaccine. Migraine-like headache and flu-like discomfort (coughing, chills) began later that evening. Did not sleep at all on the 2nd night. Chills and headache are still present.
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| 43 | 2021-04-13 | anxiety, nervousness |
Patient began with feeling anxious/shaky. EMS was notified 11:30, assessed patient and administered ...
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Patient began with feeling anxious/shaky. EMS was notified 11:30, assessed patient and administered IM Benadryl. Patient then began to develop a feeling of chest and throat tightness, c/o it was difficult to catch her breath at 11:35. Patient then developed stridor and IM Epinephrine administered at 11:37. Symptoms began to improve, patient was stable and taken via ambulance to hospital.
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| 43 | 2021-04-13 | insomnia, depression, feeling abnormal |
Depression, exhaustion, insomnia, edema, brain fog, bloating, constipation, lower back pain, muscle ...
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Depression, exhaustion, insomnia, edema, brain fog, bloating, constipation, lower back pain, muscle fatigue, muscle cramping
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| 43 | 2021-04-14 | disorientation |
Mild/moderate anaphylactic reaction lasting about 45 minutes, trouble swallowing, fast pulse, disori...
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Mild/moderate anaphylactic reaction lasting about 45 minutes, trouble swallowing, fast pulse, disorientation, tight throat. Epinephrine not used.
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| 43 | 2021-04-14 | nervousness |
After receiving the first shot I had normal side effects - a headache that went away in 24 hours and...
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After receiving the first shot I had normal side effects - a headache that went away in 24 hours and a sore arm that lasted 36-48 hours. I did notice a slight jitter/shaky feeling and a little tinitus. One week later the tinitus became much louder and continual. This has continued for a week. I also have moments of vertigo and an overall achy/tired feeling that I have been in bed for the past 4 days.
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| 43 | 2021-04-14 | nervousness |
Patient reported nervousness prior to receiving vaccine. Patient reported blurred vision, possible v...
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Patient reported nervousness prior to receiving vaccine. Patient reported blurred vision, possible vertigo, slight nausea. Patient never lost consciousness. Patient was moved to fresh air, given ice pack, bottle of water. Left without issue.
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| 43 | 2021-04-15 | disorientation |
Patient had a severe shaking experience. It lasted about 5 minutes. Not a seizure but very similar...
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Patient had a severe shaking experience. It lasted about 5 minutes. Not a seizure but very similar. Patient was aware during the experience. very disoriented afterwards. Patient said she had tingling in her head. which lasted about 1-2 hours.
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| 43 | 2021-04-15 | loss of personal independence in daily activities, sleep disorder |
caller says she is shaking, has trouble breathing. weak and cant stand up it started the day after t...
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caller says she is shaking, has trouble breathing. weak and cant stand up it started the day after the shot. the 4th day she couldnt sleep fever was 37.7 every day has good days and bad days now she cant function after getting the shot. adv go to hcf.....or contact your PCP.....or try telehealth. she doesnt want to since she has been there 3 times, it cost a lot of money she has had sx on and off for 3 month, her sx had mostly disappeared except for weakness. she has had fatigue for months, diarrhea 50 times a day treated in hcf for dehydration, had kidney infection then it went to my heart. ....couldn't feel legs or hands, she can walk after month 5 or 6, the soles of her feet hurt, she has pain in her toes. denies wt loss sx change from top of body to lower body caller doesnt think that people who had covid should have the vaccine
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| 43 | 2021-04-16 | insomnia |
headache; swelling in left armpit; difficulty sleeping; fever; fatigue; body aches; sweating; This i...
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headache; swelling in left armpit; difficulty sleeping; fever; fatigue; body aches; sweating; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received second dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201) via an unspecified route of administration, administered into left arm on 12Feb2021 08:45 (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Patient was not pregnant. It was also reported that the patient was taking unspecified concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249) administered into left arm on 22Jan2021 08:30 AM (at the age of 42-year-old) for COVID-19 immunization. On 12Feb2021 14:00, patient experienced headache, swelling in left armpit, difficulty sleeping, fever, fatigue, body aches and sweating. The patient did not receive treatment for the events reported. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 01Feb2021. Outcome of events was not recovered.
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| 43 | 2021-04-17 | feeling abnormal, insomnia |
Pfizer-BioNTech COVID-19 Vaccine EUA First symptom on 4/16/21 at 12:30 am was skin becoming sensitiv...
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Pfizer-BioNTech COVID-19 Vaccine EUA First symptom on 4/16/21 at 12:30 am was skin becoming sensitive to the touch and difficulty sleeping. In less than an hour, chills began with shaking all over my body. Nausea began shortly afterward with a headache in the front of the head. Took 1 extra strength Tylenol and 2 chewable Tums. Extra blankets eventually helped with chills, nausea subsided after a couple of hours. Woke up around 5:00 am with a severe headache like a band all around my head. Took 1 ibuprofen. Headache eventually became mild around 9:00 am. During the daytime on 4/16/21, I experienced fatigue, muscle weakness, muscle soreness, fogginess, mild headache, and difficulty staying warm. I took ibuprofen during the day to help with pain/headache. On 4/17/21, I experienced muscle weakness/pain and fatigue. On 4/18/21, I continued to experience fatigue and mild muscle weakness. I am still unable to exert myself with any amount of energy.
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| 43 | 2021-04-17 | feeling abnormal |
Bells palsy; Metal taste in mouth, mild on first afternoon but stronger tasting on next two days; he...
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Bells palsy; Metal taste in mouth, mild on first afternoon but stronger tasting on next two days; her body started to feel strange/ just felt weird; This is a spontaneous report from a non-contactable consumer (patient). A 43-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in left arm, on 12Mar2021 at 02:30pm (at age of 43 years old), as a single dose, for COVID-19 immunisation. Medical history included migraine and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ondansetron (ZOFRAN) and oxymetazoline hydrochloride (CLARITIN ALLERGIC), Nurtec and allergy immunotherapy; all started on an unspecified date and for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the BNT162b2 vaccine. On 12Mar2021 (at 6:00pm), the patient experienced a metal taste in her mouth, mild on first afternoon but stronger tasting on next two days. On Day 2, it was reported that her body started to feel strange, could not quite describe feeling, further described as it was not really a tired feeling or a painful feeling, just felt weird. On 25Mar2021, the patient experienced Bells palsy. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the events metal taste in her mouth, body started to feel strange/just felt weird. The clinical outcome of the events, metal taste in her mouth, body started to feel strange/ just felt weird, was recovered on an unspecified date. The clinical outcome of the event Bells palsy was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 43 | 2021-04-18 | anxiety |
right after the vaccine, I had heart palpitation and a headache but I thought it was my anxious acti...
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right after the vaccine, I had heart palpitation and a headache but I thought it was my anxious acting up. Later that night, my arm became quite sore but I got itchy and the headache became a severe migraine so I took a Tylenol and the Rizatriptan 4 hrs later. The following day, I could not get out of bed with severe body ache, light headedness, heart palpitation and slight difficulty breathing. I have been in bed since but the heart palpitation and more difficulty breathing and wheezing are intermediate but strong at onset. I am also still itchy.
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| 43 | 2021-04-18 | excessive sleepiness |
Headache, nausea, extreme fatigue/tired, felt unwell. I slept for four hours in the afternoon and th...
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Headache, nausea, extreme fatigue/tired, felt unwell. I slept for four hours in the afternoon and then got up to eat dinner and went back to sleep early. Felt like an absolute champ in the morning with no lingering side effects.
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| 43 | 2021-04-18 | sleep disorder |
Second dose of vaccine received on March 10, 2021. Thereafter I started having severe lower back pai...
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Second dose of vaccine received on March 10, 2021. Thereafter I started having severe lower back pain. The pain radiated to my quads, down to my shins and feet. The pain circulates throughout the lower half of my body. Symptoms include: Dull Achy pain, pins and needles, numbness, burning sensation. Because of the pain I cannot sleep at night. I have been to the emergency room 4 times for the severe pain. During my last visit I was admitted to the hospital. Running Diagnosis is : Covid Vaccine Induced Neuropathy.
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| 43 | 2021-04-19 | feeling abnormal |
Persistent burning/ pain in all joints, especially hips, shoulders, shoulder blades, neck. Uncomfort...
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Persistent burning/ pain in all joints, especially hips, shoulders, shoulder blades, neck. Uncomfortable to lay, sit, stand for last 48 hours and not sure how much longer I can take this.
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| 43 | 2021-04-20 | anxiety |
Patient felt anxious after vaccine administration about 5 minutes after dose given. Tremors in hands...
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Patient felt anxious after vaccine administration about 5 minutes after dose given. Tremors in hands. No difficulty breathing or swelling. Patient states she gets anxious every now and then. Patient monitored for about 30 minutes. She felt "better" and was able to get up and leave when she felt comfortable.
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| 43 | 2021-04-20 | feeling abnormal |
Diarrhea on/off for 8-9 days following vaccine. began the evening of the vaccine along with malaise...
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Diarrhea on/off for 8-9 days following vaccine. began the evening of the vaccine along with malaise, fatigue. Diarrhea has resolved but continues to have " unsettled feeling"
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| 43 | 2021-04-20 | insomnia |
I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to ...
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I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to where I got the shot/ like whenever I take a step to walk it's feels like my head is going to explode; really bad back ache; My face and my back started getting like hot, like heat, like very hot reaction/like radiating heat in my back it is like surrounding my spine, its right in the middle of my back; It feels like heat and pressure around my spine area; high pressure behind the right eye; My arm started hurting; the arm I got the shot in; This is a spontaneous report received from a non-contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733), intramuscular (reported as in the muscle) in left arm on 01Apr2021 (at the age of 43-year-old) at 0.3 ml, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that initially, right afterward she meant her arm started hurting which was normal the arm she got the shot in, she wasn't worried about that. But then her face and her back started getting like hot, like heat, like very hot reaction. She did not know how to describe it, it was like radiating heat in her back it was like surrounding her spine, it was right in the middle of her back. It felt like heat and pressure around her spine area. And in her head, it had not lit up. She had headache so badly that her right eye which was to the opposite side to where she got the shot. She had very high pressure behind the right eye. It was literally like whenever she took a step to walk it was felt like her head was going to explode. It was for her a headache and really bad back ache. When paraphrased the above concern, patient stated It was for days at the time of this report. First adverse reaction was on the actual day that she received the vaccine that was 01Apr2021. Second shot was reported as 29Apr2021. When probed for if patient still experiencing adverse event patient stated that she was still experiencing. As per outcome of event patient stated for its persisting. As per treatment she took an ibuprofen (ADVIL) for the first-time last night before the present report. Just because she needed to get sleep. She had not slept in days. So, she took ADVIL to get rid of the pain last night that was only the things she had done since Thursday 01Apr2021. But it didn't even work. She woke up and felt the exact same. Dose of Advil was reported as 200 mg, she took one 200 mg tablet. She just took it the day before the present report (04Apr2021). The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-04-20 | mental impairment, loss of personal independence in daily activities |
Arm pain and swelling at injection site about 2 inches in diameter, full body aches with low grade f...
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Arm pain and swelling at injection site about 2 inches in diameter, full body aches with low grade fever. Extreme fatigue. Mental slowness when it came to simple daily tasks.
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| 43 | 2021-04-20 | panic attack, anxiety |
The patient felt like her throat was swollen and like her temperature had spiked. It was not an all...
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The patient felt like her throat was swollen and like her temperature had spiked. It was not an allergic reaction but she was very anxious and became very upset about what could possibly happen. We offered to call 911 and she refused but let us escort her to the local health center. After speaking with a nurse there, I was told that her blood pressure was high at first but eventually became normal. They saw no signs of an allergic reaction and feel that this was due to anxiety and a panic attack. I spoke with the patient around 5:30pm and she said her throat still felt swollen like a balloon was there but felt ok otherwise.
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| 43 | 2021-04-20 | sensation of foreign body |
Approximately 5 minutes post vaccination at the county public health center drive through vaccine cl...
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Approximately 5 minutes post vaccination at the county public health center drive through vaccine clinic while patient was in the observation parking area the patient beeped her horn and indicated to staff she did not feel well. She had flushing of skin of the chest, and a cough that was just starting. EMS was called at 12:07 PM, and per standing order RN administered 50 mg of Benadryl intramuscularly in the right deltoid at 12:08 PM. The patient progressed to persistent coughing, wheezing, and difficulty talking stating she felt like a lump in her throat and tightening in her throat. Again, following standing order RN administered 0.3 mg of Epinephrine in the left thigh intramuscularly at 12:14 PM. EMS arrived by ambulance at 12:17 PM. Patient was stable upon EMS arrival with all signs/symptoms of allergic anaphylactic reaction gone. EMS evaluated patient and patient signed declination to go to the hospital for evaluation. She remained on site until 12:41 PM when her father / mother came to pick her up from the vaccine clinic site. Follow up was done with patient on 04-21-2021 @ 11:30 AM. She states that no further reaction occurred, and she took no further medications.
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| 43 | 2021-04-21 | feeling abnormal |
Almost immediately after receiving the shot I felt my heart rate elevate. My neck was very warm. It ...
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Almost immediately after receiving the shot I felt my heart rate elevate. My neck was very warm. It took a good 1 to 2 hours for my heart to go back and for me to feel ok.
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| 43 | 2021-04-21 | impaired work ability, feeling abnormal, loss of personal independence in daily activities |
Day 1: Symptoms of fatigue, malaise develop at 12pm. Symptoms of fatigue, malaise worsen, headache d...
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Day 1: Symptoms of fatigue, malaise develop at 12pm. Symptoms of fatigue, malaise worsen, headache develops. Go right to bed after work at 4:30pm Day 2: Extreme fatigue, malaise, brain fog. Severe joint pain, immobility. Inability to go to work, bedridden. Later that evening, Redness, pain, and swelling of right eye (iritis) begin to develop, indicating beginning of lupus flare. Day 3: Iritis increase in severity, Moderate to severe aches and joint pain, moderate fatigue, malaise, brain fog. Contact rheumatologist & ophthalmologist. Prednisone therapy withheld to prevent inhibiting immune response to vaccine. Day 4-14: All symptoms persist, then dull to functional levels by Day 14. Rheumatologist recommends this flare be reported to VADERS. 3/17: Given 2 wk prednisone taper for Lupus flare that developed days earlier. (Extreme fatigue, malaise, brain fog. Severe joint pain, immobility. Inability to perform most daily activities, occasionally bedridden & inability to go to work, Iritis (Redness, pain, and swelling of right eye) 4/5: Given 2 wk prednisone taper for Lupus flare that developed days earlier. (Extreme fatigue, malaise, brain fog. Severe joint pain, immobility. Inability to perform most daily activities, occasionally bedridden & inability to go to work, Iritis (Redness, pain, and swelling of right eye) 4/18: Redness, pain, and swelling of right eye (iritis) begin to develop, indicating beginning of lupus flare. 4/19: Inability to go to work, bedridden due to extreme fatigue, malaise, brain fog. Severe joint pain, immobility. Inability to perform most daily activities, occasionally bedridden & inability to go to work, Iritis (Redness, pain, and swelling of right eye) 4/20: Some spotting. At this point menstrual cycle delayed 20 days
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| 43 | 2021-04-21 | mental impairment | No period or ovulation since 2nd vaccine. It has now been 69 days. |
| 43 | 2021-04-21 | panic reaction, feeling abnormal |
I had side effects beginning the morning after that lasted 7 full days. they seemed to be the normal...
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I had side effects beginning the morning after that lasted 7 full days. they seemed to be the normal side effects; sore arm (injection arm) nausea, headache, body ache, extreme exhaustion, diarrhea, heart palpitations, loss of appetite, upset stomach, brain fog, pain and sensitivity in face and glands. these side effects happened through the 7 days, ending by the evening of the 15th. they were all consistent except the pain in my face and glands only happened a couple times through that week and only lasted a short time each event. HIGH ALERT SIDE EFFECT: on the evening of 4/13 at 11:20 PM. I had been asleep for about 90 minutes, I woke up suddenly with a super rapid heartbeat and acid reflux. my left arm (injection arm) was totally numb, my fingers were tingling and ice cold. I was unable to grasp a phone of hold anything. I tried to shake it off for about 30-45 minutes. I began to panic so I connected to a teledoc via phone. he indicated it COULD be a side effect of the vaccine and to try and get sleep and see if it was still there in the morning. I went to bed again about 2:30AM and woke up at 5:00AM and the sensation was gone and it I was back to normal.
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| 43 | 2021-04-23 | anxiety |
Patient describes heart rate as "pounding and beating more," radial pulse is 110 after vaccination. ...
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Patient describes heart rate as "pounding and beating more," radial pulse is 110 after vaccination. Patient is given food and water and instructed to take deep, slow breaths and is taken into Med OBVs. Vitals at 11:40 were: HR:116, RR: 24, BP: 150/85, SPO2: 100. At 12:02 patient states that palpitations seem lighter. States patient has stress and anxiety makes her heart rate increase, asks "Is my 15 min injection over," informed it was, VS were: HR: 126, RR: 126, BP: 152/96, SPO2: 100. 12:20 patient states " I feel so much better and I want to get out of here and take my mask off." VS were: HR: 110, RR: 20, BP: 142/86, SPO2: 100. patient's vital were stable and was released at 12:20 with spouse.
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| 43 | 2021-04-23 | sleep disorder |
Starting around 1:00 am (almost exactly 12 hours following vaccination), patient experienced chills ...
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Starting around 1:00 am (almost exactly 12 hours following vaccination), patient experienced chills (alternating hot/cold sensations, sometimes hot/cold at the same time in different body parts), violent shaking/shivering, fever ranging from 99.9 to 102 degrees F (even after taking 400-600 mg of ibuprofen every 6 hours), body aches / pains in virtually all bones and muscles, and some organs (painful ear drums, eyelids, swallowing room temperature liquid felt painful in esophagus but no throat soreness); moving muscles to change position felt like bones would break and/or muscles / ligaments would tear; unable to find a singular comfortable position; unable to sleep; heart racing while in resting / reclined position - watch showed 15+ minutes of "fat burning" heart rate and "5 floors climbed", despite lying reclined and trying to sleep for more than 8 hours (having not walked more than about 1000 steps in the day to use the bathroom and drink fluids). The following day, fever broke, but patient woke sweating with a temperature of 96.6 degrees F (lower than the patient's average temp in the 97s-98.6 range). Body aches were mild to moderate, but mild nausea and diarrhea were experienced for all waking hours, and appetite was less than normal. Exhaustion still experienced in the third day (today 4/24), and body aches mild. No known fever at this time.
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| 43 | 2021-04-24 | anxiety |
I felt very anxious for two days after the vaccine. Since I am prone to anxiety I could tell that it...
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I felt very anxious for two days after the vaccine. Since I am prone to anxiety I could tell that it was above and beyond my regular anxiety. It felt like what I experienced when my buproprion dose was increased too much.
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| 43 | 2021-04-24 | impaired work ability |
Slight fever within hours of shot. On day 2 I was unable to move my back and could not stand up lik...
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Slight fever within hours of shot. On day 2 I was unable to move my back and could not stand up like my back and legs seized and on day 3 my neck was stiff and could not move it. Visit to my GP who immediately put me on muscle relaxers and is keeping me out on short term disability until symptoms go away.
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| 43 | 2021-04-25 | feeling abnormal |
Day after the 2nd dose, I had the following symptoms which lasted about 1 day: Chills Fatigue Body a...
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Day after the 2nd dose, I had the following symptoms which lasted about 1 day: Chills Fatigue Body aches Nausea Brain fog
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| 43 | 2021-04-25 | nightmare, insomnia |
Intense ringing in ears(tinnitus), unable to sleep-nightmarish flash images during rest- first 2 nig...
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Intense ringing in ears(tinnitus), unable to sleep-nightmarish flash images during rest- first 2 nights, joints swollen and aching (over 1 week), onset of seasonal allergies for 1st time( sneezing 20x row, sinus pressure-over 1 week).
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| 43 | 2021-04-25 | restlessness, abnormal dreams |
The 2nd and 3rd night after shot had very intense dreams and tossing and turning all night. Headach...
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The 2nd and 3rd night after shot had very intense dreams and tossing and turning all night. Headache on/off from date of shot 4/9 until 4/17, or 8 days after. BIGGEST event: 4th, 5th, 6th nights after shot (4/13, 4/14, 4/15), woke up 2 or 3am with elevated heart rate for myself (90bpm vs. 55-60 typical). Also very hot. Took an hour to calm down each night. Ended up in ER after 3 nights of elevated heart rate (4/15) to get checked out, but there was nothing found, and they said maybe it was a vaccine reaction, but may never know. Second dose is 5/3, so will see if have similar reactions....
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| 43 | 2021-04-26 | feeling abnormal, sleep disorder |
At 8:00 pm after receiving the vaccine at 3:00 pm I started with chills. Went to bed to try to slee...
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At 8:00 pm after receiving the vaccine at 3:00 pm I started with chills. Went to bed to try to sleep and rest. Then this tingling feeling started. It would happen at different places through out my body. It would be in my arms, hands, chest, head, legs, feet, side or everywhere. Then it would be in just one area for a period of time. Next morning I started to get electrical shock feelings on top of the tingling. By Saturday I was in bed as my legs felt too weak to walk. The tingling was mostly just in my legs at this point. The electrical shock feeling was still coming and going but the tingling never stopped in my legs and feet. It would wake me up out of a dead sleep. This kept happening and I went to the doctor Monday morning. I had started to improve some. Still weak in my legs, tingling and some shock feelings. The doctor felt it was a nerve response to the vaccine and would pass after a few more days. It has improved as I am able to be up and doing things now. Unfortunately the tingling hasn?t stop at all in my right legs. Especially my last three toes and they hurt, burn and just feel odd most all the time. I still get shock feelings at times in that foot and some times other places but not as often. I still get tingling in the side of my head at times still also. Now today 4/27/21 my right hand is hurting and hard to move. My toes feel like they are curling under at times and they are perfectly straight. I still have a few nights where the shock feeling with wake me up in the night. Tomorrow will be two weeks from my vaccine. I wondered if this has happened to others, when does it stop, and should I get the second vaccine? I do not want to go back to the point where it was hard to walk even and the pain.
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| 43 | 2021-04-26 | sleep disorder |
Started with an extremely sore arm at 10PM on the day of the 2nd dose, which was yesterday, April 26...
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Started with an extremely sore arm at 10PM on the day of the 2nd dose, which was yesterday, April 26, at 2:00 in the afternoon. Went to bed after taking OTC pain reliever and finally got out of bed because I couldn't sleep due to arm pain at 3:30 AM. About 4:30 AM I took my temperature to find a low fever of 100.7. That has been ranging from 100.7 to 99.4 all day today so far. At about 11AM I started to feel like I have the flu. My body aches all over, my joints hurt, I have a headache, and I am still unable to lift my left arm. I was completely fine with no symptoms yesterday when I went in to get the second dose of the vaccination. Today I feel like I got hit by a bus.
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| 43 | 2021-04-27 | confusional state |
I started to feel periods of confusion shortly after the first dose and continue to feel short perio...
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I started to feel periods of confusion shortly after the first dose and continue to feel short periods of confusion. My second dose is scheduled for May 8, 2021.
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| 43 | 2021-04-28 | confusional state |
Within 5 minutes, I experienced light-headedness, dizziness, and a sense of confusion. This lasted f...
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Within 5 minutes, I experienced light-headedness, dizziness, and a sense of confusion. This lasted for about 20 minutes, then subsided. After that, I felt increasing fatigue. After 8 hours, I experienced extreme shaking and tremors throughout my whole body. This lasted for about 1 hour. I did not feel chills or hot or cold during this time. I felt extreme fatigue and weakness and was not able to get up from my bed to seek help. It was very scary. After 24 hours, I felt normal and healthy again.
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| 43 | 2021-04-28 | disorientation |
Pt received the pfizer vaccine yesterday and at 0100 today began feeling short of breath, HA, chills...
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Pt received the pfizer vaccine yesterday and at 0100 today began feeling short of breath, HA, chills, tachycardia with HR in the 160's, and disorientation. Pt treated with IV fluids and EKG completed.
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| 43 | 2021-04-28 | feeling abnormal |
The day after the vaccine I experienced brain fog, fatigue, and sore arm. I also got my period. I ha...
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The day after the vaccine I experienced brain fog, fatigue, and sore arm. I also got my period. I have a history of painful periods but after an endometrial ablation over 10 years ago I have had normal pain. The period after the vaccine was incredibly painful and the consistency of the discharge was completely different. Pale pink clots that almost looked like uterine lining instead of clots I'm used to seeing. I want to report this because I've talked to other women who've had something similar but I didn't see anything about it on the CDC website.
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| 43 | 2021-04-28 | insomnia |
Severe fatigue, moderate body aches, and mild headache started approximately 12 hours after vaccine ...
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Severe fatigue, moderate body aches, and mild headache started approximately 12 hours after vaccine administration and led to insomnia on night of 04/27/2021. Severe fatigue and moderate body aches persisted for 36 hours. Mild fatigue continues through 04/29/2021. Mild sore throat started midday on 04/29/2021 and continues.
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| 43 | 2021-04-28 | sleep disorder |
She got her vaccine, she had no side effects other than her mouth being really really dry. She went...
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She got her vaccine, she had no side effects other than her mouth being really really dry. She went to bed, and was awakened at 3:00 AM with ringing in her ears. She is living on 3 hours of sleep a day due to the persistent ringing in the ears. She went to the tinnitus center who gave her some medication for the swelling and to wait and see if it goes away or if this is permanent. Right now she is very upset that the public is not being informed of this information.
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| 43 | 2021-04-29 | feeling abnormal |
14 hours after injection, experienced severe headache, bode aches, high fever, unable to eat, nausea...
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14 hours after injection, experienced severe headache, bode aches, high fever, unable to eat, nausea, brain fog. Could not move all of Friday, 4/22. Saturday, 4/23, was just at about 50% of "normal".
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| 43 | 2021-04-29 | hallucination |
Five minutes after injection, felt nauseated, face went cold and tingly, started rapid breathing, bl...
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Five minutes after injection, felt nauseated, face went cold and tingly, started rapid breathing, blood pressure elevated, felt very parched, hands tingly, thought I was going to pass out. This happened with the first Covid vaccine shot as well, so I lied down immediately after this shot, but it didn't help. I've never had this reaction to any other vaccine. Symptoms improved after 10-15 minutes, but I had to move very slowly. Felt very parched the rest of the evening and now as well (the next day). Had hallucinations of bright lights in my right peripheral vision that evening (which I've never had).
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| 43 | 2021-04-30 | insomnia, thinking abnormal |
problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top...
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problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top of my head and my hands hurt; Nauseous; my hands and feet started going numb; they itch they burn; feet are painful; uncomfortable; blood clot/a clot or something in her legs; from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein; she thought she was having a stroke; cramps; burning from my calf to my feet; pain in her neck then to her back; pain in her neck then to her back; different temperatures like hot and cold make it bad and irritating; can't sleep well because of her symptoms; Swelling in her Feet; can't think right; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm in the morning of 01Apr2021 (Batch/Lot Number: ER8727) as a single dose for COVID-19 immunization. Medical history included ongoing complex regional pain syndrome, ongoing fibromyalgia, ongoing arthritis - all diagnosed 20 years ago. Her mother has lupus and rheumatoid arthritis and she can't have the vaccine, states she doesn't know if something could be genetic. Low potassium in the past and stated that she has a lot of allergies to medications, but she consulted with the pharmacist and he said it would be okay. There were no concomitant medications. No additional vaccine was administered on the same date of BNT162B2 and no prior vaccination within four weeks. The patient was having weird symptoms and she tried looking online and in different groups to find out if anyone has similar symptoms, but she hasn't been able to find anything. She began by saying she has health issues; she has Fibromyalgia and Complex Regional Pain Syndrome. She doesn't know if studies were performed on patients with those disorders that took the vaccine. It's been about 3 weeks since getting the vaccine (Apr2021) and she started having symptoms that she thought could be a blood clot. From the knees down, she was having a lot of pain, cramps, burning from her calf to her feet. She would keep rubbing them and massaging them. It was excruciating pain. She was having symptoms and she did go see her Nurse Practitioner on 14Apr2021 because she thought she was having a stroke or a clot or something in her legs or that she was having a problem with her cholesterol. The nurse thought maybe it was her electrolytes, because she had low potassium in the past, but everything came back normal. Her feet were painful but not as bad in Apr2021. She felt like her condition but it's flaring up like 200% it's like over a 10 on the pain scale. She can't think right, she can't work, and was very uncomfortable in Apr2021. The leg pain felt like it is really deep in the vein, it doesn't feel like it is superficial, and she can feel stuff or liquid flowing. Her pain alternates from her head to her neck to her feet and it is very uncomfortable. Her hands and feet started to go numb, not completely numb but like when they fall asleep from sitting on them and then hit something and it hurts. Her arms were burning like crazy; they itch, they burn in Apr2021. Different temperatures like hot and cold make it painful, bad and irritating, and she can't sleep well because of her symptoms. She doesn't know the exact dates, but it has been about a week, but it is changing. It started with cramps in her legs from her knees down. That is where she had injuries and she thought it was her cholesterol. From her knees down, she has cramps and pain and it is very uncomfortable, she felt a really deep pain. She has pain in her neck then to her back, it started in her lower extremities and it is going up. It has stayed the same and she has to keep taking Tylenol to control the pain. Her symptoms got worse and she started taking Tylenol and that helped and then on 15Apr2021, her hands and feet started going numb and she had a headache and pain on the top portion of her head (reported as brain) and her hands hurt, and she was nauseous. She hasn't heard back from the nurse practitioner, so she decided not to go and get it done because she felt it is from the vaccine. She also has swelling of feet in Apr2021, and now she just woke up an hour ago and she slept somewhat okay, but she had to take Tylenol. Now that she is standing, it felt like her legs are starting to hurt again. Treatment included Tylenol, which helps a little and she has to keep taking it. If she doesn't take Tylenol, she can't even function. The events from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein, cramps, my hands and feet started going numb, they itch they burn, feet are painful, uncomfortable, pain on the top of my head and my hands hurt/headache, swelling in her feet, nauseous, pain in her neck then to her back, different temperatures like hot and cold make it bad and irritating had not resolved, while the event can't sleep well because of her symptoms was resolving, and the outcome rest of the events was unknown.
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| 43 | 2021-05-04 | loss of personal independence in daily activities, disturbance in attention |
severe joint pain and fatigue - short lived (24hrs or less) early menstrual cycle onset - 9 days ear...
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severe joint pain and fatigue - short lived (24hrs or less) early menstrual cycle onset - 9 days early, much more painful and much heavier bleeding than usual. Very unusual for personal cycle and concerning. Will seek medical care if heavy bleeding continues for much longer. Fatigue has set in and causing disruption to concentration and ability to perform work.
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| 43 | 2021-05-07 | crying |
Currently 4 days of bleeding; increased energy; sore left arm; overly emotional cry ie for a couple/...
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Currently 4 days of bleeding; increased energy; sore left arm; overly emotional cry ie for a couple/few days; menstruating when I had my period only 14 days before; This is a spontaneous report from contactable consumer, patient. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration, in the left arm on 09Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, and thyroid issues. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant drugs included ofatumumab (KESIMPTA) from 30Mar2020. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ocrelizumab and experienced hypersensitivity. On 21Apr2021 at 12:00, the patient experienced currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before. The outcome of the events, currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before was unknown.
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| 43 | 2021-05-11 | feeling abnormal | Foggy head, headache, muscle pain, joint pain, fatigue |
| 43 | 2021-05-19 | disorientation |
fainted; hit my head; I woke up disoriented moments later; ears are ringing from my head hitting; He...
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fainted; hit my head; I woke up disoriented moments later; ears are ringing from my head hitting; Headache; Feel dizzy; noticed muscle aches; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 11:15 (at 43 years old, not pregnant) as 2nd dose, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC); mometasone furoate (NASONEX). The patient took Fioricet before and had allergies. The patient had her first dose of bnt162b2 vaccine on 13Apr2021 for Covid-19 Immunisation on left arm at 43 years old. All events reportedly started on 05may2021 03:00. Patient woke up in the middle of the night to use the bathroom. She thought she was feeling fine, but then noticed muscle aches as she walked. She decided to take Motrin. She walked to the sink and felt dizzy. She got so lightheaded, She sat on the edge of the tub with my head between her legs. That was the last thing She remembered. Based on the evidence the next morning, she must have stood up put Motrin in my mouth and poured a glass of water. Then she fainted and hit her head on the bathroom floor. She had never fainted before in her life. She woke up disoriented moments later with two Motrin still on her tongue and having no idea where she was. She had to crawl back to bed. The next morning, she found the spilled a glass of water and Motrin pills all over the floor. She now had a persistent headache and her ears are ringing from her head hitting the bathroom floor. She did not know that dizziness was a potential side effect or she may have taken precautions. The outcome of the events was recovering. No other vaccine in four weeks.No Covid prior vaccination.Not Covid tested post vaccination. Information about the Lot/batch number has been requested.
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| 43 | 2021-05-24 | feeling abnormal | 4th day headache, brain fog, diarrhea, stomach pain, nausea 5th day dizzy, very dizzy, all day |
| 43 | 2021-05-25 | disturbance in attention, anxiety |
labs are abnormal; blood pressure dropping; Then 8 days later i developed throbbing pain head to toe...
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labs are abnormal; blood pressure dropping; Then 8 days later i developed throbbing pain head to toe; low grade temp; sweats; swelling of joints, especially my fingers, hands and feet; swelling of joints, especially my fingers, hands and feet; diarrhea; dizziness; problems thinking; anxiety; About 4 hours after receiving my Covid vaccine I started to feel fatigue/severe fatigue; This is a spontaneous report from a contactable Nurse (Patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 08Apr2021 16:00 (Batch/Lot Number: EK8734) at the age of 43-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient was not pregnant. Medical history included Rheumatoid Arthritis, fibromyalgia, anxiety/depression, Known allergies: Sulfa, Covid-19 prior vaccination. Post the vaccination, the patient was not been tested for COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. About 4 hours on 08Apr2021 after receiving her Covid vaccine she started to feel fatigue. Then 8 days later on 16Apr2021 08:00 AM, patient developed throbbing pain from head to toe, severe fatigue, low grade temp, sweats, swelling of joints, especially her fingers, hands and feet, diarrhea, blood pressure dropping, dizziness, problems thinking, and anxiety. His symptoms have progressively gotten worse and she had seen her family doctor, and her rheumatologist. Events resulted in: Doctor or other healthcare professional office/clinic visit. Leflunomide (ARAVA) and ibuprofen (MOTRIN) to help with inflammation and swelling. Her labs were abnormal, but chest X-ray normal on an unknown date. She have been off work since 26Apr2021. The outcome of the events was not recovered.
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| 43 | 2021-05-26 | feeling abnormal |
Became very fatigued, nauseous beginning around the 48 hours. Nausea would come and go and has last...
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Became very fatigued, nauseous beginning around the 48 hours. Nausea would come and go and has lasted over the course of the 60 hours proceeding the vaccine. I feel shaky and weak--which also comes and goes during the same time frame. Head feels "foggy".
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| 43 | 2021-05-27 | nervousness |
Client received her second dose of the Pfizer Covid-19 Vaccine (Lot #EW0185 exp. 08/2021) on 5/27/21...
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Client received her second dose of the Pfizer Covid-19 Vaccine (Lot #EW0185 exp. 08/2021) on 5/27/21 at 09:41 AM. At approximately 1005 the client walked to the EMT station complaining of cramping on her right lateral side. EMT and RN responded. The client was a 43-year-old female who was alert and tracking with her eyes. The client had a chief complaint of shortness of breath. The client stated that she began to feel pain on her right side and that it was giving her mild shortness of breath. This was the client's second dose of the Pfizer vaccine. The client denied any known allergies or significant medical history. The client was not on medications. The primary assessment revealed that the client's airway, breathing, and circulation are intact. The client was negative for hives, swelling, discoloration, signs or symptoms of shortness of breath, or other signs of anaphylaxis. The client was alert and oriented to person, place, time, and event. The client stated that she ?did not have anything to drink? and was ?feeling a bit nervous?. EMT had the client lay down on the cot and took the first set of vitals at 1007 and were as follows: Blood pressure: 124/88, Pulse: 68 and regular, O2 saturation 98%, and lung sounds clear, respirations 20. The client then consented to stay an additional 30 minutes after her initial observation. After 5 minutes the client stated she was feeling better after drinking some water. The second set of vitals was taken at 1014 and are as follows: BP 122/82, pulse 72, O2 saturation 98%, lung sounds clear., respirations 18. After her first 15-minutes of observation, the client stated that she was ?feeling better? and refused to complete the remainder of her thirty-minute observation. All pertinent information was given to her and her husband by EMT and RN. The client was also instructed to call 911 if a severe allergic reaction occurred later in the evening and was educated on the signs and symptoms to watch out for. The client departed at 1020 in positive disposition with her husband.
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| 43 | 2021-05-28 | insomnia, feeling abnormal |
next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I c...
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next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; Hearing loss; tunnel vision; After a couple of minutes, started feeling faint/dizziness; weakness; nausea; got hot; started sweating excessively; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 07Apr2021 20:15 at age of 43-year-old (Batch/Lot Number: Ew0151) at single dose for COVID-19 immunization. Medical history included know allergies to wheat. The patient is not pregnant at the time of report. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no other vaccine in four weeks or other medications in two weeks. After a couple of minutes on 07Apr2021 at 20: 30, the patient started feeling faint. Hearing loss, tunnel vision, dizziness, weakness, nausea, got hot and started sweating excessively. The patient was able to walk with assistance after 20-25 minutes. The patient also developed sore arm on 07Apr2021, then the next night of 08Apr2021, she couldn't sleep because she was itchy and feeling ticking all over her body. The events did not result in emergency room visit or physician office visit. There was no treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Apr2021.
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| 43 | 2021-05-28 | sleep disorder, loss of personal independence in daily activities |
Tinnitus constantly since the day following the second dose. Worse at night and when tired. Never ...
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Tinnitus constantly since the day following the second dose. Worse at night and when tired. Never experienced it before vaccinations. It affects ability to relax and sleep.
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| 43 | 2021-05-31 | feeling abnormal |
10-15 minutes after injection felt lightheaded/loopy--similar to 1st dose. vitals stable water given...
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10-15 minutes after injection felt lightheaded/loopy--similar to 1st dose. vitals stable water given observed in car for an additional 20-30 minutes
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| 43 | 2021-05-31 | impaired work ability, insomnia |
Fatigue Nausea Headache Fever- approximately 9pm start, continued for 20 hours Body/Join Aches- caus...
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Fatigue Nausea Headache Fever- approximately 9pm start, continued for 20 hours Body/Join Aches- caused difficulty sleeping Lasted approximately 24 hours- unable to work during this time
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| 43 | 2021-06-01 | feeling abnormal, loss of personal independence in daily activities |
sharp shooting pain; she can barely walk; felt like she was hit with a cannonball; bedridden; to be ...
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sharp shooting pain; she can barely walk; felt like she was hit with a cannonball; bedridden; to be isolated in part of her lower back and her glutes/back is destroyed/it dissipated to her lower back and glutes and is extremely painful; She can barely move/can barely move, barely get in and out of cars, barely stand up from sitting position; Arm is not sore anymore at all; transverse myelitis; barely stand up from sitting position; panic; inflammation of my lower spine; kind of distracted; difficulty with normal everyday functions; She had muscle aches/All caller's muscle are sore/she had muscle pain in all of her body; fever; Eyes weren't burning anymore/burning eyes; to be isolated in part of her lower back and her glutes/it dissipated to her lower back and glutes and is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the arm left on 11May2021 at 15:00 as single dose for COVID-19 immunisation. Medical history included stomach issues, ongoing lyme disease (this condition started and diagnosed about 10 years ago), hay fever, dust allergy, pollen allergy, animal dander allergy, motion sickness (this condition started probably before Lyme), patient said she got sick when she goes on boat; every time she was on a boat she lost her lunch. Family medical history included diabetes, but the patient has never had diabetes. Concomitant medications included ongoing promethazine for stomach issues (it is antihistamines, nothing radical and taking it since got Lyme disease about 10 years ago), ongoing Belsvia. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 21Apr2021 at 14:30 (at the age of 43 years old) as single dose for COVID-19 immunization. The patient previously also received the flu shot several months before. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No AE(s) following prior vaccinations. The patient got her second Pfizer covid vaccine on May 11 and felt like she was hit with a cannonball and was bedridden for a day. She had muscle aches on 12May2021 which she expected but now they seem to be isolated in part of her lower back and her glutes and it seems to be getting worse. Patient can barely move, sit down or stand up and it was a sharp shooting pain. All her other muscle pains have resolved. On 12May2021, patient had muscle aches which though was normal for the first couple of days and so most of the muscle aches went away except the patient back was destroyed that reported as worsened. Stated it was that side of the body in pain. The patient was trying to sit up right now and was having really sharp shooting pain on back. The patient figured this would have resolved itself by now. Stated she was kind of scared this might not go away. On 12May2021, patient arm was not sore anymore at all and eyes weren't burning anymore. The arm was sore day the day after receiving the second dose Pfizer Covid Vaccine, 12May2021. On 12May2021, patient had a fever and about 24 hours the fever lasted; could barely move; burning eyes that back to normal and also lasted for 24 hours. The patient can barely move after receiving second dose Pfizer Covid Vaccine, sharp shooting pains, really, really bad. The patient can barely move, barely get in and out of cars, barely stand up from sitting position. The patient assumes this was a side effect of the second dose Pfizer Covid Vaccine and was it would dissipate by now, but it was getting worse and worse. The patient stated the pain was now isolated to the lower part of her back on the gluts. All muscles were sore, started to get worse, all muscles in whole body were sore but it was now isolated to that area. That was a really big deal, patient can barely function. Thought it would get better, thought it would resolve but it is getting worse. The patient can barely stand up or sit down, that's how bad the pain was. Patient stated it was a pure, really sharp pain and the patient got stuck. The patient got stuck taking a piddle on the toilet for like 15 minutes after the patient first received the second dose Pfizer Covid Vaccine. Patient thought it would go away. All patient's muscle were sore. Noticing it was isolated in that specific area. Pretty much the patient's whole body function was like lower back, whole gluts almost, mainly on injection side. Stated all soreness in whole body, like hit by a cannon ball. The pain in rest of muscles dissipated, they felt normal but the muscles above the gluts, patient's whole function, whole body function was obliterated right now. Whenever the patient tries to move, had a sharp piercing pain. The patient tried to make sure she slept good and in good positions and everything. The patient states she was kind of distracted. Patient can barely walk, she's experiencing sharp shooting pain and difficulty with normal everyday functions (she's been bedridden because even going to the toilet was a big deal, she got stuck and was unable to get up and sit down), she's concerned because the other side-effects resolved but she got the vaccine a week ago and it's getting worse, she had muscle pain in all of her body and it dissipated to her lower back and glutes and was extremely painful. Patient also had burning eyes but this symptom went away and fever. She would like to know if anyone else has experienced anything like this and if it's normal to experience these side-effects, particularly the severe debilitating muscle pain 7 days after the second dose of the vaccine because she still has this symptom and it's getting worse. Patient said she was stuck lying in bed. She said if she switches sides she got the sharpest pain and it was like she gets it in her organs, like her lung was being punctured. Her primary care didn't know her well enough to give her anything for the pain for a couple of days. The pain was sharp, shocking. She felt like its in her hips; she can't even use toilet on her own, it takes forever. She was un-functionable and obliterated. The walking issue started a couple days after the vaccine. It was with all the muscles in her body, she was bedridden. She expected it to resolve. She said it isolated to that area, ironically her arm wasn't sore anymore, nothing else, but she was extremely sore in that area in her glutes. It was getting worse and it made her panic, she was not walking, she was handicapped, she was completely crippled. Also said the muscle pain started the day after her vaccine and went for 7 days after. The difficulty walking start day was hard to say; it was a gradual manifestation and it was not like all of the sudden she got the shot and can't walk. It was several days getting worse and now was is sort of in demise. Clarified these events occurred after her second vaccine, she had no problems with the first. Patient also stated she thought she had developed transverse myelitis, inflammation of her lower spine from the vaccine, from second Pfizer vaccine, side effect, she can barely move. AE(s) did not require a visit to emergency room, for events not being able to barely walk and being in extreme pain that resulted in physician office visit and she went to the doctor's on 17May2021. No surgeries to report. Lab data included body height was 160 cm or 5 feet, 3 inches; patient weight was like 145 pounds. The outcome of events fever, burning eyes was recovered on 13May2021. The outcome of events transverse myelitis, feeling abnormal, bedridden, Movements reduced, Pain in arm, Panic disorder, Spondylitis, Distractibility was unknown; while of the other events was not recovered.
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| 43 | 2021-06-01 | feeling abnormal |
severe dizziness; fog fines; This is a spontaneous report from a contactable consumer (patient) via ...
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severe dizziness; fog fines; This is a spontaneous report from a contactable consumer (patient) via sponsored program. A 43-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203 and expiration date: not reported) via an unspecified route of administration, administered in arm right on 27Feb2021 12:30 as second dose, single for COVID-19 immunization at Public Health Clinic (at the age of 43years). The patient medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported and BIRTH CONTROL (both as other medications in two weeks). Previously, received PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot Number: EL9264 and expiration date: not reported) via an unspecified route of administration, administered in arm right on 06-FEB-2021 13:45 as first dose, single dose for COVID-19 immunization at Public Health Clinic (at the age of 43years). No other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. On 28Feb2021 02:15, the patient experienced severe dizziness and fog fines. The patient was on day 3 post second covid vaccine and continued to have severe dizziness and fog fines. Both adverse events resulted in Doctor or other healthcare professional office/clinic visit and no treatment was given for these. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-06-01 | sleep disorder |
Within a half hour to 45 minutes post injection, I started having a sharp pain in my left eyebrow. o...
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Within a half hour to 45 minutes post injection, I started having a sharp pain in my left eyebrow. over the next hour or so, the pain worsened around my left eye, and I noticed a numbness in my forehead and upper cheeks (Similar feeling to botox but also slightly tingly). The discomfort lasted throughout the evening. By bedtime, I was extremely fatigued and having feverish symptoms (chills, aches, headache, fatigue) though my body temp was not elevated much. When I woke up the next morning, my temperature was increasing, chills and body aches were worse. I was somewhat expecting that, given accounts from others. Highest temp was 102.8 over the next 24 hours. But most concerning was my resting heartrate was elevated all day (tracked via apple watch). My resting HR even while sleeping was from the upper 80s and as high as 103 bpm. After bedtime that night, I started having pretty severe body aches in my torso. Most of the other aches had lessened but these got worse, preventing sleep, and lasted through most of sunday 5/30. By evening, I felt much better, and by Monday, I was back to normal, all symptoms gone.
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| 43 | 2021-06-02 | feeling abnormal, depressed mood |
Every joint in my body is painful; Need a nap in order to function; Mood changes (very sad and angry...
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Every joint in my body is painful; Need a nap in order to function; Mood changes (very sad and angry); Mood changes ( very sad and angry); Mood changes ( very sad and angry); This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 12:45 (Batch/Lot Number: En6203) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, depression, food allergy from an unknown date and unknown if ongoing. Concomitant medications included montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient previously took septocaine and experienced drug hypersensitivity. On 10Mar2021 the patient experienced every joint in my body is painful, need a nap in order to function, mood changes (very sad and angry). The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-06-02 | feeling abnormal |
I had the vaccine and I got sick immediately after like 4 hours after and each day I got sicker and ...
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I had the vaccine and I got sick immediately after like 4 hours after and each day I got sicker and sicker, I had fever, chills, sore throat, and each day I felt crappier, the head ache, stomach ache, diarrhea, we assumed it was from the vaccine and Friday I woke up with a rash all the way from my arm to my hand, and that day I kind of knew this was not because of the vaccine and I called my doctor and he said this does not seem like from the vaccine but he had me go to his office and when he saw my arm he said we should get you tested for Covid. On Saturday I woke up and we were supposed to go to our friends house and I felt miserable and I could not smell her essential oils. For dinner we were having chicken tacos and I could not taste anything. By then I knew I had Covid and I still went and got the test on Saturday morning, and tested positive. I did not have apetite and I wanted every blanket on me. My boss called and he had Covid too. I insisted my client got tested too. I was scared to sleep because I was shocking in the mucus. They recommended a chest x-ray but I was too sick to get it done. Even now I still have a hard time. Now I have bronchitis and I am going to the doctor on Friday to see if this is a result of Covid or something not related. Right now I am on antibiotics, steroids, and inhaler.
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| 43 | 2021-06-02 | insomnia, thinking abnormal, anxiety |
Since 4/13/21 I have been dealing with joint muscle pain, joint swelling, fatigue, sweats, low grade...
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Since 4/13/21 I have been dealing with joint muscle pain, joint swelling, fatigue, sweats, low grade fevers, cough, chest pain, increase in anxiety, problems hearing out of right ear, and having a humming in right ear at times, diarrhea, problems thinking, weight loss, problems sleeping.
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| 43 | 2021-06-02 | loss of personal independence in daily activities, feeling abnormal |
Six hours after receiving the injection I had overwhelming fatigue. I felt foggy. I was driving home...
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Six hours after receiving the injection I had overwhelming fatigue. I felt foggy. I was driving home and I did not feel safe operating my car. I got home and I didn't do anything else the rest of the day. That night I experienced severe abdominal cramping. I woke up feeling fatigue, I had a headache, I felt chills and had a slight fever. I felt nauseous and had multiple loose stools that I couldn't control. This continued throughout Tuesday and all day Wednesday. I could make it to the restroom, but it was definitely a fecal emergency. When I woke up on Thursday, I felt better. I didn't really feel normal until Saturday (5 days after receiving the vaccine).
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| 43 | 2021-06-03 | anxiety |
Patient received her first dose of the Pfizer vaccine at 2:27PM and was under observation for 30 min...
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Patient received her first dose of the Pfizer vaccine at 2:27PM and was under observation for 30 minutes. Patient did not report any symptoms/side effects while under observation and left the facility when her 30-minute period was up. Patient returned to Building with her spouse at approximately 3:10PM with tremors and reported feeling anxious because she believed the vaccine needle was still in her arm. Our team reassured her that this wasn?t the case, the RN explained that we use retractable needles for safety reasons, and we asked the patient to stay for additional observation. At approximately 3:35PM, patient?s spouse called for assistance because patient was not responding. Patient was assessed by our MD lead and was unresponsive to verbal stimuli but responsive to physical stimuli; BP was within normal limits. MD lead and spouse escorted patient to ED via wheelchair at approximately 3:45PM for further evaluation.
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| 43 | 2021-06-03 | feeling abnormal |
Immediately after receiving my first shot, blood pressure shot up to 148/60 (normally 120/60 or less...
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Immediately after receiving my first shot, blood pressure shot up to 148/60 (normally 120/60 or less), heart racing, felt dizzy, and legs felt funny, heavy. This higher heart rate persisted throughout the first day and evening, and on day 2 I woke up with wheezing and was sent to the ER. Blood pressure readings there were the same. Had a headache for three days also. On day 3, started feeling slightly better, but then awoke with lightheadedness, brain fog, tinnitus, and the feeling of a tight scalp. This persisted for two more days. On 6/1 was seen in outpatient care with blood pressure still higher (138/60), and tinnitus, with lower legs feeling like they were in cold water.
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| 43 | 2021-06-06 | confusional state |
The night of the vaccine, around 11 pm, I started getting hard hitting right sided muscle fasciculat...
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The night of the vaccine, around 11 pm, I started getting hard hitting right sided muscle fasciculations that developed all along the nerve path endings in the right side of my face (this lasted until 29 MAY 2021 - I have had a history of this, which included blepharospasm and right sided facial muscle fasiculations x4 years, but they have been non existent past few years). My resting head tremor came back, which I haven't had in like 2 years (it is pretty much gone now, but it lasted until 29 MAY 2021 and it only happens at rest). I started getting heart palpitations the night of the vaccine (they lasted until 29 MAY 2021). I went to bed, woke up the next day, and those aforementioned symptoms continued all day long, PLUS my phrenic neuropathy came back, which I haven't had in like 4 years. With that, I get intense stabbing in the tip of my left shoulder, my LUQ/Spleen area, and lower left side of spine, and the stabbing occurs in all 3 spots simultaneously. That lasted for DAYS 2, 3, 4 after getting the vaccine. When this flared up before, my family doctor told me the pain in the tip of the left shoulder is called "referred pain" because the problem is actually with the diaghragm and how the phrenic nerve runs through the diaphragm up through the neck. Anyways, the vaccine flared up my pain for 3 days. It is 10/10 stabbing pain that takes your breath away and makes me freeze when i get it, but the pain is short. It is like 3-5 stabs, then it goes away for like a couple hours, then comes back. That lasted for days 2,3,4 after the vaccine. I also was having problems with depth perception and was having problems gaging myself going down steps. My balance was perfectly fine, though.. i just couldn't gage where i was as i was moving too well. I was also having confusion, loss for words, and problems speaking. My mouth muscles weren't working right and it was frustrating because it was making me stutter. I felt extreme muscle fatigue in all 4 extremities, like it felt like I ran a marathon. All those symptoms lasted until 29 MAY 2021, except the phrenic neuropathy was only those 3 days after the vaccine. Today is 7 JUN 2021 and I feel fine now. I am still having a little bit of jerky movements but not bad overall. Because I have had a history of all these same exact movement issues in the past, I did not go to the doctor, because I have been through this before, since i have lived with this for 7 years now, and again I wanted to reiterate that I have been without issues for 2 years, so being that my issues started the day i got the vaccine, it is likely my body had a neurological flareup due to my body's immune response to the vaccine. I have an appointment with a doctor tomorrow to discuss.
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| 43 | 2021-06-08 | feeling abnormal |
Approximately 2 weeks after receiving the second Pfizer vaccination, I started to have multiple hot ...
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Approximately 2 weeks after receiving the second Pfizer vaccination, I started to have multiple hot flashes per day. I have never had even one hot flash in my entire life. I thought I was coming down with something, but they have continued each day several times a day. I did have severe fatigue, vertigo, and brain fog for at least 1. 5 weeks afterward as well, but those have dissipated at this time.
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| 43 | 2021-06-08 | feeling drunk |
I fainted after receiving the vaccine. However, I was still drowsy and dizzy after three hours. I ...
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I fainted after receiving the vaccine. However, I was still drowsy and dizzy after three hours. I tried to drive home and could not. I felt drunk and was burping. I was admitted to the hospital's ER. They told me I would not have to pay the bill, but still got a 5,000 bill. I was tested for everything. They told me I had orthostatic hypotension, so they could not let me go unless my blood pressure was normal. They tested me for everything else. I was given an IV. My hypotension lasted for about seven hours, then I had a fever for three nights after that. I was told in the ER that they don't recommend me getting the second dose. I am not sure what to do. The only other thing they found was that my potassium and calcium was low.
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| 43 | 2021-06-08 | impaired work ability |
Update: 1st day 5/27/2021 afterwards I had to leave work early bc I was dizzy, nauseous, body aches,...
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Update: 1st day 5/27/2021 afterwards I had to leave work early bc I was dizzy, nauseous, body aches, very weak. Day 2 was better in the morning but as the day went more body aches and headaches. Towards the end of day 2 I can?t taste anything. Day 3 sinus is all the getting on my last nerves. Nose running, head congestion, body aches, and still can?t taste anything. Now I don?t know if it?s just my allergies bc I was in pollen a little bit yesterday. PLEASE understand that I am sensitive to foreign things and have had reactions to other vaccines.
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| 43 | 2021-06-09 | impaired work ability |
Exactly two weeks after I developed severe chills, and a horrible headache. Around this time I also...
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Exactly two weeks after I developed severe chills, and a horrible headache. Around this time I also developed a rash on the right/back side of my midsection I thought was poison Ivy because I spend a lot of time outdoors exercising. I am not allergic to poison Ivy however, and it was not very itchy (just a little). I took a picture. Then developed a small painful rash on the front of my right/back midsection with little pustules. The headache got worse over days and severe lower back pain and gas. When I laid down I could hear blood pumping in my ears. I missed two and a half days of work despite working from home and needing to be present online. The whole thing lasted a week, but I have a mark from the second rash still on me despite that is it is a month or so later.
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| 43 | 2021-06-10 | anxiety |
I had noticed over a period of time sleepiness , unplanned weight loss, extreme anxiety. My thyroid ...
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I had noticed over a period of time sleepiness , unplanned weight loss, extreme anxiety. My thyroid levels were abnormal.
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| 44 | 2021-01-01 | impaired work ability |
Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection ly...
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Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection lymph nodes very sore and swollen in armpit (pain with applying deodorant) Four days after injection bruising with about 3x3 cm area of redness/swelling present at injection site Daily headaches managed with ibuprofen Not anything too concerning but not comfortable. I have never reacted to a vaccine prior
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| 44 | 2021-01-04 | anxiety |
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin...
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Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
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| 44 | 2021-01-04 | depressed mood |
Initially I was fine, but after 2 hours I started feeling joint pain. The next day the pain got wors...
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Initially I was fine, but after 2 hours I started feeling joint pain. The next day the pain got worse and caused me to limp at work. I started feeling down. That night, I went home and had chills and fever. I was sweating in my sleep. I was fine on Christmas and now I have bronchitis like symptoms. I've seen 3 different providers at urgent care and was told that they don't know much about the vaccine. They told me to use Albuterol and go to the hospital if I get worse. I was told that I still have the antibodies from already having COVID twice and it may be causing me to have problems now. The first time was really bad and I developed pneumonia, but didn't go to the hospital due to all of the deaths occurring in city.
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| 44 | 2021-01-04 | sensation of foreign body |
Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she...
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Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she felt as if she had a "lump in her throat". Denied any type of SOB or breathing issues. @ 1650, Ee stated she felt an itching, burning, and tingling to her lips and chin. Ee also had mild edema noted to her lips. Also stated that she had onset nasal congestion. Benadryl 25mg given @ 1652. Ee remains @ observation @ present time, 1706. @ 1715 Ee stated that she had mild itching to entire body. Around 1720, stated that the symptoms were easing up. @ 1725, Ee stated that the symptoms were better, but slight itching still remained. Insisted on leaving observation, stated she was okay. Ee left observation @ 1726.
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| 44 | 2021-01-05 | nervousness, insomnia |
Headache; Low grade fever - 99.3; Shaky and jittery feeling that kept me from sleeping soundly; Shak...
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Headache; Low grade fever - 99.3; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; This is a spontaneous report from a contactable Healthcare Professional reporting for a patient. A 44-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730), intramuscular in the left arm on 30Dec2020 at 09:00 as a single dose, for COVID-19 immunisation. The patient had no known medical history or allergies. Concomitant medication included rosuvastatin calcium (CRESTOR). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Dec2020 at 2300, the patient experienced Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly. No treatment was given for the events. The clinical outcome of Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly was recovering.
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| 44 | 2021-01-05 | panic reaction |
Symptoms - ? EE reports she waited for 30-minute observation period with no adverse reaction. EE le...
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Symptoms - ? EE reports she waited for 30-minute observation period with no adverse reaction. EE left work to drive home after vaccine and reports approximately 45 minutes later felt ?hot and cold? all over her body and felt ?panicky.? EE reports she pulled over and called her husband. At time of call (approx. 13:33), EE reports still feeling a little ?tingly? on her entire body and ?odd.? EE reports mild shaking to bilateral hands. EE reports last time she ate was at approximately 06:45 this am. Home remedies? - EE was in Starbucks parking lot at time of call and was going to be getting lunch after call. Recommendation? EE educated to eat and drink something, EE verbalized back understanding. EE educated to call vaccine support line for worsening symptoms, EE verbalized back understanding and denied further questions at this time.
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| 44 | 2021-01-06 | impaired work ability |
Headache & Fever Narrative: Employee reports experiencing headache and fevers that started a few hou...
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Headache & Fever Narrative: Employee reports experiencing headache and fevers that started a few hours after vaccine was administered, incapacitated from coming to work but not severe enough to seek medical care.
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| 44 | 2021-01-06 | sleep disorder |
tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BIL...
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tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BILATERALLY - felt like she was going to pass out and have diarrhea and vomit at same time - these symptoms awakened her from sleep at 11:45pm; sxs lasted about 15 minutes and then abated; tingling in 4th/5th fingers BILATERALLY persists today- though much less intense - reports at level of 1/10; never did vomiting and never had diarrhea; never passed out; feeling well today - able to run 4 miles and teach yoga and work at a physical therapist
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| 44 | 2021-01-07 | anxiety, feeling abnormal |
Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became ha...
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Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became hard to breathe, my fingers were tingling and my mouth got very dry. I pulled over and called 911. The paramedics stated my BP was within normal limits of around 140/80. My normal is closer to 90/65. Once symptoms resolved I attempted to drive home. Once again, the same symptoms returned. I pulled over. I then made my way to a safe location and waited for family to come. Since the event I have had times of mild labored breathing while walking. While driving I become very anxious and the feelings of an anxiety attack return. I saw my nurse practitioner 2 days ago who referred to the driving anxiety as a form of PTSD and prescribed Prozac and Xanax. I have not take the Xanax, but have taken two nighttime doses of Prozac. Yesterday, I did not feel as though I had taken medication. My drive to work was uneventful. My drive home involved tightening of the chest, labored breathing and anxiety. This morning I cannot tell if I am feeling the vaccine or Prozac in my system, but I feel off. Swimmy headed, watery mouth, heaviness in my arms and shoulders. I need guidance on taking the 2nd vaccine or if I should seek further medical treatment. I have added a vit B vitamin a day to my regimen since the date of the vaccine.
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| 44 | 2021-01-07 | impaired work ability |
FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, L...
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FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, LOSS OF APPETITE , PAIN AT VACCINATION SITE, LEFT AXILLARY PAIN ON ABDUCTION. UNABLE TO GO TO WORK DUE TO SYMPTOMS
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| 44 | 2021-01-07 | loss of personal independence in daily activities, sleep disorder |
Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at inject...
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Pfizer-BioNTech COVID-19 Vaccine EUA Given at Hospital L upper arm has been achy / painful at injection site and has not gone away, gets worse with some motions, has not been red or swollen Makes dressing, reaching, dishes, laundry, putting on a backpack, working with patients all painful (I am a physical therapist in the hospital) I have an old injury to the long head tendon of my biceps in the L arm and originally thought it just flared that up for some reason, but the pain is also more lateral by the injection site I have been resting it, trying not to aggravate it, using some tylenol as needed for sleeping as positioning is hard lately, and it's been hurting more towards the end of the day It is not getting better, and I feel like may be getting a little worse. I am going to start icing it this weekend too. It is starting to affect how I do my daily activities and my job - I am considering going to the doctor
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| 44 | 2021-01-07 | sleep disorder |
Beginning at 10:30 pm, I had severe chills and body aches through the night. It felt like the flu bu...
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Beginning at 10:30 pm, I had severe chills and body aches through the night. It felt like the flu but no fever. I slept until 1:30 the next day (1/6) I noticed a rash on the outer border of my left shoulder blade around 1:30 on 1/6. I was tired but ok the rest of 1/6. I felt totally normal on 1/7.
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| 44 | 2021-01-08 | anxiety |
Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medic...
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Patient was extremely anxious prior to vaccine. She told me she did get seizures but she took medication for it and I informed her that it would still be recommended to get the vaccine. She was visibly anxious even after vaccine. Immediately after she began crying to her friend and said she "was just SO afraid of needles". I told her to take some deep breaths and after a minute or two she went to the observation room. Approximately 15 minutes later she rushed back into the room looking like she might hyperventilate or have hypoglycemia (shaking, cold sweats). She sat down and I tried to calm her down. I asked someone to get her orange juice. During the next couple minutes she did not seem to be getting any better and started shaking. I requested someone call 911. Another staff was helping so I moved to get and administer an epi-pen injection. By this time the patient was not responsive, but was still breathing. I instructed staff to help move her to the floor for monitoring and if needed, cpr. She regain partial consciousness. Her breath and pulse were always present, so there was no need to begin cpr. After a few minutes EMT arrived and transported patient to local hospital. During all of this, other employees at the facility were attempting to contact family members, which they were eventually able to do. About 30 minutes later the staff informed me they had spoken to family members who were at the hospital and that she was improving, but they had not seen her yet.
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| 44 | 2021-01-08 | impaired work ability | Dizziness, Headache & NauseaVomiting Narrative: Need to stay home due to N/V, missed work day. |
| 44 | 2021-01-09 | feeling abnormal |
Large, lemon size swollen area in the axillary armpit. Area is marshmellowy feeling, not hard nor l...
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Large, lemon size swollen area in the axillary armpit. Area is marshmellowy feeling, not hard nor lumpy. Area aches and appears to be growing in size
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| 44 | 2021-01-09 | memory impairment |
I am not sure if related on not. This event was 13 days after my COVID-19 1/2 immunization. Otherwis...
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I am not sure if related on not. This event was 13 days after my COVID-19 1/2 immunization. Otherwise, I am a very healthy physician, normal BMI, I have also been tested 5-6 times negative for COVID. I do get exposed in my job, but wear proper PPE. Viral infection in FEB that was like COVID-19 sx, I did AB test as soon as it was available, and negative. ---The Event: Monday morning (1/4/21), after getting out of shower, I was talking to my husband (who is MD)and started having BROCA's aphasia sx (could not get words out coherently), then fell into bed and started right wrist and right foot posturing. This lasted 10 min. I have non-memory of it, but my MD husband witnessed it. After 10 minutes, I was back to normal, except shaky and some word finding difficulties. After 30 min, totally back to normal.
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| 44 | 2021-01-10 | feeling abnormal |
Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tin...
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Pt states she started feeling "wierd" about 15 min after the injection. She states she felt some tingling on her face and then after 5 more minutes she said she felt her throat tingling. Our safety officer who is a DR was called ans ordered a dose of epinephrine 0.5 ml to be given and then call the EMS.
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| 44 | 2021-01-10 | feeling abnormal | Light headedness, Foggy head, body ache, swelling in the axilla for 3 days after injection |
| 44 | 2021-01-11 | nightmare, excessive sleepiness, nervousness, sleep disorder, sensation of foreign body |
Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm follow...
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Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm followed by numbness and tingling (pins and needles), a few minutes later I experienced a dull headache. The arm sensation slowly subsided by the time my fifteen minutes was up. The dull headache lasted through the night Around 9 pm, I experienced chills, that lasted for 2 days with body aches and sore right and left arm. During the night, I had a hard time sleeping experiencing nightmares. Woke up at 2 am took a walk felt a little better. Chills continued throughout the night. Friday- chills continued with body aches and a general feeling of malaise. Temp was 98.7 at highest, bp 122/79, hr 80, and blood sugar 149, I have no hx of diabetes. Saturday- "hungover feeling" - headache that came in waves with a general feeling of malaise. Sunday- Pounding headache, extreme fatigue-slept until 1500 woke up and then went back to bed, body aches-worst I have felt in years. Monday shaky feeling somewhat better still malaise. Tuesday vomited all my breakfast, feeling of phlegm or something stuck in my throat. BP 120/77 hr 64 temp 98.4. Continued body aches.
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| 44 | 2021-01-11 | nightmare | Uncontrollable chills, achiness, headache, nightmares |
| 44 | 2021-01-12 | feeling abnormal, feeling drunk |
About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't...
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About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't feel right." No SOB. C/o 7/10 migraine headache. Nausea but no vomiting. Frontal lobe pain. Dizzy. Felt like she was drunk. BP 136/29, HR 79. Became slower to respond to questions and a rapid response was called. Transported to ED for observation where patient received acetaminophen 975mg po x 1 and metoclopramide 10mg po x 1. Patient declined NS 1L bolus. Per ED note, patient presented with likely vasovagal episode after receiving COVID-19 vaccination. Patient's symptoms improved and patient was discharged home.
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| 44 | 2021-01-12 | feeling abnormal |
numbness to forearm then to lower leg that then took on a dermatomal pattern, brain fog w word findi...
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numbness to forearm then to lower leg that then took on a dermatomal pattern, brain fog w word finding issues that progressively worsened, LLE weakness. ct brain neg. MRI/MRA head and neck neg. labs neg. MRI of c spine t spine l spine s spine neg. emg and eeg neg. discharged from hospital. symptoms fluctuating. slowly improving.
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| 44 | 2021-01-12 | impaired work ability, feeling abnormal |
18 hours after second dose I had Temp 99.0, chills, body aches, fatigue, headache not relieved by Ty...
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18 hours after second dose I had Temp 99.0, chills, body aches, fatigue, headache not relieved by Tylenol or Advil, injection site pain. The symptoms were so severe that I was unable to go to work this morning. I have a headache, fatigue, feel foggy, and injection site pain still.
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| 44 | 2021-01-13 | anxiety |
"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild ...
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"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild soreness to back of tongue. sent for obs. took zyrtec, tylenol prior to getting vaccine. eupneic, a/ox4, skin w/d. no distress" Blood pressur 160/91
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| 44 | 2021-01-14 | anxiety | Nausea, Dizziness, anxiousness, elevated Blood pressure, dry mouth, tachycardia |
| 44 | 2021-01-14 | feeling abnormal, panic reaction |
Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the c...
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Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization. Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested.
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| 44 | 2021-01-14 | feeling abnormal |
feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm...
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feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed; chest pain; chest pain, going into her back, on her left side; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, NDC number: 5926710001), intramuscular on 07Jan2021 (around 10ish in the morning) at single dose at right arm for covid-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. At the beginning of the week, patient had some vertigo but when she went in for her second vaccine, the vertigo was gone already. There were no concomitant medications. There was no adverse event following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC: 59267100002 Lot: EH9899) intramuscular on 17Dec2020 at single dose at right arm for covid-19 immunization. Patient received the second dose of the vaccine in the morning, around 10 something on 07Jan2021 at the hospital she worked at. She started feeling badly around 7:00 at night 07Jan2021 with chills, 101.6 fever, terrible muscle aches, a headache. Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed. She was having chest pain, going into her back, on her left side. When probed for the outcome of these symptoms, patient stated she had a fever, but not quite as high. She had been taking paracetamol (TYLENOL) and it was not helping. Patient provided the following product information for the paracetamol she was taking: TYLENOL, 500mg NDC: 6984270778 Lot: 9MR0454 Expiry date: Oct2021. The back pain/muscle pain was still there. She had chills but not as badly. The soreness in her arm had improved. Her arm was still sore, but not like it was yesterday. Outcome of events feeling badly, headache and chest pain was unknown, outcome of events chills, fever/ 101.6 fever, arm was so sore she couldn't even move it was recovering, outcome of events back pain/muscle pain was not recovered. The report is considered as non-serious. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. History of all previous immunization with the Pfizer vaccine considered as suspect. No further information was provided or obtained.
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| 44 | 2021-01-15 | feeling abnormal | Fever 100 at 24hrs after shot Chills 6hrs Aches 24 hrs Joint pain 24 hrs Brain fog 1-2 days |
| 44 | 2021-01-15 | impaired work ability | Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: missed work 1/8/2021 |
| 44 | 2021-01-15 | sensation of foreign body |
About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed heada...
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About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed headache, dizziness, felt something stuck in throat and difficult to swallow. Also acid reflux. Sent to ER. B/P 170/98, still had feeling of difficulty swallowing, headache and acid reflux. Was given Tylenol, Pepcid and Ativan. After several hours B/p was normal and had slight headache when I went home. Following day felt tired and still with headache. Tylenol not helping.
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| 44 | 2021-01-16 | feeling abnormal | Extreme lethargy, nausea, ?foggy brain? |
| 44 | 2021-01-17 | impaired work ability |
Symptoms began January 10, 2021, and included severe vertigo / dizziness with vomiting. Symptoms ha...
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Symptoms began January 10, 2021, and included severe vertigo / dizziness with vomiting. Symptoms have persisted, despite treatment with antivert, zofran, and phenergan. I am unable to walk without assistance. I am unable to drive and unable to work at this time.
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| 44 | 2021-01-18 | impaired work ability | fever, joint pain, muscle pain, eye pain. called in sick to work. |
| 44 | 2021-01-20 | impaired work ability, sleep disorder |
near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for C...
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near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for Covid 19; lost weight; No sense of taste or smell; No sense of taste or smell; losing hair; heart rate started increasing; high blood pressure; Increased cough; Sleepy; tired; Headache; This is a spontaneous report from a contactable other healthcare professional (patient) through the Medical Information Team and Pfizer-sponsored program Pfizer First Connect. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly on the arm on 19Dec2020 11:15 at a single dose for COVID-19 immunization. Medical history included tachycardia and stroke from 2019 and diabetes mellitus diagnosed in summer of 2020 and ongoing. Family medical history included father had type 2 diabetes. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET) for diabetes. The patient previously took regular flu shot and had body aches; it did not happen at the year of report but in years past she did have it. The patient took the COVID vaccine for precaution as she was a healthcare worker/paramedic and stated there was no prescriber. She received the vaccination at a health department facility, not a military facility. She had no previous immunizations and no additional vaccines were administered on the same date as COVID-19 vaccine. The patient received her first dose of COVID-19 vaccine on 19Dec2020 and after nine days, she tested positive for COVID-19 on 30Dec2020 and had an inpatient hospital stay. She mentioned she was so happy that she did not have any symptoms for those days. She stated that she got the shot on the 19th and later that evening was when she started having symptoms. She tried to sleep and it woke her up, she felt sleepy, tired and experienced headache on 19Dec2020 20:00 to 21:00. On 28Dec2020 23:00, she had an increased cough. She initially had increased cough from wearing mask and was having post nasal drip, then she got wet cough and that was when she decided to get tested. She went back and forth on dates; stated she was confused with the dates because of being in the hospital, it had been a while and the dates were all meshing in together. Her specimen was collected and they did the test on 29Dec2020 then found out that she tested positive for COVID virus with a COVID test nasal swab on 30Dec2020 17:30. She mentioned she lost weight after she got COVID, had no sense of taste or smell on unspecified dates. She did not know if it was related to her thyroid but she started losing hair and her heart rate started increasing on Monday, so they took her off all her meds and said the COVID was doing crazy things to the body. She had to go on Carvedilol for the sinus tachycardia and had high blood pressure now. This was all new after she tested positive. She has had bouts of tachycardia before and did have a heart monitor as she had a stroke last year. So those have never been persistent or symptomatic. If she did have a high heart rate, it always went down. This one was symptomatic. She did fine the whole week after the shot, just had that little bit of sleepiness, was tired, and had a headache. The patient reported near syncope with sinus tachycardia due to COVID-19 and hypothyroidism on 08Jan2021 14:30 to 15:00, which required hospitalization from 08Jan2021 to 10Jan2021 (2 days). ER or physician's office was required. She never went to the ER for the vaccination, it was just for the near syncope with sinus tachycardia due to COVID-19 and hypothyroidism that she went and was then admitted to hospital. She just got out of the hospital the day before report (10Jan2021), was there for two days and was still recovering. She was supposed to receive her second vaccination on the day of report however her doctor did not know if she should get the second dose due to double antibodies. She did not ask if she still had the virus or it went away. She has not been to work in two weeks. Outcome of the events tested positive for COVID virus was not recovered; near syncope with sinus tachycardia due to COVID-19 and hypothyroidism was recovered with sequel; sleepy, tired and headache was recovering; while the remaining events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-21 | insomnia |
Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye...
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Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye bloody Abdominal pain for 3 days unable to sleep due to discomfort Nausea off and on for 3 days with abdominal pain Fatigue Faint with abdominal pain Light headed off and on
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| 44 | 2021-01-24 | insomnia |
Woke up from sleep at 3:02am (13hrs post injection) Severe headache (most prominent at base of neck,...
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Woke up from sleep at 3:02am (13hrs post injection) Severe headache (most prominent at base of neck, behind eyes, and top of head) throbbing pain. Hurt to move eyes. Photosensitivity (eyes must remain shut at all times) Nausea, fever (102.3), sweats, chills Severe body aches (most prominent in lower back, hips, and legs/knees) Tylenol/ibuprofen alternating (reduced pain down to 4/10) 1st applied ice to lower back and surrounded head. This allowed me to sleep for almost 4 hours. Then applied heat to lower back. Continued to drink normally and eat bland diet These symptoms lasted all day. Around 11:30pm on 1/25 symptoms resolved with the exception of a headache requiring ice packs again throughout the night and tylenol. 9:22am today, still mild headache and get dizzy or a vertigo feeling if I change position too quickly or rotate my head too quickly
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| 44 | 2021-01-25 | feeling abnormal |
Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, hea...
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Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old female patient received (not pregnant) her first dose of bnt162b2 (BNT162B2 also reported as Covid 19brand Pfizer BioNTech, lot EJ1685), intramuscular in the left arm 22Dec2020 10:00 at SINGLE DOSE for Covid-19 immunisation. She received the vaccine in a hospital. Medical history included covid prior vaccination: Yes. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced chills, low grade fever, body aches, headache " brain fog" on 23Dec2020 01:00. No treatment was given. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-01-26 | anxiety |
Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing...
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Patient described feeling flushed and hot all over, some tightness in the chest, anxiety and ringing in her ears, tension in her neck and arm in the left side where she received the vaccine. Took her pulse and lay her on a cot, gave her water. After about 20 minutes of rest, she felt well enough to drive home.
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| 44 | 2021-01-26 | feeling abnormal | Cold chills, fever, throwing up,diarrhea,extreme headache and body aches |
| 44 | 2021-01-26 | insomnia |
arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior c...
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arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior clavicular region; Fever (99.9 at highest); chills; first dose was received on 27Dec2020/2nd dose on 13Jan2021; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date:May2021), via an unspecified route of administration on the left arm on 13Jan2021 13:30 at single dose for covid-19 immunisation. The first dose was received on 27Dec2020 13:30 on the left arm, Medical history included hypertension, anxiety, GERD (gastrooesophageal reflux disease) and insomnia. Concomitant medication included atenolol, omeprazole (PRILOSEC), hydroxyzine hydrochloride (VISTARIL) and unspecified multivitamins. The patient previously took neomycine and experienced drug hypersensitivity. The patient experienced fever (99.9 at highest), chills, arthralgia, fatigue, insomnia, soreness at site of injection, swollen lymph nodes on left anterior clavicular region on 14Jan2021 05:45. No treatment was given for the events. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The reporter considered the events non-serious.
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| 44 | 2021-01-27 | feeling abnormal |
fever; hip pain; 'pretty intense joint pain, felt like it was on fire; She feels ''like death today"...
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fever; hip pain; 'pretty intense joint pain, felt like it was on fire; She feels ''like death today"/she did not feel good; Chills; This is a spontaneous report from a contactable nurse. A 44-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248) intramuscular on 14Jan2021 single dose for COVID-19 immunisation. Vaccine location was deltoid left. No other vaccine was received in four weeks. The patient medical history was not reported. Historical vaccine included first dose of BNT162B2 (Lot: EL1284) received on 28Dec2020 around 7pm, intramuscular injection right deltoid. There were no concomitant medications. The patient experienced fever (she woke up with a fever of 101.3 at 6am), pretty intense 'joint pain, felt like it was on fire' on 14Jan2021; with the first dose of the covid vaccine she had really bad hip pain about 24 hours after (as reported) and it lasted about 12 hours but she could still walk and move, it was just annoying. The patient was ''like death today"/ she did not feel good' on 14Jan2021, chills on 14Jan2021. Her temperature has improved and it is around 99. The outcome of fever and chills was recovering, of 'pretty intense joint pain, felt like it was on fire' was recovered on 15Jan2021, of she feels 'like death today'/ she did not feel good and hip pain was unknown.; Sender's Comments: A possible contributory effect of suspect BNT12B2 on reported fever cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-27 | feeling drunk |
I was just hot, I got hot; Hands started hurting; Really bad headache; Feeling kind of boozy; This i...
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I was just hot, I got hot; Hands started hurting; Really bad headache; Feeling kind of boozy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included high blood pressure and diabetic. Concomitant medications included lisinopril for high blood pressure, metformin for diabetes, and amlodipine. Today (11Jan2021), the patient just got hot and her hands started hurting. She was just feeling kind of boozy. She really had a bad headache. The patient was thinking why the lady didn't ask her if she was taking any medication or anything, she just asked if the patient was allergic to anything. The patient was not allergic to anything but she was taking medications. The patient asked if she should go and take her medication for tonight or hold until her symptoms go away. No treatment was received for the adverse events. The patient just lied down and have been sleeping for two hours. Outcome of the events was unknown.
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| 44 | 2021-01-28 | impaired work ability, insomnia |
The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hou...
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The 2nd injection was done much lower in the arm than the first one. Extreme pain started within hours of injection, could not touch my arm. The pain radiates from the shoulder to finger tips with sharp shooting, stabbing pains at times. A lot of pressure. There is a burning feeling from my shoulder to finger tips. By the end of day on 01/18/2021, I had decreased range of motion in my arm, it is difficult and very painful to try and extend my arm out to the side, which continues to today 01/29/2021.. My entire arm is still tender and sore, tricep, bicep, and shoulder. It is difficult to sleep and work due to the pain.
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| 44 | 2021-01-28 | impaired work ability |
Had the common side effects: headaches, fevers up to 101.5, severe body aches, fatigue in the the mo...
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Had the common side effects: headaches, fevers up to 101.5, severe body aches, fatigue in the the morning after the shot, but also had concurrent severe vomiting and nausea. Vomited approximately 20 times day after the vaccine, starting about 18 hours after the vaccine. Other symptoms were present about 13-14 hours after the vaccine. Vomited continued for 14 hours. Severe nausea continued for 2-2.5 days. No diarrhea. No abdominal pain. Too weak to drive to the ER. Had Zofran at home and took 8 mg of Zofran ODT every 4-6 hours for 36 hours beginning with the onset of vomiting. Missed 3 days of work but was able to orally rehydrate.
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| 44 | 2021-01-29 | impaired work ability, hallucination |
At around 530 pm Friday I had extreme tiredness, felt feverish, was freezing. Took advil and laid o...
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At around 530 pm Friday I had extreme tiredness, felt feverish, was freezing. Took advil and laid on couch. Fell asleep, per family hallucinated. About 1 to 2 hours later I could not smell.
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| 44 | 2021-01-31 | feeling abnormal |
Soreness at injection site within 1 hour. Swelling at injection site within 1 hour pain and swelling...
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Soreness at injection site within 1 hour. Swelling at injection site within 1 hour pain and swelling continued until Thursday (4 days later). Feeling ?off? or unwell without any other symptoms -3 hours after injection and lasted until 5:00pm next day when symptoms increased. Starting 5:45pm Lethargy, shaking all over, feeling of ?freezing ?, upset stomach, fever of 101- continued into the evening. Fever resolved with Advil and rest. Shaking and upset stomach stopped sometime overnight. Feeling very tired next day.
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| 44 | 2021-02-01 | crying |
Migraine that was so sever just moving my head would make me cry or cause me to throw up. Extreme n...
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Migraine that was so sever just moving my head would make me cry or cause me to throw up. Extreme nausea and chills Lasted for one day
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| 44 | 2021-02-03 | feeling abnormal |
Tiredness; headache; felt out of it; tingling tongue and lips; tingling tongue and lips; body spasms...
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Tiredness; headache; felt out of it; tingling tongue and lips; tingling tongue and lips; body spasms in abdomen throughout the night; This is a spontaneous report from a contactable other healthcare professional, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3248, via an unspecified route of administration on 18Jan2021 at 10:15 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Fluoxetine hydrochloride (PROZAC), valaciclovir hydrochloride (VALTREX), Cetirizine hydrochloride (ZYRTEC ALLERGY) all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took iodine and experienced drug allergy. On 18Jan2021 at 12:00, the patient experienced tiredness, felt out of it, tingling tongue and lips, headache, body spasms in abdomen throughout the night. The patient did not receive any treatment for the events. The clinical outcomes of tiredness, felt out of it, tingling tongue and lips, headache, body spasms in abdomen throughout the night were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-02-03 | feeling abnormal |
Dizziness, nausea, Fainting, extreme headaches, brain fog, impacted depth perception, extreme muscle...
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Dizziness, nausea, Fainting, extreme headaches, brain fog, impacted depth perception, extreme muscle pain, knots in large muscles, diarrhea.
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| 44 | 2021-02-04 | anxiety |
rapid heart beat; severe anxiety; This is a spontaneous report from a contactable healthcare profess...
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rapid heart beat; severe anxiety; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 20Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included allergies: artificial orange in food and anxiety. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) for birth control. The patient previously took first dose of BNT162B2 for covid-19 immunization on an unspecified date; and ammonia and experienced allergies. The patient was not pregnant at the time of vaccination. On 20Jan2021 14:00, the patient experienced rapid heartbeat and severe anxiety. The patient didn't go to the hospital and just worked through it herself as she has anxiety anyway. This lasted for about 4 hours. The patient did not receive treatment for the events. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on 20Jan2021.
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| 44 | 2021-02-04 | sleep disorder |
Stayed home with fever and body aches first day. Second day radiating pain in arm, back, left should...
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Stayed home with fever and body aches first day. Second day radiating pain in arm, back, left shoulder, arm pit and under rib cage. Itching and could not sleep. Can touch, turn or sleep on her left side.
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| 44 | 2021-02-05 | sleep disorder, feeling abnormal |
At 7pm, i experienced chills, shivering, head fuzziness, muscle aches and right arm pain. At 9pm, ex...
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At 7pm, i experienced chills, shivering, head fuzziness, muscle aches and right arm pain. At 9pm, experienced fever, headache and numbness in my finger tips. Took ibuprofen 600mg. Did not see any improvement for an hour. Went to bed at 12:30. Awoke at 3am with same symptoms. Took ibuprofen 600mg at 6am. Symptoms came back 1:30pm that day. Took another ibuprofen 600mg. The rest of the evening was good except for a headache.
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| 44 | 2021-02-05 | sleep disorder |
Received injection at 9:15 AM and that same day at 6:00 PM starting feeling a headache. At 4:00 AM ...
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Received injection at 9:15 AM and that same day at 6:00 PM starting feeling a headache. At 4:00 AM on 2/5/21, woke with body aches, severe headache, and significant fatigue. Took Tylenol morning of 2/5/21 which helped some and the side effects lessened throughout the day. Woke with only mild headache on 2/6/21.
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| 44 | 2021-02-07 | feeling abnormal |
Feeling ichy/unwell within 2-3 minutes post vaccination. Feeling dizzy and weak, flushed skin, overw...
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Feeling ichy/unwell within 2-3 minutes post vaccination. Feeling dizzy and weak, flushed skin, overwhelming fatigue, out of it. Administered lactated ringer and famotidine Potential vasovagal response. Felt improved within 2.5 hours 48 hours later began abdominal pain (7/10) and diarrhea lasting 36 hours, with diminishing severity of pain and volume of diarrhea; mild nausea without vomiting. Treatment includes Allegra every 12 hours and Naproxen Sodium.
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| 44 | 2021-02-08 | anxiety |
Started with headaches on 4th day out from vaccine. By that Sunday I was lethargic, had pains throug...
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Started with headaches on 4th day out from vaccine. By that Sunday I was lethargic, had pains throughout my body, zaps of pain, inflammed joints, anxiety, Stomach/acid reflux, Pains/aches in body - short temporary pains, Electrical like pulses of pain in head left front side mainly, also in right hand, felt weak - no energy, Legs felt a bit numb or tingly, hips and lower back feel tender, knees too
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| 44 | 2021-02-08 | insomnia |
Dizziness onset approximately 30 minutes after shot, resolved after laying down for a while. Develo...
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Dizziness onset approximately 30 minutes after shot, resolved after laying down for a while. Development of fever, body aches, and chills by about 10 pm. Fever went from 99.5 at 10 pm to 103 at 5 am (was wrapped in blankets to try to control chills). Attempted to bring fever down with cold washcloth and drinking ice water, which dropped it to 101 within an hour, but then it went back up to 102.7 at about 6:30 am. Chills have somewhat improved, muscles still quite tender. I did not sleep all night secondary to these symptoms.
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| 44 | 2021-02-09 | anxiety |
warm sensation; anxiety; sore arm; This is a spontaneous report from a contactable consumer, reporti...
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warm sensation; anxiety; sore arm; This is a spontaneous report from a contactable consumer, reporting for herself. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration at the right arm on 23Jan2021 17:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. On 23Jan2021 17:30, the patient experienced warm sensation, anxiety and sore arm. No treatment was received. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date. Information on the batch/lot number has been requested.
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| 44 | 2021-02-09 | disturbance in attention, feeling abnormal, loss of personal independence in daily activities, memory impairment, sleep disorder, mental impairment |
Severe myalgias started during sleep the night of the vaccine administration. Next day myalgias per...
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Severe myalgias started during sleep the night of the vaccine administration. Next day myalgias persisted & worsened and brain fog started (difficulty/inability to perform ADLs, memory lapse, difficulty thinking, concentrating, forming sentences, functioning very slow, etc). Throughout the day severe headache set in, myalgias persisted and brain fog worsened. By 8-9pm symptoms were extreme, took about 1000mg of expired Children's Tylenol. By 11pm myalgias improved. Slept through night. Next morning all symptoms had resolved.
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| 44 | 2021-02-09 | feeling abnormal, insomnia |
fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. b...
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fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue. bp 129/93 heart rate 115. Headache with flush face and arms and legs super heavy feeling on Sunday. Tuesday night experienced facial and head swelling, started in the middle of my forehead gradually filling up my entire head and face. Wednesday my whole face/eyes and head swollen, with tightness on my chest. My primary care provider prescribed methylprednisolone tablets USP Dosepak 4mg. I did take Benadryl and tylenol Tuesday. I also applied ice packs to my head and face. Headache still comes and goes with brain fog. Slight swelling remains on my forehead and eyes.
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| 44 | 2021-02-09 | feeling abnormal |
Staff stated that she was assisting a client registration at a vehicle so she was walking and talkin...
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Staff stated that she was assisting a client registration at a vehicle so she was walking and talking at which time she felt an aura coming (fogginess/lightheadedness, nausea, feeling faint), Staff stated that she received the vaccine the day before and was starting to feel symptoms. Staff was visibly pale and advised to sit down. Staff asked to be laid on the ground because she felt faint at which time onsite life guards were notified. Blood glucose, Blood pressure, pulse rate and O2 saturation all monitored and with in normal limits. Staff stated that the symptoms were starting to resolve and asked to sit in chair. Another set of vitals was taken while the client was sitting and all vitals were with in normal limits. Patient's son (emergency contact) was notified and arrived onsite. Staff stated she felt better and was going to go home and lie down. Escorted to son's vehicle by wheelchair. Staff notified supervisor when she arrived home and per supervisor staff stated she was feeling better.
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| 44 | 2021-02-09 | excessive sleepiness |
I went to sleep for four hours when I woke up I had a hard time walking. My legs were sore for abou...
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I went to sleep for four hours when I woke up I had a hard time walking. My legs were sore for about 24-36 hours. I was very tired for about 7 days all I did was sleep.
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| 44 | 2021-02-10 | confusional state |
Severe myalgia; severe arthralgia; severe Headache; rigors; extreme fatigue; chest pain; palpitation...
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Severe myalgia; severe arthralgia; severe Headache; rigors; extreme fatigue; chest pain; palpitations; tachycardia; Confusion; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on the right arm on 12Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included arthritis, B12 deficiency and Allergies: Wasp venom. The patient previously received first dose of BNT162B2 on an 21Dec2020 for COVID-19 immunization (first dose, intramuscular, right arm). Concomitant medication included paracetamol (TYLENOL) and cyanocobalamin (B 12). On 12Jan2021 19:00 PM, the patient experienced severe myalgia, severe arthralgia, severe Headache, rigors, extreme fatigue, chest pain, palpitations, tachycardia. Confusion. Fatigue began approx 6 hours post injection. Other symptoms culminated at around 12 hours post injection. Severe symptoms lasted approx 24 hrs with moderate symptoms following for another 48 hours, followed by mild symptoms for another 12 hours. No treatment was received for the events. Events were reported as non-serious: did not result in death, not life-threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 44 | 2021-02-10 | feeling abnormal |
Tingle to face started about 4 hours after dose, was ongoing a few hours then off and in for 1-2 day...
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Tingle to face started about 4 hours after dose, was ongoing a few hours then off and in for 1-2 days. Extremely tired with brain fog started evening of second shot and has been ongoing. Just starting to improve after 4 weeks.
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| 44 | 2021-02-10 | impaired work ability |
Right eye doesn't close all the way when blinking or closing symptoms started 2/6/21 also couldn't k...
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Right eye doesn't close all the way when blinking or closing symptoms started 2/6/21 also couldn't keep mouth closed shut tight to swish after brushing teeth same night. Headache above right eye, right ear pain and right side neck pain all starting 2/6/21 morning. Had televisit on 2/8/21 who advised me to be further checked out. At the er they did an head ct without contrast which was normal did a neuro exam and determined I had bell's palsey. Prescribed prednisone 20 mg tid x 7 days and valacyclovir 1 gm tid x 7 days. They also advised to tape my eye shut when sleeping. My eye hurts when I drive or focus on pc or tv so I had to miss 2 days of work thus far.
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| 44 | 2021-02-17 | feeling drunk |
The evening of her vaccine she developed jittery feeling (worse than having too much caffeine), felt...
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The evening of her vaccine she developed jittery feeling (worse than having too much caffeine), felt like her muscles were jerking, feeling unbalanced and uncoordinated (almost fell on stairs) due to vertigo sensation and whole body weakness. A feeling of being both "drunk and high". Word finding has been harder, but this is part of her baseline. Some numbness into left hand, 4th and 5th digits only.
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| 44 | 2021-02-17 | sleep disorder |
Major chills start 10pm.. lasted most of night. Took Motrin .. tossed and turned will chills with ch...
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Major chills start 10pm.. lasted most of night. Took Motrin .. tossed and turned will chills with chattery teeth until about 3pm slept an he and a half and chills agains. 9a motrin fever of 102.2.. headache arm sore all over upper arm! Motrin at 2pm headache stopped fever also
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| 44 | 2021-02-18 | anxiety |
Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine, ...
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Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine, developed palpitations, chest pressure, feeling flushed and anxious, nausea, tingling on left side of body and face, elevated blood pressure, and slight dizziness while driving home. Was seen at ER a few hours later; cardiac workup was done with CXR, bloodwork, EKG and heart monitoring and was treated with Benadryl IV. Was sent home for 2 days out of work and instructed to take Benadryl as needed.
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| 44 | 2021-02-21 | impaired work ability |
I started feeling really tired (couldn't move type tired). I called off worked for few days. On the ...
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I started feeling really tired (couldn't move type tired). I called off worked for few days. On the 1/7 noticed right of my face was drooping about 10 days couldn't smile and wiggle both ears.For me to talk it was very difficult due to right side of my face being so weak. I went to walk in clinic was diagnosed with Bell's Palsy. As of today I still couldn't lift my eyebrow (right) and smile still slightly cooked.
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| 44 | 2021-02-23 | loss of personal independence in daily activities |
Enlarged painful lymph nodes on right side neck and body under arm. Hot arm, diarrhea, extreme fati...
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Enlarged painful lymph nodes on right side neck and body under arm. Hot arm, diarrhea, extreme fatigue, headache. My neck and underarm are still achy and enlarged. My body is still sore and I have not been able to continue with my daily activities. I have not felt like this since I had mono as a 19 year old. I have 5 children and have gone through natural childbirth 3 times. I?ve received all my vaccinations faithfully and have never in my life reacted this way. I am not getting the second dose until I have blood work done to see how my high my antibody levels are. I respect and am grateful for your work However I need to see data on my body?s reaction to even consider getting another dose.
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| 44 | 2021-02-24 | sensation of foreign body |
Had reaction with first dose. Given Benadryl 50 mg oral at 17:00 just prior to vaccine administratio...
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Had reaction with first dose. Given Benadryl 50 mg oral at 17:00 just prior to vaccine administration. Within 10 minutes of vaccine administration she developed scratchy throat, felt like lump in throat, then progressed to itching all over body, no visible rash, became nauseated and dizziness. Denied any SOB or tongue swelling. About an hour after vaccine given began to vomit. Patient then transported to ED for further evaluation and treatment. Admitted to ED at 18:25 where she received Decadron 10mg IV, Pepcid 20mg IV and Zofran 4mg IV. Vomiting resolved as well as chest tightness, dizziness, headache, throat itching resolved. She was dismissed from ED at 20:03.
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| 44 | 2021-02-24 | sensation of foreign body |
Woke up at 1 am with irritation in throat causing me to cough until I sat up . Throat just kept feel...
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Woke up at 1 am with irritation in throat causing me to cough until I sat up . Throat just kept feeling very scratchy and irritated and like something was ? stuck ? in the back of my throat . Tried drinking some water and continued trying to clear throat . Eventually took Benadryl 50 mg orally And if it didn?t improve was contemplating going to ER. Was able to fall asleep about an hour and a half later . When I woke up throat was still sore and scratchy feeling but didn?t feel like there was anything ?stuck ? anymore . Also had some mild itching on face especially my eyelids .
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| 44 | 2021-02-25 | anxiety |
Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening an...
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Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening and reported to RN that she was feeling lightheaded and dizzy after about 20 minutes of observation. States she is feeling slightly anxious. BP 160/96 pulse 108 sat 98%. Patient is not reporting any other symptoms. Patient reports a History of HTN and anxiety States she does not normally feel lightheaded/dizzy. States this BP is elevated for her. Patient given water and crackers, with slight relief of dizziness. EMS called and at pt side for evaluation. At 1212p, Bp 173/91, hr 94, sat 97% given cracker and water, which patient stated made her feel slightly better. EMS evaluating patient Emotional support provided. At 1220, BP 182/98, pulse down to 85, with sats at 95%. Patient feeling better. EMS transported patient to a quite space and continued to monitor. Patient speaking with husband as well. At 1242, EMS released stating patient feeling better and BP down to 160/90. Patient encouraged to discuss with PCP events. She was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening and reported to RN that she was feeling lightheaded and dizzy after about 20 minutes of observation. States she is feeling slightly anxious. BP 160/96 pulse 108 sat 98%. Patient is not reporting any other symptoms. Patient reports a History of HTN and anxiety States she does not normally feel lightheaded/dizzy. States this BP is elevated for her. Patient given water and crackers, with slight relief of dizziness. EMS called and at pt side for evaluation. At 1212p, Bp 173/91, hr 94, sat 97% given cracker and water, which patient stated made her feel slightly better. EMS evaluating patient Emotional support provided. At 1220, BP 182/98, pulse down to 85, with sats at 95%. Patient feeling better. EMS transported patient to a quite space and continued to monitor. Patient speaking with husband as well. At 1242, EMS released stating patient feeling better and BP down to 160/90. Patient encouraged to discuss with PCP events.
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| 44 | 2021-02-27 | feeling abnormal |
Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes ...
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Ear pain 2 minutes after injection Left arm completely numb 8 minutes after injection Hot flashes 10 minutes after injection Chest pain and tightness 15 minutes after injection Brain fog delayed movement thyroid meds left my system 20 minutes after injection
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| 44 | 2021-02-28 | confusional state, feeling abnormal |
1 minute after receiving the vaccine my face and tongue began to tingle. The tingling lasted 3 hour...
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1 minute after receiving the vaccine my face and tongue began to tingle. The tingling lasted 3 hours. 30 minutes after receiving the vaccine I felt confused and in a fog. That lasted 2 days. The following morning I also had flu like symptoms. Those lasted 24 hours.
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| 44 | 2021-02-28 | emotional distress |
Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin...
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Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
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| 44 | 2021-03-01 | feeling abnormal, panic attack |
I experienced palpitations, dizziness and I felt like I was having a panic attack within 5 minutes o...
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I experienced palpitations, dizziness and I felt like I was having a panic attack within 5 minutes of the vaccine. I took Adavan medication. The following day I felt extreme exhaustion and fatigue. I was unable to do my work because I was so tired and had brain fog. More importantly, panic, heart racing feeling that was concerning to me because I thought it was related due to my seizures. Had a consult to my PCP and neurologist and they are monitoring me due to my symptoms. This has happened to me three times. As far as my second dose I had no reaction to the vaccine.
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| 44 | 2021-03-02 | disorientation |
Impaired thinking, began about 2 hours after vaccination. It is still ongoing. Loss of appetite. Nau...
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Impaired thinking, began about 2 hours after vaccination. It is still ongoing. Loss of appetite. Nausea. Rapid heart palpitations. Went to ER three days after the vaccine. Was given fluids and sent home. Continue to feel disoriented and fatigued.
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| 44 | 2021-03-02 | disturbance in attention |
Dizzy, difficulty standing and walking, throat felt tight, breathing slowed down, trouble transferri...
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Dizzy, difficulty standing and walking, throat felt tight, breathing slowed down, trouble transferring thoughts to words
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| 44 | 2021-03-02 | impaired work ability |
2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side...
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2/25/21 11:36 AM Patient states that her symptoms (swollen around left eye to her throat, right side of her face feels fine, tight through, light bumpy rash on her chin) increased over the last hour and now do not seem to be getting worse. She is able to breathe without difficulty. She will take 50 mg Benadryl and if symptoms progress she will go to the ER for further treatment and evaluation of an allergic reaction to COVID vaccine. She will call Dr. back later and may need note for work. 2/26 11:30 AM Received text message from patient. "I woke up with trouble breathing, hives on my neck and jaw and swollen face. Nausea and diarrhea. Trouble swallowing so I took Benadryl. Swelling went down on face but still tight in throat. . Dr. "instructed her to go to ER if symptoms worsen and told her I would check on her on Monday. I asked her if her symptoms were not changed, worse, or improved. She answered: "They got worse this am from 5 to 10 and feeling better now. As far as swelling and breathing feels better. 3/1 10:21 AM Dr. Spoke with patient 10:21 am. She states that she is feeling much better and no longer has difficulty breathing or feeling of throat tightness. She does still have nausea, with occasional vomiting, and diarrhea. She felt well enough to return to work today. 3/3 11:09 AM Dr. spoke with patient. She stated that she is finally feeling "back to normal". We discussed severity of side effects and recommendation to defer 2nd Pfizer vaccination. She stated that at one point she was "close to going to the ER".
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| 44 | 2021-03-06 | sensation of foreign body | Lump in throat-cleared by EMS, resolved. |
| 44 | 2021-03-07 | feeling abnormal, insomnia |
generalized aches and pains; fatigue; head fog; hot and cold flashes; Nausea; vomiting; insomnia; Si...
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generalized aches and pains; fatigue; head fog; hot and cold flashes; Nausea; vomiting; insomnia; Site pain persisted; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265 and expiry date: unknown), via an unspecified route of administration on the right arm, 04Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included HTN and Asthma. Patient was not pregnant at the time of administration. Concomitant medication included Olmesartan, bupropion hydrochloride (WELLBUTRIN), loratadine and vitamins. The patient previously took sulfur and morphine and experienced allergies. Events began with insomnia the night of injection on 04Feb2021 23:00. The following morning of 05Feb2021, patient woke with generalized aches and pains, fatigue, head fog, and hot & cold flashes. She had nausea and vomiting midday. Symptoms resolved by second day on 05Feb2021 but site pain persisted on Feb2021. TYLENOL and ibuprofen were given as treatments for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination.
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| 44 | 2021-03-08 | anxiety |
patient received pfizer COVID19 vaccine and 10 minutes later complained of racing heartrate. checked...
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patient received pfizer COVID19 vaccine and 10 minutes later complained of racing heartrate. checked her blood pressure 147/102 HeartRate 117. Patient says she suffers from anxiety and was also feeling very anxious. no injection site reaction, no redness or swelling at injection site, no difficulty breathing. monitored patient and continued to check blood pressure. diastolic blood pressure and heartrate remained elevated last reading was 124/102 HR 108. Called her primary Dr who advised to monitor and have her come to office if blood pressure did not go down. Monitored her as instructed. HR and Diastolic BP was still elevated. Patient does suffer from high blood pressure as well as anxiety and after 1.5 hours went home to take her anxiety medication and continue to monitor her blood pressure at home and was instructed to go to doctor if blood pressure did not go down.
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| 44 | 2021-03-09 | nervousness |
Pt. stated she started feeling tingling in her fingers 5 min. after getting vaccinated. The tinglin...
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Pt. stated she started feeling tingling in her fingers 5 min. after getting vaccinated. The tingling on her fingers went away but she started feeling tingling in her knees. Vital signs were taken. O2 sat 100%, BP 134/63, HR 86. Patient stated she was nervous when vaccinated, but the tingling was new. At 3:53 pm patient stated the tingling is going away on its own. At 4:01 pm she stated she was feeling ok and is ready to go home.
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| 44 | 2021-03-10 | excessive sleepiness |
Within 4 hours on date of second dose (3/8/21) only felt tired and site injection soreness. 27 hours...
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Within 4 hours on date of second dose (3/8/21) only felt tired and site injection soreness. 27 hours after vaccine (3/9/21) I felt "unwell", out of sorts, very tired. at 31 hours I had body aches throughout my body, no energy, light headed, could not be up and about for more than a few seconds, no appetite. Slept for about 3 hours then went to bed officially from 8pm to 6am and felt 100% normal.
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| 44 | 2021-03-11 | depressed mood |
Within a minute of getting the vaccine, my throat closed off. I could still breathe, but it was hard...
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Within a minute of getting the vaccine, my throat closed off. I could still breathe, but it was hard. I also felt a strange sensation in my chest (this latter sensation I only remember feeling twice). The difficulty breathing came and went for about 15-30 minutes. The EMS was called, and they took my blood pressure, blood oxygen level, and listened to my lungs, heart, and throat. They said they sounded normal. After this, I waited at a parking lot for another 15-20 minutes. I felt a bit strange, but I could breathe better. They did not inject the EPI Pen.
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| 44 | 2021-03-11 | nervousness |
1447: Post vaccination approximately 20 minutes. Patient had c/o dizziness, feeling shaky, nauseate...
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1447: Post vaccination approximately 20 minutes. Patient had c/o dizziness, feeling shaky, nauseated, and light headed.
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| 44 | 2021-03-13 | anxiety |
The patient was anxious for a week before her second vaccine. After vaccination she again was anxiou...
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The patient was anxious for a week before her second vaccine. After vaccination she again was anxious but did not want to be transported. Her daughter who drove her said she was able to take her to her Dr. if the problem persisted. We ran an AMA and released her to her daughter. Pfizer Covid 19 EUA
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| 44 | 2021-03-14 | loss of personal independence in daily activities |
The day after receiving the vaccine I woke up with a lot of soreness in the arm of the injection sit...
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The day after receiving the vaccine I woke up with a lot of soreness in the arm of the injection site. I was tired and had some nausea that increased with activity. By early afternoon I was too tired to continue my daily activities and had to call out of work. Since receiving the vaccine, I have experienced fatigue and mild nausea daily that is only relieved by frequent rest.
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| 44 | 2021-03-14 | nightmare, insomnia |
Sleeplessness throughout the night.; aches with no fever 12 hours after the vaccination. / aches wi...
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Sleeplessness throughout the night.; aches with no fever 12 hours after the vaccination. / aches with no fever 24 hours after vaccination lasting 12 hours; Chills; Swollen lymph node in armpit of vaccinated arm 48 hours after vaccination.; Vivid nightmares 14 hours after vaccination.; This is a spontaneous report from a non-contactable other healthcare professional (patient). A non-pregnant 44-years-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3247, via an unspecified route of administration on 06Feb2021 09:45 (at the age of 44 years old) at SINGLE DOSE in the left arm for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had no allergies.Historical vaccine information included BNT162B2, Lot EL9269, on 16Jan2021 10:00 AM in the Left arm, Dose number 1. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Feb2021 21:00, the patient experienced chills and aches with no fever 12 hours after the vaccination, sleeplessness throughout the night. The chills and aches with no fever 24 hours after vaccination lasting 12 hours. Patient experienced vivid nightmares 14 hours on unspecified date in Feb2021 after vaccination. Patient experienced swollen lymph node in armpit of vaccinated arm 48 hours on unspecified date in Feb2021 after vaccination. No treatment was received for the events. Outcome of the vivid nightmares, Ache , Sleeplessness throughout the night, chills, Swollen lymph node in armpit was recovered in Feb2021. No follow up attempts are possible. No further information is expected.
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| 44 | 2021-03-15 | insomnia, feeling abnormal |
lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel ...
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lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel like golf balls was reported as worsened; lymph nodes under her arm pits and under her arm feel like golf balls/lymph nodes in neck swollen; Fever is 99.6 this morning; hurt all over from her toes to her fingers and from her fingers to her toes; lack of sleep; Headache; Chills; feels like wires are squeezing and pressing her/Feels awful; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 13:00 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia Diagnosed with it 5-6 years ago, ongoing chronic lymphocytic leukaemia Diagnosed almost a year ago. The patients concomitant medications were not reported. The patient experienced, lack of sleep on 05Feb2021 21:00. It was reported that she got the vaccine more than 48 hours ago. Stated that she feels awful on 05Feb2021 10:00. Stated that she has a fever on 06Feb2021, chills and headache on 05Feb2021 19:00, hurt all over from her toes to her fingers and from her fingers to her toes on 05Feb2021 22:00. Stated that she is in a lot of pain and that it feels like wires are squeezing and pressing her on 05Feb2021. Stated that it is horrible. Stated that the lymph nodes under her arm pits and neck feel like golf ball under arm and arm pit on 06Feb2021 12:00. Stated today the doctor will see her because it will have been 3 days in a few hours. Clarified that this is for the Covid vaccine. Stated that she is working in a retirement place with an older person. Stated that they decided to give to it to her. Stated that she asked her doctor and he told her that it was okay. Later clarified that the lymph nodes in her neck are just swollen and the lymph nodes under her arm pits and under her arm feel like golf balls. Stated that her fever is 99.6 this morning (06Feb2021). Stated that it improved when she took three Advil (600mg). Stated that she feels like wires are squeezing and pressing her again when the Advil wears off. Was told to alternate with Tylenol and is taking a lot of liquids. Clarified that she thought that the pain was fibromyalgia but that it felt worst than fibromyalgia. Stated that the lack of sleep improved because she takes a higher dosage of Advil or Ibuprofen for sleep. Outcome of the event fever is 99.6 this morning, hurt all over from her toes to her fingers and from her fingers to her toes, feels awful, lack of sleep recovering. Outcome of the event lymph nodes under arm feel like golf balls was reported as worsened (Condition worsened) was unknown. Outcome of the other events was not recovered. Information on the lot/batch number has been requested.
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| 44 | 2021-03-16 | excessive sleepiness |
High fever, extreme fatigue, slept over 30 hours, chest pains, chills, no energy, sore throat, both ...
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High fever, extreme fatigue, slept over 30 hours, chest pains, chills, no energy, sore throat, both diarrhea and vomiting for about 24 hrs, excruciating headache for three days
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| 44 | 2021-03-17 | anxiety |
Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to am...
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Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to ambulate to observation on her own and then signaled staff for help, felt hot, felt dizzy, felt nausea, staff immediately assisted to chair, RN @ side; inquired re food; had lunch; sips of beverage w sugar given able to eat cracker. She stated she felt better, was upright in her chair, no SOB, no complaints of swelling throat, itchy etc. After some initial sips of liquid, still feeling dizzy lowered to floor by staff w wedge cushion and legs and feet elevated above heart per protocol b/p 140/96 pulse 86. Stated she had been anxious re injection, but denied ever having this experience after injection. Additional information for Item 18: Reviewed the POD form questions again with her, denied any issues. She then stated she was feeling much better again, her warm feelings were going away from ice in a glove that we had used from her initial dizzy, warm/hot feeling. Around 3:30 she felt nausea again, so we sat her up and gave her a bucket to use to vomit if needed. She was unable to vomit. She wanted to sit up on floor. We sat with her and she sipped on clear beverage. She began to get cold. We put her legs back up took b/p 140/91 pulse 86. No change. We called nursing DON for District to make her aware and by that time patient experiencing chills. We called her husband to be on his way to drive her home after 30 minutes @ 3:45. She continued to tell us she felt better for a few minutes only to then tell us she was feeling nausea again. Rolled her to left side, helped her to prop us to vomit but she was unable to vomit anything. B/p readings 147/91, 150/90, 140/87,150/88She desired to sit upright again. So on floor with nurse holding and b/p cuff on sat her up to try to vomit, unable to do so. Lowered back to floor with legs upright where she remained local Paramedic on site and he came to assist, a portable recliner that allowed for legs to be elevated above heart was set up. Patient felt that she could transfer with paramedic and staff help and passed out while attempting briefly, chilling when she was alert, then passing out again; 911 was called and arrived by 3:55, patient and husband initially wanted to take patient home after hearing patient state she felt better once paramedics had evaluated her. However in front of husband, patient again passed out, and after she was conscious stated she could not feel her arms. and when he observed this he agreed it was best for her to be evaluated and then was transported to ER. Per phone conversation this morning, at 10:41 husband stating that patient still not able to stand without passing out on her own and they were continuing to evaluate her. No additional medication given on site at Mass vaccine site.
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| 44 | 2021-03-17 | feeling abnormal |
Waited the required 15 minutes after vaccine and done just fine. Started my drive back home and abou...
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Waited the required 15 minutes after vaccine and done just fine. Started my drive back home and about 15 minutes into my drive I began feeling very funny in my head, my heart rate went sky high, started shaking all over my body. Could barely drive called 911. Was advised to pull over and await for ambulance. Ended up at ER with elevated heart rate, chest pain and feeling winded. I could breath ok no swelling in throat but just felt like a elephant was on my chest
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| 44 | 2021-03-17 | feeling abnormal |
Like a spider bite after 7 minutes, could feel the vaccine run into my shoulder, then my neck and en...
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Like a spider bite after 7 minutes, could feel the vaccine run into my shoulder, then my neck and enter my nasal cavity. At which time it seemed to dry up what ever nasal mucus I had. Almost immediately I felt dizzy and light headed. Then came the my heart beating faster. My breathing quickened cold sweats began with the palms of my hands. This continued for about 3-4 minutes. When my heart/ blood pressure seemed to go back to normal, I sat for an additional 15 minutes. I had 3 more incidents that day of dizzy and lightheadness throughout the day but not to the extent of the initial, almost passing out, spell. For 12 hours after injection, other than the typical reported symptoms of sore arm, fatigue which I did experience, i felt like I was in a haze, similar to when you have a fever for 11 hours. And oddly, almost immediately the haze and fatigue lifted. No other adverse reactions after that.
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| 44 | 2021-03-17 | feeling abnormal |
I received my first round of the Covid19 vaccine on Tuesday. They had us wait for 15 minutes to see ...
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I received my first round of the Covid19 vaccine on Tuesday. They had us wait for 15 minutes to see if there were issues. Sitting there I had no issues. By the time I got back to work maybe 15 minutes later I felt like I was foggy headed. It was like a was on a high dose of cold medication. I was also very flushed. I was okay sitting but movement brought it on. I was also pretty tired.
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| 44 | 2021-03-19 | sensation of foreign body |
Felt like a lump in throat, which I suppose was slight swelling. Occurred approximately 30 minutes a...
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Felt like a lump in throat, which I suppose was slight swelling. Occurred approximately 30 minutes after receiving vaccine, and we had already left vaccination clinic. I felt like I needed to clear my throat, drank lots of water and after 10 minutes, the ?lump? sensation stopped. No other allergic reactions after that.
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| 44 | 2021-03-21 | anxiety |
3/21/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ...
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3/21/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: Chest pain, she reports that she is asthmatic .but does not have her inhaler. Assessment : Time of assessment 1615pm Alert and oriented and Anxious. No visible respiratory issues, no wheezing or stridor heard. Actions taken: took to stretcher, 1615 VS taken at 1615 BP- 144/58. P 84, O2 98%, 1625 recheck VS- BP- 114/65, P-74, O2- 94%, lying on stretcher family in the room, she reports feeling better. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/21/2021 3:45 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc
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| 44 | 2021-03-21 | feeling abnormal |
About 3 hours after the injection I began to feel tired and lethargic. 10 hours after the injection ...
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About 3 hours after the injection I began to feel tired and lethargic. 10 hours after the injection I began to feel more cold than normal. 12 hours after the injection I realized I had a fever and it took about 3 hours to break. By the next morning, today, I felt sore all over my body, like I had been non-stop throwing up. I had a raging headache in my right eye. Still feeling very lethargic. 27 hours later I still feel not myself.
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| 44 | 2021-03-21 | insomnia |
Shot at 10:30 AM Thursday, experienced intense soreness in right arm (far worse than the 1st shot in...
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Shot at 10:30 AM Thursday, experienced intense soreness in right arm (far worse than the 1st shot in left arm) and by mid-afternoon headache. Overnight woke with fever, chills, headache and sore arm making sleep impossible. Ill all day Friday - fever, chills, fatigue, no appetite, headache, arm soreness. Friday evening awoke with intense pain in right arm pit, breast, upper ribs - extremely swollen lymph nodes (size of avocado). Extremely tender and sore. Pain continued throughout Saturday, Sunday, and now into Monday. Also still fatigued and feeling run down.
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| 44 | 2021-03-22 | nightmare |
I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea...
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I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea; diarrhea; headache; I have been having vivid nightmares during this time as well; metallic taste; This is a spontaneous report from a contactable consumer (patient). The 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 09:45 AM (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic fatigue syndrome, Epstein barre. The patient was not pregnant. No other vaccine in four week. No covid prior vaccination. The patient did receive other medications in two weeks. The patient experienced i have epstein barre and it feels like it has been reactivated, waves of dizziness, fatigue, nausea, diarrhea, headache, i have been having vivid nightmares during this time as well, metallic taste on 24Feb2021 14:00. Reported as: I have Epstein barre and it feels like it has been reactivated. I have waves of dizziness , fatigue, nausea, diarrhea, headache and metallic taste. I have been having vivid nightmares during this time as well. I developed a metallic taste in my mouth. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.The patient had covid tested post vaccination via Nasal Swab on 03Mar2021 and was negative. It's unknown if the patient received treatment. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.
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| 44 | 2021-03-23 | anxiety, panic attack |
Patient was extremely anxious prior to receiving Pfizer IM injection. Once she received the vaccinat...
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Patient was extremely anxious prior to receiving Pfizer IM injection. Once she received the vaccination she reported that she was having ?trouble breathing?. She stated she has asthma and that she needed her inhaler. She pulled a benadryl from her pocket and took it. Patient denied feeling any swelling in her throat. Two nurses stayed with the patient until she stated she was feeling better. Nurse escorted the patient to the observation area. After sitting in the observation area for several minutes the patient had used her inhaler and stated that she felt like she was going to pass out. 911 was called, the patient was assisted to the floor, vitals were monitored BP 170/90 HR 148 R16; Spo2 100%. Both Nurses stayed with the patient until EMS arrived to educate relaxation techniques and deep breathing. Patient was taken to the hospital via ambulance. While waiting for EMS that patient had called her daughter and stated she was having a ?panic attack? her daughter stated ?what is wrong with you, you need to get help?. Patient reports having a long history with anxiety.
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| 44 | 2021-03-23 | anxiety |
Hives on the neck and face and anxiety. BP 166/110 HR 78 Sp02 98%. Benadryl 50mg po given and monito...
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Hives on the neck and face and anxiety. BP 166/110 HR 78 Sp02 98%. Benadryl 50mg po given and monitored for 30 min
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| 44 | 2021-03-23 | emotional distress |
She had previous reaction to Paclitaxel and was given vaccine in high risk COVID vaccine allergy cli...
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She had previous reaction to Paclitaxel and was given vaccine in high risk COVID vaccine allergy clinic. We pretreated her with cetirizine but did not test her to PEG. She developed significant distress, nausea and cough 2-3 minutes after receiving the vaccine. There was no hypotension, wheezing noted. She was treated promptly with epinephrine 0.3 mg. Within five minutes she started to feel better aside from adverse effects from Epi. Left arm and shoulder pain. No significant shortness of breath. She had a large amount of clothing on so were unable to fully see skin but no visible rash. She was transferred to the emergency department.
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| 44 | 2021-03-24 | nervousness |
Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous...
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Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous/shakes; Immediately felt tingling, got shaky and nauseous; hard time swallowing and couldn't breathe right; hard time swallowing and couldn't breathe right; Waves of heart racing; her left leg and arm, her right leg had pins and needles and loss of feeling; wheezing; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 09:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient experienced immediately felt tingling, got shaky and nauseous. It was coming in waves. she was having a hard time swallowing and couldn't breathe right. She was in the holding. For 15 minutes and she received dismissed annoyed no help from an EMT working in the waiting area for effects. She left. Got a mile down the road and called 911 she was unable to get enough oxygen in. The ambulance arrived and immediately gave her epinephrine, Benadryl, and a breathing treatment along with other medications. She arrived at the hospital and she was doing better and they kept her for observation. She was feeling fine, left with an Epipen and prednisone. The next day (18Mar2021) she felt great until the night time she started wheezing again. She woke up on Friday (19Mar2021). Having shakes and hard time breathing and waves of heart racing. she made a doctor's appointment and received a inhaler. Her symptoms were not getting better and she took Benadryl which helped. By that night her left leg and arm, her right leg had pins and needles and loss of feeling. Treatment included Epinephrine, Benadryl, Prednisone, Albuterol. No COVID tested post vaccination. Events immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right required clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. Outcome of immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right was recovering.
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| 44 | 2021-03-25 | feeling abnormal |
pt noticeably antsy, asked if she was ok. she stated that she was trying to power through but couldn...
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pt noticeably antsy, asked if she was ok. she stated that she was trying to power through but couldn't. Nurse asked her to see the injection site. When she took off her sweatshirt, stating she felt on fire, the site and her arms were extremely red. She was asked to remove her mask and we discovered her lips and area around her nose was starting to swell. At that time she stated that her tongue felt "weird". Assessing the situation, the nurse administered an Epi-pen while I dialed 911 and gave information. Epi-pen very helpful, to the point she "wished we hadn't called the ambulance" . Once the EMTs arrived, they assessed her and after some time, had her sign a release form since she declined attention. Pt was informed that she would not be allowed to finish her shift and was asked if someone could come get her. The daughter was on her way. The nurse and I sat with her, watching to make sure she didn't have a rebound reaction which she did not in the hour + we were with her. Daughter arrived, took instruction from the nurse and took her home.
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| 44 | 2021-03-25 | mental impairment, memory impairment |
I had long term Covid symptoms from early February 2020 to late February 2021 including, intense con...
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I had long term Covid symptoms from early February 2020 to late February 2021 including, intense concussion like brain fog for months, coughing for months, problems with my fingers seizing up and twitching uncontrollably, and extreme exhaustion for months. I had finally started to feel Covid free, except for some problems with my left hand, by end of February 2021. I got the first dose and about 45 minutes or so later the exhaustion came back suddenly - like someone removed all my batteries - and I started having trouble talking, thinking, remembering. Reading and writing work, but talking is difficult. My hands feel swollen and lacking dexterity and strength. I had an odd headache in the middle of the night (on day 2) with some sharp pain that kind of seeped around my scalp. I thought at first I had been stung by a bee and it went away as quickly as it came. But then the pain would suddenly appear on another part of my scalp. There was a tingling/seeping/spreading out feeling just before it would disappear. I woke up the next morning with a more normal headache, took IBU and CBD gummies, ate breakfast and it?s gone. I feel like all I can do is lay in bed and stare at the wall. This is exactly as I felt when I had Covid (though without finger seizures and coughing). I find myself coming to tears with a fear that it won?t ever go away or I?ve brought it on again by getting the vaccine.
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| 44 | 2021-03-28 | impaired work ability |
The first shot on March 6, 2021, I only felt muscle pain in my left arm unable to move it on the ne...
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The first shot on March 6, 2021, I only felt muscle pain in my left arm unable to move it on the next day due to the injection. Nothing else. The second shot on March 27, 2021 I started with fever, chills, night sweats, stomach cramps, headache, sore throat, nausea, tiredness, shortness of breath, muscle pain, weakness, unable to concentrate or do my job.
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| 44 | 2021-03-29 | feeling abnormal |
At about 10:30p-11:30p on 01-14-2021 I went to bed and I woke up feeling weird. I had a rapid heart...
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At about 10:30p-11:30p on 01-14-2021 I went to bed and I woke up feeling weird. I had a rapid heart rate of 140bpm. I did not lose consciousness. I called 911 and they came to my home with an ambulance. My BP was 200/100. My heart rate was 130. They told me i had tachycardia with BP elevated and my husband took me to the ER for evaluation. At the ER, lab work was done, they hooked me up to monitors and I had an episode where my heart rate increased. I was discharged home and to follow up with my PCP and everything seemed fine. About two weeks later I had same episode where heart rate elevated and now with chest pain. I went again to the ER and they did more tests on me. I saw a cardiologist and he had me wear a holster monitor. With the holster monitor I had one minor episode where my heart beat elevated. I will see my cardiologist next week. I did not receive my second dose of Pfizer vaccine.
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| 44 | 2021-03-29 | feeling abnormal |
I started having normal side effects such as sore arm, extreme tiredness and headache within 2 hour...
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I started having normal side effects such as sore arm, extreme tiredness and headache within 2 hours. By later that night I was in a dazelike state, had a lot of forgetfulness and lived life but as if I was sleepwalking and started having seizures over the next few days. A week later I'm still having seizures, have no recollection of anything starting from the night of the day I got vaccinated
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| 44 | 2021-03-29 | impaired work ability |
I had an asthma attack at work. I felt nausea. I checked into a Medical Center ER when I was havin...
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I had an asthma attack at work. I felt nausea. I checked into a Medical Center ER when I was having the attack and I couldn't control my breathing body aches - and they gave me anti-nausea medicine. A few days after that I was non stop throwing up - I couldn't get out of bed. I was still having intermittent vomiting - about once a week - and I'd have to take off work. This kept happening up until about a month ago (with the vomiting). It was horrible. I had headaches, too - they weren't major but were bothersome - I had them for about three weeks and then they went away. A couple of weeks later - I was still throwing up and I went to ER - but I don't remember the date of second visit - they gave me IV and Zofran. I had stomach pain from the vomiting. I was admitted into hospital last week - the 18th and was discharged the next evening. I was using inhaler every day for two times a day. They dosed me with a lot of antibiotics - IV antibiotics and also Steroids - Zumatrol and they sent me home with doxycycline HIC 100 mg and those were for 10 days; twice a day; and I haven't been needing my inhaler since last Friday.
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| 44 | 2021-03-30 | feeling abnormal |
While waiting in the observation area and approximately 10 minutes after receiving the injection, I ...
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While waiting in the observation area and approximately 10 minutes after receiving the injection, I felt a strange wave come over me and I became very lightheaded and felt weird all through my body. I can't really explain the sensation. I passed out and when I came to, I was very weak. The staff at the facility gave me oxygen and took my blood pressure. They called the paramedics. The parademics did an EKG which was normal and they took me to the ER for some other routine testing, which was all normal and then I was released. Since then, I have felt a bit nauseous and tired.
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| 44 | 2021-03-31 | sensation of foreign body | Lump on the throat. Pt was given Benadryl 25 mg PO. HR 48 (However states that this HR is normal) |
| 44 | 2021-04-01 | confusional state |
Purplish red spots on bottom of feet, lasted >day; headaches, fatigue, confusion, numbness in hands/...
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Purplish red spots on bottom of feet, lasted >day; headaches, fatigue, confusion, numbness in hands/ arms and feet. All but spots continue today. Nausea for 3 days, 3/29-3/31. Diminished sense of smell and taste, still.
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| 44 | 2021-04-02 | anxiety |
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify:...
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Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient showed signs of anxiety starting before injection
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| 44 | 2021-04-03 | feeling abnormal |
tingling in arms, legs and torso. Hot flashes in face weak legs and sense of fogginess. Fast and irr...
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tingling in arms, legs and torso. Hot flashes in face weak legs and sense of fogginess. Fast and irregular heartbeat.
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| 44 | 2021-04-04 | feeling abnormal |
Patient felt slight tingling in fingers. Called her back at 3:30pm and she said it seemed better bu...
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Patient felt slight tingling in fingers. Called her back at 3:30pm and she said it seemed better but her hand and fingers still felt a little "weird". Vaccine definitely went into deltoid - took picture of site with pts phone and mine.
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| 44 | 2021-04-04 | feeling abnormal |
First vaccine. Aches, pins and needles in both hands and feet, vomiting, headaches, blurred vision, ...
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First vaccine. Aches, pins and needles in both hands and feet, vomiting, headaches, blurred vision, lightheaded, feeling spaced out, exhaustion
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| 44 | 2021-04-05 | feeling abnormal |
14hrs after the injection, I woke up and didn't know why. Within a minute or so, I started sweating ...
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14hrs after the injection, I woke up and didn't know why. Within a minute or so, I started sweating profusely. I started getting massive pain and achiness in my lower abdomen and down through the tops of my legs , down to the top of my knees. I have a very high pain tolerance and it was excruciating. No position lessened the pain. I thought I had to go to the bathroom twice and felt like I would have explosive diarrhea, but nothing happened either time. I just sat there in pain and sweating. I managed to get a drink of water when I started having this low level feeling that I would throw up and decided not to drink too much. I never threw up either. I laid in bed and went from sweating to freezing and back again. I was seriously considering calling 911, but after about 1.5 hours, the pain went from constant to waves and then I got extremely tired and just fell asleep. The next day I was tired and the fatigue lasted probably 3 days, but I had none of the other symptoms again. My arm hurt from the injection (though I really didn't feel the injection itself) for probably 3-4 days, but I ended up with a bruise for more than a week. I never had any Covid symptoms prior to that and I only had neck and shoulder achiness and some fatigue for about 2 days after the 2nd shot - along with the arm soreness, but no bruise.
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| 44 | 2021-04-05 | panic attack |
PT OBSERVED FOR 40 MINUTES STATES FEELS LIKE A PANIC ATTACK BP 137/80 PULSE 122 SAT 98 DENIES ANY S...
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PT OBSERVED FOR 40 MINUTES STATES FEELS LIKE A PANIC ATTACK BP 137/80 PULSE 122 SAT 98 DENIES ANY SOB OR CHEST PAIN PULSE REMAINES 110-131; MD IN TO SEE PATIENT DISCHARGED
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| 44 | 2021-04-05 | sleep disorder |
PT STARTED XOLAIR OVER A YEAR AGO & STARTED WORKING WELL FOR HER W/IN 2 DOSES & WAS CONTROLLING HIVE...
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PT STARTED XOLAIR OVER A YEAR AGO & STARTED WORKING WELL FOR HER W/IN 2 DOSES & WAS CONTROLLING HIVES UNTIL ABOUT NOV/DEC 2020. AT THAT TIME SHE STARTED NOTICING VERY MINIMAL HIVES COMING BACK. PT RECEIVED 1ST PFIZER COVID VACCINE ON 3/11. NO CHANGES TO HIVES, STILL MINIMIAL. RECEIVED 2ND DOSE OF VACCINE ON 4/1. THAT DAY/EVENING SHE HAD ARM PAIN & FATIGUE (EXPECTED OF VACCINE). SHE WOKE UP OVERNIGHT W/ SEVERE ITCHING. FRIDAY AM HIVEALL ALL OVER BODY & SEVERE ITCHING. SAT/SUN THE HIVES STARTED RAISING & STILL ITCHING. MONDAY THE SX WERE SO SEVERE SHE WAS NAUSEOUS. MD STARTED HER ON TOPICAL CORTISONE & 5 DIFFERENT ANTIHISTAMINES. CORTISONE HELPS FOR ABOUT 15 MINUTES & ANTI-HISTAMINES DON'T SEE TO RESOLVE ITCHING. PATIENT IS TO FOLLOW-UP WITH MD FOR TREATMENT OF HIVES & POTENTIAL OF COVID VACCINE CAUSING SUCH AN IMMUNE RESPONSE THAT IT OVERWHELMED THE XOLAIR'S EFFECTS AND CAUSED THE HIVES TO OUTBREAK SEVERELY.
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| 44 | 2021-04-06 | sleep disorder |
Joint pain in fingers, wrist, elbows, toes, ankles, knees. Extreme fatigue and prolonged sleeping; s...
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Joint pain in fingers, wrist, elbows, toes, ankles, knees. Extreme fatigue and prolonged sleeping; still after 10 days after vaccination.
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| 44 | 2021-04-07 | crying |
uncontrolled weeping; thoughts of self harm; extreme startle response; Emotional liability; This is ...
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uncontrolled weeping; thoughts of self harm; extreme startle response; Emotional liability; This is a spontaneous report from a contactable other Healthcare Professional reported for herself. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm right on 11Feb2021 12:00 at age of 44-year-old (Lot Number: EU9809) at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included PMDD (premenstrual dysphoric disorder) but controlled by chemical menopause over 3 months, known allergies to shellfish. Concomitant medications included naproxen and elagolix sodium (ORILISSA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose bnt162b2 (Lot number: EL8982) administered in arm left on 21Jan2021 at 11:45 (at age of 44-year-old) at single dose for COVID-19 immunization. The patient experienced emotional liability, uncontrolled weeping, extreme startle response, thoughts of self harm on 12Feb2021 16:00. The events was reported as non-serious and did not result in emergency room visit or physician office visit. Patient received treatment for the adverse events which included clonazepam. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
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| 44 | 2021-04-07 | loss of personal independence in daily activities |
2:00am 100.1 fever, aches, headache, chills 10:00am-6:00pm 101-102 fever w Advil, aches, headache, c...
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2:00am 100.1 fever, aches, headache, chills 10:00am-6:00pm 101-102 fever w Advil, aches, headache, chills, tiredness. Unable to do daily activities. 6pm 99.1 fever
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| 44 | 2021-04-08 | impaired work ability |
Fever for a couple days, weakness, arm soreness for 1 day, nausea, diarrhea. Thursday and Friday. Mi...
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Fever for a couple days, weakness, arm soreness for 1 day, nausea, diarrhea. Thursday and Friday. Missed work both days. Treatment followed CDC recommendations for common side effects.
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| 44 | 2021-04-08 | irritability |
Sore arm and hot that evening. The next day - body aches, prickly skin, joint pain, swollen lymph no...
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Sore arm and hot that evening. The next day - body aches, prickly skin, joint pain, swollen lymph nodes (sore in armpits and behind ears), extreme tiredness, less alert, more irritable.
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| 44 | 2021-04-08 | nervousness |
Dizziness and nervousness immediately after receiving vaccine. Patient stated that she is feeling b...
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Dizziness and nervousness immediately after receiving vaccine. Patient stated that she is feeling better, was given another 15 min additional observation-Voice that she is leaving. Understanding verbalized.
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| 44 | 2021-04-09 | crying, impaired work ability, anxiety, sleep disorder, nightmare |
Developed PTSD or Secondary Trauma syndrome within 2 weeks of second shot. Had to go on medical leav...
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Developed PTSD or Secondary Trauma syndrome within 2 weeks of second shot. Had to go on medical leave as I was not sleeping, crying, developed intrusive thoughts, nightmares, anxiety. Have been seeing therapist and psychiatrist, placed on Prozac instead of Cymbalta. Doing CBT and exposure therapy, sleep journaling. I remain off work currently
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| 44 | 2021-04-09 | disorientation |
I fainted; I was disoriented and the room was spinning.; I was disoriented and the room was spinning...
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I fainted; I was disoriented and the room was spinning.; I was disoriented and the room was spinning.; extremely nauseated; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 24Mar2021 at single dose in left arm for COVID-19 immunization. Medical history included Cancer. No known allergies. No covid prior vaccination. Patient was not pregnant at time of vaccination. Concomitant medication in two weeks included letrozole. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that when patient woke up in the middle of the night. Patient was disoriented and the room was spinning. patient fainted and then was extremely nauseated all on 25Mar2021 02:00 AM. No treatment for adverse events. No covid tested post vaccination. The outcome of events was recovering. Information about lot/batch number has been requested.
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| 44 | 2021-04-09 | feeling abnormal, confusional state |
From about 4:30 -8 pm that evening my head felt confused. When I would look at a list it appeared ou...
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From about 4:30 -8 pm that evening my head felt confused. When I would look at a list it appeared out of order but when I looked at it later it was in order. It felt like I didn?t have control of what was going on in my head.
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| 44 | 2021-04-09 | sleep disorder, feeling abnormal, insomnia |
About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went comple...
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About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went completely numb and tingling. Scalp tingling and numb. Felt like circulation was cut off. Severe Shortness of breath. Extreme feeling of adrenaline. The next day on March 14th, had extreme vaginal bleeding on day 14 of cycle. Bled for another 7 days which led to extreme anemia. The shortness of breath is every day since the first dose. Heart palpitations (heart rate went up to 190!). After the second dose on 4/03, all symptoms got worst. Left leg went completely numb the same day which I went to the emergency room for. The neurological tingling and numbness was spreading to my whole body. Arms, legs, face, ears, scalp, inside my head. I was worried for a heart attack since all of my symptoms of left arm and shoulder pain and numbness etc. I was released from the emergency room 12 hours later. I continued to have severe symptoms. The shortness of breath was so bad that I didn't sleep for 2 nights straight because my oxygen would drop. I also had severe insomnia and no appetite and lost 5 pounds in 1 week. Major adrenaline feeling. I went back to the emergency room 2 more times this week to check out my heart and lungs. All of my doctors recommended ER since they couldn't help me. My neurologist said he is getting lots of these symptoms from people post vaccine. My shortness of breath and elevated heart rate and numbness and tingling are still here and I can barely go up and down stairs without being out of breath and having a 130-140 heart rate and super low blood pressure and night sweats. It is awful.
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| 44 | 2021-04-10 | sleep disorder |
I awoke at 1am with a 101 fever and my skin hurt. I felt hot and cold but was not sweating. By 3 a...
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I awoke at 1am with a 101 fever and my skin hurt. I felt hot and cold but was not sweating. By 3 am my fever had risen to 102.3. I waited an hour hoping it would come down on its own but it stayed at 102.3 and I now had a headache. At around 4 am, I took 2 500 mg Tylenol. Approximately 20 minutes later, I began to sweat and fell asleep. I awoke about 30 minutes later and my temperature had fallen to 101.5 and I was sweating. I fell back asleep and awoke at 9:45 am with a splitting headache but a normal temperature.
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| 44 | 2021-04-11 | anxiety |
Pt reported at 0953 lightheaded, anxious. @ 0954 160/110, HR 95, OxSat. 100%, Blood Sugar 99. @100...
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Pt reported at 0953 lightheaded, anxious. @ 0954 160/110, HR 95, OxSat. 100%, Blood Sugar 99. @1004 BP 142/108 HR 93, OxSat 95%.
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| 44 | 2021-04-12 | feeling abnormal |
Numbness bilateral legs same day at night. Blurred and the overlapping visión few days while progre...
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Numbness bilateral legs same day at night. Blurred and the overlapping visión few days while progressing over the next 3 weeks, heat intolerance, left side numbness of body. Foggy/ light headedness, dizziness, vertigo and disbalance all progresss over the month the slowly started disappearing over a month after 3 dieses of high steroids and anti- inflammatory.
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| 44 | 2021-04-12 | sleep disorder |
A knot arose overnight at the vaccination site on my upper left arm. The knot is very red. The sur...
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A knot arose overnight at the vaccination site on my upper left arm. The knot is very red. The surrounding area is swollen, hot to the touch and very painful. I woke up from the pain several times after midnight when I rolled onto my left side. I do not plan to seek medical attention.
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| 44 | 2021-04-13 | anxiety, nervousness |
a 44 year old female who has completed a 15-minute observation period with the following signs and s...
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a 44 year old female who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: other - dry throat, coughing, vomited x 1. Endorsed that she is very nervous with the vaccine, started having dry throat and coughing with watery eyes. Then vomited x 1 with partial digested emesis. no hematemesis per patient. pt kept on coughing and anxious. Otherwise vital signs stable, physical exam unremarkable. Given cetirizine and albuterol inhaler 2 puffs. Improved post medications. Referred to allergy clinic and
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| 44 | 2021-04-14 | anxiety |
My menstrual cycle is late. I had no idea this was a known side effect. I have reached out to other ...
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My menstrual cycle is late. I had no idea this was a known side effect. I have reached out to other women on Social Media and most of them have reported the same issue with their menstrual cycle. Please make this known to every woman getting vaccinated. Despite the side effects, I am grateful for this vaccination. However knowing that my menstrual cycle might be disrupted would have avoided emotional anguish, wasting over a hundred dollars on pregnancy tests, and a major anxiety attack.
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| 44 | 2021-04-15 | disturbance in attention, feeling abnormal |
4/15 Woke up with sore arm, to be expected, had full body aches, chills, brain fog, trouble concentr...
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4/15 Woke up with sore arm, to be expected, had full body aches, chills, brain fog, trouble concentration, extremely tired. Had a fever of 100 degrees. Felt like really bad flu symptoms. Slight headache. Just mostly extremely tired and hurt all over. Woke up on 2nd morning after the shot, 4/16 with no more pains or discomfort.
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| 44 | 2021-04-15 | impaired work ability |
Extreme dizziness - like I was drunk all of the sudden - Severe Tiredness, bad Headache, Muscle pain...
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Extreme dizziness - like I was drunk all of the sudden - Severe Tiredness, bad Headache, Muscle pain, Chills, Fever 100 - 100.6, Nausea (dry heaving). Missed two days of work. I am going to work today but still feel like crap. I had the same reaction, but less to the first dose. 3/23/21
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| 44 | 2021-04-16 | disturbance in attention |
Neck,shoulder, back,leg pain. Armpit and under arm pain radiating to elbow Pain at injection site ...
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Neck,shoulder, back,leg pain. Armpit and under arm pain radiating to elbow Pain at injection site down to fingers Dizzy, difficulty focusing with black spots lasting a few hours
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| 44 | 2021-04-17 | feeling abnormal |
Moderate to severe left arm pain/ tenderness. Mild joint stiffness and mild joint pain in left han...
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Moderate to severe left arm pain/ tenderness. Mild joint stiffness and mild joint pain in left hand. Mild fatigue, mild mental fog.
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| 44 | 2021-04-18 | impaired work ability |
Got the 1st Pfizer vaccine on 4/10. Started getting dizzy with vertigo and nausea 4/14. Have missed ...
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Got the 1st Pfizer vaccine on 4/10. Started getting dizzy with vertigo and nausea 4/14. Have missed worked. Cannot stand up for more than a minute or two before the vertigo gets debilitating. Have been in bed, dizzy, for 7 days straight.
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| 44 | 2021-04-20 | memory impairment, feeling abnormal |
On day 5 after my first shot I experienced extreme brain fog. I was struggling to find words and my...
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On day 5 after my first shot I experienced extreme brain fog. I was struggling to find words and my mind will completely blank out in the middle of speaking a sentence. I have a difficult recalling and retaining new information. My symptoms worsened as the week went on and continues to be an issue 3 weeks after my first shot although the severity is lessening daily.
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| 44 | 2021-04-20 | sleep disorder |
Headache 4 days Fever 3 days Body Aches 3 days Fatigue 4 days Loss of Appetite 2 days Sleep problems...
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Headache 4 days Fever 3 days Body Aches 3 days Fatigue 4 days Loss of Appetite 2 days Sleep problems 4 days Rashes current
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| 44 | 2021-04-20 | sleep disorder |
At 2am, 12 hours after shot woke up with severe chills and couldn?t get out of bed. Took Advil a and...
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At 2am, 12 hours after shot woke up with severe chills and couldn?t get out of bed. Took Advil a and Tylenol to sleep. Woke up next morning and took Tylenol at 8am so I could try to have a normal day. Held off on medicine but started to feel exhausted and got hot / shaking chills again at 3pm and could not get warm . Took a nap to try to avoid medication but then took Advil/Tylenol again at 5pm because my fever reached 103 and I was too uncomfortable. Fever broke an hour later and I was able to sleep all night. Felt 90% better in morning and pretty normal by 48 hours after shot though continued to have fatigue and some periodic nausea into following day and one instance of diarrhea. Also arm was sore.
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| 44 | 2021-04-21 | anxiety | Dizziness, anxiety, severe headache, with improvement after observation. Vitals wnl. |
| 44 | 2021-04-22 | amnesia, agitation |
Agitation suicide attempts lost all time for four days. Had to be restrained. Doesn?t even remember ...
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Agitation suicide attempts lost all time for four days. Had to be restrained. Doesn?t even remember shot. Walked out of house and doesn?t remember
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| 44 | 2021-04-22 | excessive sleepiness | Headache, muscle soreness, dull kidney pain, exhaustion, slept all day so far. 4-23-2021 |
| 44 | 2021-04-24 | anxiety |
tightening of the chest; Anxiety; mood changed; allergic reaction; itching of the anal area; night t...
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tightening of the chest; Anxiety; mood changed; allergic reaction; itching of the anal area; night terrors; bodily pain; This is a spontaneous report from a contactable consumer (patient) from a Pfizer- sponsored program. A 44-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) at the age of 44-years-old, via an unspecified route of administration in left arm on 07Apr2021 at 09:00 at single dose for COVID-19 immunization. Medical history included ongoing parasitic infection which she had when she was 10 and she still has symptoms on occasion. She was cleared by infectious medicine. The parasite was Strongyloides. The doctors told her it was a foreign strain and they didn't know how she got it. She used to do beach combing when she lived in a different place and that might be how she got it. She was treated for it and they did a strain test recently and she didn't have enough to be treated for it. The parasites do move throughout the body and sometime goes through your lungs. She didn't know if that's what caused her breathing issues. She has ongoing chronic migraine headaches which she treats everyday or every other day with a tryptan medication. She mentioned that she has COVID from Oct2020 to Dec2020 but could not confirm; the patient thought it was a poisoning, she reported it as a potential poisoning because she got so sick so suddenly and severely. It took months to recover. She went to doctors and to the hospital for it. They couldn't really determine at the hospital, they thought it was viral but they haven't identified the strain yet. Back in Oct2020 and Dec2020, she had chest tightening, but then it did not get to chest pain as much, but some might consider it pain but it was tightening. She also had a history of pregnancy loss and post-partum depression. Concomitant medication included an unspecified tryptan medication for chronic migraine headaches. There were no additional vaccines administered on the same date as the COVID-19 vaccine. The patient previously took TORADOL injection and pyrantol pamoate (as reported) for parasitic infection/ Strongyloides which caused anal itching. On 07Apr2021, the patient experienced tightening of the chest throughout the day that progressed after receiving the vaccine, she took BENADRYL incrementally while she felt the pressure. She mentioned that it resolved but it had her anxiety high because of how the medical personnel at the place were reacting to her. She wasn't having a reaction that they could see or treat with an epinephrine, so she did not know if it was recorded as a side effect, but they did monitor her and was okay. She did have some nasty little domestic arguments because of her anxiety and how her mood changed. She stated that it was out of fear and the response of her spouse about what to do about her discomfort. She added that she also knew someone else who had an injection at the same place who experienced the same symptoms and went to a hospital for it. The patient didn't have the chest tightness immediately because the nurse there said she could take BENADRYL. She knew that it said not to take the BENADRYL before getting the vaccine because it could mask an allergic reaction, but she took it anyways because it was frightening how they respond, they weren't acknowledging she was having tightening in the chest, they just continued to say she was not having enough of an allergic reaction to treat her with this. Her husband may have had some COVID related agitation or aggravation because he also received the same vaccination. Her husband also experienced soreness around the injection sight. Chest tightening began about 45 minutes to an hour after receiving the vaccine. She decreased her physical activity, it was tightening and it was building but she took BENADRYL incrementally, half of a tablet, about every 2 hours. She did not continue taking it if she did not feel it, she continued to feel the tightening and continued to take it and it continued to resolve. Sometimes, she took a whole tablet and sometimes half and then half again, continued taking it to the maximum level she believed. She got up to 150, but she read somewhere she could take 300, but she took 150 mg. She still had tightening so at 1:30 am she called ambulance and they checked her out. She didn't have enough symptoms to be treated with epinephrine. They stated that her husband could take her to the hospital. She and her husband argued because he was worried about getting to work the next day and sleep. They went to an emergency room of a hospital for monitoring. She was still having chest tightness on occasion, but it resolved mostly. She has taken BENADRYL like once since. She slept okay last night so it is mostly resolved after going to the hospital but she still had a dose once or twice more like 6 hours apart. She would say it resolved on Thursday, 08Apr2021, around 11:00. She had a parasitic infestation at age of 10 and she still has symptoms on occasion. She was cleared by infectious medicine. She did experience anal itching again on Apr2021, after getting the vaccine. She was guessing that whenever she was given the injection it affected the parasite's comfortability in her body, and they were attempting exit if they were present. Her doctors thought that the anal itching was a mental health thing, remembering that she had it before. Her lung Xray was unremarkable on an unspecified date. On Apr2021, she has been having night terrors where she was physically being run into or walked into in other places and she hasn't been in those places, knowingly or willingly, she was only in the areas she was comfortable or familiar with, except to have that portion of night terrors to indicate otherwise and bodily pain. This was all relative, it was not directly related to the vaccine except that if you have it and you are experiencing a symptom you are panicked and upset or unable to leave where you were physically because of the symptom. The outcome of the event chest tightness was recovered on 08Apr2021 at 11:00 and unknown for all other events.
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| 44 | 2021-04-25 | panic attack | Patient reported nausea and had panic attack. She felt dizzy. |
| 44 | 2021-04-25 | sensation of foreign body |
Feeling of lump in throat and slight headache that subsided before I got back there. Lower lip on r...
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Feeling of lump in throat and slight headache that subsided before I got back there. Lower lip on right side was visibly swollen. Blood pressure and O2 were in normal range. had here stay an additional 10 minutes after she was evaluated. she felt good and left
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| 44 | 2021-04-25 | sleep disorder |
Sharp pain in chest area, near heart. Usually a couple times a day. I thought it might be heart burn...
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Sharp pain in chest area, near heart. Usually a couple times a day. I thought it might be heart burn, but it seems to be everyday, various times, no matter what I eat. It also feels different than heart burn. Kinda like a pulsating feeling. This morning it woke me up out of my sleep and scared me.
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| 44 | 2021-04-26 | feeling abnormal |
Received the 1 dose lil bit of chest tightness after 20 mins release to leave by 4pm my right eye st...
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Received the 1 dose lil bit of chest tightness after 20 mins release to leave by 4pm my right eye started twitching, a Finally got home received the first dose of Pfizer yesterday morning and within hours I felt horrible got all the side effect of course and had to go to the hospital this morning. Having SOB dry cough and horrible upper back pain. Dr and I?m wheezing a lot so I got a shot of steroids and two neb treatments X-ray showed inflammation the cause was the vaccination activated my asthma and the rest side effect nd within hours I felt horrible got all the side effect and had to go to the hospital this morning. Having SOB dry cough and horrible upper back pain. Dr and I?m wheezing a lot so I got a shot of steroids and two neb treatments X-ray the cause was the vaccination activated my asthma and the rest was side effect
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| 44 | 2021-04-27 | depressed mood |
the 2nd covid shot affected my menstrual system. The last day of my period was 04/12/2021, yet only ...
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the 2nd covid shot affected my menstrual system. The last day of my period was 04/12/2021, yet only 2 days later I started experiencing headaches, extremely sore and heavy feeling breasts, tender nipples, bloating, gas, cramps, fatigue, muscle aches, moodiness, sadness -- all of the symptoms that usually occur a few days before my period begins. It has been two weeks since the 2nd shot and all of these symptoms are still persisting. I don't know if my period will come early, or if I will just continue having these symptoms until my period starts, (if it starts on time), or when the symptoms will stop.
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| 44 | 2021-04-27 | sleep disorder |
Started with chill, then body ache all over. At night I experienced audio hallucinations. On the ...
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Started with chill, then body ache all over. At night I experienced audio hallucinations. On the second night after the vaccine, I heard my dad calling my name and woke me up from my sleep. It happened twice that night. Then the following night, I heard my daughter calling for me and woke me up from my sleep. I went back to sleep, then I hear my dad called for me again. On Sunday night, it happen again. This time, my sister calling for me. Every time it's loud and clear. It stop after that Sunday night. I didn't take any treatment.
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| 44 | 2021-04-28 | anxiety |
Severe body aches within 4 hours lasting for at least 2 days (still aching, but not as severe 2 days...
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Severe body aches within 4 hours lasting for at least 2 days (still aching, but not as severe 2 days later), treated with Ibuprofen 800 mg every 8-12 hours as needed Fever - mild, beginning at 24 hours after shot and breaking about 12 hours later High Heart Rate - ongoing from 24 hours, treated with Metroprolol - heart rate up to 130 bpm when sitting, doing nothing Anxiety - high heart rate and fever contributed to an anxiety attack about 29 hours after immunization, other contributing factors were high blood pressure and dehydration caused from not taking normal meds and not drinking adequate fluids; taking meds and drinking water and lemonade helped relieve the anxiety Dizziness - extreme dizziness occurred at the same time as the fever and lasted until after the anxiety attack; it seemed to ease after eating dinner and drinking lemonade but never completely disappeared until the next morning
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| 44 | 2021-04-28 | loss of personal independence in daily activities |
I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't wal...
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I haven't been able to work since/I can't function; my left leg went completely numb; I couldn't walk; my immune system attacking the nerves; The shortness of breath is very bad; My pulse is high; My blood pressure is low; I have major neurological symptoms now.; My left eye is now affected too and blurry.; keep feeling my face and now my tongue and mouth go numb; keep feeling my face and now my tongue and mouth go numb; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the second dose. A 44-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the right arm via unspecified route on 03Apr2021 (at 44-years-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot unknown expiry information not provided) in the left arm on 13Mar2021 at 12:00 (at 44-years-old) and experienced face, head and ears started tingling, shortness of breath, numbness and weakness, severe burning all over her nerves of her body, and abnormal uterine bleeding. The patient denied any known allergies and being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and the patient denied receiving any other vaccine within four weeks of this vaccine. The patient reported that on 03Apr2021 she received her second shot and within four hours her left leg went completely numb and she could not walk. The patient reported that she went to the emergency room three times since that time. The patient reported that she was told it was her immune system attacking her nerves. The patient reported that the shortness of breath is very bad, her pulse is high, and her blood pressure is low. The patient explained that she has major neurological symptoms now. The patient stated that she has had two magnetic resonance imaging (MRI), on computerized tomogram (CT) and two x-rays though no results were provided. The patient explained that she has appointments with neurologist and immunologist. She is unable to work since she has to be on video with people and keep feeling my face and now her tongue and mouth go numb. The patient stated that she was scared to eat food, so she does not choke. The patient mentioned that her left eye is affected too and blurry. The patient exclaimed that she cannot function, it is scarring her little kids and has affected her entire family. The patient reported that events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage]; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the events left leg went completely numb, could not walk, immune system attacking her nerves, shortness of breath, pulse is high, blood pressure is low, neurological symptoms, unable to work/ cannot function, feeling my face and now her tongue and mouth go numb, and left eye is affected too and blurry, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) :-PFIZER (Same reporter/patient/product, similar events with first dose)
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| 44 | 2021-04-30 | sleep disorder |
12 hours after the shot, I had pain in my arm that woke me up, I was also very tired a few hours af...
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12 hours after the shot, I had pain in my arm that woke me up, I was also very tired a few hours after the shot and the next day. 24 hours after the shot I developed a welt about the size a quarter on my arm, at the injection site, it was slightly raised and red. I was feeling a general malaise, and had a headache for about 2 days and developed a little bit of a cough. About 3 days after the shot, I developed mini lumps below the skin of my jaw on both sides, near the Parotid area. They felt itchy but never broke the surface, they seemed to be like a skin boil. They were about 1/4 inch round balls, and they lasted for several days. I also had a few other itchy hard spots on each arm and one on my back. I massaged the ones on my face and they went away in about a week. On April 27th I woke up with a itchy painful skin blemish on the inside of my right arm(other side of the elbow), that had broke the skin, 4 days later is is still very itchy. I was quite healthy the entire time of quarantine for the past year, after the getting the shot, I feel less healthy. I am only reporting this now, because I am scheduled to get my second dose in a few days.
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| 44 | 2021-05-03 | feeling abnormal |
Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me d...
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Dizzy, black dots in vision, weak, nausea, all black vision, very dizzy - they took me and laid me down with ice on the back of my neck and I felt better. All day felt weak and woozy and brain fog. Lethargic and spacey the following two days. Three days after the shot, I had a pain in my hand and a blood vessel started popping out and hurting. It was quite painful for that evening and night and after ice and rest and ibuprofen, swelling was down the next morning and it's still just a little tender to the touch.
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| 44 | 2021-05-05 | agitation |
Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cra...
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Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cramps; Hydroxyzine HCL; Amoxicillin; Acetaminophen.
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| 44 | 2021-05-10 | loss of personal independence in daily activities |
pregnant at the time of vaccination; Swollen lymph nodes/ painful swollen lumps; Shingles/ pustules ...
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pregnant at the time of vaccination; Swollen lymph nodes/ painful swollen lumps; Shingles/ pustules on my head and neck; The pain progressed over the course of a week before it became unbearable; prevented her from daily activities including work; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8737) via an unspecified route of administration, administered on the left arm on 29Mar2021 19:00 as 1st dose, single for COVID-19 immunization. Medical history included dermatomyositis, antisynthetase syndrome and Sjogrens syndrome. Concomitant medications included metformin; insulin glargine (BASAGLAR); hydroxychloroquine and levothyroxine sodium (LEVOTHYROX). The patient previously took azathioprine and experienced allergy. Patient was pregnant at the time of vaccination. Within hours, patient developed painful swollen lumps and pustules on my head and neck, later diagnosed as swollen lymph nodes and shingles on 30Mar2021 04:00. The pain progressed over the course of a week before it became unbearable and patient was treated at ED and given antiviral for shingles. She is on DAY 16 and the pain from the swollen lymph nodes still prevented her from daily activities including work. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Treatment received for the events in the ED included morphine drip and acyclovir RX. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19: Nasal Swab test: negative on 06Apr2021. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother reported she became pregnant while taking bnt162b2. The mother was 24 Weeks pregnant at the onset of the event. The mother was due to deliver on 17Jul2021. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 44 | 2021-05-14 | feeling abnormal |
blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right...
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blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right; Head felt weird; Felt Cold; lightheaded; This is a spontaneous report from a contactable consumer reporting for herself. A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 22Apr2021 at 11:30 (Batch/Lot Number: EW0171) as a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date and no vaccination administered in the 4 weeks prior. Medical history included ongoing Hashimoto's Thyroid (diagnosed with this condition many, many years ago). There was no relevant family history. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 01Apr2021, Lot Number: ER8737; in right arm. On 22Apr2021, about a half hour after the shot she states her head felt weird, she couldn't swallow, she felt cold, and she could not breathe right. On 23Apr2021, she was driving her husband and blacked out. Her tongue also began to swell. She just happened to be by the exit ramp to the hospital. She visited the Emergency Room. They told her she was having a delayed anaphylactic reaction. No relevant tests were performed according to the reporter. All of her symptoms recovered when she started prednisone on 23Apr2021. She was prescribed prednisone, taper dose with last dose 27Apr2021. She still remained with lightheadedness and still could not drive. The only one persisting was the weird feeling in her head, almost like a lightheaded feeling. She could not drive due to this symptom There was no physician office visit for the events. The events delayed anaphylactic reaction, blacked out, tongue swelled, couldn't swallow, couldn't breathe right, and feeling cold were resolved on 23Apr2021. The lightheadedness and head felt weird were ongoing (not recovered).
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| 44 | 2021-05-18 | feeling abnormal, memory impairment |
Three weeks of extreme fatigue. Exhaustion that didn't let up after sleeping or coffee or anything. ...
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Three weeks of extreme fatigue. Exhaustion that didn't let up after sleeping or coffee or anything. And I have what would be considered "brain fog". I'm usually a fast-brained, quick-witted individual and I feel foggy and forgetful. I also had six weeks of extreme fatigue when I had COVID in early November (and still have not recovered my sense of smell or taste). After about six weeks, my fatigue disappeared.
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| 44 | 2021-05-23 | disorientation | Are swelling and paralysis, fever, disorientation, headaches, |
| 44 | 2021-05-24 | depressed mood |
Within 24 hours of having my second dose of the COVID-19 vaccine, I became moderately depressed. Not...
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Within 24 hours of having my second dose of the COVID-19 vaccine, I became moderately depressed. Nothing had occurred in the days prior to trigger an episode nor had I suffered from a episode for a while. I have since encountered two other people who have had the same reaction and have encouraged them to retort it as well.
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| 44 | 2021-05-24 | disturbance in attention |
Initial shot: nausea, extreme fatigue for 5 days. Second shot: immediate arm pain, warm. In the ...
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Initial shot: nausea, extreme fatigue for 5 days. Second shot: immediate arm pain, warm. In the first day lightheaded, limbs heavy feeling, unfocused, flushed, fatigue, hives for about an hour. Next day headache, lightheaded, neck tightness, fatigue, lymph node pain, arm pain, nausea. Next day nausea, arm pain, stomach pain, fatigue. Next day nausea and fatigue. Nausea lasted 5 days.
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| 44 | 2021-05-24 | emotional distress |
11:40- pt asked if her hands and face should be itching 11:41- gave Benadryl 50 mg PO and checked O2...
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11:40- pt asked if her hands and face should be itching 11:41- gave Benadryl 50 mg PO and checked O2 she was at 96% on room air 11:45- pt started saying her throat felt tight O2 92% face was red and could see signs of distress so she was given an EpiPen, ambulance was called 11:50- did vitals BP 140/78, HR 103, O2 93% pt stated she felt like she was going to pass out and it was still hard to breath 11:55- pt still struggling to breath O2 92% voice muffled, face visible red, signs of distress 2nd EpiPen given 12:03- ambulance arrived pt never lost consciousness
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| 44 | 2021-05-25 | anxiety |
evaluation of chest tightness. She reports chest pain?described as tightness in her left chest. Pa...
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evaluation of chest tightness. She reports chest pain?described as tightness in her left chest. Pain does not radiate. She states she experienced symptoms about 10 minutes after taking her first Pfizer Covid?19 vaccine at 14:10 today. She also reports mild shortness of breath and lightheadedness. She states symptoms feel like anxiety. No rash, throat discomfort, leg swelling. Patient states she is starting to feel better at this time. Presentation likely consistent with anxiety. Vaccine adverse/allergic reaction was also considered but less consistent at this time. Patient states feels like anxiety reaction. Discussed consideration for as needed medication for intermittent anxiety attacks?safety precautions were discussed.
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| 44 | 2021-05-25 | feeling abnormal |
Severe vomiting for 8 hours and some diarrhea. Head fuzziness comes and goes along with nausea. Star...
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Severe vomiting for 8 hours and some diarrhea. Head fuzziness comes and goes along with nausea. Started May 21st, still have some nausea, slight diarrhea and fuzziness on May 26.
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| 44 | 2021-05-26 | poor quality sleep | low grade fever, full body achiness, headache, unable to sleep well for 22 hours |
| 44 | 2021-05-27 | depressed mood |
Note that this was following my second dose. (dose one on 4/17/2021 had no symptoms aside from mild ...
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Note that this was following my second dose. (dose one on 4/17/2021 had no symptoms aside from mild arm soreness). My second dose, on 5/10/2021 resulted in extreme fatigue that afternoon and remained for two weeks. During that time period I also became quite depressed, which is very rare for me, but I do not know if the depression was a result of the vaccine or the extreme fatigue that came from the vaccine.
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| 44 | 2021-05-27 | memory impairment, feeling abnormal |
shortly after receiving the vaccine, she developed lightheadedness, frontal headache and a feeling o...
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shortly after receiving the vaccine, she developed lightheadedness, frontal headache and a feeling of "fuzziness." "I knew it was going to start." She describes a globus sensation. She developed nausea without vomiting. Took 40 mg of prednisone and 25 mg of diphenhydramine. EMS was contacted. She tells me that she lost vision and couldn't see the paramedics when they arrived. Discharged from ED, then returned on 3/17/21, when she began experiencing face itchiness and flushing, numbness of her mouth and lips, throat inflammation, and vision loss. Patient took Prednisone this morning with little symptom relief. Compared to yesterday, the only new symptom is throat inflammation. 4/30/21 Primary care visit: presents to the clinic for evaluation of globus sensation. Patient reports that this has been an issue ever since she got her first dose of Pfizer COVID-19 vaccine. She feels as though there is something in her throat and feels pain or discomfort, most often in the mornings and evenings for several weeks. She feels the need to "clear" her throat often. She denies any trouble eating or swallowing. She feels as though her neck and face still appear swollen compared to her baseline, since getting the vaccine. She reports occasional post nasal drip but denies significant nasal congestion and does not feel this is the typical time for her to struggle with her allergies. She has noticed frequent nose bleeds in the past 2 weeks, now daily. She states that she will sometimes bleed up to 15-20 minutes. She has been feeling more tired and "foggy" or more forgetful in the past few weeks as well and fears this is starting to affect her work performance.
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| 44 | 2021-05-30 | feeling abnormal, disturbance in attention |
Left arm (deltoid) pain, swelling, knot in the muscle larger than my entire hand, redness, hot to th...
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Left arm (deltoid) pain, swelling, knot in the muscle larger than my entire hand, redness, hot to the touch. Migraine, severe fatigue, muscle and joint pain to the point of barely being able to move from the bed, not able to take a deep breath without pain, brain fog, loss of concentration, difficulty with word recall
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| 44 | 2021-05-31 | confusional state |
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was seated after vaccination the...
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Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was seated after vaccination then collapsed. I went over after was alerted and flipped patient from her face. She was awake but confused at what happened. I sat with her while she came to and our front store manager got her water. She was breathing well and was starting to become aware, and she refused an offer to call an ambulance. We sat until she felt comfortable to get up and the store manager walked with her. She reported to himthat was not the first time she had passed out that day
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| 44 | 2021-05-31 | confusional state |
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was seated waiting after her vac...
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Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was seated waiting after her vaccination. She collapses to the floor. I went out after being alerted what happened and flipped her from her face, she was awake and confused as to what had happened. I sat with her while our front store manager grabbed her water. I asked if she felt she needed an ambulance and seeing as she was breathing fine and starting to come to she said she did not want an ambulance. She later informed our front store manager that she had fainted 3 times that morning.
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| 44 | 2021-05-31 | sleep disorder |
Shingles outbreak at right back spreading to front chest under the breast. Bad case. Started acycl...
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Shingles outbreak at right back spreading to front chest under the breast. Bad case. Started acyclovir night of 5/19 for 10 days. The weekend of the 16th I woke up feeling a deep dull ache at my lat and shoulder blade on the right side at 2am. Thought it was muscular and used a ball to massage the area which felt better, but I could not fall back asleep. Got better during the day and some thing happened on the 17th. I put a heating pad on the area and fell asleep. Woke up with a rash, but thought it was a heating pad burn and this is what it felt like. Blisters were starting to form on the 18th and I had the chills all day. I thought this was because it was a 2nd degree burn so made an appointment to see the doctor on the 19th at 4pm. At the doctor, they diagnosed this as shingles and said I was not the only person who had come in 2-3 weeks post Pfizer shot with Shingles. 2 weeks post shingles- The rash is fading. Still experiencing rib pain, and dull aching pains in my back where it originally started- at the Lat/shoulder blade. I wake up every night in pain at 2 or 3am and sleep on/off for maybe 1 hour at a time the rest of the night.
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| 44 | 2021-06-02 | depression, feeling abnormal, anxiety, crying, emotional distress |
DAY ONE -fatigue -physiological anxiety that lasted a couple of hours - feeling like I had way too ...
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DAY ONE -fatigue -physiological anxiety that lasted a couple of hours - feeling like I had way too many shots of espresso -palpitations a couple of times -swelling, tenderness to palpate, and sharp intermittent pain in upper knuckle of right pointer finger joint (this has never previously occurred, so assuming it's related to the vaccine; there was no injury or strain that preceded it) DAY TWO -worse fatigue , headache, and constipation -mild body aches (could also be fibromyalgia) -severe depression as the day went on, including crying spells, thoughts of suicide, negative obsessive thoughts (I do have a history of depression but wasn't depressed at the time of the vaccination, and these depressive symptoms were extreme for me) -feeling generally "out of it," not right in my head, emotional and exhausted
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| 44 | 2021-06-02 | thinking abnormal |
on day 4, patient thought she was having a stroke, had sob and heart palpitations, face had numbness...
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on day 4, patient thought she was having a stroke, had sob and heart palpitations, face had numbness, trouble thinking and speaking, went to er, er was very busy, left and went to urgent care, had ekg and tested for clotting and thyroid, all tests came back clear. symptoms resolved on their own. patient will be following up in the future with cardiologist
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| 44 | 2021-06-03 | confusional state |
3 hours after injection, developed profuse sweating on neck in air conditioned room followed by hive...
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3 hours after injection, developed profuse sweating on neck in air conditioned room followed by hives on neck and chest, itching, pain. was advised to take benadryl. fell asleep within one hour. Hives reoccured every day for one week. I still have redness and bumps. 12 hours after injection, developed very sore arm, pain with range of motion, headache which resolved with Motrin, fatigue-slept 18 hours. 3 days after injection developed diarrhea which is still occuring 3 weeks after. developed severe PMS 2 weeks earlier than usual which has never happened. Breasts not just tender-they hurt. terrible cramps, which i never get. bleeding through super ultra tampon every 45 minutes which has never happened. Unable to exercise because of dizziness and fatigue. I typically exercise 5 days per week including jogging, hiking, resistance training. today, June 3, I became very confused and felt like my brain wasnt sending signals to my body. I cannot remember what I needed to do 5 minutes ago. I went to fill up my sink to do dishes and poured water on the counter instead of drain, I poured coffee in my eye.
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| 44 | 2021-06-03 | feeling abnormal, anxiety, restlessness |
Bad body aches from lower back down legs; Unwell feeling all night; feverish; chills; bad taste in m...
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Bad body aches from lower back down legs; Unwell feeling all night; feverish; chills; bad taste in mouth; restless; Stomach turning; A red very warm blotch on my arm around the injection site; Anxiety; Feelings disappeared then came back not as harsh around 30 hours after; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 44-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN8581) as unknown, single for covid-19 immunisation. Medical history included CVC (Central venous catheter). Concomitant medications included Metoprolol succinate 25 mg, Omeprazole 40 mg, Cetirizine hydrochloride. Patient had known allergies. Patient did not receive any other vaccine within 4 weeks. Patient neither diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 post vaccination. On an unknown date, the patient experienced bad body aches from lower back down legs 12 hours later, unwell feeling all night, feverish, chills and bad taste in mouth, restless, stomach turning. Her feelings disappeared then came back not as harsh around 30 hours after. Patient went to work feeling ok thought she was back to normal but when she showered, she noticed a red very warm blotch on her arm around the injection site which slightly disappeared after 12 hours and had anxiety. The patient was recovering from the event red very warm blotch on her arm around the injection site. The outcome of all other events was reported as unknown. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-06-03 | insomnia |
post 10m-strange warm feeling in arm that stopped a few minutes later; palms and right side of throa...
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post 10m-strange warm feeling in arm that stopped a few minutes later; palms and right side of throat began to itch; rash on chest and hands/rash worse; but like heartburn 60m; itching increased (palm, soles of feet and back of knees worst; general body itching); couldn't sleep; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH, COVID-19 Vaccine, Formulation: solution for injection; Lot Number: EN6201 and Expiration date were not provided), via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:30 as 1ST DOSE, SINGLE for covid-19 immunization. Facility type vaccine: Other. If other vaccine in four weeks: no. Medical history included asthma, atypical trigeminal neuralgia, overweight, small fibroids. Sulfa allergy, Iodine IV contrast allergy. Concomitant medications cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took moxifloxacin hydrochloride (AVALOX), Gadolinium, gabapentin and experienced drug allergy. On 21Feb2021 16:30 the patient experienced post 10m-strange warm feeling in arm that stopped a few minutes later, palms and right side of throat began to itch, rash on chest and hands/rash worse, but like heartburn 60m, itching increased but not intense/ itching continued (soles of feet and back of knees worst; general body itching, couldn't sleep. Therapeutic measures were taken as a result of post 1the patient experienced post 10m-strange warm feeling in arm that stopped a few minutes later, palms and right side of throat began to itch, rash on chest and hands/rash worse, but like heartburn 60m, itching increased but not intense/ itching continued (soles of feet and back of knees worst; general body itching, couldn't sleep. Resulted in: Doctor or other healthcare professional office/clinic visit. Treatment received by the patient were Benadryl, Claritin, and Pepcid. If covid prior vaccination: No. If covid tested post vaccination: No. The outcome of event was recovering. Follow-up attempts completed. No further information expected.
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| 44 | 2021-06-06 | anxiety |
Client received her 1st dose of COVID Pfizer vaccine at 17:14. After leaving vaccine site and sittin...
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Client received her 1st dose of COVID Pfizer vaccine at 17:14. After leaving vaccine site and sitting in her car for 5 minutes she returned to the vaccine site at 17:44 and communicated to the Ancillary Co-Lead that she was having trouble swallowing. Ancillary Co-Lead sat client in a chair and requested EMT & Nurse assistance over the walkie-talkie at 17:45. Lead RN, Co-Lead RN, and EMT reached client at 17:47. Client stated her throat was dry and she was having mild trouble swallowing. EMT requested client to stick out her tongue. EMT, Lead RN, and Co-Lead RN observed that client's tongue appeared white and chalky. Client stated no SOB, trouble breathing, or any other symptoms. Client stated she has no allergies and has never experienced passing out or any adverse reaction to a medicine or medical procedure. Client was alert & oriented times 4. Client stated that she started to have an odd feeling in her throat when she was sitting in the observation room, but did not think anything of it and left. After getting in her car, client drank a immunity booster shot, noticed trouble swallowing and came back to the site. Client stated she was unsure if the immunity shot contained caffeine. Client stated that she has a doctor she sees regularly, has no underlying medical conditions and takes no medications. Client also stated that she had a hysterectomy 6 months prior and could be experiencing surgical menopause. Client indicated that she was nervous about getting vaccinated and felt anxious both before and after receiving the vaccine. Tech brought client a bottle of water. EMT proceeded to take client's vital signs at 17:55 as follows: BP: 146/88, HR: 75, O2: 99. The client's friend who came to the site with her also walked up at that time. Client communicated that she does not have high blood pressure. Client requested more water and ended up drinking a total of 4.5 bottles. Client stated that she had no dinner the night prior and only had a protein shake and small amount of soup today. Client stated that she was starting to feel better and that her throat was just really dry. EMT obtained 2nd set of vitals at 18:06 as follows: BP: 142/80, HR: 98, O2: 99. Client stated she was just feeling anxious about the incident, but feeling better overall. Client stated she was swallowing OK. Client stood up and stated that she felt OK. Lead RN recommended client go to urgent care if swallowing issue returned and to call 911 if she experiences any SOB or trouble breathing. Lead RN also communicated to client that she can follow up with her HCP and/or allergist for input on receiving 2nd shot of Pfizer vaccine. Client left with her friend at 18:11 and was walking with a steady gait.
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| 44 | 2021-06-07 | irritability |
I experienced a heavy period which came early. After that I haven't had a period in 6 months. I'm ha...
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I experienced a heavy period which came early. After that I haven't had a period in 6 months. I'm having night sweats, irritably, hot flashes. And I am not pregnant.
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| 44 | 2021-06-09 | feeling abnormal, panic attack |
30 minutes after receiving the first Covid-19 vaccine I was driving home when I felt a shortness of ...
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30 minutes after receiving the first Covid-19 vaccine I was driving home when I felt a shortness of breath and my thinking became very fuzzy. No one was on the street I was driving and I panicked and dialed 911 because I thought I was about to blackout and I wanted someone to come help in case I did. The operator talked me through whatever was happening. It was decided I had had a panic attack and no ambulance was called. Nothing like this had ever happened to me before. I had a headache the rest of the day but no more panic attacks.
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| 45 | 2020-12-31 | feeling abnormal |
12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 d...
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12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 days ago. The site on her left deltoid where she got the shot is warm and read. It also itches. No pain into the rest of left arm. no numbness of tingling at site or distally. no trouble breathing or tingling around mouth/throat. 01/01 - EE notes that her arm was very sore and she had a bad headache. As the days went on, it got redder, hotter, and more swollen. On 12/20, she began to feel bad. On 12/28 while at work, she heard that her supervisor was COVID (+). Throughout the day she felt worse and worse. Was seen at urgent care and COVID was negative. Prescribed Cephalxin and predinose 01/01 -- arm is much better today. Today it is still bruised. She thinks it was bruised previously but that the bruise could not be seen under the redness and swelling
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| 45 | 2021-01-03 | impaired work ability |
Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headach...
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Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headache is not uncommon for me but the extreme drowsiness is). I slept solid through the night (unusual) and the puppy woke me around 5am. (ususal) I felt that i had a heavy? head. My thoughts seemed clear but my head had a fullness to it. Its difficult to describe. I was not stuffy. I had trouble staying awake, to the point I was nodding off at times I should have been able to stay awake. I did not feel safe to work and felt obligated to call in. I slept solidly for the next 5 hours. Later in the day, my affected arm began to have pain radiate from the injection site to my wrist. (probably not unusual). 600mg of Ibuprofen did not seem to help much. By the time I went to bed last night (24+ hrs after receiving the vaccine) I noticed my axillary nymph nodes were extremely tender to the touch and remain so this morning. The pain in my arm still continues to radiate to my wrist but not as intense.
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| 45 | 2021-01-05 | anxiety |
[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative br...
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[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative breathing; believed it to be anxiety related until seeing CDC produced list of symptoms from vaccine. [2] Mild soreness, mild redness at injection site: started 4 hours after vaccine, lasted 24-36 hours. [3] Felt feverish and flushed, arthralgia: started approximately 18 hours after vaccine (12/31/2020). "Fever" initially managed with Tylenol 650 mg. Later that evening took naproxen 440 mg to address arthralgia, which lasted about 2 days. No medication taken on 1/1/2021.
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| 45 | 2021-01-05 | emotional distress |
Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine...
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Patient II, a 45-year-old female with a history of vaccine-related anxiety, presented to the vaccine clinic for her second-dose of the pfizer COVID-19 vaccine. Pharmacist then delivered vaccine. Almost immediately after administration, the patient started showing signs of distress including difficulty speaking, and going in an out of consciousness. Ice packs were placed on the back of patient's neck, and she was given water in order to hopes to stimulate consciousness. At this time, the pharmacist placed a pulse oximeter on her finger to monitor. Her oxygen stats dropped to 75% and heart rate dropped to a value slightly greater to slightly under 30 beats per minute as indicated by the pulse ox blinking at 30. Pharmacist timed the period of bradycardia, after 60 seconds an epinephrine pen 0.3mg was administered to the left lateral thigh. Rapid response code was called and team came 1.5 - 2 minutes after epinephrine administration. Oxygen was given to the patient at the scene where her recorded blood pressure was 94/54 mmHg. She was then transported into the emergency department via wheelchair. Patient stabilized and was discharged back to work approximately an hour after arrival.
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| 45 | 2021-01-05 | sleep disorder |
Gradual increase in Sjogrens symptoms (muscle aches and pains, muscle stiffness, unable to get comfo...
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Gradual increase in Sjogrens symptoms (muscle aches and pains, muscle stiffness, unable to get comfortable, unable to sleep, heavy limbs)
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| 45 | 2021-01-06 | anxiety, restlessness, insomnia |
Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- re...
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Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Hyperactive anxiety reaction- restless, impulsive and hyperactive.; Sleep affected- awake 22 hours; Hyperactive anxiety reaction; This is a spontaneous report from a contactable nurse reporting for herself. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685 /expiration date: not provided), via an unspecified route of administration in the left arm, on 28Dec2020 at 07:45 AM (at the age of 45 years old) as a single dose for COVID-19 vaccination. Relevant medical history included penicillin allergy. The patient did not have any chronic diseases or illnesses. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 at 10:00 AM, the patient experienced hyperactive anxiety reaction- restless, impulsive and hyperactive. The patient could not sit still or control fidgeting and her sleep was affected, as she was awake 22 hours. The patient did not receive treatment for the events. The outcome of the events hyperactive anxiety reaction- restless, impulsive and hyperactive and sleep was affected was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19.
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| 45 | 2021-01-06 | feeling abnormal, impaired work ability | Fever and body aches, feels poorly. Stayed home from work |
| 45 | 2021-01-07 | loss of personal independence in daily activities |
typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting...
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typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.
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| 45 | 2021-01-07 | restlessness |
Fatigue, fever 100.7, moderate headache, chills, muscle ache, joint pain, restlessness, fatigue, woo...
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Fatigue, fever 100.7, moderate headache, chills, muscle ache, joint pain, restlessness, fatigue, wooziness, mild nausea, mild abdominal pain. No asthma symptoms.
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| 45 | 2021-01-09 | nervousness |
1825 Patient reported feeling "Shaky", patient reports having same reaction with first vaccine and w...
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1825 Patient reported feeling "Shaky", patient reports having same reaction with first vaccine and was observed in ED for 90 mins, had increased BP at that time that resolved by discharge. 1825 BP 156/101 HR 80 Patient declined ED, food, drink and had a rapid response nurse friend at chairside. assessment repeated at 1840 B/P 136/94 HR 80, 1850 BP 140/100 HR 75 pt. reporting feeling better. Pt. reported feeling much better and left with friend at 1900.
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| 45 | 2021-01-10 | feeling abnormal |
BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal ...
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BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal headache at night and took Tylenol 500 mg for headache relief. January 4, 2021- The slight numbness in tongue continued and my face started to feel a little different too. I had headaches on and off throughout the day and evening. January 5, 2021- Woke up to get ready for work and noticed that my right eyelid was a little swollen and the right side of my mouth looked different. I arrived at work and my right eye was not closing properly and I was having difficulty blinking. I left work an hour later and went to ER to seek treatment. I was prescribed Prednisone and Valacyclovir for a seven day course. The first time I had Bells Palsy was in 1997 when I was 22 years old.
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| 45 | 2021-01-10 | loss of personal independence in daily activities |
Chills with no fever; Cramping in legs; super tired with no energy; Body aches; tiredness/Feeling su...
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Chills with no fever; Cramping in legs; super tired with no energy; Body aches; tiredness/Feeling super tired with no energy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that the 45-year-old female patient who receive first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on Saturday (02Jan2021) at single dose (once by injection in the right arm) for covid-19 immunisation. Medical history included ongoing Hypothyroidism from 2008. Concomitant medications included levothyroxine at 75 ug ongoing from 2008 for Hypothyroidism. Medical Professional and told by her work that she could get it because contact with COVID patients. The consumer calls for information about if the side effects she is experiencing after the administration of the COVID-19 vaccine will last for more days. The consumer reported tiredness and other side effects to DSU. A Consumer calls for information about if it would be appropriate the second dose of the COVID-19 vaccine is not administered considering that she had adverse reactions. Consumer calls for information about if the second dose of the COVID-19 vaccine would cause her more side effects than the first one. Received the vaccine on Saturday, 02Jan2021. The day she got it she did not feel anything at all. She was completely fine. She did not even have pain at the injection site. The next day, on Sunday she started feeling super tired with no energy, had body aches, and cramping in legs from 03Jan2021. She has had these for the past 3 days now. She also had chills with no fever from 03Jan2021 to 05Jan2021. She took Tylenol for the first 2 days, but it did not help her at all. She is feeling a little better today, but not much. Her question is, how long will these side effects last? Tylenol: She says it did help a little bit. She think she would just sleep because she was uncomfortable. The Tylenol just did not make her symptoms go away completely. LOT/Batch: AA46487, EXP: Apr2022 UPC: The consumer says the number under the barcode is: 5187536. Feeling super tired and body aches: Has improved about 20%. She says these are all medically significant as she is not able to do what she was able to do before getting the vaccine. She is super tired with no energy and she is confined to her bed most of the time. The consumer confirms this is her first dose of the COVID Vaccine. She thinks she got the standard dose. Vaccine card does not have the expiration date or NDC written on it. Unknown causality. She said that she could be positive for COVID. She is unsure. The outcome of the event Chills with no fever was recovered. The outcome of the event Cramping in legs was not recovered. The outcome of the other events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-11 | abnormal dreams |
A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was ...
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A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was sleeping I had very vivid dreams. I was cold all night. When I woke up my arm was sore to touch , to move and both ankles hurt to walk and I started itching on my face. Started Saturday in the evening( chin, nose) Eyelid and underneath was red and I also had a headache. I had blotches on my cheek. Next day I woke up and no change but I was extremely fatigued.. Monday 10am it started going away. By evening majority of pain was gone. About 98% recovered. I still have some itching and chills.
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| 45 | 2021-01-11 | nervousness | SOB, dizziness, nervous, headache Treatment: IV Prednisone, IV Benadryl |
| 45 | 2021-01-11 | sensation of foreign body |
Received Pfizer covid vaccine 1st dose at 1615, c/o lump in throat at 1616, which became worse. Her...
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Received Pfizer covid vaccine 1st dose at 1615, c/o lump in throat at 1616, which became worse. Her HR was also in 120's. At 1618, Epi given x1, then pt transferred to ED
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| 45 | 2021-01-11 | sleep disorder, abnormal dreams |
Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afterno...
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Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afternoon around 4 or 5 got really hot and then in the evening around 9 got really cold and face started to itch. chin was bumpy and face was itching, eyes were still hurting with slight headache. I did have vivid dreams at night and slept not well. in the am my face was itchy red eyelids and under eye, patch like rash on face and itch . Ankles hurt to walk (joints hurt) and arm site was painful and hurt. was cold on and off during day and monday it was hard to wake up, v ery drosy and exhausted. Later that day the face cleared up and i could walk fine and headache was gone . I did feel a little cold monday night. Tuesday everything gone except a slight itch here and there on my face. I feel fine and arm pain is gone as well.
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| 45 | 2021-01-12 | anxiety |
The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours a...
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The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours after injection I had chills, anxiety, slight shortness of breath, headaches, body aches. Today I have had nausea that comes and goes, the red knot is still present on my right arm and the redness has increased a small amount from the marking placed last night. The injection is not in my deltoid muscle or even close and I am wondering if that is at the least what created the redness and the knot.
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| 45 | 2021-01-12 | feeling abnormal |
At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck....
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At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck. The next day this continued with a fever of 99-100, malaise, and chest discomfort. At the 48th hour, today?s date, fever still present, body aches are improved, but my head feels hot and now with a stiff neck. I feel very tired and mental status seems ?foggy?
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| 45 | 2021-01-13 | feeling abnormal, impaired work ability |
1. Dec. 30, 2020- Headaches for about 24hrs after 1st COVID-19 injection, treated w/ 500 mg of Ibupr...
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1. Dec. 30, 2020- Headaches for about 24hrs after 1st COVID-19 injection, treated w/ 500 mg of Ibuprofen at 1:00 am, reduced/eliminated headaches by Dec. 31, 2020 3:00 p.m. 2. Jan. 01, 2021- Woke up/laying down when the dizziness/room spinning began lasting about 10 seconds. Dizzy/spinning episodes continued from 01/01/2021-01/05/2021 (decreasing in episodes on 01/04/2021- 01/05/2021). The dizzy/spinning episodes would happen randomly when I first woke up, through out the day/night, about 6-7 times a day, and lasting about 10 seconds. A few times I felt like I would faint. Treated with rest, sleep, drinking water, and took off work for 1 week due to the danger of driving or going outside the home. 3. I would randomly wake up with hot sweats and nausea from 01/01/2021-04/01/2021, treated by drinking water, and resting. 4. I experienced the general feeling of being unwell, fatigue, and foggy mind that lasted about a week after the 1st COVID-19 vaccination. Treated with rest and was off work for 1 week.
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| 45 | 2021-01-14 | confusional state |
After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then...
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After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then she couldn't remember her name and date of birth for 5 minutes. She then felt her throat was swelling. 911 was called and paramedics checked her blood pressure and vitals were within range. She was monitored at the hospital and was doing fine.
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| 45 | 2021-01-14 | nervousness |
Patient felt heart racing, shaky, and flushed a few minutes after COVID shot number 1. VS 186/98 H...
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Patient felt heart racing, shaky, and flushed a few minutes after COVID shot number 1. VS 186/98 HR 97 RR 16 Temp 36.5 No SOB or throat tightness. Patient sat for 15 minutes after vital signs. Given water. Felt much better. BP 145/94 HR 87 RR 14. No more shaking of hands. Discharged from clinic and recommend to report for next shot and let them know to monitor for 30 minutes.
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| 45 | 2021-01-15 | confusional state, hallucination |
Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection...
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Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection site pain
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| 45 | 2021-01-16 | impaired work ability |
2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head woul...
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2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head would explode- severe left eye pain like my eyeball was going to Pop out 4 hrs post shot- chills no fever temp 97.1 fatigue- took a nap. 12 hrs post shot - severe headache, moderate arm pain and mild swelling at site. SEVERE joint pained tiny joints in ties feet, finger, wrists, neck jaw. Knees were the worst. 16 hours later the joint pain is unbearable . Muscle aching and headache continues at the same time as joint pain. 24 hours post Injection. Chills,moderate painful stomach aching from the inside. Nausea. No vomiting, no energy. Could not work, had to leave. 29 hours post shot- now all symptoms at the same time chills, headache, severe joint pain, stomach pain, nausea, felt like I couldn?t drive home or walk to my car. Got home. Called dr. Went to bed. Slept 14 hours. 48 hours post shot- symptoms decreasing. Headache mild joint pain is the worst. Tired and very cold feeling 72 hours- feeling much better.
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| 45 | 2021-01-17 | anxiety |
Was feeling anxious right after vaccine given. Laid in cot for a short time, then stated her throat ...
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Was feeling anxious right after vaccine given. Laid in cot for a short time, then stated her throat felt like it was closing.
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| 45 | 2021-01-17 | sleep disorder, crying |
4am 1/16: fever, chills, headache, and myalgia. Allodynia of scalp trunk and thighs, Acetaminophen a...
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4am 1/16: fever, chills, headache, and myalgia. Allodynia of scalp trunk and thighs, Acetaminophen and Aspirin helped somewhat. 9pm severe fatigue, followed by worsened fever, worsened headache, throat tightness, nausea, myalgia, and waking hourly until 8am. Oral temp at 9am (1/17) was 100.6. Acetaminophen plus aspirin helped. 1/17 all day headache, malaise, poor appetite, and crying. 1/18 woke every 3rd hour to change clothes from night sweats. By 9 am had abdominal cramps, low grade headache, still malaise, and still low appetite. Still not recovered fully.
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| 45 | 2021-01-18 | abnormal dreams |
Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; ...
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Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; petichiae on site arm below injection site; sneezing; vivid dreams; swelling in legs; lower appetite; thirsty; more frequently urination with larger amounts; more frequently urination with larger amounts; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 04Jan2021 at 15:45 on arm at single dose for COVID-19 immunization. Medical history included Chronic sinusitis and had known allergies with Gluten and Sulfa. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tizanidine hydrochloride (TANIN, reported as tanins) and had known allergy. The patient experienced sleepiness, pain at site for more than 24hours less than 48hours, itching on arm below injection site, headache, petichiae on site arm below injection site, sneezing, vivid dreams, swelling in legs, lower appetite, thirsty, more frequently urination with larger amounts on 04Jan2021 at 19:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.
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| 45 | 2021-01-18 | anxiety, feeling abnormal |
Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels...
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Patient felt flushed, hot, faint occurring approximately 30 minutes after receiving vaccine. "Feels wierd." Feeling anxious. At 3:10pm, BP 165/74 HR=78 O2 sat=99%. At:3:30pm, BP=155/72. Symptoms improving. Patient released from clinic at 3:32pm.
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| 45 | 2021-01-18 | anxiety | Dizziness, eye swelling, throat tightness, sense of impending doom, mild tachycardia |
| 45 | 2021-01-18 | sleep disorder, impaired work ability |
Cough, tachycardia, flushing. Initially improved without treatment, took antihistamine at home, but...
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Cough, tachycardia, flushing. Initially improved without treatment, took antihistamine at home, but cough and a feeling of pressure in face worsened. Cough persisted and she was unable to sleep that night. Took Benadryl, Pepcid and pushed fluids. No further airway prolbems, but did not work the next day. Was back at work and back to normal on Jan 15.
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| 45 | 2021-01-19 | feeling abnormal |
a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, thro...
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a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, throbbing headaches, difficulty operating a vehicle. The dizziness has now gotten bad enough that it is causing nausea.
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| 45 | 2021-01-19 | nervousness |
3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States sh...
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3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area. 3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.
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| 45 | 2021-01-20 | insomnia |
Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete b...
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Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete body ache, muscles, joints, everything, terrible headache. Was on couch and walked upstairs. By the time I got there, I was nearly vomiting and on the verge of losing consciousness. I laid down on the cold tiles and tried to stay conscious. I couldn't even talk. Saliva was pouring out of my mouth uncontrollably. After awhile it let up enough to scoot into the bedroom and climb into bed. Then an entire night of worsening chills, fever, aches, eye pain, sore throat, pulsating ringing in my ears. Little if any sleep. I tried to get up and sit in a chair this morning at 3am and within minutes was so nauseated and light headed I had to lay back down flat. Tried to drink some hot tea and Gatorade at 5am. Thought I heard someone walking around the house and then realized it was heartbeat pounding in my ears. This morning my feet are super sensitive, I have urinary frequency and urgency, and the pulsatile tinnitus is back. Later today had episode of sharp chest pains front to back that resolved after about five minutes. Treatment has been rest today.
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| 45 | 2021-01-20 | sensation of foreign body | Pain and numbness on the left side of the body from head to toes, lump on L side of throat |
| 45 | 2021-01-21 | impaired work ability |
Large baseball sized, painful, hard, reddened, lump on arm day one decreased to golf ball size 4 da...
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Large baseball sized, painful, hard, reddened, lump on arm day one decreased to golf ball size 4 days later. I had moderate chills progressed to severe chills, stomach pain, and muscle/joint pain. Unable to work following day. I reported. It advised someone would be calling me. No one ever did. Chills, stomach and joint pain resolved. Still fatigued with painful lump on arm.
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| 45 | 2021-01-21 | insomnia |
Vaccine received around 8am, 1/18/21. Normal day, no events, developed a little soreness at injectio...
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Vaccine received around 8am, 1/18/21. Normal day, no events, developed a little soreness at injection site. Woke up around 1:30am on 1/19/21 and could not go back to sleep with overall malaise and pain in my right axilla (ipsilateral to vaccine); upon palpation of this area, I could feel enlarged lymph nodes, very sensitive to the touch (never had this from a vaccine, and I take usual flu shots and others occasionally recommended). Malaise slowly went away during the day, pain in right axilla persisted, although not as bothersome for about 2 days. On 1/19/21, I also had myalgia, which were still present on 1/20/19, but slowly subsided. Today 1/22 the enlarged right axillary adenopathy is still palpable, mild to no pain.. No additional symptoms.
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| 45 | 2021-01-25 | anxiety |
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual received the Pfizer Covid-19 vaccine at 8:40 am. S...
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"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual received the Pfizer Covid-19 vaccine at 8:40 am. She began to feel as if she was having any anxiety attack at 8:45 am. Her vitals were 132/82, 20, 99, 99% RA at 8:50 pm. We administer 2 liters oxygen per nasal cannula. 8:55 am B/P 130/80,20, 102-99 P, 99 % RA. 9 am Benadryl 50 mg given IM in RD. Patient swallowing intact. Individual stated she felt better. 9:05 am vitals 120/72. 18, 74, 99% RA. Individual went home with family with no noted distress.
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| 45 | 2021-01-25 | feeling abnormal |
Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the ho...
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Started to feel bad when I left after 15 minutes wait time. Upon leaving I almost pulled into the hospital parking lot to wait, but decided to try and drive home. I began to feel light headed, dizzy, dry mouth, it felt hard to swallow. I knew I did not feel well so I drove myself to the fire station that was closest to me. They took my blood pressure upon arrival and it was 141/93. My normal blood pressure is around 116/63, so it was considerably high. I do not have a history of high blood pressure. The morning of the vaccination I had, had a very small cup of coffee and had eaten a piece of raisin bread. I had also taken two 250 mg generic acetaminophen tablets with 65mg caffeine prior to the vaccination. I also experienced chills and a low grade fever of 100 degrees.
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| 45 | 2021-01-26 | anxiety |
Severe anxiety ( Pt has never had anxiety before in her life), Pain in arm tremendous, numbness in a...
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Severe anxiety ( Pt has never had anxiety before in her life), Pain in arm tremendous, numbness in arm. Pt still having Anxiety.
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| 45 | 2021-01-26 | feeling abnormal |
intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; p...
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intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic. Medical history included mild asthma and known allergies to bee stings. There were no concomitant medications. Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-26 | irritability, anxiety |
joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irrita...
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joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irritating; still having joint pain and muscle aches in her knees and lower legs; body aches; a fever for about 3 days; feeling heaviness in her chest; She was chocking it up to anxiety; This is a spontaneous report from the contactable nurses (one is the patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration, on the right deltoid, on 04Jan2021 at a single dose as she wanted added protection (Covid-19 immunization). The patient medical history was not reported. The patient has no heart issues but has a family history of heart disease. The patient's concomitant medications were not reported. The patient was asking if it is okay to take second dose after experiencing side effects of fever, body ache, joint pain, probably anxiety, chest heaviness 8-10h after (not wheezing, 98% O2 saturation) which returned next day and subsided. On 04Jan2021, the patient got her first dose of the Pfizer COVID Vaccine, she was one of the lucky people who had joint pain, body aches, and a fever for about 3 days. She noticed about 8-10 hours after she got the vaccine that she started feeling heaviness in her chest, chest felt tight and heavy; not shortness of breath, harder to take a deep breath. She had no wheezing. In Jan2021, her oxygen level was 98%. She was chocking it up to anxiety in Jan2021. It went away. She had it the same day and the next day intermittently. It was short and passing. She is still having joint pain and muscle aches in her knees and lower legs. It is intermittent and mainly at night. She is supposed to get the second dose next Friday and asking should she go ahead and get the second dose. The joint pain had went away intermittently on Tuesday, then hit her harder on Wednesday. Thursday she felt okay but the Friday again was having the pain. It is still occurring. It is mainly at night. In the day she feels okay. It is when she lays down to relax that it kicks in. It is mainly irritating but she would say it is medically significant as it has lasted for a while, almost 2 weeks now and she is still having issues. She takes 1000mg of acetaminophen (TYLENOL) to knock it out. The heaviness in her chest lasted about 1.5 hours the first day, and then went into Tuesday intermittently. The patient recovered from anxiety in Jan2021, body aches and fever on 07Jan2021, heaviness in her chest recovered on 05Jan2021, while other events were not recovered. The reporter assessed the events of Joint pain and muscle aches in her knees and lower legs, and irritating as medically significant. The reporter causality of the events for joint pain and muscle aches in her knees and lower legs, body aches, fever and heaviness in her chest were related to the suspect drug, causality for other events was not reported. Information about lot number/batch number was requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of events of Joint pain and muscle aches in her knees and lower legs and irritating. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-26 | nervousness |
Reported feeling dizzy, lightheadedness adn tingle and thick in the throat. BP 135/65 SP02100%, HR ...
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Reported feeling dizzy, lightheadedness adn tingle and thick in the throat. BP 135/65 SP02100%, HR 66 bpm. Given apple juice and didn't feel lightheadeness or tnling. Then expressed waves of episodes reported by the patient. Monitored for 117 minutes. PRovider called 1 hour after monitoring symptoms that were not worsening. Still felt shakey. Given option to go to ED or be transported by ambulance. Went via ambulance to ED. Did not receive any additional treatment in the ED. ED noted that it did not appear to be anaphylactic reaction.
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| 45 | 2021-01-26 | sleep disorder, impaired work ability |
I'd heard about these side effects, was more than I expected, couldn't go to work that day since I w...
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I'd heard about these side effects, was more than I expected, couldn't go to work that day since I was in bed with side effects. Felt like more than any vaccine I'd received in my life, so decided to report just since this is a new vaccine. About 10 hours after vaccine, chills and fever started, fever up to 101, body weakness, lack of appetite, headache/migraine. Insomnia that night, up all night due to symptoms. . All symptoms except migraine resolved over the next 24 hours. Migraine continued so I took 50 mg imitrex x 3 over the course of the next 36 hours until that finally resolved . So all symptoms gone after around 2.5=3 days.
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| 45 | 2021-01-27 | anxiety, panic attack |
Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contacta...
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Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El01Y0, expiration date not reported), intramuscular on the left arm, on 08Jan2021 at 10:30, single dose for Covid-19 immunization. The patient has no medical history and no concomitant medications. The patient previously took the first dose of bnt162b2 (Lot number: EJ1685), intramuscular on the right arm, on 18Dec2020 at 10:00 AM for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Jan2021, at 10:35, the patient experienced flushing feeling with tachycardia 5 minutes post vaccine. On 15Jan2021, she is day 7 post vaccine and experiencing panic/anxiety, tachycardia, and vertigo type feelings. Since the vaccination, the patient has not been tested for COVID-19. The patient received treatment (prescription/monitoring) for the events. The outcome of the events was not recovered. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
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| 45 | 2021-01-27 | anxiety |
Patient c/o dry throat and slight cough. No SOB nor difficulty breathing. Scratchy throat. Elevate...
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Patient c/o dry throat and slight cough. No SOB nor difficulty breathing. Scratchy throat. Elevated BP however patient noted that it was because she was anxious. Symptoms resolved within 30 minutes and patient left the clinic.
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| 45 | 2021-01-27 | feeling abnormal |
COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patie...
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COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK570), via an unspecified route of administration in the left upper arm on 21Dec2020 at a single dose for COVID-19 immunization. Medical history was none and there were no concomitant medications. The patient stated that she felt yucky afterwards on 23Dec2020, experienced shortness of breath on exertion and coughing on 26Dec2020; chills, dizziness, headache, muscle pain, body aches, fever on 28Dec2020; loss of taste, loss of smell and COVID-19 pneumonia on 07Jan2021. All the events were reported as being medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 29Dec2020. Therapeutic measures were taken as a result of COVID-19 pneumonia and included: started on bronchodilator, cough elixir, steroids and azithromycin (ZITHROMAX). The outcome of muscle pain, body aches and COVID-19 pneumonia was recovering and of loss of taste and loss of smell was not recovered. The causality of the suspect vaccine to the events was reported as related.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
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| 45 | 2021-01-28 | anxiety, feeling abnormal |
Pt waited her 15 minute waiting period without issue. Pt then left the clinic & reports that she did...
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Pt waited her 15 minute waiting period without issue. Pt then left the clinic & reports that she did not feel right so she came back to the clinic. Pt reported some numbness & tingling in her arms & hands, nausea, increased anxiety, & shaking. 1mL dexamethasone 4mg/mL given IM to right buttock. Pt placed on 2LPM 02 via NC for comfort. Pt tolerated well.
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| 45 | 2021-01-28 | feeling abnormal |
26th January 2021-after the injection-she became foggy funny headed for about an hour-her words 27th...
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26th January 2021-after the injection-she became foggy funny headed for about an hour-her words 27th January 2021-Chills, nauseated 28th January 2021-Body aches, left deltoid area extra tender, nauseated, HA, she has a history of migraines 29th January 2921-A lot better today she took Tylenol for her symptoms-told to go to the ER if her symptoms get worse, PCM if she needs to
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| 45 | 2021-01-31 | impaired work ability |
DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT...
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DAY 1 (Thurs. 1/14/21 - received 2nd dose of the vaccine at 8:49 am central time): 15 MINS POST SHOT: acute tingling around mouth and tongue; BP spiked and face became very flushed. Waited with nurse until 1 hour post shot. BP stayed above normal all day, as did fatigue. 12 HOURS POST SHOT: sever headaches warranting migraine medicine but I only took Tylenol and Ibuprofen since Maxalt (10 mg) can raise BP. Alternated Tylenol and Ibuprofen every 3 hours but would only get about 2 hours of relief each time. This continued through the night. DAY 2 (Fri. 1/15/21): 23 HOURS POST SHOT: Headache remained. but was lessened after taking Mucinex D. Extremely fatigued, which remained throughout the day. 24 HOURS POST SHOT (9:00 am): Saw NP at clinic, BP was normal. Was prescribed Fioricet, ESGIC 50-325-40 and advised to take it if headache returned. If ineffective after 2 hours, advised to take Maxalt 10 mg. 10:10 am: took Fioricet with no impact to headache, took Maxalt at 12:10. 28 HOURS POST SHOT: Severe, painful heartburn in my chest and upper back - Mylanta provided no relief. Headache returned and started having severe abdominal pain and shortness of breath. 29 HOURS POST SHOT (~2PM) Went to urgent care; vitals were all normal. Received fluids and "GI cocktail" containing lidocaine. Heartburn pain subsided but headaches and abdominal pain. Was advised to go to Emergency Department and did. ED ran multiple labs and ECG to rule out gallbladder, pancreas, etc. Headaches and abdominal pain at this point were excruciating and debilitating. Shortness of breath was significant. ED staff said they have seen the different reactions I was having to the vaccine, just not all together in one patient at the same time. Pain subsided after fluids with Benadryl, Toradol and Reglan. Was discharged approximately 4 hours after arrival. MD prescribed Reglan for continued headaches through the weekend. DAY 3 (Sat. 1/16/21): 48 HOURS POST SHOT: Severe headache when I awoke. Reglan did not provide relief. After two hours, took Maxalt 10 mg . Headaches and significant fatigue continued with such severity I took Maxalt as frequently as allowed per dosing instructions. I stayed in a dark room until Monday (1/18/21, Day 5), ensuring I was staying well hydrated and nourished. The fatigue was so significant that movement was very labored. It should be noted that I am a very active person and I had zero energy and missed two days of work (Fri and Mon). DAY 4: headaches were less frequent DAY5 (Mon. 1/18/21): At 3:30 PM (~126 hours post shot) - it was like someone flipped a light switch and the fatigue and headaches were gone and I felt like I was back to normal. DAYS 6-7, (Tues. and Wed 1/19-20/21) - worked a normal day at work. DAY 8 (Thu. 1/21/21): extremely fatigued again, like over the weekend, but it only lasted today. Of note, the lips and tongue tingling would come and go following the initial weekend of severe reactions. While noticeable, it was not as significant as within the first 15 mins of receiving the dose. On Monday 1/25/21 at approximately 3:00 PM, the tingling was very noticeable and my BP spiked again. Since that time until now, I have had no reactions.
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| 45 | 2021-01-31 | impaired work ability | 100.6 fever, diarrhea, very sore and hard injection site. called in sick to work. |
| 45 | 2021-02-02 | anxiety |
The day after the second shot, I developed upper right sided chest pain and pressure, lateral to the...
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The day after the second shot, I developed upper right sided chest pain and pressure, lateral to the sternum extending at times to mid-clavicular line. Sometimes it felt deeper than surface. I do have a scar from my port which was removed in 11/2020 and the location of the pain correlated at times with the scar but not consistently. I thought the pain was sore muscles since I had done some light weight exercises with my arms the morning of the vaccine. But the pressure aspect of it was different than sore muscles. And I could feel a localized pain when I swallowed or burped, like it was on the inside of my esophagus. The pain didn't seem to hurt with deep breaths. I thought it'd get better if it was related to muscles and the vaccine, but it just seemed to linger. I tried mylanta to test the esophagus theory and it improved. Then after a few more days of not resolving, I saw doctor. My biggest concern and fear at that visit was breast cancer recurrence. I was envisioning and enlarged node in my chest or lung. Eek! I had had a couple episodes at some point of painful swallowing prior to all this that I recalled in the visit so we opted to do an EGD. He also prescribed omeprazole which seemed to help. Had EGD done on 1-27-2020. Normal except for a loose GE junction which wasn't a surprise since I occasionally experience reflux. I'm seeing my oncologist next week for my usual 3 month visit. Thankfullly the pain has almost resolved. Pressure is no longer there. Feeling way less anxious about cancer recurrence.
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| 45 | 2021-02-02 | feeling abnormal, memory impairment |
symptoms started Saturday, Jan 9th after my vaccine on Friday Jan 8th. Had terrible fatigue and te...
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symptoms started Saturday, Jan 9th after my vaccine on Friday Jan 8th. Had terrible fatigue and terrible headaches, very mild nasal congestion, chills, and a rash on my chest. On Monday, 1/11/21 I was tested for COVID and positive as I was still not feeling well and lost my taste and smell. I can?t recall if I lost taste and smell on the 10th or the 11th. Those first few days I slept most all day and the days run together a little bit. I think maybe mid week, I started with tinnitus. About Wednesday, Jan 13th, I started with what looked like chicken pox mostly on my legs and back- these were itchy and fluid filled. Symptoms were starting to improve on Thursday Jan 21st in regards to my ?pox? as I think it was that day where I did not have any new ones that developed. My fatigue and headaches started to improve that day or the Friday after as well. I still notice some fogginess or mild memory issues, tinnitus is better but not fully gone, taste and smell are returning, fatigue continues to improve, headaches are intermittent.
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| 45 | 2021-02-02 | loss of personal independence in daily activities |
Extreme numbness and tingling in left hand, beginning 15 minutes after vaccination. Numbness was sev...
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Extreme numbness and tingling in left hand, beginning 15 minutes after vaccination. Numbness was severe enough to interfere with normal activities such as typing, texting, dialing phone. Patient became nauseated and very dizzy (unable to walk unaided) within 1 hour of vaccination. Numbness improved after 24 hours, and was back to normal after 72 hours. Nausea and dizziness lasted for 24 hours. No previous reactions to vaccines of any kind.
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| 45 | 2021-02-02 | sensation of foreign body |
numbness tingling lips, mouth, tongue Swallowing took more effort - "lump in my throat" Was given be...
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numbness tingling lips, mouth, tongue Swallowing took more effort - "lump in my throat" Was given benadryl, sx's started improving a couple hours later.
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| 45 | 2021-02-03 | feeling abnormal, impaired work ability |
Severe fatigue and headache lasting at least 2 weeks after vaccine. Symptoms still continuing. Had i...
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Severe fatigue and headache lasting at least 2 weeks after vaccine. Symptoms still continuing. Had immediate chills, fever, sweats, etc consistent with vaccine response. However has severe ongoing fatigue, mild dyspnea on exertion, brain fog, etc causing inability to work.
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| 45 | 2021-02-03 | feeling abnormal |
Fever chills body aches and headache started about 7 hours after shot. Symptoms continued throughout...
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Fever chills body aches and headache started about 7 hours after shot. Symptoms continued throughout night. Fever resolved next day. Fatigue and brain fog all day until 7 pm when symptoms resolved very quickly. Tylenol and one dose of advil
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| 45 | 2021-02-03 | panic reaction |
impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more...
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impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more dizziness with visual disturbances; increasingly more and more dizziness with visual disturbances/She feels things are moving that aren't; This is a spontaneous report from a contactable physician, the patient. A 45-year-old female physician received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231, Expiry: Apr 2021), intramuscularly in the left deltoid on 30Dec2020 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included heartburn. Concomitant medications included (dexlansoprazole) DEXILANT for heartburn from an unspecified date (reported as a year and a half). The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced dizziness with visual disturbances. She was having increasingly more and more dizziness with visual disturbances where today (20Jan2021) she felt nauseous from that. It was impairing her from driving because she felt things were moving that weren't and made her panic on the interstate, as of an unspecified date. It. Initially it was bothering her while driving, but now she noticed it while sitting at her desk or when she ate. It was all the time now. The reporter assessed the events "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" as being between disabling and medically significant. The patient did not visit the emergency room or a physician's office, although stated it probably did require it. The patient queried whether to receive the second dose today as her symptoms were worsening. The clinical outcome of "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" was not resolved, and of nauseous, "impairing her from driving/ bothering her while driving" and panic were unknown.; Sender's Comments: Based on a compatible temporal relationship causality between events dizziness with visual disturbances and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-02-04 | anxiety, panic attack, depression |
On January 27, 2021 at around noon I received the first dose of the Pfizer/BioNTech Covid-19 vaccine...
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On January 27, 2021 at around noon I received the first dose of the Pfizer/BioNTech Covid-19 vaccine. After approximately 10-15 minutes I noticed a reaction. I was really lightheaded , short of breath, and shaking. It felt like I was going to pass out. I was given water and a bar to eat, and eventually I got to a place where I felt that I could drive. I went for a walk with a couple of friends, but was having a hard time walking because of shortness of breath, and was still lightheaded plus I had skin tingling on both sides of my face. I ate something afterward the walk and felt better within an hour. The next day I seemed to be fine, but then Friday (two days after the shot) I became increasingly lightheaded/dizzy and nauseous. Additionally, I had issues on Friday and Saturday with anxiety and trying to hold off mild panic attacks plus depression and nausea. I was still lightheaded/dizzy and had shortness of breath for a week after the shot. which has extend to today (February 5, 2021), over a week after the shot.
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| 45 | 2021-02-04 | anxiety |
headache; tiredness; get palpitations; chest pain; arm weakness when standing too long; Anxiety; Thi...
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headache; tiredness; get palpitations; chest pain; arm weakness when standing too long; Anxiety; This is a spontaneous report from a contactable other HCP (patient). A 45-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as 5730, pending clarification), via an unspecified route of administration on 18Dec2020 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 45 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included asthma and known allergies to epinephrine, latex, sulfa. Concomitant medications included amoxicillin (AMOXICILLIN), ibuprofen (MOTRIN). On 19Dec2020 at 01:00 PM the patient had headache and tiredness ever since get palpitations, chest pain, arm weakness when standing too long or when first get up. Heart doctor thinks it's due to vaccine or anxiety but never had this before shot. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment for the events included anti anxiety medication, metoprolol. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination the patient was tested for COVID-19 (nasal swab) on 18Jan2021 which resulted negative. Information about lot/batch number has been requested.
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| 45 | 2021-02-04 | anxiety |
In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicate...
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In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicated so was not going through any withdrawal. She was getting vitals and CIW checked regularly. First dose of chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9. She had repeat vitals at 5:50pm, CIWA 1, vitals: P 67, 118/79, 94% on RA, T 98.3. she had complained of some "pressure in her head" and feeling anxious, but otherwise denied other complaints. she was talking with others in the group, then other patients report she suddenly started having seizure like activity around 6:45pm, med techs came to help and found her stiff, gurgling. they tried to get vitals on her, called 911, noticed that at 6:54pm she had lost a pulse and they started CPR. paramedics arrived at 7:08pm and she was brought to ED. Pt BIBA in cardiac arrest. Pt was at Detox Center when she was reported to have seizure-like activity followed by collapse. She was found to be pulseless and CPR initiated by staff members. EMS arrived and performed approx 15 min of CPR and gave pt epi x 3 and bicarb. No shocks administered but they did not report a rhythm. In the emergency room the patient arrived and was found to be pulseless with PEA arrest, CPR was initiated, patient was intubated. ROSC ultimately achieved, patient remained very acidotic despite ventilator adjustment, head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37, she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia, consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5, pronounced dead at 2:48AM.
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| 45 | 2021-02-06 | sleep disorder |
Pain in left shoulder that has not disappeared . Hurts whenever I get dressed, reach overhead, exerc...
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Pain in left shoulder that has not disappeared . Hurts whenever I get dressed, reach overhead, exercise or sleep.
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| 45 | 2021-02-07 | feeling abnormal |
swelling on the left side of her jaw and throat began to swell/swelling on left side of face and thr...
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swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat; Tingling; swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw; felt a funny sensation in her throat and face/still not feeling herself; soreness; left arm was sore; throat still feels funny; feels scratchy; feeling fatigued; This is a spontaneous report from a contactable consumer reporting for herself. A 45-years-old female patient started to receive bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EH9899, exp date 31Mar2021), via an unspecified route of administration in the left arm, on 15Jan2021 at 14:30, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced left arm was sore on 16Jan2021 with outcome of recovered, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat on 18Jan2021 with outcome of recovering, tingling on 18Jan2021 with outcome of recovering, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw on 18Jan2021 with outcome of recovering, felt a funny sensation in her throat and face/still not feeling herself on 18Jan2021 with outcome of not recovered, feeling fatigued in Jan2021 with outcome of not recovered, soreness on 16Jan2021 with outcome of recovering, throat still feels funny; feels scratchy on Jan2021 with outcome of not recovered. The patient visited the emergency room for left arm was sore, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat, tingling, swelling on the left side of her jaw and throat began to swell/swelling on left side of face and throat/whelping up on the left side of jaw. The patient was treated in the emergency room with prednisone, Benadryl and acid medicine for her stomach.
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| 45 | 2021-02-07 | feeling abnormal |
Day1: swelling in axillary and clavicle lymph nodes Day 2: lymph nodes near breast tender and swoll...
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Day1: swelling in axillary and clavicle lymph nodes Day 2: lymph nodes near breast tender and swollen Day 3: brain fog, feeling jittery, chills, fever 100.2
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| 45 | 2021-02-07 | feeling abnormal |
Tired; Feel bad; Weak; Sore arm; Fever 100.3; This is a spontaneous report from a contactable consum...
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Tired; Feel bad; Weak; Sore arm; Fever 100.3; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: unknown; reason why batch/lot was unknown: misplaced/discarded) via an unspecified route of administration at left arm on 21Jan2021 09:45 AM at a single dose for COVID-19 immunization. Medical history included anxiety, high blood pressure (HBP). Since Covid - short of breath still racing heart. Allergies to medications, food, or other products included penicillin and apple juice. Prior to vaccination, the patient was diagnosed with COVID-19 (short of breath still racing heart). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included niacin, lisinopril, venlafaxine and montluskat for allergy. Facility where the most recent COVID-19 vaccine was administered was at public health clinic/veterans administration facility. The patient was not pregnant at the time of vaccination. The patient experienced adverse events included tired, feel bad/weak, sore arm, fever 100.3; with start date on 22Jan2021 at 03:00 PM. The events were reported as non-serious. The outcome of events was resolving. Treatment Tylenol received for fever. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 45 | 2021-02-08 | feeling abnormal |
faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arriva...
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faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE). The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM. Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-08 | memory impairment |
Feeling ill and tired went to sleep 3:30pm. Could not focus to read text or email. Memory issues wit...
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Feeling ill and tired went to sleep 3:30pm. Could not focus to read text or email. Memory issues with dizziness. 19 days since and improving but memory and focusing occasionally an issue. Dizziness stopped on day 16. Had one of the worst migraines on about day 10.
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| 45 | 2021-02-09 | feeling abnormal, sleep disorder |
I received Pfizer dose #1 on 1/13/21 with no AE. I received Pfizer dose #2 on Mon 2/1/21. On Wed ...
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I received Pfizer dose #1 on 1/13/21 with no AE. I received Pfizer dose #2 on Mon 2/1/21. On Wed 2/3/21, I awoke with hives on my neck and chest, I took a Clarinex. The hives progressed t/o the day. I took a Benadryl that evening. I had difficulty sleeping d/t the burning and itching. I took another Benadryl at 0130 on 2/4/21. By 0930 on 2/4/21 my entire torso and scalp was inflamed. My shoulders were swollen. I had difficulty swallowing. I had a sudden "brain fog" with difficulty speaking and a major headache. I took another Benadryl. I then slept for 21 hours with a half hour awake period for lunch and scheduled Benadryl every 6 hours. My PCP recommended Pepcid 20 mg po BID x 5 days so I started that as well, and I took tylenol for the headache. The next day my rash had improved. I was tired but not extremely fatigued like the day prior. I gradually felt better t/o the day. Saturday 2/6/21, I awoke with resolution of all s/s.
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| 45 | 2021-02-09 | feeling abnormal |
Headache; Myalgia; Chills; Lymphadenopathy; Brain fog; This is a spontaneous report from a contactab...
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Headache; Myalgia; Chills; Lymphadenopathy; Brain fog; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ek9231) via intramuscular in left arm on 02Jan2021 18:00 at single dose for COVID 19 immunization. The patient received the vaccine in hospital. Medical history included asthma, migraine. Known allergies included Latex allergy. Concomitant medication included oral contraceptive pill (OCP), ergocalciferol (VIT D), melatonin, ubidecarenone (COQ10) and fexofenadine hydrochloride (ALLEGRA). No other vaccine was received in four weeks. The patient didn't have COVID prior vaccination. The patient experienced headache, brain fog, myalgia, chills, lymphadenopathy on 03Jan2021. Therapeutic measures were taken as a result of events including ibuprofen (MOTRIN). The events did not require Emergency Room Visit or Physician Office Visit. No COVID was test post vaccination. The outcome of events was recovered in Jan2021.
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| 45 | 2021-02-09 | feeling abnormal |
metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report...
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metallic taste in her throat; strange sensation; very rapid heart rate; This is a spontaneous report from a contactable health care professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 08:30 on the left arm at a single dose for COVID-19 immunization. Medical history included allergy to penicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. The patient reported that minutes after the injection, she had a metallic taste in her throat, strange sensation, and then very rapid heart rate. It subsided in about two minutes. The patient did not receive any treatment for the events. The patient recovered from the events. The events were reported as non-serious.
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| 45 | 2021-02-09 | impaired work ability | fever, chills, head/body aches. called in sick to work. |
| 45 | 2021-02-10 | feeling abnormal |
Mental fog; Soreness at injection site; Fatigue; Fever ( low grade: 1-2 degrees over basal); This is...
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Mental fog; Soreness at injection site; Fatigue; Fever ( low grade: 1-2 degrees over basal); This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 5318), via an unspecified route of administration on the left arm on 27Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant. Concomitant medication included esomeprazole magnesium (NEXIUM), ibuprofen (ADVIL), beclometasone dipropionate (QNASL), diphenhydramine hydrochloride (BENADRYL) and doxylamine succinate (UNISOM). The patient previously took naproxen (ANAPROX) and experienced allergy. The patient experienced mental fog, soreness at injection site, fatigue and fever ( low grade: 1-2 degrees over basal) on 27Jan2021 18:00. No treatment and hospitalization was caused by the events. The outcome of the events was not recovered.
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| 45 | 2021-02-10 | impaired work ability |
Severe fatigue, muscle aches, joint pains in shoulders and hips progressing to the point of difficul...
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Severe fatigue, muscle aches, joint pains in shoulders and hips progressing to the point of difficulty getting up from a sitting position. Missed work on week 3. Worsened each week until that point. Improves with rest but worse after on feet more. Extreme exhaustion. Some chest pressure started on week 2
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| 45 | 2021-02-10 | sleep disorder |
Severe pain all down my right arm into hand and up into jaw and severe headache on right side behind...
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Severe pain all down my right arm into hand and up into jaw and severe headache on right side behind me eye, moderate chills, mild nausea maybe due to the pain. Symptoms started 2/10/21 at 6pm and progressively got worse to the point of being unable to sleep. Took Tylenol at 1:30am and the pain decreased and was able to sleep some, 4 hrs later symptoms returned. Took more Tylenol. 2/11/21 5:57pm still have mild sore arm, mild headache off and on and mild chills.
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| 45 | 2021-02-11 | feeling abnormal |
Patient came in and got her first dose of the Pfizer COVID vaccine at 1515. Patient stated she had n...
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Patient came in and got her first dose of the Pfizer COVID vaccine at 1515. Patient stated she had no allergies and no issues with vaccines in the past. Patient received the vaccine in the right deltoid, IM. Patient tolerated procedure well. Patient walked to main lobby to wait for her 15 min observation time by a staff member. Approximately 5 minutes after receiving the vaccine the patient approached the staff member observing patients that are in their observation window and stated ?something doesn?t feel right?. At this time the staff member called for a nurse to the lobby. When I got to the lobby and asked the patient what was going on she stated ?that she feels weird in her entire body?. I asked the patient if she was able to walk and took her back to the clinic to an exam room. Once in the exam room the patient stated that she ?just feels weird and that her heart is racing?. The patient started to get red blotchy spots on her shoulders. The patient stated that she was having no trouble breathing and did not feel like her throat or tongue was swelling. The patient?s blood pressure was 190/100, HR 89 and oxygen saturation was 98%. I gave the patient 50 mg of Benadryl PO. Patient stated she was only allergic to erythromycin and takes sertraline and vitamins as her only medications. I had the patient lay down as she felt a little dizzy. The patient was breathing heavily but was not having any trouble with SOB at this time, she called her husband to come join her. The patient continued to feel the same symptoms but they were not worsening. Approximately 5 minutes later her blood pressure had decreased to 170/94. The patient stated that she was feeling the same. 20 minutes after the patient took the Benadryl her red blotchy spots had decreased and she was starting ?to feel better overall?. The patients husband stated that he would watch her tonight and continue to monitor for symptoms. I recommended that she go in and be evaluated if her symptoms persist. The patients blood pressure 30 minutes after taking Benadryl was 140/94, pulse 73, oxygen 97%. The patient left with her husband with the understanding that if her symptoms get worse or persist to go in and be seen.
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| 45 | 2021-02-11 | insomnia |
Heart palpitations, cold/numb face half hour after vaccination. Sore arm 2/5/21. Woke up feeling lik...
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Heart palpitations, cold/numb face half hour after vaccination. Sore arm 2/5/21. Woke up feeling like I slept wrong and pulled muscles in my back 2/8/21. Shortness of breath, sore back and chest, left side, hard time getting comfortable going to sleep, 2/9/21. Condition spread to left chest during the day, wondered if I was having a silent heart attack, very difficult time getting to sleep, felt like I had a cracked ribs, back left, 2/10/21. Pain grows to include right side of chest and back, lungs feel like they can't get filled deeply without pain, sleeping pain shifts to right side, 2/11/21. Yearly gyno appt, Dr said lungs and heart sound good, likely side effects of vaccine. Cracked ribs sensation moves to right side of back, difficulty getting comfortable, woke up several times from discomfort, 2/11/21. Shortness of breath and pain breathing during the day, 2/12/21
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| 45 | 2021-02-14 | insomnia |
0930 R arm tingling. BP 142/88, HR 83, lung clear equal, )2 99, HR 83 RR 14. 0940 had some water, ...
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0930 R arm tingling. BP 142/88, HR 83, lung clear equal, )2 99, HR 83 RR 14. 0940 had some water, 0945 had some snacks. Pt c/o sleeping deprived. No Health Hx, no medications, last physical on 10/20, no surgeries. Pt was prescribed Norvasc but currently not taking. Pt was advised to call PCP to follow up and if the symptoms worsen to call 911. 1005 HR 75, good pulse RR 18, lungs clear & equal. BP 140/90. 1010 Pt feeling better, called the ride. 1016 Pt stated she is going home and eat. 1020 Pt's ride got to the building to pick her up. This RN walked the pt. The pt stated she was feeling much better and was going to call PCP asap.
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| 45 | 2021-02-14 | loss of personal independence in daily activities |
I exp headaches, shoulder aches and really bad nausea. The headache from dose 2 was worse than first...
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I exp headaches, shoulder aches and really bad nausea. The headache from dose 2 was worse than first dose. I also exp numbness(limp feeling) bilateral arms. I was unable to cook had to be in bed for 2 days.
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| 45 | 2021-02-14 | panic attack |
Vaccine administered at 1727. Patient reported reaction to influenza vaccine in 2019. Patient advise...
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Vaccine administered at 1727. Patient reported reaction to influenza vaccine in 2019. Patient advised to wait 30 minutes while being supervised. Reaction noted to start at 1736. Patient reported "Fire feeling" and "Tingling on my tongue." Blood pressure in right arm 190/78. Heart rate 85-90's, oxygen saturation level 98% on room air, and respirations 20 breaths per minute. Patient reported dry mouth and hot sensation. Cheeks and chest flush. Patient denied shortness of breath and swelling of the mouth and tongue. Patient reported "Could be a panic attack." Educated on importance of deep breathing. Exercise completed. Bottle of water provided. Benadryl offered and patient declined at this time. 1742: "Fire feeling" began to resolve. 1756: Blood pressure in right arm 160/80. Heart rate 81 and oxygen saturation level 97% on room air. Respirations 16 breaths per minute. Temporal temperature 98.6 degrees F. Patient reports headache in frontal region.
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| 45 | 2021-02-16 | feeling abnormal |
Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burnin...
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Throat and mouth "feels funny" following injection of Covid vaccine approx 1717. Slight chest burning. Patient ambulated. Drinking water without diffuculty. Patient states tongue "feels funny" after getting covid vaccine. Patient states within minutes after the injection her tongue began to feel funny. She denies oral/lip swelling, numbness/tingling, difficulty swallowing, drooling, headache, nausea/vomiting, chest pain, shortness of breath. She also states her chest was burning just after receiving the vaccination however that has since resolved. No palpitations or syncope. No recent illness. No history of adverse reaction to vaccines. No known food/medication allergies. Patient is sitting comfortably on the exam table drinking water without difficulty. Patient states at this time her mouth feels better but "does not feel normal." Patient states she has a history of mitochondrial myopathy and has some esophageal motilty issues at baseline. 1808: patient was given diphenhyramine 25 mg PO x 1. She reports mild improvement in symptoms. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. 1830: patient states symptoms have resolved. She is sitting comfortably in the chair. No signs of distress. She states she thinks she got too anxious. No headache, dizziness, nausea, oral edema, difficulty swallowing, chest pain, shortness of breath. Patient states she feels comfortable leaving at this time. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss second dose of covid vaccine. 1/15/21: Pt received 2nd dose of vaccine. About 10 minutes after, pt developed a rash at injeciton side. Rash spread up chest and onto back. Pt was taken to convenient care for further evaluation. At convenient care, pt stated she had no difficulty breathing but that something just didn't feel right. Rash spread to right arm and started to itch. Pt endorsed experiencing throat/tongue swelling but did not think it was closing off or actualy swelling. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. After treatment and about 1.25 hours of monitoring, pt felt well enough to go home. Pt was prescribed epinephrine 0.3 mg IM 2-pak kit. 1/15/21: Pt received 2nd dose of COVID vaccine and develped rash. Pt received epinephrine 0.3 mg IM x 1 and diphenhydramine 25 mg IM x 1. Discharged to home after treatment and monitoring with prescription for epinephrine 0.3 mg IM 2-pak kit.
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| 45 | 2021-02-17 | insomnia |
Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection;...
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Abdominal pain; severe nausea; headache; numbness in hand; itching on body on the side on injection; itching on body on the side on injection; dizziness; insomnia; night sweats; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown, unable to locate or read details), via an unspecified route of administration on 23Jan2021 16:15 (04:15 PM) at single dose on right arm for COVID-19 immunization. Patient was not pregnant at the time of report. The patient medical history was not reported. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications included fluticasone, salmeterol, montelukast and paracetamol (TYLENOL). Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The most recent COVID-19 vaccine was administered in School or Student Health Clinic The patient experienced abdominal pain, severe nausea, headache, numbness in hand, itching on body on the side on injection, dizziness, insomnia, night sweats, low grade fever, all on 24Jan2021 02:00. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovering. Patient has not been tested with COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 45 | 2021-02-18 | impaired work ability |
Eye soreness/pain. Halos around light. Light sensitivity. Headache. Nausea. Dx: Iritis both ey...
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Eye soreness/pain. Halos around light. Light sensitivity. Headache. Nausea. Dx: Iritis both eyes. Dx on Friday January 8, 2021. Steroid eye drops prescribed. Infection and steroid drops are ongoing as it has not resolved yet. Needed to stay home from work due to headache/nausea. Headache and nausea is on the Covid symptom list and the hospital I work at would not allow me to work until I'd had a negative Covid test.
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| 45 | 2021-02-19 | fear, anxiety, panic attack |
I had a sore arm and a slight headache the day after the Pfizer injection. I went out to the grocery...
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I had a sore arm and a slight headache the day after the Pfizer injection. I went out to the grocery and had a total panic attack. I had to leave the store. It took amazing effort to do this. I then had to sit in my car for an hour and talk to a friend to de-escilate enough to drive home. I have spent the entire week very close to my bed. Even getting up and taking a shower causes me to panic- heart rate increase, shallow breathing, cold sweat, the feeling that I am coming out of my body or will pass out. All I have been doing is laying around for one week?s time. I have anxiety but nothing like this. I do not know if I should take the second injection. I am fearful that this will be so much worse after taking the second injection. I did call my PCP and the nurse did a phone review with me telling me that I should take the second injection and that anxiety / panic attacks are not a known side affect of this injection.
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| 45 | 2021-02-22 | insomnia | fever, chills, joint pain, nausea, headache, overall pain, insomnia |
| 45 | 2021-02-25 | feeling abnormal |
Fever, chills, sweats, headache, body aches, brain fog. Beginning a few hours after 2nd vaccine and ...
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Fever, chills, sweats, headache, body aches, brain fog. Beginning a few hours after 2nd vaccine and ending 72 hours later approx.
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| 45 | 2021-03-01 | sleep disorder |
Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to s...
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Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.
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| 45 | 2021-03-02 | loss of personal independence in daily activities |
short of breath to the point that I had to go to the ER, symptoms lasted for about 10 days and I sti...
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short of breath to the point that I had to go to the ER, symptoms lasted for about 10 days and I still not feeling 100%, dizziness, unable to function for 10 days, only laying down make me feel better
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| 45 | 2021-03-06 | feeling abnormal |
Approximately 3 - 5 minutes after the vaccine I got a very hot feeling in my chest. I then started...
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Approximately 3 - 5 minutes after the vaccine I got a very hot feeling in my chest. I then started to feel lightheaded and just weird. I was taken to lay down. My blood pressure was taken and it was elevated. I don't recall the exact numbers. I then began to develop hives on my chest and neck and a few minutes later I began coughing. An ambulance was already on site. They took me in the ambulance and gave me 25 mg of Benadryl and a dose of epi. The coughing subsided for about 10 minutes then began again. I was given another 25 mg of Benadryl. At the hospital I was observed. At approximately 5:30 I began to cough again. It was decided that I needed steroids and was given steroids in my IV. Once I stopped coughing I was discharged and sent home with a prescription for steroids and an Epi-pen
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| 45 | 2021-03-07 | feeling abnormal |
groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have verti...
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groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.
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| 45 | 2021-03-07 | excessive sleepiness |
The evening of the vaccination when I got home did not feel like myself, extremely fatigued. I went ...
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The evening of the vaccination when I got home did not feel like myself, extremely fatigued. I went to bed and in the middle of the night I developed shaking chills and had a fever of 101F. Next morning I called Employee health and told them I was having headache, the shaking chills, body pains. They told me to call them back if it got worse. I called them in the afternoon since the symptoms got worse and I also developed a pain in my flank area, like kidney pain (in the back, but not the back). This happened on Sunday 01/10). I took a lot of Tylenol and Ibuprofen that did not help me at all with the fever or the pain (it reached 102F). On Monday, 01/11 the fever broke in the afternoon but I ended up with an extreme fatigue and I slept the whole day. When I woke up on Tuesday, within one hour of waking up I was feeling totally fine.
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| 45 | 2021-03-10 | impaired work ability |
I began with chills 9 hours after receiving the vaccine, which then transitioned to severe shaking a...
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I began with chills 9 hours after receiving the vaccine, which then transitioned to severe shaking all night. Temp was 102 at the highest, severe headache( worst ever) for 3 days. The next day I had difficulty walking and had to lean on the wall to ambulate due to lower extremity weakness which lasted 2 days and spinal pain. I missed 3 days of work due to the illness after the 2nd covid vaccine. 12/23/21 After the 1st Pfizer vaccine Lot # CJ 1685, I began with chills 6 hours later and felt like I had brain fog the whole next day, just didn't feel right.
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| 45 | 2021-03-11 | impaired work ability |
The day I got the vaccine around 5PM I started feeling really tired and started having symptoms from...
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The day I got the vaccine around 5PM I started feeling really tired and started having symptoms from the vaccine, a really bad headache, muscle aches, temperature of 100.2F, chills, nausea and I noticed my arm hurt and then my noticed my lymph nodes under my right armpit swollen (painful - lasted about a week) all other symptoms about 2 days. I had the vaccine on a Thursday, on Friday I could not even finish my work day. The overall symptoms lasted about2 or 3 days. Consulted with PCP on the phone who suggested hot and cold compresses.
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| 45 | 2021-03-12 | sleep disorder |
On 3/8/21 around 4:45 pm I got the first dose of Pfizer COVID vaccine. In the evening around 11 pm,...
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On 3/8/21 around 4:45 pm I got the first dose of Pfizer COVID vaccine. In the evening around 11 pm, I experienced difficulty in breathing and had a slow heart rate. In addition to muscle pain on my left arm where I got the shot, whenever I almost felt into sleep I was startled and woke up from short of breath. I wore a watch to check on my heart rate. On the low end it went into 53 ~ 54 especially when I felt short of breath. On the high end it was around 67 ~ 70 which is my normal heat beat when at rest.
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| 45 | 2021-03-14 | impaired work ability |
Physician who received the Pfizer-BioNTech covid-19 vaccine has had subsequent neurologic and syste...
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Physician who received the Pfizer-BioNTech covid-19 vaccine has had subsequent neurologic and systemic complications requiring loss of work and multiple visits with specialists.
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| 45 | 2021-03-14 | sleep disorder |
I had no side effects until several hours later when I went to bed and woke up at 3:00am with pain i...
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I had no side effects until several hours later when I went to bed and woke up at 3:00am with pain in my breast on the right side. It feels like a pulled muscle but is also in the same area as a breast tumor that was removed decades ago. My right arm and right breast are tender to the touch and I have occasional sharp pain I the breast. No feeling of lumps though.
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| 45 | 2021-03-15 | anxiety | VS 170/100, 112; Anxiety, tachcardia, hypertensive, no meds given, patients resolved. |
| 45 | 2021-03-15 | feeling abnormal | HEADACHE, BRAIN FOG AND FATIGUE |
| 45 | 2021-03-16 | insomnia |
Sore arm left site started at 8 PM 3/16. Then after midnight had chills and fever and nausea, temp 1...
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Sore arm left site started at 8 PM 3/16. Then after midnight had chills and fever and nausea, temp 101.6 shivering, body aches, dizziness when sat up. Took Advil, slept some more Hard time sleeping. 7:45 AM 3/17 had fever 102.1 F this AM, and took Tylenol. Now temp 101.1 F.
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| 45 | 2021-03-16 | sleep disorder |
This is a continuation from Dose 1 and 2 worsening symptoms pain in PIP,both elbows.I have more pai...
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This is a continuation from Dose 1 and 2 worsening symptoms pain in PIP,both elbows.I have more pain late at night causing me to not be able to sleep. Im exp stiffness and in the last month both hands little numb.The past week exp neck/back pain. I have had bloodwork which is has been normal. Before the vaccine I haven't had any of the symptoms.
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| 45 | 2021-03-18 | loss of personal independence in daily activities, excessive sleepiness |
Heavy cramping and bleeding - period began early and heavily. Unable to hold tampons without body cr...
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Heavy cramping and bleeding - period began early and heavily. Unable to hold tampons without body cramping ( even light while I use regular, and super through period usually). Exhausted, some back pain and discomfort from cramping. Unable to stand upright to walk due to cramping on day 2 after vaccination. Tried to rest. Stayed in bed on day three, slept 15 hrs on day four as pain was extreme. Bought and Wore heavy pads to protect. Alternating loose stools and constipation. Full abdomen pain. Not able to leave house alone for groceries. Won?t drive.
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| 45 | 2021-03-19 | insomnia | chest pain, fatigue, headaches, chills, arms soreness, insomnia |
| 45 | 2021-03-20 | anxiety, disturbance in attention, depression |
Back muscle pain and tiredness the day of the shot. Within 24 hours of the vaccine, anxiety, depress...
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Back muscle pain and tiredness the day of the shot. Within 24 hours of the vaccine, anxiety, depression, lack of focus. It was like a severe PMS in the mental sense, and two weeks of it, and the tiredness worsened over the two weeks. I am not someone who suffers from PMS like in general, it was exceptional, and the only difference in my routine was the shot precisely the two weeks before a cycle.
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| 45 | 2021-03-21 | excessive sleepiness |
Extreme fatigue, and all over body aches. No fever, just the aches and headaches for two days. Too...
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Extreme fatigue, and all over body aches. No fever, just the aches and headaches for two days. Took Nyquil and slept most of he day both days.
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| 45 | 2021-03-21 | insomnia |
Within 10 minutes of receiving the injection, as I was scheduling my second dose and then while I wa...
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Within 10 minutes of receiving the injection, as I was scheduling my second dose and then while I was waiting, my left should (upper left side of my back) started aching. I do not normally have any kind of a response to any vaccine, so I didn't immediately connect this pain with my COVID-19 vaccine, however, it continued to get progressively worse and ultimately became my entire arm, shoulder, neck and head. I had a lot of difficulty sleeping for the next two nights and I noticed yesterday morning (Sunday, 3/21/21) that my left clavicle was completely obscured by significant swelling (I assume lymphnodes). Golf ball-sized swelling. Today (Monday, 3/22/21) the swelling continues to be significant and I think maybe covering more area. Not as pronounced of a lump, but more of a squashed, larger lump, if that makes sense?
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| 45 | 2021-03-22 | anxiety, feeling abnormal |
Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy ...
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Approximately 15 minutes after receiving second COVID vaccine dose I developed a red somewhat itchy rash to chest, abdomen, back and bilateral arms. I was wheelchaired over to the Urgent care section of the building with a Dr following along. By the time I reached the Urgent Care room I was feeling the same strange feeling in my mouth tongue and throat that I had felt with the first vaccine. I felt as if my tongue and possibly lips may be swelling a little though I don?t think they were. It was hard to swallow but I have a mitochondrial disorder which causes trouble swallowing at times too so it may have been a little worse than what I usually feel with that. I seemed to be having trouble pronouncing words as my tongue seemed to be in the way and my voice weaker. By blood pressure was elevated as it was after the first vaccine. I was given a subcutaneous shot of epinephrine and the symptoms started to improve within approximately 15-20 minutes though I was very shaky and anxious from the epi. I was then given an IM injection of Benadryl. After possibly an hour and a half I was sent home with my husband an epi pen and a script for prednisone. I continued to have a strange feeling in my mouth and throat on and off for a couple of days but less severe and I did not use the epi pen for
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| 45 | 2021-03-22 | disturbance in attention, sleep disorder |
Pfizer-BioNTech COVID-19 Vaccine EUA around 2:30 am began having chills, and muscular aches both of...
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Pfizer-BioNTech COVID-19 Vaccine EUA around 2:30 am began having chills, and muscular aches both of which continued for approximately 18 hours. around 7:30 am began also having headaches which persisted for about 12 hours. Also had fatigue, possible due to not sleeping well due to sx. Around 10:00 am began having difficulty concentrating, headaches, muscle aches and chills intensified. Around 11am confirmed fever of 100 d F, took Tylenol which lessened chills. General malaise continued through evening, 8pm, took another Tylenol, by 9 pm began having series of intense and persistent (nonstop) heart related symptoms (chest pounding, tachycardia, shortness of breath,) which continued for several hours. (exact time unknown, I am guessing it lessened around 2am or so.) Following am, all symptoms gone. (might have continued to have some intermittent heart stuff as that has been ongoing every day, but non-stop intense cardiac feelings were not continuing by morning.
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| 45 | 2021-03-22 | feeling abnormal, anxiety |
5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, he...
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5 minutes after vaccine patient felt anxiety attack in chest, bottom of throat/ chest felt tight, heart raced, shaking and sweating, hands trembled, light headed, felt both hot and cold at same time. Patient alerted pharmacist and sat down in chair. 23 minutes after vaccine patient not 100% but better, feel fuzzy in head, shaky and feel sweaty but not sweating, carpet looks weird (patient states has hallucinations from other drugs). 25 minutes after vaccine patient light headed, vision not perfect. 28 minutes after vaccine patient's body feels warmer 32 minutes after vaccine patient feels unbalanced, body warm, legs heavy. 36 minutes after vaccine patient's feet feel heavy, feel more normal, temperature difference, sweating stopped, feel more like herself. 39 minutes after vaccine patient's feet feel smidge heavy, feel like herself. 41 minutes after vaccine patient left observation.
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| 45 | 2021-03-22 | impaired work ability, hallucination, feeling abnormal |
On the day after my vaccine I was sweating all day but did not think anything of it. By the end of ...
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On the day after my vaccine I was sweating all day but did not think anything of it. By the end of the day I was not feeling myself, I went home and felt like I needed to rip my clothes off because I was so hot. I was sweating but freezing at the same time. I changed my clothes and went to bed. I then began freezing where I my teeth were chattering and could not get warm. I had on 3 blankets and was shaking. I fell asleep and was having hallucinations and talking to my grandparents that are deceased. I woke up not know anything but what I was told by my husband and daughter. I took my temperature and it was 104.1. I then continued to alternate between tylenol and ibuprofen for the rest of the night. I slept from 6:00 pm the night of the 12th to 10:00 am on the 13th. I still had a fever but developed a headache that nothing was helping. my fever was 101.4. I was told to go to the doctors to get checked by my job which I did, they examined me and the next day I went back for a COVID swab. I was in bed for the next 12 days and everyday I was developing various symptoms. By day 4 I had no taste and impaired smell and day 5-12 I had body aches, congestion and a cough that would not go away. I was our of work from 01/12/21-01/25/21.
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| 45 | 2021-03-23 | anxiety, nervousness |
46 yo female presents for "palpitation" and chest tightness x 15 min. She reports that she has hx of...
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46 yo female presents for "palpitation" and chest tightness x 15 min. She reports that she has hx of ASD closure 5 years ago but has not taken any meds. At the moment she feels "nervous" and anxious. Consulted with Dr. , Dr, ok'd to go home.
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| 45 | 2021-03-23 | anxiety, panic attack |
I had severe anxiety / panic attacks, high heart rate, severe dehydration (6 pounds lost within 10 h...
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I had severe anxiety / panic attacks, high heart rate, severe dehydration (6 pounds lost within 10 hours of the injection), chills, headaches, body aches, dizziness, nausea, extreme fatigue. I developed an eye infection for which I had to go to the doctor. I am currently doing eye drop treatments for this as well as topical lid scrubs. The anxiety / panic continues. I had extreme fatigue for several weeks. Other symptoms lasted 48 hours.
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| 45 | 2021-03-23 | delirium |
I woke up with severe chills from 4am-10am and then had fever of 103 plus that afternoon, could bare...
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I woke up with severe chills from 4am-10am and then had fever of 103 plus that afternoon, could barely get up out of bed, nausea, weakness, dizziness. Aches all over my body and joints especially, intense headache, pain at injection site. The next night, same thing, woke up at 5am with chills and fever of 103 plus and all the other symptoms the second day. I was in so much pain I considered going to the doctor but could barely move. Tylenol did not touch it. I was delirious. The third night/day the fever finally had broken but I was still super weak and tired. The next day I was better. Anyway, if I had the option I would not take the vaccine again because of these side effects.
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| 45 | 2021-03-23 | feeling drunk |
About 30 minutes after the shot I got really tired. 30 - 45 minutes later I got really happy and sta...
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About 30 minutes after the shot I got really tired. 30 - 45 minutes later I got really happy and started to laugh a lot. It got worse with movement and was containable if I was sitting still. I was unsteady on my feet as well. I kept losing my balance. I would describe it as euphoria or intoxicated. Lasted until about 10:30 pm when I got really tired and fell asleep pretty quickly. This morning I am just tired and sore with a headache.
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| 45 | 2021-03-24 | feeling abnormal | Nausea, feeing ?foggy?, tired |
| 45 | 2021-03-24 | feeling abnormal |
I woke up with cold/flu like symptoms and severe vertigo on Sunday March 21 2021. I could not even ...
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I woke up with cold/flu like symptoms and severe vertigo on Sunday March 21 2021. I could not even walk straight the vertigo was so severe. Monday the cold symptoms were much better mostly fatigue and I still had vertigo but not as bad. To this day I still have the vertigo. When I get up or down from a laying position the room spins. If I lean my head back even when I'm standing the room spins. If I stand too long I get a fuzzy feeling. My vision is also a bit cloudy than before.
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| 45 | 2021-03-24 | insomnia |
Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high bl...
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Instant Lupus flare; Instant extremely high blood pressure and pulse rate; Instant extremely high blood pressure and pulse rate; Instant red face; tightness in chest/Instant hot fire feeling in stomach and chest.; Instant hot fire feeling in stomach and chest; Shortness of breath; Sore throat; diarrhea; upper back pain; Tiredness; rash on arm; chills; insomnia; This is a spontaneous report from a contactable consumer. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 08:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included lupus, high blood pressure, asthma, anemia. No pregnant. No covid prior vaccination. No known allergies. No other vaccine in four weeks. Other medications in two weeks. The patient's concomitant medications were not reported. The patient experienced instant lupus flare, instant extremely high blood pressure and pulse rate, instant hot fire feeling in stomach and chest, instant red face, shortness of breath, tightness in chest, sore throat, diarrhea, upper back pain, tiredness, rash on arm, chills, insomnia on 18Mar2021 08:15 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: instant extremely high, blood pressure measurement: instant extremely high, sars-cov-2 test(Nasal Swab): negative on 07Jul2020, on 11Nov2020, on 15Dec2020, on 01Feb2021. Treatment received as Emergency care and needed extra bp and Lupus meds. The patient experienced Emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Information on the Lot/Batch number has been requested.
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| 45 | 2021-03-24 | memory impairment |
Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine...
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Coughing; Dizziness; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Vaccine site became red, hot, hard; Fever; Body aches; She felt like she was going to die; feels awful; Constipation; Couldn't keep her eyes open; Chills; Sore arm; Tired; couldn't keep her eyes open; Nauseousness; Lightheaded; it felt like someone was playing with my head and controlling her memories; sugar levels going up; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6205 and expiration date 30Jun2021 received on 03Mar2021 as a single dose (at the age of 45 years), unspecified route in left arm for COVID-19 immunisation. History included thyroid removed in 2014 and diabetes in 2019 (diagnosed about a year and a half ago), Cirrhosis liver, fatty liver. Concomitant medications include metformin for diabetes, glyburide for diabetes, levothyroxine sodium (TIROSINT) for thyroid disorder, cetirizine hydrochloride (ZYRTEC), omeprazole, ascorbic acid (VITAMIN C), zinc, ergocalciferol (VITAMIN D), bifidobacterium lactis (PROBIOTIC), fluticasone propionate (FLONASE), albuterol (SALBUTAMOL), and budesonide, formoterol fumarate (SYMBICORT). Following the vaccination on 03Mar2021, she came home at night with sore arm and started getting chills. She felt very nauseous. She could not open her eyes anymore. She went to sleep and woke up in the middle of the night. She felt like someone was controlling her memories. It felt like someone is taking away memories (Mar2021) and she was trying to hold on. Like something was messed up in her head. The next day she woke up with a sore arm and felt fine. She had a little nauseousness but it was controlled. On Friday (04Mar2021), the vaccine site became red, hot, hard, and had a white ring around it. The more red it became the more fever, nauseousness, and constipation she had. She couldn't keep her eyes open. She started coughing. She had to use her inhalers even more. Her inhalers are Albuterol and Symbicort and she doesn't have a lot number to provide for her inhalers. All day she felt that way. She felt like she was going to die, has body aches. It was awful. She also had dizziness at nighttime she took the ice pack and froze her arm because she couldn't take it anymore. Saturday, 05Mar2021 she woke and still had dizziness and couldn't go to the bathroom. She feels nauseous. She can't keep her eyes open. Sunday (06Mar2021) it was better (unspecified events), but she is not herself. Ever since then she feels like she is always tired. Today it has been a week after and she is so tired. She called the number and one of the representatives said she wouldn't do the second dose. The doctor said it is side effect. She also reported that she is lightheaded. She said her sugar numbers have been sky high. She told the nurse that it didn't hurt like the flu shot. She did not have NDC, lot, and expiry to provide for flu shot. Lab information in Mar2021 included Sugar levels were up and weight: 203 to 205 pounds. Outcome of events was unknown.
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| 45 | 2021-03-24 | sleep disorder |
I started with a cough and that got progressively worse until I started throwing up. After throwing ...
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I started with a cough and that got progressively worse until I started throwing up. After throwing up I felt like I could not get enough air for about 40 mins. I had a Abuteral inhaler left from fighting bronchitis so I took a few puffs of that and started to feel a little better. Through the night I continued to throw up a few times and having a lot of coughing. The next day mt throat was on fire and could not really talk. I am assuming this was from all the coughing and throwing up.
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| 45 | 2021-03-25 | feeling abnormal | on day two brain fog slight headache dry cough |
| 45 | 2021-03-28 | anxiety |
Anaphylaxis type reaction with chest tightness and throat fullness. Pt had reaction first dose with ...
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Anaphylaxis type reaction with chest tightness and throat fullness. Pt had reaction first dose with Benadryl IM used with a lot of anxiety . Second dose very anxious gave Epi x 2 and Benadryl with pt going out via 911. Pt was awake and talking BP 175/106, P81 O2sat 98%
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| 45 | 2021-03-28 | insomnia |
Immediate reaction: dizziness and muscle cramps, especially in left side and a lot in my left foot.....
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Immediate reaction: dizziness and muscle cramps, especially in left side and a lot in my left foot...whole foot cramped up immediately...dizziness and cramping went away in about 40 minutes. Since then, I have been having extreme rushes of adrenaline for almost a week now...lasting almost all day. I will wake up feeling ok, but as the day progresses, the adrenaline starts up. It has been unbearable. I've had heart palpitations, fluttering, jumping, etc because of it. It feels as if I am on prednisone (I was on 60mg 8 years ago and it really messed with my adrenal glands). I am unsure if I can take the second dose because of the side effects I had from the first. I know thousands of people and I know no one
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| 45 | 2021-03-29 | feeling abnormal |
(3 days after): Pain in hand/wrist, body aches, nausea (2 days after): Fever, Pain at the injectio...
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(3 days after): Pain in hand/wrist, body aches, nausea (2 days after): Fever, Pain at the injection site (that radiates into hand and wrist), nausea, body aches, chills, extreme exhaustion. (1 day after): Stinging sensation of left ear and scalp, headache, lethargy, exhaustion. (Day of Vaccine): spaced-out feeling (like everything was in slow motion).
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| 45 | 2021-03-31 | feeling abnormal |
First day and first night extreme Sore arm- no sleep Second day - fatigue, foggy head, nausea , mo...
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First day and first night extreme Sore arm- no sleep Second day - fatigue, foggy head, nausea , moodiness, extreme finger joint pain Third day (today) - Headache , ears ringing, low fever, joint pain, sensitive skin, exhaustion,
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| 45 | 2021-03-31 | impaired work ability |
Extreme fatigue, flu like symptoms, low grade fever for 3 days. Improvement starting to be seen on A...
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Extreme fatigue, flu like symptoms, low grade fever for 3 days. Improvement starting to be seen on April 1st, return to work possible on April 2nd, normal activities resume.
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| 45 | 2021-04-01 | loss of personal independence in daily activities, insomnia |
it was worse; I had to take Benadryl to sleep; eye lid tingling; Also reports pain on the top of her...
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it was worse; I had to take Benadryl to sleep; eye lid tingling; Also reports pain on the top of her head and last night aching on left side of her head; Eyelids with poking sensation; lip is jerking, jerking of eyes; pain on left side of her neck; I feel my gland is swollen with a lump on left side; I have had tingling and a needle pain sensation all over my body./Tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head; Has to work through the pain/Pain ran down along left side of neck a couple of nights ago also;; Left top of head aching sensation; It is effecting her work and daily life.; This is a spontaneous report from a contactable pharmacist. A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205, Expiration date: not reported via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 14:25 (at the age of 45-years-old) as single dose for COVID-19 immunization. Medical history included ongoing hepatitis B, Kidney stone from 2019 and ongoing. Concomitant medication(s) included tenofovir disoproxil fumarate (Dosage text : 300mg Tablet once daily at night) taken for hepatitis b. The patient's father has high blood pressure and heart problems and mother is fine as stated. The patient experienced tingling and a needle pain sensation all over my body/tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head on 07Mar2021, had to take benadryl to sleep on an unspecified date with, eye lid tingling on an, on 16Mar2021 lip is jerking, pain on left side of her neck, feel the gland is swollen with a lump on left side, also reports pain on the top of her head and last night aching on left side of her head, eyelids with poking sensation, jerking of eyes, left top of head aching sensation, it is effecting her work and daily life, has to work through the pain/pain ran down along left side of neck a couple of nights ago. Therapeutic measures were taken as a result of insomnia. The outcome of event Tingling needle like sensation like someone poking needles, eyelids, arms, legs, back, face, belly, all over body, tips of fingers, bottom of feet, top of head, Lips Jerk, Jerking of Eyes, Left side of neck lump like a swollen lymph is Not Recovered, Left top of head aching sensation, Pain ran along left side of neck is Recovered. Follow up (17Mar2021): New information included clinical information and description of product complaint: Is there a Product Complaint: Taking benadryl last two nights to sleep, did not help last night. Product strength and count size dispensed: 25mg. Additional lot numbers: P117225. Is a sample of the product available to be returned, if requested: No No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering a plausible temporal association, a causal relation between the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-04-02 | feeling abnormal | SPACEY DIZZINESS |
| 45 | 2021-04-05 | anxiety |
45 yo F with history of strial fibrillation and anxiety, who had elevated HR as high as 160s felt li...
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45 yo F with history of strial fibrillation and anxiety, who had elevated HR as high as 160s felt like her atrial fibrillation. Started right after her vaccine was given, felt a little anxious then her HR increased. She took her home Metoprolol (which she uses as needed for her afib). Nurse observed her for 30 minutes prior to my eval, HR now normalized to 80s-90s. BP 105/78, SaO2 99%. Pt asymptomatic at this time, states she is feeling better. Offered ED visit, but states she would rather follow-up with her cardiologist, has his phone number and will call him today.
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| 45 | 2021-04-05 | feeling abnormal |
About 20 min after shot felt ?funny? - started feeling strange/not well, like something was not righ...
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About 20 min after shot felt ?funny? - started feeling strange/not well, like something was not right, kind of going into shock. Then within a min or 2 swallowing became difficult. Gave myself injection of my son?s epi pen and had friend take me to ER. Started feeling better after epi pen so did not admit to ER. Called PCP and reported event and discuss. Did not go in to see my PCP, just discusses on phone.
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| 45 | 2021-04-05 | loss of personal independence in daily activities |
severe weakness, low blood pressure, tachycardia, feels faint/near syncope, mild but new dyspnea on ...
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severe weakness, low blood pressure, tachycardia, feels faint/near syncope, mild but new dyspnea on exertion and severe tremor of hands interfering with activities such as feeding herself, occasional mild headache. admitted to observation in emergency center, discharged home
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| 45 | 2021-04-06 | anxiety | C/o anxiety, shaking of head, did not eat breakfast. B/P 122/71, HR 82, O2Sat 98, T 98. |
| 45 | 2021-04-06 | confusional state |
RN, went to the patient vehicle to check on her during her observation. Upon arriving, the patient s...
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RN, went to the patient vehicle to check on her during her observation. Upon arriving, the patient stated she felt dizzy and light headed. She was given a Gatorade to see if that would help. After a few sips she became more confused and diaphoratic. Code green was initiated and EMT arrived to evaluate patient. After EMT evaluated patient and determine she was better, I monitored for another 15 minutes. Patient felt better and was no longer dizzy.
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| 45 | 2021-04-06 | insomnia |
Develop Tinnitus. Saw doctor. No solution. On meds now. Hopefully it will stop over a period of tim...
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Develop Tinnitus. Saw doctor. No solution. On meds now. Hopefully it will stop over a period of time. Not being able to sleep due to ringing in my ears especially left side.
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| 45 | 2021-04-06 | restlessness |
Initial reaction: night of April 1-2: moderate leg aches, restlessness, hip joint pain, feeling fev...
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Initial reaction: night of April 1-2: moderate leg aches, restlessness, hip joint pain, feeling feverish w/out fever, mild chills April 2-3: moderate to severe fatigue, lethargy symptoms eased on evening of April 3 Secondary reaction: April 4, evening through today, April 7: lymph nodes in left armpit, left side of neck, left jaw sore and tender, possibly slightly swollen. Back left jaw felt slightly numb on first day. Left side of neck feels as if muscles sprained. No fever. Brief, mild tenderness at injection site on right arm.
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| 45 | 2021-04-07 | impaired work ability, restlessness |
4/01 received vaccine at 945 am By 6pm I developed low grade fever, restlessness, difficulty breathi...
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4/01 received vaccine at 945 am By 6pm I developed low grade fever, restlessness, difficulty breathing. Next day 4/02 I was feeling worse. Breathing issues body aches and chills. Went home sick from work. 4/03 symptoms worse lost taste and smell. Contacted clinic, they did a covid test it was negative. Symptoms continuing to get worse. Troubles breathing, chills, extreme fatigue I can not get from room to room with out loosing my breath. Went to ER , they said they will do another covid test and that came back negative. They prescribed me steroids, cough suppressant and albuterol inhaler. Today I am still struggling to breathe can not work still. I am extremely exhausted. I feel winded just getting from room to room. Today is one week from 1st shot. Symptoms are not getting better.
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| 45 | 2021-04-08 | feeling abnormal |
Severe Nausea Vomiting 2 hrs after. Forceful vomiting from car door no time to get anywhere. Chills...
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Severe Nausea Vomiting 2 hrs after. Forceful vomiting from car door no time to get anywhere. Chills Vulvar pressure- this is strange and I almost don?t mention it except for it came on suddenly same time as vomiting and was severe ! Site soreness up thru neck Cold sweats Loss of apetite Tired Immediately 3-4 hrs after severe fatigue and drowsiness Slowed pulse Foggy brained Hot skin Red skin allover
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| 45 | 2021-04-08 | nervousness |
Two days after the vaccine my arm became really hot and swollen. It was a circle about the size of a...
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Two days after the vaccine my arm became really hot and swollen. It was a circle about the size of a baseball on my left arm around the site of injection. It looked like cellulitis. I also had a lump under my arm. II took some Tylenol which helped. It was there for almost two weeks and it gradually went down. The Lymph node under my arm also went down in the same amount of time. I am nervous about getting the second dose.
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| 45 | 2021-04-10 | feeling abnormal |
Immediate dizziness, then about 8 hours later fatigue, brain fog, body aches which have lasted 36 ho...
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Immediate dizziness, then about 8 hours later fatigue, brain fog, body aches which have lasted 36 hours so far
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| 45 | 2021-04-10 | feeling abnormal |
Please see below for the worst symptoms that started on 4/9, but in chronological order here it is: ...
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Please see below for the worst symptoms that started on 4/9, but in chronological order here it is: 12 hours after receiving the vaccination: chills, body aches, headache and feeling of drunkenness, pressure in eyes, painful gums in mouth. On Thursday 4/8: muscle aches, chills, tiredness, pressure in head with drunkenness feeling again. On Friday 4/9 at ~ 2:30pm I got a sudden feeling of coldness and started shaking and teeth were chattering uncontrollably, my lips turned blue, this lasted for about 20 to 30 minutes. Headache and body aches continued. Measured fever of 100.5 degF. On Saturday 4/10: pressure in head intensified, feeling as if someone squeezing on head. Saturday night/early Sunday morning burning feeling in legs. sudden sweats. On Sunday 4/11 at time of writing, still feeling pressure in head, body aches, and chills.
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| 45 | 2021-04-10 | sleep disorder |
Intense pain in my upper left arm near the injection site which woke me up at 4 AM after receiving t...
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Intense pain in my upper left arm near the injection site which woke me up at 4 AM after receiving the vaccine about 12 hours prior. Pain so intense I could not go back to sleep. Within an hour, the pain radiated down through my arm and spread through my entire body, resulting in very intensely uncomfortable aching, as if every cell in my body hurt, unlike anything I had experienced before. An hour later, I began to experience nausea, but that passed within an hour. Low fever. The whole-body aching has continued for nearly 12 hours now. Tylenol helped somewhat, but did not fully alleviate the very uncomfortable experience that made walking, typing on my computer, and even just lying still very uncomfortable, with occasional shooting pains.
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| 45 | 2021-04-11 | anxiety |
Describes a sensation of lightheadedness and anxiety after vaccine. Minutes later, this progressed ...
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Describes a sensation of lightheadedness and anxiety after vaccine. Minutes later, this progressed into "involuntary twitching" of all extremities. Patient was evaluated in urgent care, and ultimately thought to be a sympathetic surge. Patient was discharged without further complication. Submitting this primarily since patient required prolonged observation in urgent care setting.
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| 45 | 2021-04-11 | loss of personal independence in daily activities, impaired work ability |
On Day 1 of shot given just a few hours after shot, I started having chills, Tooth pain, burning nos...
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On Day 1 of shot given just a few hours after shot, I started having chills, Tooth pain, burning nostrils, burning throat. I went to sleep and later at 1 am in the morning I woke up and had an extremely painful sore throat. The next day (Day 2) began the severe chest congestion and nasal congestion. This interfered with my asthma and ability to breathe. I also had body aches, and severe nausea and headache. Each day the symptoms seemed to increase not get better. Day 3 was severe enough for me to contact my physician as I didn?t feel it should be getting worse. I also had Diarrhea on Day 3. Finally I started taking Sudafed on Day 3 which helped alleviate the congestion symptoms while taking but I could tell it wasn?t better when the medication would wear off. Day 4 the coughing was so severe my chest started to hurt and I started to have Armpit and breast pain under the arm on the side of the injection site. Day 5 I started to get a severe Ear Ache in my left ear. I cannot be up and out of bed for more than a few minutes or the nausea gets too severe. Day 6 is today and I called my Physician again. They agreed that the symptoms should not be lasting this long and had me rapid tested for Covid-19 which came back negative. I went in for an office visit and it appears I have a secondary infection in my throat (possibly caused by the drainage). They prescribed me Azithromyzcin for the infection, Cough syrup with codeine for the cough, and Zofran for the nausea. They told me to alternate Tylenol and ibuprofen for the other aches and pains and to call them Friday if symptoms do not improve. I have already missed 3 days of work and the doctor just wrote me a note for 3 days more off of work because I?m so nauseated I can?t move around.
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| 45 | 2021-04-12 | nervousness |
fast heart rate for weeks, tired, dizzy, nervous , could not raise my arm that had the injection for...
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fast heart rate for weeks, tired, dizzy, nervous , could not raise my arm that had the injection for two days and still sore. I have a hard time breathing after walking a short distance.
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| 45 | 2021-04-13 | anxiety |
Patient reported feeling anxious, dizzy, lightheaded, nauseated Patient provided water and seen by m...
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Patient reported feeling anxious, dizzy, lightheaded, nauseated Patient provided water and seen by medical team Vitals were stable and patient refused medical transport and verbalized AMA Patient stated symptoms improved
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| 45 | 2021-04-13 | sleep disorder |
Woke up around 2am with intense body aches - unable to get comfortable or sleep. For the next 24 ho...
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Woke up around 2am with intense body aches - unable to get comfortable or sleep. For the next 24 hours had body aches, muscle fatigue and severe headache. Once symptoms improved they improved substantially. The next day my head hurt only when I would bend down (e.g. to pick something up off the floor), and my fingers hurt when I was typing. The day after that, good as new.
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| 45 | 2021-04-14 | feeling abnormal, crying, loss of personal independence in daily activities, restlessness, sleep disorder |
Within 20 minutes of getting my second dose shot my head felt very cloudy and weird. By 9:30pm that...
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Within 20 minutes of getting my second dose shot my head felt very cloudy and weird. By 9:30pm that evening I was extremely tired and starting to ache. I had a hard time sleeping and getting comfortable that night and woke up the next morning with a terrible headache and a very very sore arm. By noon I felt like I was not able to function. I had severe chills (it felt like someone had drilled a hole in my head and was pouring ice water into it that would then run the length of my body). My head hurt and every joint in my body ached. I alternated between sleeping and crying. Around 10:30pm my chills finally broke and the sweats started and continued through the next morning. By noon on 4/15 I was feeling back to normal.
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| 45 | 2021-04-14 | impaired work ability |
Sunday afternoon she felt tired, slept and took day off on Monday. Felt better on Tuesday and Wedne...
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Sunday afternoon she felt tired, slept and took day off on Monday. Felt better on Tuesday and Wednesday. Wednesday evening felt bad again, chills, fatigue, temp 99.4. Normal for her is 97. Chills, fatigue, nausea. Left chest pain like a bruised chest. Headache slight. Achy feeling.
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| 45 | 2021-04-14 | insomnia |
Aches, fever, chills, and severe insomnia that has persisted for 28 hours after the shot. I don?t no...
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Aches, fever, chills, and severe insomnia that has persisted for 28 hours after the shot. I don?t normally suffer from insomnia, but I can?t sleep at all.
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| 45 | 2021-04-15 | feeling drunk |
From ED Physician's Note 4/16/2021: 45 yr female presents to ER complaining of left arm and leg fee...
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From ED Physician's Note 4/16/2021: 45 yr female presents to ER complaining of left arm and leg feeling heavy since yesterday (4/15/2021) morning. Patient states she got the Pfizer first vaccine on Wednesday (4/14/2021) morning, felt fine throughout the day, went to bed without any problems or symptoms. Patient states she awoke yesterday morning feeling as if she was" drunk". Patient states she feels like her left arm and leg are heavy and at times is having slurred speech. Patient states she feels like her walking is off and that she is dragging her left leg. Patient denies any numbness and tingling in the upper or lower extremities. Patient denies any headache or dizziness, vision changes, fever, chills, body ache, infectious respiratory symptoms, chest pain or shortness of breath.
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| 45 | 2021-04-16 | feeling abnormal, nervousness |
Arm sore within 2-3 hours Within 18-20 hours feel terrible. Constant headache, chills and a bit shak...
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Arm sore within 2-3 hours Within 18-20 hours feel terrible. Constant headache, chills and a bit shaky, no fever but goosebumps all over, all of skin is uncomfortable when touched or clothes rub too hard, jaw sore and feels uncoordinated, aches and pains come and go all over body (legs, lower back, neck, arms), nausea, send ivory to light and sound
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| 45 | 2021-04-18 | memory impairment, feeling abnormal |
Mild arm pain at injection site. I also gave been having difficulty the past 2 weeks trying to reca...
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Mild arm pain at injection site. I also gave been having difficulty the past 2 weeks trying to recall certain words or remember people's names. It's been enough that I noticed and it is out of character for me. It just feels off. It's not normal and I don't have memory recall issues. I hope it goes away.
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| 45 | 2021-04-18 | nervousness |
Reported raid heartrate 5 minutes after vaccine. Heartrate 132-144 on initial assessment, BP 128/78,...
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Reported raid heartrate 5 minutes after vaccine. Heartrate 132-144 on initial assessment, BP 128/78, RR18, o2 sat 99 on RA. Had patient lie down and heartrate decreased every 5 inutes- 99/84/88/75. BP stable 120's/80's. No signs of anaphylaxis. No CP or SOB. Reports some nervousness with injections and vaccine.
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| 45 | 2021-04-19 | disorientation | Spike in blood pressure, dizziness, severe headache blurred vision, disorientation |
| 45 | 2021-04-20 | feeling abnormal | Headache, muscle aches, swollen glands, foggy thinking, fatigue |
| 45 | 2021-04-20 | insomnia | One night of insomnia followed by persistent tinnitus |
| 45 | 2021-04-21 | disturbance in attention, feeling abnormal |
arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist....
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arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist. immediately that area swelled up and turned red. today (4/22) it is still significantly swollen, though swelling has decreased. also immediately felt "spacey" and feet and forehead felt tingly. within 30 minutes it felt odd to walk because legs/feet felt a bit numb. the spacey feeling stayed for 6 full days during which i felt exactly the same as i had when i had a concussion about 6 years ago. i could think but i couldn't multi-task, communicate well, focus well, speak normally. it's hard to explain but it felt like i had a concussion and it was really scary. i tried to drive at day 6 and realized i could not do it. by day 7, my head started to clear up and i felt better mentally.
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| 45 | 2021-04-21 | feeling abnormal |
Pt started having PVCs, pitting edema, fatigue, arm pain, brain fog and bradycardia the day after va...
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Pt started having PVCs, pitting edema, fatigue, arm pain, brain fog and bradycardia the day after vaccination. Symptoms persisted fo 10 days before slowly starting to improved. Still c/o feeling fatigued and foggy 3 weeks later.
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| 45 | 2021-04-21 | thinking abnormal |
Headache, dizziness, clouded thinking, neck pain, fatigue has persisted. Have tried: Ibuprofen, Tyl...
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Headache, dizziness, clouded thinking, neck pain, fatigue has persisted. Have tried: Ibuprofen, Tylenol, Excedrine, Ibuprofen PM to sleep it off and nothing brings any relief
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| 45 | 2021-04-22 | feeling abnormal |
pain and pulling sensation under my arm. uncomfortable sensation in chest, back. moderate pain and s...
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pain and pulling sensation under my arm. uncomfortable sensation in chest, back. moderate pain and swelling in arm, chest and back that lasted 4 days. severe headache lethargy, fogging /hangover sensation
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| 45 | 2021-04-23 | disorientation |
Both my partner and I, who got our shots at the same time, are experiencing extreme waves of dizzine...
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Both my partner and I, who got our shots at the same time, are experiencing extreme waves of dizziness and light headedness. Last night, as I was walking out of my room, I was suddenly on the floor. I didn't lose consciousness, but it scared the heck out of me. Super disoriented, having a hard time keeping a thought in my head. And this comes and goes. Sometimes it's mild like the feeling of being on a boat, and other times, it's me clinging to the counter top for dear life. This is really scary.
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| 45 | 2021-04-23 | insomnia |
Body aches, fever, headache and insomnia starting on the evening of event (Wednesday) and continuing...
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Body aches, fever, headache and insomnia starting on the evening of event (Wednesday) and continuing the following day. Took Tylenol Extra Strength on Thursday afternoon, all side effects went away. No other symptoms until Friday night when headache returned out of the blue, persisting today (Saturday).
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| 45 | 2021-04-24 | feeling abnormal |
is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not d...
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is passing out at 7PM; had two antibody tests and she's been negative; Patient verifies she is not dizzy, she just feels like yuck; Patient states she has pain; she felt like she couldn't breathe; she felt like, not herself, like un-well. Patient states she is feeling unwell since; zapping, basically like a electric shock; nausea and vomiting; nausea and vomiting; extreme fatigue/that night she was exhausted, she couldn't pick up her head; head just doesn't feel right/she couldn't pick up her head; fever; closing of her throat; heat coursing through her body, felt heat in her vessels/she was a bloody, hot mess; chills; This is a spontaneous report from a contactable other health professional. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:00 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Patient states she had chronic strep throat, she was sick four times a year for the first 12 years of her life. Patient stated she has no allergies, she was a healthy woman. Concomitant medication included simvastatin taken for an unspecified indication from 2020 and ongoing. On 26Mar2021, the patient experienced nausea/vomiting happened almost immediately, soon after the injection. The patient stated she wasn't feeling well, she had to go home from work, but the symptoms started that day almost immediately and persisted for a few days later. She has this zapping. The patient stated it was actually a term, it's basically like an electric shock that she was feeling throughout her body, like from head to toe on 08Apr2021. The patient stated and her head just doesn't feel right, just like dizziness. The patient stated she has pain and was uncomfortable. Patient stated she was concerned about what to do moving forward. Patient stated the day she got the shot, within three minutes, she felt like she couldn't breathe. Patient stated it was not emotional, she's very self aware, she was a psychologist. Patient stated it was a closing of her throat, but that has turned on and off as well. Patient stated then she had heat coursing through her body, felt heat in her vessels, down the center of her throat down in to her throat into the center chest and down into legs. Patient stated that night she was exhausted, she couldn't pick up her head. Patient stated she threw up and had chills, she felt like, not herself, like un-well. Patient states she was feeling unwell since. Patient states she did travel that Monday after, which she doesn't know if it made it worse, but was gone only for an hour, then got sick again that night with fever and throwing up. Patient states then yesterday, she started getting these zaps in her body, it felt like someone had put a taser to her all over her body. Patient stated she was just not herself, she wasn't at her normal. Patient stated she passed out at 7PM at night. Patient verified she was not dizzy, she just felt like yuck. Patient stated she also experienced chills and fever, that happened later that day on 26Mar2021. Patient stated she came back to work and she just felt like she needed to go home. She was instantly not well. Patient stated she has had two antibody tests and she's been negative. Patient stated she checked after that, she made sure she had no antibodies. Patient clarified she checked her antibodies twice before getting the vaccine. Patient stated her resting heart rate was at 55, she was in athletic shape, she was healthy. Patient stated when she had the both, she was on the toilet and throwing up at the same time, she was a bloody, hot mess. Patient states she ripped her clothes off, she was hot. The outcome of the event nausea, vomiting, fatigue, "head just doesn't feel right" was recovered with sequel on 03Apr2021l; fever was recovered with sequel on 07Apr2021; chill was recovered on 03Apr2021; electric shock was not recovered and unknown for the other events. The patient did not received any recent vaccines for SARS-COV2 other than Pfizer- BioNtech COVID-19 Vaccine prior to the event being report and has not received any other vaccines around the time of Pfizer- BioNTech Vaccine Vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-04-24 | feeling abnormal |
Pain in arm a few days, then fatigue set in, then worse fatigue, then flu-like pain, for several day...
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Pain in arm a few days, then fatigue set in, then worse fatigue, then flu-like pain, for several days, then arms and legs felt heavy and lymph nodes painful everywhere all over my body, then shakiness, severe pain behind my neck/shoulders/back, legs feel like lead, arms lead, fuzzy feeling in my head because my arms and legs won't work properly, pain, just pain everywhere, fatigue and can't move. Mostly the pain is the worst part of it. Pulsating feeling in my lymph nodes and all over my body. It's been three weeks since vaccination and it's only gotten worse.
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| 45 | 2021-04-25 | impaired work ability |
Shingles - severe headaches, high fever, body pains, very painful breakout on forehead and scalp. 3 ...
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Shingles - severe headaches, high fever, body pains, very painful breakout on forehead and scalp. 3 emergency room visits and one doctor?s office visit. 2 weeks+ (so far) of missed work.
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| 45 | 2021-04-25 | sleep disorder |
I woke up several times throughout the night feeling dizzy and nauseous. I also feel pressure in my ...
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I woke up several times throughout the night feeling dizzy and nauseous. I also feel pressure in my head, headache and pain down the right side of my neck. It is now 6 o?clock in the morning and I still feel this way.
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| 45 | 2021-04-26 | feeling abnormal, restlessness |
Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness...
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Dr consult EMS called to assess via 911 Dr visit in person Urgent Care Trouble breathing, dizziness, heart pain, numbness and tingling in extremities, blurred vision, muscle spasms, poor muscle tone, rapid heart rate, drop in blood pressure, elevated heart pressure, trouble talking, brain fog, intestinal upset, cold sweats, tremor, poor coordination, restlessness, fatigue Onset at time of vaccine administration Labeled NOT anaphylaxis
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| 45 | 2021-04-28 | feeling abnormal, impaired work ability |
Approximately 5-6 days after my second Pfizer vaccine dose, I began having paresthesias in patchy ar...
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Approximately 5-6 days after my second Pfizer vaccine dose, I began having paresthesias in patchy areas on the outside of my right ankle. Over the next 3-4 weeks, the paresthesias (burning, tingling, temperature sensation) progressed to the other leg and then ascended up the legs bilaterally to the upper thigh area. I consulted my neurologist and he ordered a MRI of the cervical and thoracic spine. The day after the MRI (4/15/21), I had two seizures in the morning after being seizure free for a year. I had significant fatigue and felt very poorly. A few hours later, I had a sudden onset of severe bilateral leg weakness. Because I could not walk, EMS was called. I went to Hospital where I was admitted for leg weakness. Additional imaging was performed. I was able to walk a few steps after receiving a dose of 1g solumedrol via IV that night. My symptoms improved over the next few days with IV steroid treatment. I was discharged on 4/19/21 and was advised to follow up with outpatient neurology. My neurologist initially diagnosed acute transverse myelitis and ordered physical therapy. I continued a steroid taper for 6 days after hospital discharge. Today (4/29/21), my symptoms have improved but continue to have adverse effects. I am able to walk but tire quickly and am very fatigued. I have been unable to work since hospital discharge.
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| 45 | 2021-04-28 | feeling abnormal, sleep disorder | Headache, body aches, fever, difficulty resting bc I feel so awful. |
| 45 | 2021-04-28 | sleep disorder |
I had a mild headache on the day of the vaccine and for the following two days after. On day 3, I d...
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I had a mild headache on the day of the vaccine and for the following two days after. On day 3, I developed a severe migraine headache that lasted for 5 days. At times, the pain was so intense that it woke me from my sleep and it was difficult to hold my head up. I saw my doctor for the headache on day 3 of the migraine who determined I did not need emergency care but should consult a neurologist and seek an MRI with contrast. I will be making these appointments in the near future. I attempted to treat the migraine with ibuprofen as directed by my doctor but it did not relieve the symptoms. I have never experienced a headache that lasted this long or of this type of intensity in my life. Total time the headache lasted was 8 days. And I am still experiencing mild head pain now.
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| 45 | 2021-04-29 | impaired work ability |
During the night, I had a really strong headache, nausea, chills, pain in my left arm that reached m...
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During the night, I had a really strong headache, nausea, chills, pain in my left arm that reached my chest, and then a lot of sweating. Wednesday I did not work, Thursday I still worked with the pains. Friday I woke up around 5:00 am with severe chest pain and nausea. The pain was not normal, I went to the Hospital, to the emergency room.
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| 45 | 2021-05-07 | hallucination |
Hallucinations; Wanting to speak but couldn't speak; out of body experience; This is a spontaneous r...
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Hallucinations; Wanting to speak but couldn't speak; out of body experience; This is a spontaneous report from a contactable consumer, reporting for herself. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 23Apr2021 at 08:45 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included thalassaemia from an unknown date, drug allergy (unspecified) from an unknown date, food allergy (unspecified) from an unknown date. The patient's concomitant medications were not reported. Past vaccination history included first dose of BNT162B2 on 02Apr2021 at 07:45 in the left arm for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced hallucinations on 23Apr2021 at 23:00 with outcome of recovering, wanting to speak but couldn't speak on 23Apr2021 at 23:00 with outcome of recovering, and out of body experience on 23Apr2021 at 23:00 with outcome of recovering. The patient did not receive treatment for the events. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 45 | 2021-05-13 | feeling abnormal |
Patient presented to Community Center at her scheduled appointment time to receive her 2nd dose of ...
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Patient presented to Community Center at her scheduled appointment time to receive her 2nd dose of the COVID Pfizer vaccine. While being processed for 2nd dose vaccination, the client reported she experienced a feeling which she describes as a "a shot of adrenaline" about 5 minutes after administration of first Pfizer COVID vaccine. RN responded. Client symptoms of elevated heart rate, shortness of breath and dizziness lasted 1-2 minutes and resolved without treatment. Client did not follow up with PCP.
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| 45 | 2021-05-16 | abnormal dreams | Fever of 103, severe body aches, trouble standing, no energy. Strange dreams |
| 45 | 2021-05-21 | insomnia, feeling abnormal |
Fever 100.8 x 30 hours chills headache in nape of neck. unsteady arm soreness weak no sleep little a...
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Fever 100.8 x 30 hours chills headache in nape of neck. unsteady arm soreness weak no sleep little appetite felt very very bad after 2nd dose on April 27. Awoke sweating profusely bed damp pajamas damn at 6:30 on Thursday, April 29 to loud ringing buzzing whining in both ears. Pressure in ears soreness in ears deep where ears meet brain. Feels as if ears will burst if I lean over. Headache in forehead. Fever 99.0 -99.4. Ear pressure aching ringing has continued since. At times, left ear feels like a void like I can?t hear. Right ear like it hears too well too loud. Music songs sound different. Like not blended. Like missing a part. When 2 many sounds happening, I can?t distinguish detail. It?s all blurred. An ambulance went by. I couldn?t hear with my left ear. Seatbelt beeping in car is faint and does not bother me now.
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| 45 | 2021-05-24 | panic attack, anxiety |
felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of...
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felt overly anxious/ Getting out of bed started up her feelings of anxiousness/ scared to get out of bed; debilitating panic attack; Short of breath; Cold sweat; Dizzy; Racing heart; This is a spontaneous report received from a contactable health care professional (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 15Feb2021 (at the age of 45-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination was reported. No other vaccine administered in four weeks. The patient previously received erythromycin, tetracycline, clindamycin hydrochloride (CLEOCIN), sulfamethoxazole/trimethoprim (BACTRIM), and all were reported as known allergies. It was reported that the day after this injection on 16Feb2021 she had a debilitating panic attack, short of breath, cold sweat, racing heart, dizzy. She had felt overly anxious since having the injection this past Monday (15Feb2021). Getting out of bed started up her feelings of anxiousness. She had spent the better part of a week scared to get out of bed. No treatment was received due to event. Patient was not tested for COVID post-vaccination. The outcome of the events was not resolved. Information on the lot/batch number has been requested. Follow-up (13May2021): Follow-up attempts are completed. No further information is expected.
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| 45 | 2021-05-25 | loss of personal independence in daily activities |
Two days after the 2nd Pfizer vaccine, Sunday May23rd, I woke up with a slight sore throat. I didn?...
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Two days after the 2nd Pfizer vaccine, Sunday May23rd, I woke up with a slight sore throat. I didn?t make much of it because I thought it was maybe my sinuses dripping more than usual. However, when I woke up Monday, the sore throat was evident and very bothering some. Throughout the day I experienced cold/flu symptoms like tiredness & coughing. I couldn?t function normal so I had to take DayQuil. At night in order to go to sleep I had to take NyQuil. Tuesday morning I woke up feeling worse, my nose was very congested, the sore throat persisted and my voice was changing. Very tired. I still did not have a fever, muscle aches nor chills. Although I did have a congested nose, I did not lose the sense of smell & taste. Today, Wednesday I lost my voice so I?m writing this. I haven?t had a cold in 2 years nor o have been exposed to people or places to catch COVID 19 so I?m almost positive these are side effects and symptoms from the Pfizer second vaccine. These symptoms needs to be brought out to the light. It is very unfair to feel like one is alone on this one. Fortunately, thanks to blogs I was able to read other bloggers who are experiencing the same symptoms, especially the SORE THROAT.
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| 45 | 2021-05-28 | anxiety |
significantly increased heart rate; do not feel well; anxiety; This is a spontaneous report received...
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significantly increased heart rate; do not feel well; anxiety; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 12Mar2021 17:00 (Batch/Lot Number: EP6955) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of bnt162b2 on 19Feb2021 17:00 (lot number: EN6200) in the left arm. Medical history included neurofibromatosis type 1. Concomitant medications included magnesium sulfate and unspecified multivitamin, multimineral, protein. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Since 05Apr2021, the patient have had a significantly increased heart rate. Things seemed to be improving but patient still do not feel well. Patient went to the ER, a cardiologist, and her primary doctor. Patient underwent several tests: blood, EKG, echo, and heart monitor. All seemed to show no signs of any problems but patient still do not feel well. Something is wrong. Since they could not find anything wrong, the doctors were saying anxiety. AE resulted in: Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment was received. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021264467 same patient/drug, different event/dose
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| 45 | 2021-05-30 | loss of personal independence in daily activities |
I felt the following beginning Saturday morning; ? Severe leg aches, in addition to pain & swelling...
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I felt the following beginning Saturday morning; ? Severe leg aches, in addition to pain & swelling in my knees and ankles ? Hot flashes and sweats throughout the day and night ? Extremely lethargic Notes: The arm of the injection site only hurt for 24hrs. The effects above were extreme (bed ridden) from Saturday (22nd) to Tuesday (25th). All have lessened but are still present with the addition of a constant, dull ache in my right arm (opposite the injection site). I would just like to add that the ?side effects? I have experienced seemed to have intensified my existing ?aliments?. Pre vaccination: ? Mild knee pain (from jogging). ? Occasional night sweats - premenopausal symptoms
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| 45 | 2021-05-30 | nervousness |
Pt states arm feels cold, tingling. Feels very nervous (has hx of anxiety attack). BP 151/94; HR 98;...
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Pt states arm feels cold, tingling. Feels very nervous (has hx of anxiety attack). BP 151/94; HR 98; RR 20. Given water, crackers, juice. Pt was reassured w/Spanish translator BP 133/73; HR 89; RR 20. Pt stable & release w/brother from vaccination site
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| 45 | 2021-06-01 | feeling abnormal |
I've been really dizzy, hard to breathe, chest pains, weird sensation going through my body and head...
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I've been really dizzy, hard to breathe, chest pains, weird sensation going through my body and head. I've been to the e..r. twice in a week. My whole body aches.
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| 45 | 2021-06-01 | sleep disorder |
Day of pain in arm Day2-5 pain in arm like a nail was hammered in it and someone punched my shoulde...
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Day of pain in arm Day2-5 pain in arm like a nail was hammered in it and someone punched my shoulder, sleepy a day Day 6- rash on neck- went away one day Day 7-woke up to level 8-10 level in my hips, lower back, pelvis, tailbone, back and side of top left leg, I had mild moderate pain level 4-5 in that area before the shot and after vaccine extreme constant pain like the pain I had in those areas 3 years ago when hit in my car by semi. The pain had been calmer for 3 years but after the vaccine it is level 9-10 pain especially at night and has not gotten better it?s been 2 months. The new symptoms never had are at night have shock like electric pain in diff spots in that area keeping me up most the night. Also the side of my left leg hadn?t heard or the tightness in back top left leg.
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| 45 | 2021-06-03 | anxiety |
PT STARTED EXPERIENCING INTENSE HEADACHES ON THE MORNING OF 5/21/2021. THE HEADACHES CONTINUED ON AN...
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PT STARTED EXPERIENCING INTENSE HEADACHES ON THE MORNING OF 5/21/2021. THE HEADACHES CONTINUED ON AND OFF FOR SEVERAL DAYS UNTIL ON 5/24/2021 AT 3 PM, SHE HAD A DEBILITATING HEADACHE WITH DIZZINESS THAT COULD NOT BE RELIEVED. THEN ON THE AFTERNOON OF 5/25/2021, SHE STARTED EXPERIENCING VISUAL CHANGES WITH BLACK SPOTS IN HER VISION. SHE WAS ABLE TO SEE HER DOCTOR ON 5/27/2021 AT 10 AM. HE SENT HER FOR A CT SCAN OF HER HEAD WHICH WAS FOLLOWED BY A MRI OF HER BRAIN. THE MRI AND CT SCAN REVEALED THAT SHE HAD A LEFT FRONTAL ISCHEMIC STROKE. SHE WAS ADMITTED TO THE HOSPITAL ON 5/27 AND DISCHARGED HOME ON THE AFTERNOON OF 5/28. SHE HAD A CT ANGIOGRAM OF THE BRAIN, AN ECHO OF THE HEART, ULTRASOUND OF THE CAROTIDS AND A HYPERCOAGULATION BLOOD PANEL. ALL OF WHICH WERE NORMAL AND SHOWED NO EVIDENCE OF WHERE THE BLOOD CLOTS CAME FROM THAT CAUSED HER STROKE. SHE CONTINUES TO HAVE HEADACHES WITH DIZZINESS, FATIGUE, AND NOW BAD ANXIETY.
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| 45 | 2021-06-03 | feeling abnormal |
She was just joking with her kids that she was turning into a robot.; Can stick a magnet to her arm/...
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She was just joking with her kids that she was turning into a robot.; Can stick a magnet to her arm/now able to have a magnet stick to her vaccination site; she finds the spot that is a little sore; This is a spontaneous report from a Pfizer sponsored program COVAX support via contactable consumer (patient). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: Unknown), via unspecified route of administration in left arm on 20May2021 at 15:00 or 15:15 as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine were not reported. Previously patient received first dose of BNT162B2 in left arm on 26Apr2021 for COVID-19 immunisation. On 20May2021, same day when the patient had second shot, she had a spot that was a little sore. It was fading away and getting better. On 24May2021, at night for the first time, patient could stick a magnet to her arm and was now able to have a magnet stick to her vaccination site. The Medical Information document states that Pfizer was unaware of any properties that have a magnetic effect. There was a search done on 30Apr2021 and 19May2021, and it failed to identify related information on this topic. No relevant tests were performed. Outcome of the event she finds the spot that is a little sore was recovering and for other events were unknown. Follow up needed, Information on the lot/batch number has been requested.
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| 45 | 2021-06-03 | insomnia |
lost complete feeling in on the right side of her face, including her ear and inside of mouth; Shing...
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lost complete feeling in on the right side of her face, including her ear and inside of mouth; Shingles; woke up in the middle of the night; Numbness; severe headaches; creepy crawly feeling under her skin on the top right side of her head; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left Upper on 02May2021 (Lot Number: EW0182) as 2ND DOSE, SINGLE for covid-19 immunisation; apremilast (OTEZLA), oral from an unspecified date (Lot Number: F2671A; Expiration Date: May2023), at 30 mg 2x/day for psoriatic arthropathy; prednisone, oral from an unspecified date (Batch/Lot number was not reported), at 7 mg, 1x/day for psoriatic arthropathy. Vaccination Facility Type: Pharmacy/Drug Store. Vaccine Administered at Military Facility: No. Medical history included allergy alert test negative, immunology test, respiratory distress, cytogenetic abnormality, endocrine test abnormal, diabetes mellitus, obesity, psoriatic arthropathy. Had no other vaccines the same day and no problems with vaccines in the past. The patient previously received the first dose of bnt162b2 (lot number EN6205) on 04Apr2021 at left upper arm for covid-19 immunisation without adverse event. The patient's concomitant medications were not reported. The patient was seen at the emergency room last Thursday and was diagnosed and began treatment for shingles (on 20May2021). She had lost complete feeling in on the right side of her face, including her ear and inside of mouth. It really started on the 8th or 9th of May with a severe headache that she ignored for about a week. The headaches were debilitating and she didn't got to the emergency room until she lost feeling. Before the lost feeling she had the creepy crawly feeling under her skin on the top right side of her head (from May2021) and then had the headaches that were so severe they woke her up from dead out of her sleep. Wednesday, 19May2021 she woke up in the middle of the night from the debilitating pain from the headaches out of her sleep. Then she went to the emergency room the 20th since at that point she lost complete feeling. She is being treated with medication, a broad spectrum antiviral, which is no fun, but it's working. Although it's not completely gone, it is better than it was, in terms of the numbness (from May2021). Was given generic Valtrex, valacyclovir hcl 1 gram to take three times daily. Mentions she had to stop her other medicines for to her underlying condition, Psoriatic arthritis, a rheumatoid condition, which is why she is reporting this. She has had this for 23 years. She had to stop the Otezla and Prednisone she takes concurrently when she got the vaccine. Told she can't take theses with the antivirals, so she is screwed right now. Was supposed to start on Xeljanz, but was told not to until after she got the vaccine, but then after the Covid shots she got the shingles then they told her not to start the Xeljanz until after the shingles. Later mentions she takes other medication for psoriatic arthritis and the doctor did do testing to rule out other issues and check her kidney functions since she is on an antiviral, more labs, a CT scan with contrast to rule out acute stroke. Her kidneys are fine and there were no issues in the veins or arteries of her brain. The events require a visit to Emergency Room. The outcome of Facial paralysis, Shingles and Numbness was not recovered. The outcome of others was unknown.
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| 45 | 2021-06-06 | insomnia |
Headache (still on day 4) & horrible itchy, hives (despite being on 2 antihistamines daily). Hives ...
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Headache (still on day 4) & horrible itchy, hives (despite being on 2 antihistamines daily). Hives are on my face, neck, chest, & both arms. The incessant itching is keeping me awake at night. Nothing is helping.
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| 45 | 2021-06-09 | feeling abnormal, nightmare |
Severe stomach pain; Diarrhea; Nausea; My back, shoulders, and neck to hurt; My back, shoulders, and...
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Severe stomach pain; Diarrhea; Nausea; My back, shoulders, and neck to hurt; My back, shoulders, and neck to hurt; My back, shoulders, and neck to hurt; Nightmares; Yeast infection; Feel like my bones are trying to come out of my body/Brain feels bigger than my skull/ Chest fullness like heart trying to come out of chest; Chest fullness like heart trying to come out of chest; Stomach bloating; This is a spontaneous report from a contactable consumer. A 45-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot number: not reported), second dose via an unspecified route of administration administered in left arm on 28Feb2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation at hospital. Medical history included immune system disorder, Von willebrand's disease, high blood pressure, arthritis, allergies: Latex and related foods, all from an unknown date and unknown if ongoing. Concomitant medications received within two weeks of vaccination included duloxetine hydrochloride (CYMBALTA); levetiracetam (KEPPRA); lisinopril (LISINOPRIL); lisdexamfetamine mesilate (VYVANSE), all taken for an unspecified indication, start and stop date were not reported. The patient previously took paroxetine (PAXIL), blood pressure medication with Diuretic, Penicillin, and experienced drug hypersensitivity. Historical vaccine given to patient previously was dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunisation in hospital and experienced slight rash. The patient was not diagnosed with COVID, prior vaccination. The patient did not receive other vaccine in four weeks of vaccination. The patient has not been tested for COVID, post vaccination. It was reported that on 01Mar2021, the patient experienced severe stomach pain with diarrhea and nausea, feel like her bones are trying to come out of her body (she wishes she had a zipper to release the aliens) caused her back, shoulders, and neck to hurt, nightmares, yeast infection with 2nd, brain felt bigger than her skull, chest fullness like heart trying to come out of her chest, and stomach bloating. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. As a corrective therapy patient took fluids and Zofran for the events. On 08Mar2021, the patient underwent lab tests and procedure which included Nasal Swab SARS-CoV-2 test; result negative, post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 45 | 2021-06-09 | feeling abnormal |
I sat for 15mins after getting my shot , I had blurred vision after about 10 minuteses and I felt ok...
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I sat for 15mins after getting my shot , I had blurred vision after about 10 minuteses and I felt ok but I was a little lightheaded. I assumed it may have been because I hadn't eaten. I got in the car and headed home we did do some shopping prior to heading home. .At that time my heart started racing I had tremors that felt like electrical pulses going through my arm we turned around and went back to CVS because the nearest hospital was too far we were just up the road from the CVS. I looked at the clock around 3:35pm and questioned whether I had waited long enough before leaving the vaccine site I was worried about anaphylactic shock at that time. I was feeling so bad when we arrived that I didn't know if I could walk the feeling shot from my arm to my abdomen and continued down my legs into my. I was advised to put my legs up I had to make myself breathe or I would have stopped breathing. It lasted for about 15 minutes and I was able to drink water after about 5 minutes . A nurse on duty sat with me and they told me to check with my doctor before getting the 2nd dose. Around 11pm that night, it started again I went to the ER at Hospital and they did an EKG and blood work to check for an allergic reaction and monitored me for about 4 hours and I was told everything was fine.
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| 45 | 2021-06-10 | feeling abnormal |
Radiculopathy that begin 4 days aftr shot #1 in left arm as a tingling in full hand that rushed up t...
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Radiculopathy that begin 4 days aftr shot #1 in left arm as a tingling in full hand that rushed up the arm. Next day same thing happened in left leg (began at toes and rushed up leg). Then the right leg. Then the right arm. (So all 4 extremities buzzing pins and needles at once.) Never experienced this before. Left side was the worst. The right side resolved after a few weeks. Left arm persists significantly to this day. Also no menstruation for 3 months ( had been very regular previously.) After shot 2 this didn't change, there was just the few days of headache and muscle aches.
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| 46 | 2021-01-02 | insomnia, loss of personal independence in daily activities |
Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/20...
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Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/2021, peripheral tingling or numbness on 1/2/2021. Took 800 mg Ibuprofen BID to help with symptoms,
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| 46 | 2021-01-03 | feeling abnormal |
Patient states she was advised by nurse that because it was intermuscular (triceps), it may be becau...
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Patient states she was advised by nurse that because it was intermuscular (triceps), it may be because she is experiencing a headache that lasted 36 hours, also fatigue for 5 days, also joint stiffness for 7 days and she states she felt very sore and stiff and had a hard time walking up and down stairs without feeling shortness of breath. Said she felt "run down". On day 8 (12/31) she felt a lump like a mosquito bite. Day 9 the injection site became red and became very hot to touch. No fever reported. She was advised to see a nurse and was advised it could be hypersensitivity and to report this. This happened on 01/02/2021
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| 46 | 2021-01-05 | feeling abnormal |
Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not ...
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Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not even move; Different waves of chills to the point of she could not even move; sweating; severe headache; just crap now; Now she smells metal; she has no sense of smell other than stinky metallic smell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right deltoid on 30Dec2020 08:15 at a single dose for vaccination. The patient's medical history included tested positive for COVID-19 from Jul2020. There were no concomitant medications. Around 30Dec2020 9:00 AM, she began experiencing extreme nausea and dizziness, extreme fatigue, different waves of chills to the point of she could not even move, sweating, severe headache, and just crap now. The patient's physician told that this is something she should report. It could possibly have been an immune response because she had possibly been exposed to COVID-19 that she probably had some sort of antibodies from then until now on Dec2020, even though she tested negative for COVID-19 and continued to test negative for COVID-19 on 2020. She smells metal on Dec2020. She has no sense of smell other than stinky metallic smell. Her taste is fine. Outcome of the headache was not recovered, of the metallic smell was unknown, of the remaining events was recovered on 30Dec2020 13:00.
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| 46 | 2021-01-05 | insomnia |
Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of ...
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Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of right toe. Blood pressure and heart rate mildly elevated beginning around 10:40 pm 1/5/21. Spoke with a triage nurse twice late pm 1/5/21 and early am 1/6/21. Advised self monitoring. Unable to sleep more than about 1 hr at a time-woke up sweaty. No temp. Woke up without dizziness/nausea but had dizziness when eating cereal and looked down. Saw general practice physician 1/6/21 after 10 am 1/6/21. Given anti-dizziness med. prescription. Dizziness/nausea, Tired/heaviness in legs gone when saw physician. Still mild altered sensation in right leg and big toe numbness that comes and goes. Elevated blood pressure at physician. Bloodwork ordered and scheduled for Saturday.
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| 46 | 2021-01-06 | feeling abnormal |
Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortnes...
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Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortness of breath, left axillary lymphadenopathy, elevated blood pressure which onset on 12/31. COVID-flu negative, normal labs, CT thorax and brain MRI negative. Has been to ED and is returning today due to continued symptoms. Reported symptoms to VSafe
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| 46 | 2021-01-06 | impaired work ability |
Chills, fever, extreme body aches, nausea Ibuprofen 400mg taken every 4-6 hours. Fever broke after ...
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Chills, fever, extreme body aches, nausea Ibuprofen 400mg taken every 4-6 hours. Fever broke after 15 hours but returned within 4-6 hours. Easier to manage on second day with ibuprofen. Loss of appetite and nausea. Compazine taken forever nausea. Currently 50 hours post vaccination, had to miss work due to symptoms. Fever free for 12 hours , co tinge to have loss of appetite and body aches
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| 46 | 2021-01-06 | nervousness, anxiety |
Patient while waiting after receiving her second COVID Vaccine dose started to feel short of breath,...
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Patient while waiting after receiving her second COVID Vaccine dose started to feel short of breath, anxious and shaky. She was taken to the ED, where they took a set of vitals, listened to her lungs (clear) and completed an EKG.
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| 46 | 2021-01-07 | anxiety | c/o anxiety ems screened vitals, |
| 46 | 2021-01-07 | impaired work ability, restlessness |
With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I co...
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With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I couldn't get warm, I felt very tired. About the next thirty hours I had body ache and head ache my arm got very heavy and hurt, I did not run a fever but felt very restless and achy. I was very tired and didn't work the following day, didn't have much of an appetite. I had some mild itching on my arm.
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| 46 | 2021-01-07 | nervousness |
Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feelin...
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Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feeling jittery and shaky. Oxygen saturation remained normal. Vital signs normal.
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| 46 | 2021-01-09 | anxiety |
Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway con...
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Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway constriction but on the outside). Severe heartburn, burping and reflux, anxiety, slightly elevated heart rate about 30 mins after injection, lasting about 30 mins. 5 hours after injection, after eating a small snack, repeat of heartburn, burping and reflux. Felt hot but temperature 97.7, then chills briefly. Anxiety and related fast heart beat and shallow breathing for about 1 hour. Took benadryl, no change.
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| 46 | 2021-01-09 | disorientation |
15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could fe...
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15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could feel my pulse escalating. Nurse in the post-shot monitoring tent took vitals to confirm pulse at 95, when typically 68. I was laid down and BP dropped to 110/78. Chest tightness that I am familiar with from asthma started to develop and my neck and throat and upper shoulders felt very tight and constricted. I had some trouble swallowing water as though my throat was constricted and my breathing felt shallow. Nurses provided care and I was asked to get up and sit in a chair again. Within a minute, I felt dizzy and disoriented again and heart rate went up. The tightness in my chest and throat and shallow breathing continued along with my voice becoming hoarse. The doctor on call asked if I?d had these symptoms before and I said I had after eating shrimp years ago. He decided to transfer me to the ER for monitoring . I stayed at the ER for about an hour and a half and was monitored. The constricted throat and asthma chest tightness did not subside but did not get worse. Doctor recommended Benadryl every 6 hours as symptoms persisted. Within a half hour of taking 25 mg of Benadryl, I started to feel improved breathing and less throat constriction and easier swallowing. After the second dose of Benadryl, symptoms were much 70% gone, except for hoarse voice abs very slight tightness with swallowing. I had informed the injection staff prior to receiving my vaccine that I am a person with a history of anaphylaxis (not to a vaccine) that required and epi pen and overnight hospital stay in the past .
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| 46 | 2021-01-10 | impaired work ability | muscle ache, fever, can barely move. called in sick to work. |
| 46 | 2021-01-10 | sensation of foreign body, feeling abnormal, nervousness |
About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: lik...
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About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: like felt like rushed through my body and then instantly my heart started racing and I felt it thump into my throat. Let nurse in attendance know and she took me to another area secluded from others and told me to relax. Sat down. Hooked me up to monitors; blood pressure cuff and finger pulse and she left to go get someone and she brought EMT back with her. Felt tight in chest; in neck felt like there's tightening; but could still breathe; felt heavy: chest. Neck felt tight. Felt like I needed an inhaler. I don't have it with me as I only have asthma in spring and fall. They kept telling me to calm down and I wasn't feeling nervous. I was trying to relax. EMT asked questions and he said that the same thing happened to him. He told me I couldn't leave Event Center until things calmed down for me. Released her when I felt fine but was just really tired and kind of shaky. I felt so exhausted. Told EMT that and he told me he would feel that way if he had just ran a marathon. I had slept 12 hours the night before. He didn't tell me what my heartrate went up to. I left event center at 9:49 pm. Started feeling strange again when doing errands and was at store afterwards (about 30 or 40 min later) - nauseous; dizzy; sweaty, clammy. Heart was racing again. I told husband I didn't feel right. Felt like I needed to sit because I was shaky. Left and went to vehicle. As we sat in car, I told him something wasn't feeling right. Mouth was so dry. He started driving. I felt like we were driving down a tunnel.Husband looked at me and said you don't look right either. Took me to ER in nearest hospital: blood pressure high; heart rate elevated; ER (Hospital) The doctor did lab work. Triponin levels elevated; potassium levels low - sign of a heart episode and needed to get in control. Gave me potassium and took more blood work and troponin levels started coming down. Dr advised me not to go back to get second dose. Personal Care Dr confirmed that I shouldn't get the 2nd dose - put in my records that I am allergic to this vaccine. The next day I had severe diarrhea and terrible pain in my arm that went all the way down and up into my neck and whole right side head hurt. (really bad headache). Extreme fatigue. Went back to work on the following Monday evening and was exhausted doing my job. When I say family Dr on Tuesday, I didn't want to be taken off work because I was in the right place where people could take care of me and I'd taken time off at holidays. That entire week was a lot of exhaustion and tiredness.
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| 46 | 2021-01-11 | feeling abnormal |
Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brai...
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Pt had vaccine at 0900, waited 15 mins without issue. Returned at 1420 c/o being hot, flushing, brain fog, chest red 1425 - bp 95/64, hr 82, rr 20, t 97.7, sats 98 1428 50 mg po Benadryl given 1432 - bp 118/68, 1440 - pt reports I am feeling better but it does come in waves. chest remains red 1445 - bp 112/74, hr 70, rr 16, sats 98. Pt reports fine to go home. does not live alone.
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| 46 | 2021-01-12 | disturbance in attention |
The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also ha...
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The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also had a muscle pain in the arm and I felt tired during the day and in the evening. My pulse rate continues to be high. My pulse rate was 100 on the second day and for number of days it is around 95. Today it was 95 most of the day. I have not been regularly checking my pulse rate before, but based on what I found in some information in my medical record, it is most likely around 75. I notice the higher pulse rate through pulsation in the chest and temples. I have a hard time concentrating on work and reading things on the screen.
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| 46 | 2021-01-12 | feeling abnormal |
After waiting in the waiting area for about 20 minutes following the vaccination, I left to return t...
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After waiting in the waiting area for about 20 minutes following the vaccination, I left to return to my car and go home. While walking through the hospital, I started to feel weird - almost light headed and fuzzy. By the time I got to the hospital entrance, my tongue had started to tingle and swell (I don't know that it ACTUALLY swelled, but that's how it felt) and I was concerned about losing the ability to breath. I started going back to the vaccination site, but the feeling started to subside. After about another 15 minutes, the feeling was gone. I did NOT report this to the vaccination site and instead just proceeded home.
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| 46 | 2021-01-13 | impaired work ability |
Symptoms started at 0100 (11hr post vaccination) Severe headache, myalgias, arthralgias, fever 101,...
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Symptoms started at 0100 (11hr post vaccination) Severe headache, myalgias, arthralgias, fever 101, fatigue, facial swelling (eyes and nose), blurred vision Symptoms lasted for 48 hours and did not respond to IBU, Toradol, or Tylenol. Headache was the worst that I have ever experienced- missed 2 days of work Symptoms resolved in the morning on 01/14/2020
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| 46 | 2021-01-13 | sleep disorder |
Received vaccine 1/13 at noon. Woke up with a migraine level headache about 3am along with a fever...
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Received vaccine 1/13 at noon. Woke up with a migraine level headache about 3am along with a fever of 101.6. My right arm is very sore/tender. I have generalized aches.
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| 46 | 2021-01-15 | feeling abnormal |
12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. ...
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12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. 2:30 -5 Skin on face feels like it is burning from the inside out & fatigue. Brainfog. 2:30 thru evening Face and neck puffy, red, hives & fatigue.
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| 46 | 2021-01-17 | insomnia, impaired work ability |
1. Runny nose/sore throat and extreme fatigue started about 4pm. 2. By 8pm I had extreme body chills...
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1. Runny nose/sore throat and extreme fatigue started about 4pm. 2. By 8pm I had extreme body chills/dizziness with a temperature of 101. That is when the muscle weakness went into overdrive. I was unable to sleep more than an hour overnight due to the chills and muscle pain. Early in the morning of 1/12 I messaged my supervisor and called the main pharmacy that I was unable to be there for my 9-5:30pm and would be out for the day. 3. Around noon on 1/12 the temperature went below 100 degrees and around 4pm on 1/12 I was finally able to eat something and start moving around. 4. On Saturday 1/16 I started having right arm weakness and my fingers tingling/numbness that hasn?t resolved. This is the arm that I received both injections in.
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| 46 | 2021-01-17 | sleep disorder |
FEVER CHILLS, BODY ACHES (DEBILITATING), DIZZINESS, NAUSEA FOR 24 HRS. SWEATING AND CHILLS. UNABLE T...
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FEVER CHILLS, BODY ACHES (DEBILITATING), DIZZINESS, NAUSEA FOR 24 HRS. SWEATING AND CHILLS. UNABLE TO SLEEP BUT NO FEVER LAST NIGHT AND THIS AM. TOOK IBUPROFEN 600 EVERY 6 HRS.
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| 46 | 2021-01-19 | sleep disorder |
Hello, When I received my second Covid vaccine, I was asked to report my side effects to this emai...
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Hello, When I received my second Covid vaccine, I was asked to report my side effects to this email address. They are as follows: After Vaccine 1 (12/22/20): I had the vaccine at around 1:30pm. I only had arm-stiffness at first. Approx. 24 hours after however (1:30pm the next day), I started having chills and feeling like I had a fever. My entire body ached but I did not have a headache. These side effects lasted through the night for approx. 14 hours. The following day I woke up with a surge of energy and felt very much like I had been given a shot of adrenalin. I?m not sure that I have ever felt as good. After Vaccine 2 (01/11/21): I had much more severe side effects after the second vaccine. I had this vaccine at approx. 1:30 pm and within a couple of hours I started to feel a bit tired. At approx. midnight that night, I started having body aches and a headache that woke me up. I had chills and was oscillating between feeling very cold and feeling very hot. Through the night I had to change my clothing several times due to sweating. These symptoms lasted for the entire following day. The second day after the vaccine I felt much better but still a little tired. Of greatest concern is that I have a lingering pain deep within my left arm (the arm into which the shots were given). Having a hard time extending my arm and doesn;t seems to be going away. Sometimes it feels tingly and I sometimes have loss of grip and/or weakness in the entire arm. Hope this helps you in compiling the side effects. Thank you.
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| 46 | 2021-01-20 | feeling abnormal |
Fever; In morning my temperature was 100.4; Headache; Felt tired from weak; Felt tired from weak; Fe...
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Fever; In morning my temperature was 100.4; Headache; Felt tired from weak; Felt tired from weak; Feels bad; Chills/shivering; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3248), via an unspecified route of administration in the left arm on 09Jan2021 as single dose for COVID-19 immunization. Medical history included covid-19 in Oct2020. The patient's concomitant medications were not reported. The patient experienced fever; in morning my temperature was 100.4 on 10Jan2021 with outcome of unknown; headache on 10Jan2021 with outcome of unknown; felt tired from weak in Jan2021 with outcome of unknown; chills/shivering in Jan2021 with outcome of recovered in Jan2021, feels bad in Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included fever at 100.4 in Jan2021. Details were as follows: patient received the first dose of the Covid-19 vaccination and woke up with a fever and a bad headache in the morning. As it related to casualty, the reporting nurse indicated yes and commented that she was fine the day prior and then when she woke up this morning, she had fever and a bad headache. She indicated that she felt like a little; she got it in the morning around the 11 O'clock. And then by the evening she felt tired. She thought that she was just tired from the week. And when she woke up on this morning, or in middle of the nigh, she was shivering a little bit. She fell asleep and woke up the next morning, with a temperature of 100.4. She said that she did not feel really that bad; she had a headache; she did not have shivering or chills then. Therapeutic measures were taken as a result of fever; in morning my temperature was 100.4, headache, felt tired from weak, shivering, feels bad, chills and felt tired from weak ; she took ibuprofen. The chills/shivering recovered in Jan2021; the outcome of the other events was not reported
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| 46 | 2021-01-22 | feeling abnormal |
Fever over 101° for 3 days, extreme body aches, chills, horrible headache, foggy feeling, congestio...
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Fever over 101° for 3 days, extreme body aches, chills, horrible headache, foggy feeling, congestion and I developed a cough
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| 46 | 2021-01-23 | disturbance in attention | Hives itching headache fatigue nausea joint and muscle pain concentration problems |
| 46 | 2021-01-24 | anxiety |
Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25m...
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Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25mg orally and chest tightness and heaviness received 2nd dose Benadryl 25mg . EMS /cardiac monitored and was transferred to a Hospital.
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| 46 | 2021-01-24 | anxiety |
I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes we...
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I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes were hurting and burning really bad.
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| 46 | 2021-01-24 | feeling abnormal, impaired work ability |
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he...
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fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
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| 46 | 2021-01-24 | feeling abnormal |
Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous...
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Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous, and not feeling right. She was tachycardic and bradycardic soon after. She was transported to the ED for evaluation. She endorsed lightheadedness, chest pain, and trouble swallowing upon ED triage. She was given diphenydramine 25mg PO x 1 dose and observed for ~2.5 hours prior to discharge.
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| 46 | 2021-01-24 | insomnia |
wet and cold sensation on chest; she would have a heard time falling asleep or get no sleep at all t...
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wet and cold sensation on chest; she would have a heard time falling asleep or get no sleep at all that night; Breast discomfort/describes the breast discomfort as a contracting feeling of encapsulation; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) injection intramuscularly in right arm on 21Dec2020 around 11:00 am at a single dose of COVID-19 immunization. Vaccination facility type was at medical center. Relevant medical history included acne, migraine, and chronic neck and upper back pain; all were ongoing, and breast implant, tennis elbow in left arm and she had the flu shot in Oct but she never got any reaction. She thought a side effect of spironolactone. Concomitant medications included rizatriptan benzoate (MAXALT, strength: 5mg, tablet) at 5mg tablet as needed for migraine, naproxen sodium (ALEVE, strength: 500mg, tablet) at 500 mg tablet, one tablet as needed for pain, and spironolactone (strength: 5mg tablet) (if her skin was breaking out she will take two tablets that night and if her face was not bad she will take one tablet) from Aug2020 for acne, breaking out; all were ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations within 4 weeks and AE(s) following prior vaccinations were reported as none. On 26Dec2020 she started feeling breast discomfort. She described the breast discomfort as a contracting feeling of encapsulation, reported it kept her up at night, she would have a heard time falling asleep or get no sleep at all that night. Her breast comfort started to lessen. The patient was breast discomfort or tenderness but she did not experience any breast discomfort till after she got the covid vaccine. She stated the breast discomfort was like a feeling that something was crawling inside, states it is like creepy crawlers. She also experienced a wet and cold sensation on her chest on 29Dec2020 and was still occurring once in a while, intermittently. At first it was just on the left breast, and the next night she felt the sensation across her chest, it felt like she spilled water and felt wet but it was not wt. She felt it while she was bed. She had breast implants. Last week she contacted her primary care doctor and she was sent to get a mammogram and ultrasound. She went to have the mammogram and ultrasound on Friday 08Jan2021 and everything was fine. She was thinking what she was experiencing was from the vaccine. The patient declined any treatment. No emergency room and no physician office required for the events. The outcome of event breast discomfort was resolving, of wet and cold sensation on chest was unknown.
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| 46 | 2021-01-25 | disorientation |
Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at i...
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Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at injection site, radiated: up and across L shoulder blade area, up neck and into head, down to L fingertips 0600 -all above continued, R knee joint pain (sharp/stabbing) 1400 -all above continued except R knee joint pain; spinal pain and intercostal pain began 1900 -all above continued; TMJ, jaw, and 'tooth' pain began Monday, 1/11/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Tuesday, 1/12/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Went to dentist (scheduled appointment on Monday) for cleaning and thorough exam...exam was normal Wednesday, 1/13/21 continuation of symptoms from 1/12/21, but pain worse, ear pain Thursday, 1/14/21 0630 had eaten a full can of chicken noodle soup. Was sitting and working on CEs for work, had taken medications for the day, but added in hydrocodone, half of a 7.5/325mg tablet and ibuprofen 200mg. Felt a severe wave of nausea. Laid my head down on my arms on the table. Do not remember getting up, but remember walking through the kitchen in front of the refrigerator, reaching up to feel my pulse, felt two beats which were too far apart and thought to myself, "I'm going to faint". Apparently I was able to walk about 6 feet further, but I don't remember it. I don't know what time I fainted, but I think I must have fallen. I woke up sometime after 7, disoriented and my head hurt, lying on the kitchen floor. My husband came to my side after I called out to him about 5 times. I was drenched in sweat and very weak. When firefighters arrived they said my heart rate was 'all over the place', from 46 to I don't know what (did not hear). Ambulance arrived around 0730. Glucose was normal. Was taken for evaluation. Was given IV NS (I think 1000mls). Labwork was drawn. CXR, CT, and EKG. ER Dr recommended I follow up with my cardiologist, as she noted mitral valve regurgitation and thought a Holter monitor would be advisable. CXR and CT normal. EKG normal sinus rhythm, but showed anteroseptal infarct of unknown age, confirmed by cardiologist who read the EKG. Also seen by my PCP at 1430, he checked my ears, as they had been hurting as well, said they were clear. Advised alternating tylenol and ibuprofen Q4-6H. Friday and Sunday 1/15 and 1/16 night sweat, TMJ pain, nauseated, headache, neckache, fatigue, shoulders sore, eyes sore, inner ear pain Sunday, 1/17 0500 woke up, lying in bed, dizzy, clammy palms, chest pain (mid-clavicular, just below left breast, stabbing), night sweat, TMJ pain, nauseated, headache, neckache, fatigue, L & R flank pain, BP 115/70, HR 54 Monday 1/18, Tuesday, 1/19, Wednesday 1/20, Thursday 1/21, Friday 1/22, and Saturday 1/23 varying degrees of: fatigue, nausea, dizziness, TMJ, jaw, and 'tooth' pain, palpitations, and ear pain. TMJ and jaw pain worsens with activity.
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| 46 | 2021-01-25 | feeling abnormal |
day of felt "fuzzy" tired chills/rigors and fever 103, body/aches. 1/7 temp 99 still taking APAP q 3...
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day of felt "fuzzy" tired chills/rigors and fever 103, body/aches. 1/7 temp 99 still taking APAP q 3 hrs. nausea. rt axilla swollen and severe pain. 18/ bilateral hand numbness and tingling up to elbow. temp normal, nausea better. no axilla or neck swelling. reports tremors (that aren't visible) when tries to write "feels not right". 1/11 all sxs resolved. ok to work.
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| 46 | 2021-01-25 | loss of personal independence in daily activities |
PVCs started after the first COVID19 Pfizer vaccine. They were frequent, had associated symptoms of ...
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PVCs started after the first COVID19 Pfizer vaccine. They were frequent, had associated symptoms of chest discomfort and breathlessness, and I went to the doctor. Their frequency/severity trended toward improving, but after the 2nd vaccine I was back to their original intensity/frequency. I do not have a history of similar. They are affecting my daily life. I've been referred to a Cardiologist.
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| 46 | 2021-01-26 | anxiety |
the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; ...
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the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; I felt a "hot flash" over my face; anxiety; the left side of my face started to tingle and went numb; the left side of my face started to tingle and went numb; Lymph nodes in my neck were swollen and painful; Lymph nodes in my neck were swollen and painful; This is a spontaneous report from a contactable Other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included allergies: Penicillin, irritable bowel syndrome (IBS) and endometriosis. The patient's concomitant medications were not reported. The patient previously took dilaudid and experienced drug allergy. A minute after vaccination on 12Jan2021, the patient felt a "hot flash" over her face, thought it was anxiety and ignored it. 25-30min after vaccination the left side of her face started to tingle and went numb, lasted a few hours and went away. That night the patient's lymph nodes in her neck were swollen and painful. The following day after vaccination on 13Jan2021, the tingling/numbness came back in her face in waves, but moved to her lips and the tip of tongue. Day 3 after vaccination on 14Jan2021, the patient still feel some slight numbness in waves still only on one side of her face and the tip of tongue, but not as intense or frequent. Not sure if this could be an allergic reaction. Injection site was left arm and it was the left side of her face effected. The patient underwent lab tests and procedures which included COVID test Nasal Swab: negative on 14Jan2021. The outcome of events was recovering. Information on Lot/Batch number has been requested.
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| 46 | 2021-01-26 | feeling abnormal |
Took second dose COVID vaccine on 1/18/21, had fever, fatigue, headache that lasted through the day ...
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Took second dose COVID vaccine on 1/18/21, had fever, fatigue, headache that lasted through the day of 1/19, only took 1g dose of Tylenol that evening mostly due to headache. I woke up feeling fine on 1/20 but then developed some shakiness that evening. On 1/21, I had fatigue/tiredness, and other than food/bathroom, stayed in bed resting. On 1/22 continued to feel fatigued and dizzy, finally checked my BP, the readings were 93/67 (did not write down HR - heart rate) and 89/68, HR87. I videoconferenced the Methodist urgent line, spoke to NP, recommended continued check BP and increase fluid intake. Still feeling slightly dizzy and tired, but better overall, just feel slightly "off", especially with exertion. BP: 1/23 - 98/76 HR84 , 104/83, HR77; 1/24 - 102/82, HR87; 1/25 - 109/75, HR68, 104/67, HR58, 98/79,HR104, 96/74, HR93; 1/26 - 94/69, HR81, 95/72, HR74, 98/64, HR80; 1/27 - 121/84, HR81 (during MD video visit), 114/80, HR75, 96/74, HR82. Spoke to my doctor today. She asked if I'd filled out this form so decided to fill out. She recommended I continue to monitor BP, increase fluid intake, restart vitamins, add electrolyte drink, add caffeinated drink (for intermittent headache) and follow-up next week if not resolved.
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| 46 | 2021-01-26 | feeling abnormal |
Fatigue; Chills; Brain fog; Headache; This is a spontaneous report from a contactable consumer (pati...
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Fatigue; Chills; Brain fog; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (left arm) on 13Jan2021 16:15 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. On 13Jan2021 17:45, the patient experienced Fatigue, chills, brain fog, headache. No treatment was given for the events. The outcome of the events was recovering. The patient has no Covid prior vaccination and was not tested post vaccination. Information on the Batch/Lot number has been requested.
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| 46 | 2021-01-27 | feeling abnormal |
About an hour and a half after the injection, I felt nausea, a headache, tiredness, and a genal feel...
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About an hour and a half after the injection, I felt nausea, a headache, tiredness, and a genal feeling of not feeling well. I ate some food and drank some ginger tea and it helped a little but after another hour I felt terrible with the same symptoms. They lasted for three days where I needed to go to bed by 6:00 PM or as soon as I could each night. On Sunday, January 24, 2021, 12 days after receiving the vaccine my eyes turned red and tired. I took my Claritin that I take if my allergies bother me and did some eye drops but it did not go away. I have had read eyes for five days now, it's more of a strained eye look and no other symptoms such as discharge, just a red eye on the whites of my eye. I do not know if this is related to the vaccine, but my allergies meds are not working, eyedrops are not working, and I had a COVID Lab test Monday 1/25/21 it was negative and a COVID Rapid test today 1/28/21 and it was negative.
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| 46 | 2021-01-30 | impaired work ability |
Headache, fatigue, muscle pain, sore throat, sinus congestion, chest tightness (slight), dry co...
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Headache, fatigue, muscle pain, sore throat, sinus congestion, chest tightness (slight), dry cough. Headache started 1/25/21. Others started 1/26/21 and progressively got worse. Went to urgent care on 1/26. Missed work on 1/26 & 1/27.
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| 46 | 2021-01-30 | loss of personal independence in daily activities |
Side effects of severe flu like symptoms for 2 days. Fatigue and moderate headache are still going ...
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Side effects of severe flu like symptoms for 2 days. Fatigue and moderate headache are still going on post 1 week after vaccine. Headache is constant dull pain. Fatigue is moderate but starting to interfere with daily tasks
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| 46 | 2021-01-30 | sleep disorder |
The evening after 2nd dose I developed itching and 3 hives over my left eye. I took Benadryl 25 m...
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The evening after 2nd dose I developed itching and 3 hives over my left eye. I took Benadryl 25 mg at 6 pm and again at about 2 am as itching intense and disrupting sleep (as did chills and myalgia.)
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| 46 | 2021-01-31 | impaired work ability |
Patient called to report that after receiving her vaccine on Friday: during the middle of the night ...
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Patient called to report that after receiving her vaccine on Friday: during the middle of the night she starting feeling chills and had a temp of 101. She took some ibuprofen and her fever broke around 9030 or 1000 on Saturday because she became very diaphoretic. She reports that she slept approx 19 hours on Sat and she had chills and sweats off on during this time period. She just felt weak and tired. On Sunday she felt better, just tired. Today, Monday 2/1 she did not come to work due to being tired and feels dehydrated due to the fever and being weak and sweating spells she had. She also states that her Right arm pit is swollen
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| 46 | 2021-02-02 | nervousness |
sensory neuro bilateral hearing loss worse on one side; tinnitus; This is a spontaneous report from ...
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sensory neuro bilateral hearing loss worse on one side; tinnitus; This is a spontaneous report from a contactable physician (patient). A 46-years-old female patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular into right arm on 05Jan2021 at 0.3 mL, single for covid-19 immunization. Time the vaccination was reported as 10:00-10:30. Medical history included food and environmental allergies. The patient had a history of autoimmune antibodies to thyroid but with normal thyroid numbers. No medication was needed, but autoimmune antibodies was found in the past. She had a propensity for autoimmune disease, it was just not active. She was diagnosed the first time she found auto antibodies 12 years before 19Jan2021 (2009) and checks her thyroid yearly and they had been normal. She still had antibodies, but thyroid hormone levels are normal without intervention. The patient's concomitant medications included Vitamin C and Vitamin D. Historical vaccine included Pneumovax 30 days before getting the COVID vaccine (06Dec2020, 46-years-old). Her pneumonia titers were low. Historical vaccine also included flu shot, she felt sick but like everyone else, she did not consider that abnormal. She thought most people felt kind of down and it did not have long term effects. It did not require any doctor visits. She did not have a rash or anaphylaxis. The patient was a physician and well versed in terms of symptoms. By evening of 05Jan2021, she developed tinnitus, which she had never had and has been there ever since. She was on day 13 post vaccine and still having bilaterally, every day and it never went away. She had a physician visit on 12Jan2021 and hearing test performed that day. They did find sensory neuro bilateral hearing loss worse on one side, her test confirmed bilateral hearing loss at 11:00 on 12Jan2021. It was mild so far in the high frequency ranges. So, they gave option to start 14 day course of high dose steroids with steroid injections into the ear, because in some cases of acute hearing loss, it can curb or reduce it. She decided to do that. Now she was going to be on steroids. She would be temporarily immunosuppressed. She did not know if that will affect the vaccine. She had not decided if she will get second shot. It is due next week, but she was a little nervous. She was considering delaying the booster a couple months out to see if more information develops. She provided her weight as between 175 to 180lb. Right now, the hearing loss was mild and it won't be that bad, but normally, it was permanent, which would be disabling hearing loss. She was going 20Jan2021, for the steroid injection in the ear canal. That would be the first injection. She was taking oral steroids now. They would see if this limits the progression. The events outcome was not recovered.; Sender's Comments: The possible causality between the reported tinnitus/sensory neuro bilateral hearing loss and the administration of COVID-19 vaccine, BNT162B2, cannot be fully denied based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 46 | 2021-02-03 | impaired work ability |
Employee described having malaise and body aches the day after vaccination (1/13/21). The symptoms w...
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Employee described having malaise and body aches the day after vaccination (1/13/21). The symptoms were severe enough to keep the employee home from work to recover and rest for 1 day.
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| 46 | 2021-02-04 | impaired work ability |
Received the first dose on 12/16/2020, I tested positive for COVID on 12/28/2020. I received my sec...
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Received the first dose on 12/16/2020, I tested positive for COVID on 12/28/2020. I received my second dose on 1/7/2020, I was still having COVID symptoms. Symptoms worsened after the second dose. My heart rate has been out of control. I have been on steroids daily, because I was so short of breath. I have not been at work since being diagnosed with COVID. I went ahead and got the second dose, because my job told me that I had to get the second dose. I still have fatigue, elevated heart rate, blood pressure is till elevated. I have been started on blood pressure medication. I have also been diagnosed with severe sleep apnea. I had a sleep study performed. I am on two new inhalers. One is a steroid inhaler for lungs and one is a rescue inhaler for when I am short of breath. It has not pleasant. Headaches are horrible and daily. I went to ER, because headache was so severe. No medication I take for headaches work. I have not been able to work since I was diagnosed with COVID.
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| 46 | 2021-02-04 | nervousness |
Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we att...
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Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO. I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.
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| 46 | 2021-02-04 | sleep disorder |
I got shot at 7 am Thursday morning. I had sore arm around 130 pm. And was all day. At 130 am Frid...
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I got shot at 7 am Thursday morning. I had sore arm around 130 pm. And was all day. At 130 am Friday morning. I woke with chills. I took my temp. It was 100.8. And he lot as high as 101.2. Between 130-430. I woke up again at 630 and it was 100.3. I have been warm all day now. I do not feel I need attention o am sweating it out.
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| 46 | 2021-02-05 | sleep disorder |
pain and tingling in left arm and hand within 1 week of first dose, tingling/paresthesias in both ha...
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pain and tingling in left arm and hand within 1 week of first dose, tingling/paresthesias in both hands and feet/lower legs 1 week after 2nd dose, daily, worse at night when trying to sleep
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| 46 | 2021-02-06 | impaired work ability |
On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itch...
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On 2/1/2021 I noticed a cluster of bumps on my left forehead by my hairline. Flesh colored, not itchy. N 2/3/2021 I developed swollen and sensitive lymph nodes in front of left ear. On the evening of 2/4/2021 rash to forehead now red and sensitive and looking more blister like. Left eye blood shot and eyelid and left face swelling. Shooting pains into head on left side. 2/5/2021 made same day appointment with pap. Shingles diagnosed and started on Valacyclovir. Appointment with Ophthalmologist scheduled for 2/8/2021. Went to ER on 2/6/2021 for left eye pain. No change in treatment. Still to follow-up with eye doctor on 2/8/2021. Not able to work due to pain and nature of worK (around pregnant women and babies<1month old).
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| 46 | 2021-02-07 | feeling abnormal |
Upper body shakiness, rapid heart rate Started within a minute of shot. Rash over face, neck and ch...
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Upper body shakiness, rapid heart rate Started within a minute of shot. Rash over face, neck and chest within 10 minutes of shot. Feeling of nausea after 25 minutes Selling of tongue with a fuzzy feeling 35 minutes after test.
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| 46 | 2021-02-07 | sleep disorder |
Severe joint point in both knees, hips, elbows, shoulders and right wrist. Severity of pain varies ...
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Severe joint point in both knees, hips, elbows, shoulders and right wrist. Severity of pain varies but is consistent and significant enough to prevent regular nightly sleep. Typical approaches to alleviating the pain, which does occur in the knees and hips due to early arthritis, are not effective. These include OTC rapid release extra strength tylenol and rest.
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| 46 | 2021-02-09 | anxiety |
The patient complained of itching skin and a scratchy throat. She stated she has a nut allergy and ...
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The patient complained of itching skin and a scratchy throat. She stated she has a nut allergy and was anxious. She has medication to take for allergic in purse and wishes to leave and go to work. She had no edema to throat or mouth. Nurse checked vital signs and lungs were clear. This was discussed with the manager.
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| 46 | 2021-02-09 | feeling abnormal |
Slight soreness at injection site; fatigue; feeling a little spacey.; This is a spontaneous report f...
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Slight soreness at injection site; fatigue; feeling a little spacey.; This is a spontaneous report from a contactable consumer (patient). The 46-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (BNT162B2, lot number: EL8982), via an unspecified route of administration in left arm on 25Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. Medical history included anxiety. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included hydroxyzine embonate (VISTARIL), sertraline hydrochloride (ZOLOFT), vitamin c [ascorbic acid], fish oil, acetylsalicylic acid ASPIRIN (E.C.). The patient previously took codeine and doxycycline and experienced Allergy. The patient experienced slight soreness at injection site, fatigue, feeling a little spacey on 25Jan2021 11:00. No treatment received. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.
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| 46 | 2021-02-10 | confusional state |
Tightening of throat; Numbness in left thumb, arm, and jaw; Confused; Rapid heart rate; Nausea; Incr...
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Tightening of throat; Numbness in left thumb, arm, and jaw; Confused; Rapid heart rate; Nausea; Increased blood pressure; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 25Jan2021 at 11:30, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to bees, penicillin, and dairy. The patient's concomitant medications included loratadine (CLARITIN) and paracetamol (TYLENOL). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a school or student health clinic facility. Within 5 minutes of injection on 25Jan2021 (starting at 11:30), rapid heart rate, nausea, and increased blood pressure began, continued, and worsened. After an hour, these got worse and seen by medics. Then the patient was transported to emergency room (ER) by ambulance but could not be seen for 4 hours. About an hour and a half after the injection (13:00), the patient experienced tightening of throat and numbness in left thumb, arm, and jaw. The patient was also very confused at that point as well. After 2 hours in waiting room, the patient felt well enough to be taken home. The symptoms slowly improved on their own. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No treatment was given for the events. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the events in Jan2021.
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| 46 | 2021-02-11 | insomnia |
First Dose: On Monday the 21st I started getting a Fever and not feeling good. I found out that day ...
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First Dose: On Monday the 21st I started getting a Fever and not feeling good. I found out that day my boss was home with Covid. I did a Saliva test (covid test), while waiting for my test above my collar bone was swollen. I was generally not feeling well. I got my results on the 25th and it was negative. On the 30th I got heart fluttering, feelin racy. It went away. On the 1st, I felt so wiped out and heart was going nuts, and I went to get a EKG that was normal but my BP was high140/high 80. On the 4th I went back to work again and still felt horrible, dizzy and they sent me to the ER and had High BP and two normal EKG', and the hooked me up to a heart monitor for a week. With both shots I had insomnia of the walls. Second Dose: it was much better than 1st dose. The Monday after the 2nd dose I got a really bad headache. I drank some Pedialyte and took a 12 hour nap and felt great after.
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| 46 | 2021-02-14 | impaired work ability |
Two days after second shot I was hit and had onslaught of left side of head with sever migraine head...
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Two days after second shot I was hit and had onslaught of left side of head with sever migraine headaches, with intermittent pounding and spiking shot of even greater intensity of pain! It is non stop day and night preventing me from sleeping well and working / do my job. I immediately went to see my PCP who gave my tramdal but I could not handle it. Now I am on Prochlorperazine which is helping some with the pain, but migraine is still there. I had an MRI, and blood lab work! No growths seen in my head...but the symptoms I have are consistent with migraine which I never had until the second shot the of vaccine. I need help! Nothing is making this away yet - I need this migraine headache to go away!
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| 46 | 2021-02-15 | anxiety | Anxious, feeling hot, and claustrophobic . |
| 46 | 2021-02-16 | anxiety |
This happened the first shot also but I thought it was just me being anxious. Immediately following...
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This happened the first shot also but I thought it was just me being anxious. Immediately following my roof of my mouth felt big. Then my tongue and lips felt the tiniest bit swollen. I could breath fine. Then my face (especially my left side) was a bit numb. The same thing happened to my friend but we couldn?t find anything online about our symptoms. I ended up telling the nurse at the front and they told me to take Benadryl and call 911 if scared. They made sure I wasn?t going to be home alone. I felt better within a 1/2 hour of taking the meds. My throat feels a little sore right now along with my arm.
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| 46 | 2021-02-18 | anxiety, feeling abnormal |
Approximately 5 minutes after the vaccination, felt a heaviness come over whole body, felt anxious. ...
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Approximately 5 minutes after the vaccination, felt a heaviness come over whole body, felt anxious. Approximately 50 min after mouth felt fuzzy/tingly, face felt tingling; had a lightening pain go across body.
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| 46 | 2021-02-18 | anxiety |
CHIEF COMPLAINT: TONGUE SWELLING (patient had her second COVID vaccine today, later developed tingl...
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CHIEF COMPLAINT: TONGUE SWELLING (patient had her second COVID vaccine today, later developed tingling in her mouth and tongue/lip swelling and dry mouth. Denies difficulty swallowing) Assessment/Plan: DIAGNOSIS at time of disposition: 1. Allergic reaction, initial encounter Symptoms: Patient had second dose of COVID 19 vaccine today at 1230 p.m. She states at around 530 - 6 p.m. she started coughing and felt like that was a hair caught in the back of her throat, states throat is tingling and looked in the mirror and states her tongue is swollen. Feels that her heart rate is abnormal, but states it could relate to anxiety. COVID vaccine clearance needed if future booster needed. Informed patient to follow up with PCP if needed after ED visit. HISTORY OF PRESENT ILLNESS: The patient got her 2nd dose of COVID vaccine today at noon. At 5 she started feeling a bit of a tickle and scratchiness of her throat and her mouth felt very dry. She was concerned about allergic reaction. No shortness of breath chest pain rash itching hives or any other concerns. She has not taken any Benadryl. The patient is in no distress. Symptoms been going on for 3 hours. This could be a very mild allergic reaction. Therefore I am giving her 50 mg of oral Benadryl. Given the symptoms been going on for 3 hours and I do not see any angioedema I am comfortable letting her go home at this point in time. I do not think steroids would be beneficial. She will return here if worsening and I instructed her to use Benadryl 50 mg every 4-6 hours if needed. BLOOD PRESSURE SCREENING: Based on last blood pressure taken in the ED of 171/98, HTN (>/=140/90), recommend follow up with PCP within 1 month.
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| 46 | 2021-02-18 | anxiety |
Patient developed headache ~20 minutes after vaccine administration. Vitals at 11:28 AM: O2 98%, HR ...
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Patient developed headache ~20 minutes after vaccine administration. Vitals at 11:28 AM: O2 98%, HR 91, BP 156/85. Vitals at 11 41 AM: O2 99%, HR 90, BP 149/90. Patient reported feeling anxious given her history of anaphylaxis to peanuts. Patient was monitored for 60 minutes. She did not develop any new or worsening symptoms throughout 60 minute observation period and she remained well appearing throughout. Reviewed s/sx anaphylaxis (facial swelling, throat itching or tightness, shortness of breath, vomiting) and advised her to call 911 immediately if these occur today.
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| 46 | 2021-02-18 | sensation of foreign body |
Evening of vaccination, felt a knot in throat. Did not have any trouble breathing, eating or drinkin...
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Evening of vaccination, felt a knot in throat. Did not have any trouble breathing, eating or drinking. The next day on 1/29/2021 felt body aches, headache, nausea, diarrhea.
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| 46 | 2021-02-21 | loss of personal independence in daily activities, sensation of foreign body |
Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) ...
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Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown. Information about Lot/batch no has been requested.
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| 46 | 2021-02-22 | impaired work ability |
Daily headaches lasted for 7 days. Arm soreness lastes for 3 days. Needed to take daily Tylenol, aff...
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Daily headaches lasted for 7 days. Arm soreness lastes for 3 days. Needed to take daily Tylenol, affected work.
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| 46 | 2021-02-25 | excessive sleepiness |
Severe headache and severe fatigue, to the point that I could not stay awake even 16 hours after the...
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Severe headache and severe fatigue, to the point that I could not stay awake even 16 hours after the shot. Then I was awake for a few hours then could not stay awake again about 24 hours after the shot. I took 400 mg of ibuprofen about 14 hours after the shot, when I was first awake enough to eat some food. I am an 110-pound female so 400 mg seemed sufficient. At about 26 hours after the shot, I took another 400 mg of ibuprofen before sleeping for the night. I developed a low-grade fever (100-100.5) at that point and through the night.
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| 46 | 2021-02-28 | mental impairment |
Mental fog; Massive head consuming headache; Extreme fatigue; This is a spontaneous report from a co...
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Mental fog; Massive head consuming headache; Extreme fatigue; This is a spontaneous report from a contactable other hcp. A 46-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration arm right single dose on 05Feb2021 for COVID-19 immunisation. First dose lot#EL8982, arm right (IM) was received on 15Jan2021, 10:00. Medical history included drug hypersensitivity (to sulfa drugs) from an unknown date. The patient's concomitant medications were not reported. The patient experienced mental fog on 05Feb2021 15:00, massive head consuming headache on 05Feb2021 15:00, extreme fatigue on 05Feb2021 15:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Feb2021. The events outcome was recovered in Feb2021 No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a causal relationship between event "mental fog" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-03-02 | excessive sleepiness, disorientation |
On Sunday I started with a severe headache. When I woke up on Monday morning I couldn't lift my head...
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On Sunday I started with a severe headache. When I woke up on Monday morning I couldn't lift my head. The headache was intense. I could not open my left eye. I had facial paralysis on the right side of my face. I had slurring of speech. When I walked I was dizzy. I fell asleep all day long, and woke up each time completely disoriented.
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| 46 | 2021-03-02 | excessive sleepiness |
body aches/body aches and especially the throbbing in head became much worse by midday/achy; slight ...
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body aches/body aches and especially the throbbing in head became much worse by midday/achy; slight throbbing in head/throbbing in head became much worse by midday; very tired; body chills and hot sweats on and off; body chills and hot sweats on and off; still lethargic and achy but improving; slept all day, and all night; eye pain which was triggered by light and eye movements; eye pain which was triggered by light and eye movements; This is a spontaneous report received from a contactable nurse (who is also the patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 11:15, at single dose, for COVID-19 immunization, at an urgent care center. There was no medical history. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included probiotics. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: unknown) received at age 46 years, via an unspecified route of administration on the left arm, on 08Jan2021 11:15, for COVID-19 immunization. On 30Jan2021 at 07:00, the patient experienced body aches and slight throbbing in head which became worse by midday; was very tired; returned to bed within 30 minutes and slept all day, and all night; had eye pain which was triggered by light and eye movements; body chills and hot sweats of and off. The patient reported that although she never had a fever according to her non contact forehead thermometer, she had body chills and hot sweats on and off. 48 hours later, she was still lethargic and achy but improving. Treatment for the events included ibuprofen 600 mg every 4-5 hours which helped but did not completely relieve the discomforts. The patient was recovering from the events.
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| 46 | 2021-03-02 | loss of personal independence in daily activities |
About 5 hours after the second dose I started feeling very fatigued, chills, and had a fever. I had...
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About 5 hours after the second dose I started feeling very fatigued, chills, and had a fever. I had these symptoms and flu-like symptoms for about 36 hours before they subsided. I then started to get over the hump and feel better. I also had a very sore, swollen, itchy injection site and arm. Then, Mon. evening, 3/1/21, 5 days after the second dose I was feeling somewhat dizzy, right before bedtime. So I just went to sleep. Today, 3/3/21, I am extremely dizzy and lightheaded and struggling to doing my daily activities. I'm not sure if this is still related to the 2nd injection or not, but I'm concerned.
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| 46 | 2021-03-03 | anxiety | Tongue soreness and anxiety, resolved without medication intervention |
| 46 | 2021-03-05 | feeling abnormal | Headache, blurry vision, heart palpitations, feeling off, eyes sore, eyes hurt, |
| 46 | 2021-03-06 | feeling abnormal |
reaction began with a Metalic taste in mouth within 10 minthen haziness, lip and throat swelling, t...
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reaction began with a Metalic taste in mouth within 10 minthen haziness, lip and throat swelling, tachycardia and high blood pressure I was given benadryl and when symptoms did not improve was taken to ER and given Decadron at 4:42pm then Famotidine and Sodium Chloride 0.9%
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| 46 | 2021-03-06 | impaired work ability |
3 hours after started feeling tired, went to bed early. Next morning - Sore arm up into shoulder and...
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3 hours after started feeling tired, went to bed early. Next morning - Sore arm up into shoulder and neck, lasted a week Whole-body muscle ache, headache, nausea, diarrhea, exhaustion, lasted two days. The shot was given on a Thursday and had to miss work the next day.
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| 46 | 2021-03-07 | feeling abnormal |
Pt started feeling shortness of breath and chest tightness. Was give zyrtec, epipen 0.3 mg, and albu...
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Pt started feeling shortness of breath and chest tightness. Was give zyrtec, epipen 0.3 mg, and albuterol inhaler. Pt then reported feeling "phlegmy" and was then transported by EMS.
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| 46 | 2021-03-08 | feeling abnormal |
20" after injection patient self-reported feeling lightheaded, dizziness, "foggy", generalized ting...
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20" after injection patient self-reported feeling lightheaded, dizziness, "foggy", generalized tingling in her hands and feet and felt like her tongue was a bit swollen. Stated she felt "funny". Also stated that she had a similar reaction after her first dose but states this reaction was more severe.
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| 46 | 2021-03-09 | anxiety |
1005: Complaint of dizziness; BP 160/90s, P 115. No SOB or respiratory difficulty. No rash. Patient ...
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1005: Complaint of dizziness; BP 160/90s, P 115. No SOB or respiratory difficulty. No rash. Patient anxious. 1030: Red, raised rash noted to begin on forehead, cheeks, and upper chest. Shaking (slightly) noted in hands. Patient states "feeling cold." BP 162/94, P 108, O2 99% RA. Patient A&Ox3 sitting in chair. 1040: Patient complaint of "lips feeling 'tingly'". Quickly progressed to full facial tingling. Denies dyspnea or chest pain. Still states she " feels dizzy." 911 called. BP 142/88, P 95, O2 99% RA. 1045: Turned over to paramedics. Patient A&Ox3. Rash still present but no worse. Denies dyspnea or chest pain. Still shaky, slight diaphoresis. Husband & son with patient. Patients belongings given to husband. Taken by EMS offsite.
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| 46 | 2021-03-09 | feeling abnormal, agitation, thinking abnormal |
Sever agitation with anger. Uncharacteristic of me and came on suddenly in the evening after receiv...
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Sever agitation with anger. Uncharacteristic of me and came on suddenly in the evening after receiving first dose of Pfizer Covid Vaccine in the morning. Severe "brain fog" on second day. Currently two days after receiving vaccine and agitation is still an issue coupled with mood swings and changes in thinking. Brain fog seems to have subsided. Other side effects have been moderate and expected: mild head ache, significant fatigue, a little achy, slight bit of nausea. Physical side effects are all normal and not severe and are expected. Mental, emotional, and thought pattern changes are of concern.
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| 46 | 2021-03-10 | restlessness |
Fatigue, severe itchiness all over body, headache, restlessness while falling asleep, lightheadednes...
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Fatigue, severe itchiness all over body, headache, restlessness while falling asleep, lightheadedness
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| 46 | 2021-03-13 | anxiety |
I felt like my vision was changing and it felt like my pupils were very tiny. I felt a strange press...
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I felt like my vision was changing and it felt like my pupils were very tiny. I felt a strange pressure in the top of my head. Not a typical headache but a weird pressure. I started feeling like I was clenching my teeth and my jaw. That night my arms were very jerky. I wasn?t thinking right. And every day since I feel like I?m tense muscles I?m dizzy I?m just not mentally like I used to be.
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| 46 | 2021-03-13 | feeling abnormal |
pain in lower back that would move to the front starting 4 days after the shot. Dizziness, nausea, f...
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pain in lower back that would move to the front starting 4 days after the shot. Dizziness, nausea, faintness, lightheadedness, palpitation and feeling there is a cloud in my brain starting 4 days after
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| 46 | 2021-03-14 | feeling abnormal |
PT. STATED PRIOR TO VACCINE THAT SHE HAS SEVERE ANXIETY AND GETS VERY ANXIOUS WITH INJECTIONS. PT. P...
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PT. STATED PRIOR TO VACCINE THAT SHE HAS SEVERE ANXIETY AND GETS VERY ANXIOUS WITH INJECTIONS. PT. PLACED ON STRETCHER PRIOR TO INJECTION. FIVE MINUTES AFTER INJECTION PT. C/O BEING HOT , FEELING "WEIRD" DENIED BREATHING DIFFICULTIES. EVALUATED BY EMTS, BP 180/120, HR 96, RR32 O2 SAT 100% ON RA. BP RETAKEN WITH MANUAL CUFF BY EMT REMAINED HIGH. PT. BP FOLLOWED FREQUENTLY OVER 30 MINUTES REMAINED ELEVATED TRANSPORTED TO ER BY AMBULANCE.
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| 46 | 2021-03-14 | nervousness |
Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips sw...
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Patient C/o facial numbness, rash and hives on face and neck 25 minutes after vaccine given. lips swelling and numbness. Epi pen given. Patient rash and hives continued. patient shaky and nervous. patient denied difficulty breathing. BP elevated. O2 sats stable. IV placed in right AC , IV Benadryl 50mg given IV push. Paramedics on site. Patient transported to ED.
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| 46 | 2021-03-15 | disturbance in attention |
Got shot on Thursday woke up Friday 2am with achy arm, by 7am full body aches and mild temp of 99.4 ...
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Got shot on Thursday woke up Friday 2am with achy arm, by 7am full body aches and mild temp of 99.4 Friday all day arm ached,small rash developed right of injection site , brainfog, dizziness. Symptoms went away by Saturday Morning just had a achy arm until Sunday. still expierencing Brain fog . Also experienced Brain fog and dizziness with first dose
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| 46 | 2021-03-16 | confusional state |
Blood pressure 155/107 Lightheaded, tongue tingling, hand/arm numbness Pressure on chest, dizzines...
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Blood pressure 155/107 Lightheaded, tongue tingling, hand/arm numbness Pressure on chest, dizziness and confusion, slow words. Uncoordinated hands and legs
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| 46 | 2021-03-16 | excessive sleepiness |
03/10/21 injection site got sorer as the day went. Felt a little tired 03/11/21 injection site very...
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03/10/21 injection site got sorer as the day went. Felt a little tired 03/11/21 injection site very sore but also felt kinda fatigued and sweating on and off. 03/12/21 woke up at 7:00 a.m with my throat red and tonsils red and lymph node on right side of neck was a-little swollen. Ear hurt on right side. I sounded muffled sounding when talked. I called in sick to work took some Tylenol and went back to bed. I slept all day till 8 p.m got up and ate something and went back to bed. 03/13/21. Throat still sore and red but a little better took Tylenol. Ear hurt on right side as well. 03/14/21 Throat a little better but still felt sore took Tylenol felt energetic all morning and about 5:30 or so felt fatigued. 03/15/21 ear still sore some throat better than before went to work. Had a temp Of 99.1 03/16/21 Sweating on and off today
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| 46 | 2021-03-16 | sleep disorder |
I awoke in the middle of the night with body pain symptoms, thirst, and slept terribly the rest of t...
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I awoke in the middle of the night with body pain symptoms, thirst, and slept terribly the rest of the night. In the morning I had above symptoms, painful lymph nodes in neck and groin, and elevated body temp of 100. But the most significant reaction was swelling and BRUISING around the eyes. Left side definitely worse than the right. I haven't heard of this, so I thought I'd reach out to you.
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| 46 | 2021-03-18 | impaired work ability |
The morning after the vaccination I woke up and felt like I had a fever, but I did not. I had the ch...
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The morning after the vaccination I woke up and felt like I had a fever, but I did not. I had the chills, body aches and really fatigued. I didnt feel well all that day and I missed work the next day. Those symptoms have gone away. However, I have been in menopause for 2 years. Havent had a period or spotting at all. The day after the vaccine I started spotting. Really light but consistent. It is still occurring now... and we are 5 days after my vaccine.
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| 46 | 2021-03-18 | insomnia, restlessness |
nausea; Headache; malaise; Cold sweats; restlessness; unable to sleep; This is a spontaneous report ...
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nausea; Headache; malaise; Cold sweats; restlessness; unable to sleep; This is a spontaneous report from a non-contactable female consumer reported for herself (Non pregnant). A 46-year-old female patient received second dose BNT162B2 (Solution for injection, lot number was EL3246) via left arm on 24Feb2021, 10:30 AM, single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose BNT162B2 (lot number:EL3247) left arm on 03Feb2021, 10:30 AM at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. After second dose vaccination patient experienced headache, nausea, malaise, cold sweats, restlessness, unable to sleep on 24Feb2021 at 08:15 PM. The patient taking treatment 600mg ADVIL taken for all events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 46 | 2021-03-21 | anxiety, feeling abnormal |
10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?. 1st Pfizer vaccine receiv...
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10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?. 1st Pfizer vaccine received @9:55a in Left Deltoid. BP 100/50, HR 76 and regular. Pt reports this BP being ?a little low for her?. Pt ate breakfast and then had a snack before coming to clinic. She has a distant history of ?getting very sick with the flu vaccine?. Within a few hours of the dose 15 years ago or so, she developed a fever of 103 and had flu symptoms of aching everywhere. The next year they gave her a pediatric dose and she had a similar response and has not had another flu shot since then. She has received allergy shots for more than 10 years and takes OTC allergy meds daily. She took her Zyrtec this am. She spoke with her allergist and received the recommendation to get the Covid vaccine. Her next allergy shots are due next week. She reports feeling fine before and during the injection and then the light-headedness started 5-6 minutes after sitting in the obs area. Site director and pharmacist aware of events. 10:22a Pt drinking water and reports ?feeling strange with swallowing and jaw feels tight?. Pharmacist to pt side and decision made to give 12.5mg of liquid Benadryl. Pt states, ?I wonder how much of this is me being anxious?. 8 oz water consumed and tolerated well. Pt reports ?tongue feels thick? with drinking Benadryl 10:24 pt reports legs feel less weak. 10:29 HR 76, BP 110/70. Husband arrived. Pt reports still feeling the same level of dizzy and throat feeling ?less tight?. 10:38 No change is s/s. Consult with pharmacist-advised giving additional 12.5 mg oral Benadryl. 10:41 Benadryl given and tolerated well. ?I don?t feel great?. Finished second 8 oz bottle of water and third given. Pt reports still feeling the same level of dizzy but has some increased thickness in throat. Improves with drinking cold water. 10:46 Pt reports although throat feels better with water, that her airway still ?feels smaller?. When describing her throat and airway, ?it?s not 100% normal, but better?. 10:50 HR 64, BP 104/64. Pt reports ?dizziness unchanged throughout, legs still feel weak, jaw and tongue feel back to normal, but back of throat still feels tight, but cold water helps but when swallowing, it still feels harder to do?. Reviewed case with pharmacist and site director, recommendation to take pt to ER for further obs. Pt agrees to go. 10:59 Pt transferred safely to wheelchair and escorted to ER. ER RN given report after pt checked in with husband beside her. Recommended to pt that she notify her PCP and Allergist of today?s event and recommended they get a recommendation for receiving the second dose.
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| 46 | 2021-03-21 | feeling abnormal |
Within 7 minutes I had a reaction of dizziness, nausea, increased blood pressure, increased heart ra...
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Within 7 minutes I had a reaction of dizziness, nausea, increased blood pressure, increased heart rate, retching and extreme fatigue. I was taken to the Emergency Room via. Ambulance. In the ambulance I was given an IV and IVY Zolfran - which seemed to make the symptoms worse, at the Emergency room they gave me Phenergan. I had a chest x-ray that didn't show anything unusual. I was then give Meclazine for the naseau and headache and a full bag of IV fluids. It was enough to get me standing on my own so I could go home after spending several hours in the emergency room. 3/5/21 - 3//21 - still had symptoms - every time I moved I got nauseous and dizzy. Followed up with my PCP's office on 3/9/21 as I was still very dizzy, nauseas, and had brain fog- I have been on Zolfran and Motion sickness medicine - since the 9th. At that time blood tests were done. I had another appointment with my PCP on 3/16/21- as I am still having nausea and while there - got very nauseas while tracking . This is 11 days after the 1st vaccine. I was referred to Otolarynology on 3/17/21. The PA I saw there determined it wasn't an ear issue and has referred me to Dr. for an ENG test which is scheduled for 3/31/21 with a follow up with Dr. on 4/13/21. I have also been in touch with my allergist - who told me to postpone my allergies shot that were scheduled on 3/19/21.
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| 46 | 2021-03-22 | feeling abnormal |
I have not had a period for over 6 months, I overlap my birth control to not have a period. Since t...
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I have not had a period for over 6 months, I overlap my birth control to not have a period. Since the vaccine I have started bleeding and the bleeding has gotten worse each day. Along with the period I am now getting cramps that I have never had in the past. Also feel very foggy in the head.
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| 46 | 2021-03-22 | impaired work ability |
Summary: Abdominal pain (similar to that experienced years previously, but not experienced approx. 2...
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Summary: Abdominal pain (similar to that experienced years previously, but not experienced approx. 2 years previous to Pfizer COVID-21 vaccination) recurred after first vaccination, worsened after second vaccination, leading to 2 ER admission and hospital admission. Ultimate cause still not determined or successfully treated; pain continues treated by opoids, gabapentin, anti-nausea medication. Patient has not been able to work since March 4th, 2021 (currently March 23rd, 2021). Details: The day after the first vaccination, abdominal pain similar to that the patient had previously experienced, but which had not presented severely for around a two years, recurred quite severely for 4-5 days. Missed 2 days of work. Pain reduced enough to resume work after 4-5 days. The day after the second vaccine dosage (2 Feb 2021), the abdominal pain worsened again, becoming more severe and more prolonged than after the first dosage. Missed four days of work (not consecutive). Pain worsened. 12 March 2021 visited PCP, who recommended immediate ER/hospital admittance. ER could not any definite cause of pain (though 8cm fibroid present, thought to be causing lower abdominal pain but not upper abdominal) and released patient. Abdominal pain became somewhat better but still continued. March 6th, abdominal pain greatly increased, leading to ER visit and hospital admittance March 6th-March 9th, 2021. CT scan 6 March 2021. Relevant results: Bowel: Multiple dilated loops of distal small bowel with fecalization of small bowel contents and a slow transition to normal caliber at the terminal ileum. The appendix is not visualized. The stomach is unremarkable. The colon is not dilated. Mesentery/Peritoneum: Small indeterminate density fluid adjacent to dilated loops of bowel in the right lower quadrant. Nodes: Scattered small abdominal nodes, none meeting CT criteria for pathologic enlargement. Pelvis: Large uterine leiomyoma. Uterine fibroid identified as probably source of pelvic and lower abdominal pain. Mid and upper abdominal pain thought not to be related, however, and may be related to dilated loops of distal small bowel and adjacent fluid. Pain treated with opoids, gabapentin, anti-nausea drugs, patient released 9 March 2021. Abdominal pain continues, partially controlled with pain medications. Lower pelvic pain has not recurred (birth control pills started at end of hospital visit). Patient has been been able to work since March 4th (currently March 23rd, 2021). Patient is applying for short-term disability due to extended absence from work caused by these issues.
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| 46 | 2021-03-23 | anxiety, sleep disorder, loss of personal independence in daily activities |
9 days after the first vaccine, my ears started ringing so loudly. About a week later, it calmed do...
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9 days after the first vaccine, my ears started ringing so loudly. About a week later, it calmed down and I did get the second vaccine. 9 days after that, my ears started ringing again, this time the volume much higher. It has been 3 weeks today and it is still ringing so loudly. It is interrupting sleep, causing anxiety and making day to day activities difficult. It is ringing all the time and is unrelenting.
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| 46 | 2021-03-23 | sensation of foreign body |
Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight...
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Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight. My heart rate felt like it had jumped and my heart was pounding. I started to feel like it was very hot and I was getting somewhat nauseated and feeling like I might pass out. I checked my smart watch and my heart rate had jumped to over 120. The lady who administered the shot got the EMT on site and they took me for observation. They took my blood pressure and it was 157/114 (which is far beyond the norm for me). They took an EKG on site which they said was not alarming in any way. They checked my blood sugar and it was normal. My oxygen level stayed within a normal range. I had some mild feeling of itching/tingling in my mouth and felt like I had a lump in my throat like a marble. My BP and HR came down some after about 15 minutes but was still high. They called an ambulance and had me go to an ER for further observation since the feeling in my mouth and throat was not resolving and my BP was not coming down to a better range after about 30 minutes. By the time I got to the ER and they monitored me, my BP was still 154/70 and my HR was still in the 80s while at rest. They kept me in observation for long enough for the doctor to feel that I was not in any immediate danger so they discharged me with instructions to return to the ER if things got worse.
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| 46 | 2021-03-24 | amnesia, feeling abnormal |
congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lu...
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congestion and wheezing in left upper lobe of lung; congestion and wheezing in left upper lobe of lung; short of breath; left side of my face became numb; tachycardic; Blood Pressure 162/110; chills; burning in my mouth; tingling throughout body; dizziness; fog brain/Memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days; fog brain/Memory loss; muscle pain; bruising not at site (in legs); lymph node swelling on injection arm sight; I finally felt pain at injection site; This is a spontaneous report from a contactable health care professional nurse, the patient. A 46-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899); intramuscular on 20DEC2020 at 22:30 (at the age of 46 years old) as a single dose, for COVID-19 immunization. Medical history included hypothyroid, Allergic to Latex. The patient previously took levonorgestrel and experienced drug hypersensitivity. The patient's concomitant medications were not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 The patient experienced congestion and wheezing in left upper lobe of lung, short of breath, left side of my face became numb, tachycardic, Blood Pressure 162/110, chills, burning in my mouth, tingling throughout body, dizziness, brain/memory loss/felt as if out of body experience" or just not normal for about 12 to 14 days, muscle pain, bruising not at site (in legs), lymph node swelling on injection arm sight and on about the 5th day Dec2020 experienced pain at injection site. The patient underwent lab tests and procedures which included blood pressure: 162/110 on an unspecified date and heart rate tachycardic on an unspecified date. The clinical course is as follows Shortly right at 15 minute mark of being monitored, I became short of breath, left side of my face became numb, then right, became tachycardic, Blood Pressure 162/110, developed chills, burning in my mouth, tingling throughout body, dizziness, developed "fog brain"/Memory loss prevalent for following 48 hours after injection, remained not as severe about a week after, muscle pain, bruising not at site (in legs) developed lymph node swelling on injection arm sight, developed congestion and wheezing in left upper lobe of lung. "felt as if out of body experience" or just not normal for about 12 to 14 days. Patent Refuse to go to ER, where advised to go after RAD team assessed, around the 5th day I finally felt pain at injection site-which that part would be normal, but I did not feel at 1st due to all the major reactions my body dealt with. As a result of the events the patient did visit a physician. Treatment was given for the events (Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, Vaccination site pain) which included Benadryl, Tylenol, IBU, and steroids, Cold and cough meds OTC. The clinical outcome of the events Pulmonary congestion, wheezing, dyspnea, hypoesthesia, tachycardia, chills burning sensation, paranesthesia, dizziness, feeling abnormal, Amnesia, Myalgia, Contusion, Lymphadenopathy, and Vaccination site pain was recovering while blood pressure 162/110 was unknown.
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| 46 | 2021-03-24 | feeling abnormal |
I immediately felt my right arm getting cold. It then started to feel heavy and weighed down. Soon a...
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I immediately felt my right arm getting cold. It then started to feel heavy and weighed down. Soon after, I started getting a mild headache toward the front of my head which intensified towards my temple area. My eyes felt strained ( the back of my eyes ). The feeling was similar to a migraine/sinus pressure. I started getting cold and then my extremities were freezing. I got chills and was shivering ( it was cold in the building, but I wasn?t that cold upon entering ). This was all in the first 15 minutes. I was told to stay for 30 minutes in the waiting area because of my allergy to erythromycin, just as a precaution. Around 20 minutes my mouth became very dry. I also had a metallic taste in my mouth. It became hard for me to swallow and I had to think to swallow because it wasn?t happening naturally. At that time I alerted someone and asked if these reactions were normal. I was given a 25mg Benadryl and had people continuously check on me. It took some time before I was able to not feel the choking closed feeling from swallowing. Once I was able to swallow it felt as if I had something lodged in the back of my throat. Similar to the feeling of phlegm. I kept having to clear my throat because that phlegm feeling wouldn?t ?wash down?. I felt light headed, but not dizzy. More of a foggy feeling. Once they felt it was safe for me to leave I came home and rested. The headache lessened, I was still cold, but not chilled. Into the evening I was very tired and foggy in thinking.
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| 46 | 2021-03-25 | confusional state |
Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusi...
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Metal flavor and swelling tongue, trouble breathing, hives, itching, fast heartbeat, mental confusion, tingling, swelling lymph nodes, body ache, headache.
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| 46 | 2021-03-25 | nervousness |
3-24-21 6:20PM PT STATES SHE FEELS LIGHTHEADED, SWEATY, HEART RACING'. STATES SHE IS 'NERVOUS ABOUT ...
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3-24-21 6:20PM PT STATES SHE FEELS LIGHTHEADED, SWEATY, HEART RACING'. STATES SHE IS 'NERVOUS ABOUT GETTING SHOT AND WAITED AN EXTRA HALF HR' AFTER HER WAIT TIME. A/O, PINK, W/D, RESP WITH EASE. 6:25PM PT STATES SHE 'FEELS BETTER'. HUSBAND HERE TO DRIVE PT HOME. GAIT BRISK AND STEADY.
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| 46 | 2021-03-26 | impaired work ability |
Received Pfizer dose 2 (Tues 3pm), 10 hours later (Weds 1am), nausea hit along with aches, chills, h...
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Received Pfizer dose 2 (Tues 3pm), 10 hours later (Weds 1am), nausea hit along with aches, chills, headache and fever. Didn?t get much sleep, took my temp at 10am and it was 101. Clothes were wet from sweating. Had to take the day off work. Symptoms (all of them) persisted the whole day, took temp again around 11:30pm (Weds), 101.2. Tylenol helped with sleeping (took the headache down enough to sleep) but the following day still had symptoms the whole day (Thurs), about 25 % less I?d say, couldn?t work Thursday either. Friday finally felt well enough to eat, shower, do household chores, etc. 2 full days of really rough symptoms. Fever, headache, nausea the worst.
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| 46 | 2021-03-26 | loss of personal independence in daily activities |
Extreme dizziness, two days after receiving my first COVID-19 vaccination, Pfizer-BioNTech. I was f...
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Extreme dizziness, two days after receiving my first COVID-19 vaccination, Pfizer-BioNTech. I was feeling fine and began to notice slight dizziness upon standing, which within an hour of noticing that slight dizziness, the dizziness became extreme. I had to go to bed and was unable to even turn my head without feeling severe dizziness. The dizziness made me nauseous, too. The next morning, I feel a bit better, I can stand up, but I can feel that the dizziness is still with me, but not as strong as last night, so far. I'm hoping that it goes away completely.
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| 46 | 2021-03-28 | loss of personal independence in daily activities |
About 24 hours after the vaccine, I began to develop the following symptoms which seemed to reach th...
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About 24 hours after the vaccine, I began to develop the following symptoms which seemed to reach their peak by 9pm that evening. I had a 103 fever, severe fatigue, body aches (mostly in the lower body/ in the legs and aching joints) and chills (I could not get warm). I was unable to function and perform my daily activities of living due to these symptoms. When I reached the 48 hour mark of receiving the vaccine, all the symptoms had subsided except for the fatigue. These were the exact symptoms I experienced when I tested positive for COVID on December 10, 2020. Except I also had severe nausea for about 10 days and gastrointestinal distress when I had the virus. FYI: I got my flu shot in November 2020.
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| 46 | 2021-03-29 | feeling abnormal |
Employee received #2 Pfizer on 3/18/21 at 3pm. At 8pm she describes experiencing vague chest pain th...
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Employee received #2 Pfizer on 3/18/21 at 3pm. At 8pm she describes experiencing vague chest pain that she attributed to musculoskeletal pain. She took Tylenol and drank fluids, went to bed. The next am, she woke up with worsening chest tightness and diffuse back pain. At approximately 1-2 pm she experienced SOB, labored breathing, and a "weird" chest discomfort "like something was sitting on her chest." She called 911, was evaluated by paramedics, VSS, BP 120s-130s, O2 sat 100%. They did not transport her to ED. She took Tylenol and drank fluids and reportedly felt "much better" by 4pm
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| 46 | 2021-03-29 | panic attack |
3/28: period-like bleeding (I have a Mirena IUD and have not had any bleeding since 7/20, prior to i...
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3/28: period-like bleeding (I have a Mirena IUD and have not had any bleeding since 7/20, prior to its insertion 8/20) *wondering if the vaccine has any impact on birth control efficacy 3/29: woke up having a panic attack (only happened one other time in my life, fall 2019)
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| 46 | 2021-03-30 | confusional state, feeling abnormal, anxiety |
feeling uneasy; BP was 150/80; confused; anxiety; flush through my whole body; shaking; didn't feel ...
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feeling uneasy; BP was 150/80; confused; anxiety; flush through my whole body; shaking; didn't feel "right"/felt funny; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), via an unspecified route of administration on 19Feb2021 (at 46 years old) as single dose for covid-19 immunisation. Medical history included ongoing hypotension and ongoing hoshimoto's disease. The patient's concomitant medications were not reported. The patient experienced feeling uneasy, bp was 150/80, confused, anxiety, flush through her whole body, shaking, didn't feel "right"/felt funny all on 19Feb2021 with outcome of unknown. The HCP told patient to take a diphenhydramine hydrochloride (BENADRYL) beforehand, and her cardiologist also provided her with a prednisone dosepak. Clinical course was reported as follows. About 10 minutes after receiving her first dose, the patient reported reactions that "hit her so hard, out of no where" including flushing throughout her entire body, shaking, feeling uneasy like "something is happening". She tried to cool herself down by taking off her coat. She did not require an epipen. When EMS arrived, her BP was 150/80 mmHg which is out of character for her, as she normally has a BP of 80/40 mmHg (very low, almost "Dead"). She also reports that she "didn't feel right" for the rest of the week following vaccination. She was very confused, didn't feel "right" and had these anxiety/felt funny for a week afterward. She also reported having Hoshimoto's disease. The people at the vaccination site thought maybe it was anxiety or a panic attack. She was nervous about receiving her second dose on 12Mar2021.
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| 46 | 2021-03-30 | insomnia |
arthritis; I lost my smell and my taste; I lost my smell and my taste; My stomach was very, very bad...
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arthritis; I lost my smell and my taste; I lost my smell and my taste; My stomach was very, very bad like diarrhea; pain like in my back, in my upper back like really bad/her lower back, like she was having a baby, it was opening in her lower back; I could not sleep that day; I felt very, very tired/I felt like I was sick; I have nausea all that; I got was like huge pain on my arm; I began to have rash all over like my left arm and my body; felt like I was sick; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) on 03Mar2021 at single dose for COVID-19 immunization. Medical history included atopic dermatitis. Concomitant medication was none. Patient used took the first dose of BNT162B2 (lot number: EL9266) on 11Feb2021 at single dose for COVID-19 immunization. patient got her second vaccine last Wednesday (03Mar2021) she was like she just have secondary effect like for one week not only it's super late and what surprised her the most it that she lost her smell and her taste, so she thought like she got the COVID, that was on the 4th day (06Mar2021) but she did 2 test, she didn't know one want to keep a track, like how they went like the first day (03Mar2021) she got the vaccine the only thing that she got was like huge pain on her arm that she did not have in her first dosage, she thought it was fine and then next day that was Thursday (04Mar2021), no she felt like she was going to die because the pain like in her back, in her upper back like really bad, she could not sleep that day, she felt like her lower back, like she was having a baby, it was opening in her lower back. She felt very, very tired like she have nausea all that, like all day long, she didn't eat anything because the nausea began in like through the night she could not sleep that night. she said one of like the things that one mention it's going to happen so affects that, then the next day that was Friday (05Mar2021) her stomach was very, very bad like diarrhea or whatever but she felt little better felt tired and then Saturday in the morning (06Mar2021), she lost the smell and the taste so that was when she thought that she really have gotten the COVID, because secondary effect it does mention that one lost smell and taste so she went to do a test and she began to have rash all over like her left arm and her body and then she did the test to the one like quickly and the other one took 2 day and both were negative then on Sunday (07Mar2021) the smell and the taste came back but she still felt pretty tired, feel a lot of rash in her left arm and in her shoulder of right part and she felt like she was sick or maybe yesterday she began to feel better but really tired, really like that one are sick, but this happen not only in today it happen like all this week, this today she began to feel better but she was like that was not because of the vaccine because she thought she got the COVID. It was also reported the first effect (event) was 12 hours lately, 03Mar2021. She thought she had arthritis she went to did her see the doctor and also the doctor like said probably 89% sure that patient don't have arthritis but she was going to do also another because she did rheumatoid test or whatever but also she put her on antibodies or whatever test, that day 2 day ago on Wednesday (10Mar2021) and then she will received those 2 test in last 2 weeks but the first one is like blood test you know. Treatment included the lady that vaccinated her told her took lots of water and Tylenol so she took Tylenol, she took 2 pills of. Outcome of very tired was not recovered. lost her smell and her taste was recovered on 07Mar2021. Outcome of arthritis was unknown, and outcome of other events was recovering.
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| 46 | 2021-03-31 | disorientation |
I woke up this morning and was disoriented, had a headache, went to get glass of water and fell down...
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I woke up this morning and was disoriented, had a headache, went to get glass of water and fell down, fainting, was unconscious for 1 minute.
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| 46 | 2021-03-31 | loss of personal independence in daily activities |
With the first dose I had a headache, muscle aches, and joint pain. But everything was back to norma...
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With the first dose I had a headache, muscle aches, and joint pain. But everything was back to normal in about 72 hrs. After receiving the second dose I had the same symptoms but the joint pain has not gone away and has actually become significantly worse over time. At this point regular over the counter pain relief is only easing the pain for short amounts of time. The muscle come and go but neither are or where common for me prior to the vaccine. The joint pain is starting to effect my daily life and at times ability to move comfortably.
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| 46 | 2021-03-31 | loss of personal independence in daily activities |
Fever 100.58, mild diahhrea, chills, nausea, pain in upper back, pain in neck, pain in shoulders, F...
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Fever 100.58, mild diahhrea, chills, nausea, pain in upper back, pain in neck, pain in shoulders, Flu-like body aches, headache. I had to leave work this morning and am in bed at home.
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| 46 | 2021-04-01 | feeling abnormal |
Beginning 6 hours after, extreme fatigue, brain fog, weakness, arm pain at injection site, loss of a...
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Beginning 6 hours after, extreme fatigue, brain fog, weakness, arm pain at injection site, loss of appetite, nausea, mild sporadic chest pains, loss of breath once. Felt all this for 24 hours. Arm pain, chest pains, loss of breath decreased after 24 hours. Brain fog, weakness, fatigue started to decrease after 48 hours. I am still having fatigue, weakness and GI issues like loss of appetite, nausea and going to the bathroom frequently. I want to hold off on my 2nd shot for several weeks.
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| 46 | 2021-04-01 | nervousness, anxiety |
Patient reported chest tightness post vaccination and then reported feeling dizzy and light-headed a...
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Patient reported chest tightness post vaccination and then reported feeling dizzy and light-headed and "shaky" all inside. Angioedema was noted by vaccinator and patient was escorted to the Emergency Department. In the ED, the patient reported chest feeling tight, difficulty swallowing, shortness of breath, and feeling itchy. ED physician noted she was feeling anxious and noted no angioedema and that oxygen saturation was 100% on room air. 50 mg of IV diphenhydramine and 1 mg IV lorazepam were administered. Patient was discharged from the emergency department with a prescription for Medrol dosepak.
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| 46 | 2021-04-02 | feeling abnormal |
Arm pain, chills, headache, vomiting, fatigue, brain fog, joint pain and aches. Chills lasted a coup...
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Arm pain, chills, headache, vomiting, fatigue, brain fog, joint pain and aches. Chills lasted a couple hours. The rest approx. 8-12 hours.
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| 46 | 2021-04-03 | disturbance in attention, feeling abnormal, memory impairment, mental impairment |
She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. S...
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She presented to the ER on 2/13 with a lot of chest pain and had some flattening of her T waves. She ended up getting a cardiac catheterization while she was there which was normal. The day prior to this she had actually received her second Covid vaccination in her left arm. She noticed achiness and soreness across her shoulders bilaterally into her chest and into her neck. She had some subjective fevers and chills and felt generally fatigued. She also had a lot of swelling in her left axilla and she ended up getting a CT scan during her workup which revealed some left axillary adenopathy. She returned to the ER on 3/16: while brushing her teeth, she developed right facial paresthesias that marched over approximately 20 minutes to involve the right arm and the right leg. She went to the hospital. She was seen in the ER. They felt this represented possible ischemia. They gave her tPA. She had a hemorrhagic nosebleed. Did not develop any other signs of bleeding. Her symptoms had not resolved. She was discharged from home. She had a headache at the time of her visit to the ER. Her headache had resolved by the time she was discharged home, but she continues to note paresthesias in the right side of her body, right face, and notes over the last day or 2, she has had increased dysarthria, dizziness and slurred speech, brain fog, a sensation of heaviness and inability to think. She states she currently does not have head pain per se, but she does note that she just feels generally poorly. She feels like her brain is working faster than her mouth muscles are. She is in today for neurologic followup, concerned about these ongoing issues. she continues to struggle with her speech feeling quite slow and deliberate, she feels like it is difficult for her to concentrate, she is forgetful, she still has intermittent episodes of paresthesias in her face, arm, and hand, she feels like she becomes heart and flushed and she has some heart rate variability with her heart going slow and fast, and she has significant disequilibrium. She is extremely fatigued where she is only able to get up for 1-2 hours before she is extremely fatigued and has to go back to bed.
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| 46 | 2021-04-04 | anxiety |
Patient had peripheral vision problems and some anxiety. The worst side effect is the severe migrai...
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Patient had peripheral vision problems and some anxiety. The worst side effect is the severe migraine headache she has had for 8 days and counting since she got the vaccine. She has a history of migraines but this one was untreatable and extended into her optic nerve. It was also on both sides of her head rather than just one (which is how it normally is). She went to the emergency room where they can usually treat it. However, this time, their treatment did not work. She said she also has a hard time finding words and is feeling more fearful when she rides her motorcycle. She does not want to ride her motorcycle right now, due to these vision problems and anxiety.
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| 46 | 2021-04-04 | feeling abnormal |
The day after the vaccination, at 10:00am, I began feeling poorly. I was fatigued, developed a feve...
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The day after the vaccination, at 10:00am, I began feeling poorly. I was fatigued, developed a fever, had chills, cough, runny nose, watery eyes, body aches, shortness of breath, headaches, loss of appetite, brain fog.. Slept 16 hours that night through the following day. Still felt bad, but could eat. Symptoms were still present but decreased in severity. Maintained a headache for four days. Arm at injection site is still hurting (tender to the touch) and swollen. Symptom free by 4/5/2021 except for arm being sore and tender. Previously had virus in July 2020. Felt like all the same symptoms including a few new ones. Did not go to doctor.
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| 46 | 2021-04-04 | sleep disorder |
On the night of 24 Feb, experienced racing heart and high blood pressure; unable to sleep. In late...
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On the night of 24 Feb, experienced racing heart and high blood pressure; unable to sleep. In late March/early April, I also experienced an early period which was heavier than usual.
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| 46 | 2021-04-05 | confusional state |
Very nauseous, dizzy, confused, the WORSE gas I have ever had in my life - sorry! Lol - on day 4 of ...
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Very nauseous, dizzy, confused, the WORSE gas I have ever had in my life - sorry! Lol - on day 4 of symptoms now
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| 46 | 2021-04-05 | feeling abnormal |
Increased muscle aches in both arms, despite receiving 1st + 2nd shots only in the same (R) arm. Dif...
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Increased muscle aches in both arms, despite receiving 1st + 2nd shots only in the same (R) arm. Difficulty lifting arms, overall body fatigue and heaviness. By 5:00pm, I had chills, enough to require a sleeping bag inside a warm home. Symptoms felt notable in that they began 5 days following my booster shot to which I had no prior adverse reaction. Symptoms disappeared within 12 hours. Following my first vaccine shot on 3/10/21 (Pfizer EN6207), I developed same-day injection-site soreness, brain fog, fatigue and a splitting headache (extremely rare) 24 hours after receiving the shot.
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| 46 | 2021-04-06 | anxiety |
Patient reported feeling dizzy, anxiety, trembling hands, and a mild headache. Patient was hypertens...
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Patient reported feeling dizzy, anxiety, trembling hands, and a mild headache. Patient was hypertensive, tachycardic, and afebrile. Blood glucose within goal.
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| 46 | 2021-04-06 | disturbance in attention |
patient fainted as lost consciousness; patient fainted as lost consciousness; patient urinated in he...
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patient fainted as lost consciousness; patient fainted as lost consciousness; patient urinated in her pants; Felt dizzy after 12 hours; patient had problems with concentrating; massive headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:30 (lot number: 1; pending clarification) at the age of 46 years old, as single dose for covid-19 immunization. Medical history included allergy to metals (titanium metal). Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 09Mar2021 21:00, the patient experienced massive headache. After 12 hours (09Mar2021 21:30), the patient felt dizzy. On 10Mar2021, around 10 am, the patient fainted as lost consciousness, urinated in her pants and had problems with concentrating. No treatment was given for the adverse events. Since vaccination, the patient has not been tested for COVID-19. The patient was recovering from all the events.
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| 46 | 2021-04-06 | feeling abnormal |
Day 0 of shot (4/5): mild headache, began ~6 hour post shot, continued into Day 1 of shot, tapering ...
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Day 0 of shot (4/5): mild headache, began ~6 hour post shot, continued into Day 1 of shot, tapering off on Day 2 Day 1 of shot (4/6): mild fatigue, brain "fog" - tapering off by ~6:00pm
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| 46 | 2021-04-07 | confusional state, insomnia |
8-9 hours after second vaccination started to experience extreme abdominal pain. Could not sleep be...
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8-9 hours after second vaccination started to experience extreme abdominal pain. Could not sleep because of pain. Was awake for nearly 30 hours because abdominal pain was so extreme. Began to vomit approximately 10 hours after second vaccine. Very frequent within first 24 hours, then developed vomiting and diarrhea at same time. Had fever, confusion and fatigue in days following. Woke up every night since vaccine (excluding first night of zero sleep) covered in sweat, feels like skin is on fire at times. Today day five, still exhausted but seems to be improving.
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| 46 | 2021-04-07 | hallucination |
Patient complains of hallucinations a few times throughout the day on the day after receiving vaccin...
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Patient complains of hallucinations a few times throughout the day on the day after receiving vaccine. On the evening she received the vaccine, she experienced arm and shoulder pain and severe headache/pain above the eyes.
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| 46 | 2021-04-07 | excessive sleepiness, feeling abnormal |
pt states that she wasnt feeling like herself and having heart palpitations. The next day she felt ...
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pt states that she wasnt feeling like herself and having heart palpitations. The next day she felt fine. 4/2/2021 she was very tired and slept 10 hours and 56 minutes which is very unusual for her. 4/5/2021 she was having trouble swallowing and is still feeling tired so slept 14 hours and 55 minutes. Every day she is sleeping more than usual and is very fatigued. Pt is waiting on a CB from her Psychiatrist and PCP and or go to UC .
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| 46 | 2021-04-07 | excessive sleepiness |
The fast after I received my dose, the symptoms began with slight nausea, then I got chills. Starte...
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The fast after I received my dose, the symptoms began with slight nausea, then I got chills. Started aching in joints and was exhausted. Slept on-and-off the whole day, fever got up to 102.5. Took tylenol that night. Woke up achy, was still exhausted, slept almost all day. Third day only minor aches, tired but able to function a few hours at a time.
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| 46 | 2021-04-07 | nervousness |
Pt received the COVID vaccine {Pfizer, lot # EN6202 and exp date 06/30/2021 at (1319)}. EMT observed...
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Pt received the COVID vaccine {Pfizer, lot # EN6202 and exp date 06/30/2021 at (1319)}. EMT observed patient return to observation area after completing required 15 minute observation period. EMT and RN co-lead responded when patient stated she felt, "shakey, flushed", had a "knot in her stomach", and her, "throat felt tight". Patient's vitals were immediately taken and had a BP of 138/82 with a HR of 106 bpm. As patient was still able to converse with staff, patient was given 50mg of PO Benadryl and was placed in the zero-gravity chair at 14:03. At 14:09 the patient's BP was 138/82 and was visibly less flushed. Then at 14:16 the patient's HR was 89 bpm and her BP was 126/72 at 14:30. Patient verbalized feeling safe, was alert and oriented x3 and left with her husband who drove the couple home from the facility at 14:34. Throughout encounter patient was offered EMS several times and patient continually declined EMS services as her husband was, "on his way".
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| 46 | 2021-04-07 | sleep disorder |
First shot (administered on 5 Mar 21, Pfizer Lot# EN6198) only had injection site tenderness (appear...
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First shot (administered on 5 Mar 21, Pfizer Lot# EN6198) only had injection site tenderness (appeared next day) and arm pain which lasted for 2 days. Second shot reaction, in order of symptom appearance; Injection site pain - within minutes of the injection Arm pain when lifting above shoulder level - within approx. 2 hours Exhaustion - started approx. 3pm Headache - started approx. 5pm and varied in intensity throughout symptoms. Chills (to the degree that a warm bath was required to heat extremities) - started approx. 7:30pm, interfered with sleep before soaking in hot water at approx. midnight. Diminished after soaking although chills did alternate with being overheated throughout the night. Mild joint pain - started approx. 7:30pm. Was worse in fingers/wrist and ankles where there are pre-existing joint issues. Nausea - started approx. 11pm. Did not advance to vomiting. Fever - temperature was elevated, 99.5F, around 12:45am and increased to 101.9F at 0345, at which point Tylenol was taken. Temperature bounced around between 99.0 and 100.5 until the morning of the 28th. Other symptoms decreased (except fatigue) and were pretty much gone by approx. 5pm on 27 Mar 21.
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| 46 | 2021-04-08 | feeling abnormal |
Pt c/o difficulty swallowing, tongue tingling, and feeling "fuzzy overall" 25 min post vaccination. ...
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Pt c/o difficulty swallowing, tongue tingling, and feeling "fuzzy overall" 25 min post vaccination. EMS called. Transferred to local hospital.
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| 46 | 2021-04-08 | insomnia |
Approximately 12 hours after receiving the shot I had intense muscle/bone/ body pain, leading to ins...
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Approximately 12 hours after receiving the shot I had intense muscle/bone/ body pain, leading to insomnia. Headache, chills, fever. Fever ~100 to 101 Approximately 18 hours after the shot I had intense muscle/bone/ body pain, headache, chills alternating with intense sweating, nausea. The intense body pain shifted around, but was largely concentrated in my sacrum area where I have a bulging disk. Fever ~101 Approximately 24 hours after receiving the shot I experienced headaches, muscle/bone/body intense pain, chills, nausea Approximately 30 hours after the shot I had all the above symptoms and I vomited. Approximately 36 hours after I had above symptoms and I had intense pain in my abdomen (liver, gallbladder, pancreas) and lower back- specifically right side, by my kidney area. Approximately 48 hours after the shot my fever was back to 99-100 and I felt much better. Still have headache, but intense muscle/ bone/body pain is much less. Nausea is still there, but slight.
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| 46 | 2021-04-09 | hallucination | Dizzy, Pain in joints, smell changed, taste, headache, pain in eyebrow, hallucinations, flushed |
| 46 | 2021-04-10 | excessive sleepiness |
Initial reaction to the second dose was as expected - within first 24 hours, minor fever of 100 and ...
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Initial reaction to the second dose was as expected - within first 24 hours, minor fever of 100 and fatigue. That resolved within 48 hours. I felt completely fine until 8 days after the second dose (4/9/2021) woke up extremely dizzy upon getting out of bed. Dizziness and mild nausea continued for 24 hours. Dizziness was positional, became dizzy upon standing up, leaning head back, leaning head over and back up. The following day, 4/10/2021, dizziness was gone but I experienced extreme fatigue, slept 9 hours at night, had two 1+ hour naps, and then slept another 9 hours that night. Day 10 woke up feeling 100% fine today and have been fine all day, 4/11/2021.
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| 46 | 2021-04-10 | sleep disorder |
Woke up at 2:30 am the morning after the shot. My hands and arms were tingling and my legs were numb...
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Woke up at 2:30 am the morning after the shot. My hands and arms were tingling and my legs were numb. It resolved but recurred at 3:30 am today 4/11/21. I awoke with stomach pain., leg numbness and tingling in my arms and hands.
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| 46 | 2021-04-10 | sleep disorder |
7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the nig...
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7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the night, it wouldn?t go away,, with pins and needles itching all day. Then again the following night (last night) my feet burned all night. In hindsight, I had had a very bad reaction after the second shot on 4/2 that started the night of the shot, when I woke up at 3 am feeling like my feet, legs and entire body was burning, then Saturday I had a high fever all day, 103.8, chills, burning sensation on and off, chest pain, heart pain, which I treated first with Tylenol then Motrin. It was a horrible two nights, but by Sunday 4/4 I was fine. I have been fatigued all week but didn?t think much about it. Then Friday night into Saturday of exactly a week after the second shot, this has happened. The burning sensation on my feet is intolerable and I haven?t slept for two nights.
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| 46 | 2021-04-12 | feeling abnormal | Ongoing headache, neck stiffness, brain fog since 2nd shot. |
| 46 | 2021-04-12 | feeling abnormal |
Started to feel badly (headache, slight fever, typical side effects) around 10-11pm Thursday... Was ...
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Started to feel badly (headache, slight fever, typical side effects) around 10-11pm Thursday... Was very thirsty so got out of bed to go the bathroom and get more water around 3am. On the way back, fainted. Not sure how long was out, but came to and was able to get up and back to bed after lying on the floor for ~10 minutes. The rest of Friday, just felt feverish, headachy and fatigued.
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| 46 | 2021-04-12 | impaired work ability |
HEADACHE, NAUSEA, CHILLS, HOT FLASHES, FEVER, LOSS OF APETITE, BODY ACHES TOOK ADVIL EVERY 12 HOURS ...
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HEADACHE, NAUSEA, CHILLS, HOT FLASHES, FEVER, LOSS OF APETITE, BODY ACHES TOOK ADVIL EVERY 12 HOURS CALLED OFF WORK DUE TO ILLNESS ON MONDAY 4/13/2021, RETURNED TO WORK 4/13/2021
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| 46 | 2021-04-12 | nightmare |
DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at...
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DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at ER
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| 46 | 2021-04-12 | sleep disorder |
15 min later, lasting 2 days - light headed out of body and loss of hunger 4hrs later, lasting 4 day...
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15 min later, lasting 2 days - light headed out of body and loss of hunger 4hrs later, lasting 4 days - severe arm, shoulder, neck, jaw, pain with inability or lift arm or use fingers due to pain. Ice and rest did nothing. Sleepless and considered going hospital, except that I could not drive and had no support. day 2-day4, all over exhaustion. was unable to sleep due to arm, neck and face pain,
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| 46 | 2021-04-13 | feeling abnormal |
Patient c/o "feeling funny" following vaccination of 2nd dose of the Pfizer-BioNTech HX. HTN-L/S cle...
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Patient c/o "feeling funny" following vaccination of 2nd dose of the Pfizer-BioNTech HX. HTN-L/S clear-bilat 0 wheezing Patient being evaluated by EMS. Vitals assessed Recommend transport. Patient refused
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| 46 | 2021-04-14 | sleep disorder |
Within 2 days experienced increased intensity of neuropathy from 1-2/10 to 8/10 at times awakening f...
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Within 2 days experienced increased intensity of neuropathy from 1-2/10 to 8/10 at times awakening from sleep and limiting her ability to run (triathlete). Constant, daily pins/needles with regions of electrical impulses in lower legs
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| 46 | 2021-04-15 | anxiety | APPREHENSION AND CHOKING SENSATION |
| 46 | 2021-04-15 | anxiety | Anxiety |
| 46 | 2021-04-15 | sleep disorder, feeling abnormal |
Around 2am Wednesday (34 to 36hrs after injection) I was aroused to a semi conscious state by sever...
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Around 2am Wednesday (34 to 36hrs after injection) I was aroused to a semi conscious state by sever trembling from chills where I could all so feel extremes heat coming from different areas on my body. I recall it felt as though someone was putting a hot compress on my leg, but the sensation would jump around. I had a sever headache localized in the center front. The following morning I had taken Tylenol for the headache and to reduce my fever, but I could not get my down to below 101.0(F) even with continues doses. Exhaustion, and mind fog all day.
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| 46 | 2021-04-16 | insomnia | Sleeplessness, headache, whole body muscle pain, pain in right temple, fever, tinnitus. |
| 46 | 2021-04-16 | loss of personal independence in daily activities |
Within minutes of the injection in my left upper arm, I noticed my fingers on my left hand were not ...
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Within minutes of the injection in my left upper arm, I noticed my fingers on my left hand were not functioning fully, kind of like trying to use your fingers after your hand has fallen asleep and is almost "awake" but not quite. About an hour later, I started noticing it hurt my arm socket to move my arm certain ways. Over the remainder of the night, it became increasingly worse, causing a sharp pain in the socket when I would move my arm at all, to the point where it was excruciating to try to undress for bed. At times, there was also a numbness or tingling that would go down my entire arm into my fingers, similar to what you feel after hitting your funny bone really hard. I was only able to sleep lying on my back...any other position was too painful in the socket. Today, the numbness and tingling in the arm and fingers has stopped, but the socket still has sharp pain to the extent that I've been keeping my arm stable against my body as much as possible (I feel no pain if I do that).
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| 46 | 2021-04-18 | loss of personal independence in daily activities |
small allergic reaction at injection site - pink area around site nausea alleviated after taking ant...
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small allergic reaction at injection site - pink area around site nausea alleviated after taking anti- nausea med Benadryl taken Symptoms alleviated that evening next day - severe neck, hip, low back pain. Difficulty walking Pain in joints still present - more hip, low back, knees - not constant but intermittent- especially after sitting for more than 20 minutes
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| 46 | 2021-04-19 | insomnia | Nausea, fatigue, unable to sleep, arm pain, body aches, headache |
| 46 | 2021-04-20 | impaired work ability |
On 3/17/2021, I began to have a very heavy mentrual period and it was 5 days early (which never happ...
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On 3/17/2021, I began to have a very heavy mentrual period and it was 5 days early (which never happens). On 3/22/21 I had a nose bleed at work, which also never happens. I got home from work at an RN and took off my compression stocking and had bad petechiae all over my lower extremities and scattered throughout my body. I immediately went to the Emergency Room. My labs at the ER showed my platelets were 2000! Normal platelets are over 150,000. They admitted my for thrombocytopenia and I was hospitalized for 12 nights. I was given platelets, high doses of prednisone, IVIG infusions 8 times, rituximab infusion 4 times, bone marrow biopsy which was negative, and nplate injections. Since discharge, I have been seeing the hematology team 3 times a week at facility, labs 3 times a week, rituximab infusion every friday, nplate injection once a week. I have not been able to work since 3/22/21. My diagnosis is an autoimmune response called idiopathic thrombocytopenia.
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| 46 | 2021-04-21 | anxiety |
Patient stated that she was tingly in her right arm 15 minutes after administration of vaccine. This...
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Patient stated that she was tingly in her right arm 15 minutes after administration of vaccine. This progressed to itching all over. Patient was very anxious stating that this occurred with the varicella vaccine as well and that "something always happens to me." Patient reported no allergies and no difficulty breathing, dizziness, tingling of the mouth or face, or numbness. 50mg of Benadryl was administered and patient was monitored for an additional 30 minutes. Patient consumed snacks and drink and felt ok to leave at 0935. Patient was educated by RN about serious adverse reactions to monitor for and to call 911 immediately if patient experienced these.
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| 46 | 2021-04-21 | anxiety |
Patient received second dose of vaccination today. Patient sitting in monitoring area and called for...
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Patient received second dose of vaccination today. Patient sitting in monitoring area and called for nursing attention. Patient reported that she felt faint and anxious after receiving vaccine. During assessment, patient reported she had fasted for blood work this morning and only had coffee and a snack of nuts. Offered patient Gatorade and nutrition bar. Patient reported nausea and still feeling dizzy after eating. Patient requested nursing to keep an eye out for her. Patient refused to lay down and rest and initially refused Medic assessment. Patient agreed to stay in monitoring area since she was sitting alone and came alone to the vaccine site. Patient stated that she was ?just nervous? and that she felt her ?chest got tight? but non-radiating. MD consult and Medics called to assess patient for concerns.
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| 46 | 2021-04-21 | feeling abnormal, sleep disorder |
Peripheral neuropathy presenting as a mild tingling in ball of big toe on each foot initially, gradu...
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Peripheral neuropathy presenting as a mild tingling in ball of big toe on each foot initially, gradually progressing over 3 days to include bottoms of both feet and traveling up calves to knees. It gets worse at night. Also started in fingertips on hands at the same time, gradually progressing over 3 days to include palms and traveling up to elbows. On day 5 tingling and 'fuzziness' is less noticeable in arms and hands. No change in legs and feet. It does make it hard to fall asleep and wakes me up Somme nights. During the day bottoms of both feet are constantly 'fuzzy' while other areas diminish. There is also a burning ring on scalp at crown on head that follows similar pattern.
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| 46 | 2021-04-21 | feeling abnormal |
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being ...
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VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/12/21,pfizer,Lot#EL3248 2nd dose:02/02/21 Pfizer,Lot# EN5318 Diagnosed covid positive:04/19/21 Exposure:Home exposure Symptoms:Cough,loss of smell/taste,Diarrhea,sore throat,runny nose,body aches,fatigue,feeling foggy,fever(subjective)
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| 46 | 2021-04-21 | sensation of foreign body |
7 minutes after receiving my 1st dose of Pfizer, I felt slight swelling in the back of my throat beh...
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7 minutes after receiving my 1st dose of Pfizer, I felt slight swelling in the back of my throat behind my punching bag. I waited a couple minutes thinking I was having a mental reaction, but then I couldn?t swallow. I notified a nurse and was given Benadryl. A few minutes later the swelling went away and I could swallow again. I was breathing just fine during all of this. Then the swelling moved to the left side of the back of my throat and my tongue on the left began to swell. I was given Epi and sent to the emergency room for observation. I continued to have weird swelling coming and going on my left side of the throat for 90 minutes. I continued to breath just fine through all of this. Was given Benadryl, solu medrol and Pepsi?s by IV injection. Sent home with 5 days of prednisone.
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| 46 | 2021-04-21 | sleep disorder, impaired work ability |
Very sore, aching arm. So bad it woke me up the first night. Next day, all over body aches, letharg...
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Very sore, aching arm. So bad it woke me up the first night. Next day, all over body aches, lethargy, some nausea. Fever of 101. Stayed home, went to bed. Day three, left arm still aches, I'm still tired.
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| 46 | 2021-04-22 | insomnia |
First 48 hours included muscle aches and cramping that cleared up as expected. As those symptoms c...
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First 48 hours included muscle aches and cramping that cleared up as expected. As those symptoms cleared, full body rash began on the evening of April 17 and is still worsening on April 23. Raised, red, and itchy small bumps all over body (including feet, ankles, legs, thighs, stomach, back, shoulders, arms). Some bumps open and weeping. Limited sleep for four consecutive nights even with oral Benadryl. Does not show much signs of improvement on Day 6.
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| 46 | 2021-04-22 | loss of personal independence in daily activities |
Feverish and sore arm at administration site 4/7-4/9/2021. Completely resolved. On 4/11/21 noted ac...
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Feverish and sore arm at administration site 4/7-4/9/2021. Completely resolved. On 4/11/21 noted aching in knees, which progressed over the next ten days to visibly swollen elbows/knees with marked limitations in activities of daily living due to pain and stiffness in knees and elbows. On exam 4/20/21 by me she had synovitis both knees and elbows - swollen, tender joints, loss of joint space. She was put on a tapering dose of prednisone, and on 4/23/21 reports pain down to level 3 from level 8. Serum-sickness type response.
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| 46 | 2021-04-22 | loss of personal independence in daily activities |
3/23- nothing 3/23- slight leg ache for 20 minutes, fever at 100.8 with 1K MG Tylenol, sore throat, ...
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3/23- nothing 3/23- slight leg ache for 20 minutes, fever at 100.8 with 1K MG Tylenol, sore throat, hot and cold but no chills (called doctor for Zithromax) 3/24- fever lessened, arm began hurting (not at deltoid muscle where shot was administered), arm lost mobility in the afternoon (could not lift above my shoulder), sneezing, coughing, runny nose 3/25- could not type in the morning, able to type later in day, 3/28- Covid tested negative 3/29- Advised doctor's Clinical Assistant I didn't remember 3/24-3/25 too well and my arm pain was still present Month of April: Resolved: Covid type symptoms loss of arm mobility Armpit pain Shoulder blade pain Present: Breast implant pain on left side (occasional) Left hand and finger numbness All symptoms on left side of body except new back pain
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| 46 | 2021-04-22 | sleep disorder |
Felt like the vaccine was burning through my veins in both of my arms....woke up in the middle of th...
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Felt like the vaccine was burning through my veins in both of my arms....woke up in the middle of the night with it and could not get comfortable due to pain and due to burning sensation.
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| 46 | 2021-04-24 | feeling abnormal |
aches keep coming and going, on and off; massive headache; weird pulling feeling on both of her legs...
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aches keep coming and going, on and off; massive headache; weird pulling feeling on both of her legs/like a light switch; burning sensation in her nose; lips swelled up; weird feeling on the edges of her tongue; she felt off; tongue swelled up; blisters on the tip of her tongue; hasn't been feeling right; face was itchy/ skin was itchy; inner ears were itchy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 31Mar2021 at 09:30 (46-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing MTHFR (genetic thing called MTHFR. She has trouble digesting synthetic vitamins and folic acid), IVF, COVID-19 virus in Mar2020. Patient had no known or documented allergies. Concomitant medications included monascus purpureus (RED YEAST RICE) and multivitamin (unspecified). The patient previously received famotidine from an unspecified date to 2021 (stopped several weeks before). Patient reported after receiving the COVID-19 vaccine her tongue swelled up and she hasn't been feeling right since she got the vaccine. When asking caller to clarify what she meant when she reported "not feeling right" she reports she didn't feel right immediately after getting the COVID-19 vaccine. On day 1 of getting the COVID 19 vaccine, 31Mar2021, her face was itchy but her face wasn't red, she had no rash or hives; her inner ears were itchy and her skin was itchy. She got the COVID-19 vaccine at 9:30 and an hour or two later her tongue swelled up. She took diphenhydramine hydrochloride (BENADRYL). She also had blisters on the tip of her tongue. The next day, 01Apr2021, the swelling had subsided but she still had a weird feeling on the edges of her tongue. It felt weird. Her tongue was not red or swollen at that time. On 01Apr2021 she felt off. Then on day 3, 02Apr2021 she had a burning sensation in her nose and her lips swelled up. On Saturday, 03Apr2021 she went to(visit to physician office) because she had a weird pulling feeling on both of her legs. The pulling feeling on her legs was like a light switch. The feeling was going on all day 03Apr2021. Then the next day, Sunday 04Apr2021, the pulling sensation on her legs was gone but she did wake up with a massive headache. She had the headache since 04Apr2021 morning. She's been having these symptoms since she received the COVID-19 vaccine and she can't attribute the symptoms to anything else. She's also had aches throughout this whole process and the aches keep coming and going, on and off. She still feels a weird thing on her tongue but she can't see anything on her tongue. She'd be in a better place except for her headache. She never had a fever. She was expecting to have flu like symptoms after getting the COVID-19 vaccine. She didn't have any of those symptoms. When probing medical history and concomitant medications she reports she's been to an allergist and she has no documented allergies. Her doctors are aware of the symptoms she's been having since she received the COVID-19 vaccine. There is something, she does know she has a genetic thing called MTHFR. She has trouble digesting synthetic vitamins and folic acid. She knows she has this genetic thing because she went through IVF to have her children and the MTHFR came up on one of the blood panels. She can't break down certain vitamins so she has to avoid anything that has folic acid in it and she can't take vitamins with folic acid in it. She reports she took no medications on the same day that she received her COVID-19 vaccine. She reports she used to take Famotidine but stopped taking it several weeks ago. She did go to the physician's office because she got really nervous when she had the pulling sensation on her legs. The physician's office had no explanation and nothing to really report. The physician's office told her to contact the CDC. She is asking if she's had an allergic reaction and should she even consider getting the second COVID-19 vaccine. Therapeutic measures were taken as a result of the events and included diphenhydramine hydrochloride. The outcome of massive headache was not recovered; tongue swelled up was recovered on 01Apr2021; weird pulling feeling on both of her legs/like a light switch was recovered on 04Apr2021; outcome of other events was recovering. Information on the lot/batch number has been requested.
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| 46 | 2021-04-24 | nervousness, anxiety |
Chills; very nauseous; Muscle weakness; lymph node under left armpit is swollen; Headache; Diarrhea;...
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Chills; very nauseous; Muscle weakness; lymph node under left armpit is swollen; Headache; Diarrhea; left arm soreness and swelling; left arm soreness and swelling; anxious; Nervous; mass on left side of thyroid, which got bigger after the second vaccine; mass on left side of thyroid, which got bigger after the second vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left aem on 31Mar2021 14:40 (Lot Number: ER8732) as single dose for COVID-19 immunization. Medical history included Menopause from 2019 and ongoing. Concomitant medication included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) taken for Menopause from 2019 and ongoing. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient previously received the first dose of BNT162B2 (lot number: EN6199) on 10Mar2021 17:10 in left arm for COVID-19 immunization, and experienced left arm became swollen and sore, sore throat and a mass on the left side of her thyroid. The patient experienced chills, very nauseous, muscle weakness, lymph node under left armpit is swollen, headache, diarrhea, left arm soreness and swelling, anxious, nervous, mass on left side of thyroid, which got bigger after the second, all on 01Apr2021. No Emergency Room/ Physician Office visited. Clinical course: Patient stated she was 6 days out from her second dose from COVID vaccine and was still having side affects and wondered if there were any recommendations on if she could take something for this and wanted to let somebody know. Patient stated her first Pfizer COVID-19 vaccine was on 10Mar2021 at 17:10 in her left arm and on that day her left arm became swollen and sore but that only lasted about 3 days and was better on the 13Mar2021. Patient also stated that on 11Mar2021, she developed a sore throat and a mass on the left side of her thyroid, which got bigger after the second vaccine that she received on 31Mar2021. Patient stated that she has never had a mass or been diagnosed with any type of mass tumors or anything. Patient stated that on 03Apr2021 she had a CT scan with and without contrast and it came back with a mass on her left thyroid, 40x36x31mm and it was definitely deviating her trachea. Patient stated that she was going to the doctor tomorrow (07Apr2021) to try to get a biopsy of this mass. Patient initially stated it was about 6 hours after the second Pfizer COVID-19 vaccine that she received on 31Mar2021 at 14:40 in her left arm that the chills, headache, being very nauseous, muscle weakness, the lymph node in her left arm pit was swollen, anxious, nervous, diarrhea, events began. She later clarified they probably ended up starting the next day around midnight. Therefore, event start date captured as 01Apr2021. Stated this woke her up out of her sleep. Patient stated these events all came on simultaneously and they were all persisting just like when they first started. Patient stated she has taken Tylenol for the events she was experiencing. She had blood work done and a CT with and without contrast. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 46 | 2021-04-25 | feeling abnormal |
Lightheaded for 48 hours. Headache, sore arm, sore neck for two weeks. Dizziness and brain fog for...
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Lightheaded for 48 hours. Headache, sore arm, sore neck for two weeks. Dizziness and brain fog for 2 1/2 weeks.
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| 46 | 2021-04-25 | sleep disorder |
Severe radiating/pulsing pain in both knee joints. The pain woke me from sleep, and repositioning di...
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Severe radiating/pulsing pain in both knee joints. The pain woke me from sleep, and repositioning did not provide any relief. Weakness and tightness when attempting to stand/walk. Unable to stand from a seated position without using hands to pull up. Episode lasted about 5 hours, pain has gone from severe to mild as of the time of writing this.
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| 46 | 2021-04-26 | insomnia |
Woke at 3:30am shaking, kept switching from freezing to sweating, achey, fidgety, nauseous, unable t...
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Woke at 3:30am shaking, kept switching from freezing to sweating, achey, fidgety, nauseous, unable to sleep, headache, temperature over 102.
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| 46 | 2021-04-27 | loss of personal independence in daily activities |
SEVERE level 10 abdominal PAIN. totally bedridden except for crawling to bathroom. completely incapa...
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SEVERE level 10 abdominal PAIN. totally bedridden except for crawling to bathroom. completely incapacitated and unable to do any normal daily activities for 3 days now. Completely disabled. I am hoping this goes away
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| 46 | 2021-04-28 | disturbance in attention, abnormal behaviour, amnesia, confusional state, hallucination, thinking abnormal |
Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensi...
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Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensitivity to lights and sounds; inability to speak; neck stiffness; vertigo; confusion; altered personality; hallucinations; memory loss; difficulty with word retrieval; migraines; recurring headaches; loss of appetite; difficulty concentrating; clumsiness; off balance; reduced speed of thought; This is a spontaneous report from a contactable consumer, reporting for herself. A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 14:30 at a single dose for covid-19 immunisation. The patient received the bnt162b2 in the hospital. The medical history was not reported. There were no allergies. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN) taken for an unspecified indication, start and stop date were not reported. On 25Mar2021 at 16:00, the patient experienced drowsiness, sensitivity to lights and sounds, inability to speak, neck stiffness, uncharacteristic behavior/ not aware of behavior, confusion, altered personality, hallucinations, memory loss, extreme sleepiness, difficulty with word retrieval, migraines and recurring headaches, loss of appetite, difficulty concentrating, clumsiness and off balance, reduced speed of thought, and vertigo, which were serious for disability. The events required emergency room and physician office visits. Therapeutic measures were taken as a result of the events and included treatment with fluids and acetaminophen (TYLENOL). There was no covid prior to or post vaccination with bnt162b2. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 46 | 2021-04-28 | feeling abnormal | Brain fog, fatigue, headache, vertigo -- lasting more than 1 week |
| 46 | 2021-04-28 | impaired work ability |
It was the 1st dose after talking to the doctor on site and they put me in for extra observation (30...
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It was the 1st dose after talking to the doctor on site and they put me in for extra observation (30 Mins). Within 12 minutes I had an allergic reaction and I spent a good two hours plus with them and now I am on the CDC watch app. The two paramedics plus doctor said they had never seen a person have all the symptoms in one shot, till they met me. The doctor said he was amazed at how sensitive my body was to the medicine but was very impressed that I had all my medications, allergic reactions and so on digitally. I go for the 2nd/final shot on 4/29 so hopefully that one doesnt have me down for days bc I leave for the DR on 5/1. I have been home and recovering sine Thursday. I had a fever, chills, my arm went numb, then I had swelling/redness and sore to the touch, chest palpitations, my asthma kicked in with the wheezing, my blood pressure sky rocketed, my sugar jumped up to 300, fatigue, tiredness, then the itching started and diarrhea. Just a lot going on from one shot.
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| 46 | 2021-04-28 | sleep disorder |
Initial reaction was noted on 4/22 she felt tired. 4/22 high heart rate (95) and BP was elevated (1...
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Initial reaction was noted on 4/22 she felt tired. 4/22 high heart rate (95) and BP was elevated (150/70 which is high for her). 4/24 in evening, woke up with an uncomfortable feeling. Felt some chest pain. Then she felt better for a day on 4/24. Then tired again 4/25. 4/28 she developed redness in her face. She feels nausea. She feels drowsy. Has heaviness in the chest when lying down. She has trouble breathing, when she has to walk up the hill.. Body aches worse after vaccine. She cannot sleep well. She spoke to an allergist 4/23, who advised her to go to ED, she did not go. Husband called on call MD, who advised her to go to ED 4/23, she did not go. 4/28 called Covid 19 hotline, advised to go to ED.
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| 46 | 2021-04-29 | feeling abnormal |
My lymph nodes in my left armpit were engaged. It felt and looked like I had a small water balloon ...
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My lymph nodes in my left armpit were engaged. It felt and looked like I had a small water balloon in my left armpit. It was painful to lay on my side. After 7 days, the swelling is gone but putting deodorant on is still tender. in addition, my energy levels went up and down over a 7 day period. Some days getting through work was challenging, even though I was working remotely. Almost 10 days out, I don't feel 100% of where I was before the vaccine.
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| 46 | 2021-04-29 | sleep disorder |
fatigue, chills, headache worst symptom is severe heartburn which started approximately 20 hours aft...
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fatigue, chills, headache worst symptom is severe heartburn which started approximately 20 hours after receiving the 2nd dose of Pfizer vaccine and has not responded to any medication or home treatment. Extremely painful heartburn kept me up at night and I still had it when I woke up, without eating or drinking anything.
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| 46 | 2021-05-05 | insomnia, impaired work ability, feeling abnormal |
I had 2nd Pfizer vaccine in my left arm at 3pm 04/28/2021 and 1130 AM 4/29/2021 was expecting severe...
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I had 2nd Pfizer vaccine in my left arm at 3pm 04/28/2021 and 1130 AM 4/29/2021 was expecting severe cramping and gastrointestinal pains I started vomiting and continued for 36 hours. I had fever chills severe fatigue. I was throwing up bile. I couldn?t eat or really do anything for 4 days. On ?Monday May 3rd those symptoms subsided but I then experienced a bad sinus infection along w high fatigue but unable to get real sleep just rest. I also felt like my head is cloudy.
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| 46 | 2021-05-10 | feeling abnormal |
had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills;...
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had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills; fatigue/ extreme fatigue; severe hot flashes; light headed; lips began to swell; heart rate and blood pressure were up; heart rate and blood pressure were up; did not feel that she was back to her "normal" as it were before receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Apr2021 07:15 (lot number: EW0151) at age of 46 years as single dose for covid-19 immunisation. The patient medical history included known allergies: Sulfa drugs and penicillin. Concomitant medications included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) daily received within 2 weeks of vaccination. Patient had historical vaccine included the first dose of BNT162B2 (lot number: ER8733) via an unspecified route of administration, administered in right arm on 24Mar2021 07:15 at age of 46 years as single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant. It started with low grade fever, chills, fatigue and severe hot flashes, within 12 hours of the shot. Then the next day, extreme fatigue and light headed. Four days later the fatigue was still coming and going and then her lips began to swell, her heart rate and blood pressure were up and she had an allergy induced asthma attack. That was when she went to the hospital. They gave her a liquid shot Pepcid and prednisone with a bag of iv fluids. And sent in prescriptions for Benadryl, prednisone and Pepcid. Patient had taken them for a week. Patient was still suffering from some fatigue that came and went with her heart rate that appeared to be elevated. Patient did not feel that she was back to her "normal" as it were before receiving the vaccine. Adverse event start date was on 18Apr2021 10:30 AM. Adverse events resulted in emergency room/department or urgent care, hospitalization. Treatment was received. Since the vaccination, patient had not been tested for COVID-19. Outcome of events was recovered/resolved with sequel.
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| 46 | 2021-05-11 | disturbance in attention |
Instant swelling of the left lymph node ( visibly seen by witness and was compared to the size of a ...
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Instant swelling of the left lymph node ( visibly seen by witness and was compared to the size of a lemon) and swelling of right (minimal) closing throat, inability to swallow and challenge to breathe, tingling in hands, 90% loss of muscle strength in legs, heart palpitations (over 90 bpm - avg. 62), loss of concentration and low Co2, and flushed/redness in skin on neck, face, hands, back. I had many witnesses and 2 called 911 thinking it was anaphylactic shock with continuous throat swelling. Paramedic said that it did not appear to be an allergic reaction but could clearly see my lymph nodes swelling. Provided oxygen, Benadryl, IV and blood tests. No infection was found and no food allergy in past. I could not move my legs for a couple of hours but eventually had swelling, muscle strength decrease and return back to normal by the end of the evening. My first dose had no symptoms. However, I placed my hormone patch on the same arm of the second vaccine that week (*note -have used for over a year with no adverse reactions). Possibility of lymph node overdrive or anaphylactic shock with the combo? Should be looked into. Very serious, life threatening event.
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| 46 | 2021-05-12 | insomnia |
SEVERE HEADACHE TO THIS DAY, DIARHHEA AND NAUSEA FOR 4 DAYS, 103+ FEVER FOR 4 DAYS, ENTIRE LEFT SIDE...
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SEVERE HEADACHE TO THIS DAY, DIARHHEA AND NAUSEA FOR 4 DAYS, 103+ FEVER FOR 4 DAYS, ENTIRE LEFT SIDE OF BODY FELT LIKE I WAS HIT BY A TRUCK, LEFT ARM SEVERELY SORE AND DISCOLORED, LASK OF APPETITE, SLEEPLESSNESS, WEIGHT LOSS.
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| 46 | 2021-05-14 | insomnia, disturbance in attention |
states she cant sleep; cant concentrate; tinnitus, ringing of ears; Ear fullness; Tingling in right ...
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states she cant sleep; cant concentrate; tinnitus, ringing of ears; Ear fullness; Tingling in right side of face, around eye and cheeks and everything; This is a spontaneous report from /Medical Information received from a contactable nurse reporting for herself A 46 year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206) on 21Mar2021 at single dose via an unspecified route of administration on right deltoid for COVID-19 immunization. Relevant medical history included ongoing autoimmune disease from 2016 (diagnosed about 5 years ago). Concomitant medications were not reported. On 21Mar2021 the patient experienced Tingling in right side of face, around eye and cheeks and everything, started little bit the day of vaccination and then just kept going and got gradually a little bit worse. The events was considered as medically significant. On 23Mar2021 the patient started complaining ear fullness, started to get full like feeling in ear, like plugged under water kind of thing described as ongoing as improved slightly but it comes and goes (as such). The event was considered medically significant. On 27Mar2021 the patient also started experiencing tinnitus, clogged/plugged ears and ringing in the ears. The event was considered medically significant. This was not going away, she also mentioned can' t sleep and can' t concentrate. Patient also informed that she is part of a huge online Support group (1500-2000) for people who have developed tinnitus after covid vaccination with either of Pfizer, Moderna or Jansen and Jansen Covid vaccine. Patient declined to provide information on the persons other people who were experiencing the same symptoms, hopefully, those persons call Pfizer on their own. She also informed that was not be getting her second dose (as such). The patient recovered from 'Tingling in right side of face, around eye and cheeks and everything' on an unspecified date in Mar2021, was recovering from ear fullness, while have not yet recovered from tinnitus, ringing of ears. At the time of the reporting outcome of other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event "tingling in right side of face" with BNT162b2 can not be fully excluded. The association between the events "ear fullness" and "tinnitus" with BNT162b2 can not be fully excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-05-18 | confusional state, nervousness, feeling abnormal |
anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations...
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anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations; her feet turned like a reddish color; fatigued; chills; felt out of sorts for a couple of days; her throat was a little sore; not feeling well; chest was just hurting; slight nausea; caller kept moving her arm in a circular motion to keep it from getting stiff; numbing tingling in my foot; numbing tingling in my foot; lost my voice; i was in bed for 1 week and 3 days; scary; a warm sensation in her stomach; felt out of sorts; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0170, first dose) solution for injection intramuscular in the left arm on 29Apr2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. Medical history included fibroids (had to have 3 blood transfusions for this), severe allergy to fish and tomato, and chronic anemia (diagnosed with this after she had her children). Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for very bad allergies. Family history included chronic anemia and Hashimoto's disease disorder (grandmother) in 2020. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Apr2021, the patient experienced anaphylactic reaction, heart palpitations, stomach burning, warm sensations, her feet turned like a reddish color, fatigued, chills, felt out of sorts for a couple of days, her throat was a little sore, not feeling well, chest was just hurting, slight nausea, kept moving her arm in a circular motion to keep it from getting stiff, numbing tingling in my foot, lost my voice, felt like I was dying, was in bed for 1 week and 3 days, scary, a warm sensation in her stomach, and felt out of sorts. The events did not require a visit to Emergency room or Physician's office. Unspecified treatment was provided for the event nausea. The outcome of the events heart palpitations, stomach burning, feet turned like a reddish color, throat was a little sore was recovered in 2021. The outcome of the events fatigued, chills, nausea was recovering. The outcome of the event warm sensation in her stomach was recovered on 29Apr2021. The outcome of the other events was unknown. No follow-up attempts are needed. No further information expected.
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| 46 | 2021-05-19 | insomnia |
No sleep for two weeks straight; hostile; Angry; could not turn off her brain; whispering to herself...
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No sleep for two weeks straight; hostile; Angry; could not turn off her brain; whispering to herself all day/all night; monkey chatter in head; had a flushed face; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 25Feb2021 (Batch/Lot Number: EL 9264) as 2nd dose, single for covid-19 immunisation. Medical history included Pervasive Developmental Delay (on the autism spectrum), penicillin allergy, shellfish allergy from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported and multivitamins. The patient previously took ceftin and ceclor and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 46-years-old on 04Feb2021 (lot number EL 3302) administered in left arm for covid-19 immunisation and no adverse effect was experienced. It was reported that after Pfizer vaccine #2, the patient immediately had a flushed face on 25Feb2021 which disappeared by the next day. The following week on 04Mar2021, the patient was hostile/angry/and could not turn off her brain; she was whispering to herself all day/all night called it "monkey chatter" in her head. There was no sleep for two weeks straight. The reporter called their gynecologist for bloodwork, thinking it could be hormonal, perimenopause; it was not. They called the psychiatrist and counselor for guidance and was recommended Seroquel, to stop the chatter in her head, and to help her sleep. They visited their family physician, who prescribed the medication, 25 mg for bedtime. The patient is finally becoming more like herself, pleasant, no whispering to herself, no monkey chatter in her head, and able to sleep at night with the support of the Seroquel. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. The patient recovered from flushed face on 26Feb2021, and was recovering from the other events.
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| 46 | 2021-05-25 | anxiety |
Post vaccination pt reported pain in epigastric region related to anxiety and difficulty breathing. ...
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Post vaccination pt reported pain in epigastric region related to anxiety and difficulty breathing. Pt transferred to med obs via hospital bed. Pt was given apple juice and water to drink while resting. Pt required a translator. Pt released at 1700. Vitals as follows: 1644 LYING BP 141/80 HR 107 SPO2 99 1656 LYING BP 123/82 HR 101 SPO2 97 1659 SEATED BP 148/81 HR 105 SPO2 96
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| 46 | 2021-05-25 | excessive sleepiness |
An hour after injection of Covid 19 vaccine Pfizer I was extremely nauseas and lethargic for 12 days...
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An hour after injection of Covid 19 vaccine Pfizer I was extremely nauseas and lethargic for 12 days. Second day after vaccine I could not keep food down and had chills, no fever. Symptoms for strong for entire week and second week slowly improved. I was unable to eat regularly and had to take frequent naps and slept more then usual. Weight loss and weakness.
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| 46 | 2021-05-26 | crying |
Client indicated she received her vaccine wihout incident at 1330. She sat in observation for 15 min...
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Client indicated she received her vaccine wihout incident at 1330. She sat in observation for 15 mins and denies having experienced any side effects. Client reported as she walked to her car, she began to experience vertigo, nausea and tingling. She sat under the tent near the observation area. MD and EMS paged. MD assessed client and recommended client remain in observation until she felt better. Client requested her adult daughter's presence as she waited. Client was observed to be crying during her assessment with MD. Client remained for continued observation. Client exited observation with her adult daughter by her side in stable condition at 1416, denied any side effects at time of departure.
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| 46 | 2021-05-28 | anxiety |
pt experienced dizziness and headaches while on the waiting area, became anxious and breathing shal...
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pt experienced dizziness and headaches while on the waiting area, became anxious and breathing shallow had some episode of nauseas, no vomiting, VS were stable, had BS; 175 HR; 78 BP:145/76 observed and hydrated on the medical tent for about 30 mins, EMS at site, patient stable.
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| 46 | 2021-05-28 | fear |
Within a few hours of receiving the shot, I experienced very very weak legs. I felt I could hardly w...
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Within a few hours of receiving the shot, I experienced very very weak legs. I felt I could hardly walk or support myself whenever my feet would touch the ground. I would manage to walk, but with difficulty and a lack of coordination. It was one of the most petrifying experiences in my life! I hope it was temporary, but after a week I visited my doctor and she claimed she had not heard of this effect yet. She did some blood work and requested an ultrasound on my legs. My blood work was all good except for a mildly elevated d-dimer. I didn't have a chance to do the ultra sound yet as I had an urgent trip to attend to. My leg weakness and heaviness cannot be described as pain. It is primarily weakness, heaviness, and discomfort. I feel that I have some sort of neurological disorder after the shot, but I don't really know for sure. The problem, is that I am still facing these issues even a month later! It's less than before and I am not as terrified as I was initially, but I feel there is some sort of permanent damage that has happened. I have opted not to go for the second vaccine under any condition. I actually wish I would have taken my chances with covid as my health and lifestyle are definitely compromised as a result of this vaccine. Some answers and remedies would be really appreciated please!
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| 46 | 2021-05-28 | feeling abnormal |
I had a traveling itch right after injection, frequent, moving every 1 to 2 minutes it would move th...
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I had a traveling itch right after injection, frequent, moving every 1 to 2 minutes it would move through my body. I started to felt like swelling in my face and arms and body started getting red and my face got puffy. Within five hours I started to feel chills, body aches, feverish, and diarrhea. I had horrible brain fog, couldn't remember passwords. I had under arm swelling and pain in my lymph nodes, extreme fatigue.
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| 46 | 2021-05-28 | feeling drunk, feeling abnormal |
Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Within 40 minutes o...
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Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Vision blurred; Body grew heavy feeling; Cclumsiness of movement; This is a spontaneous report received from a contactable Other Health Care Professional. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number; EL9262 and Expiration Date was not reported) via an unspeci-fied route of administration in Arm Left on 21Jan2021 15:00, as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, diverticulum, asthma all from an unknown date and unknown if ongoing. Concomitant medication(s) included liothyronine sodium (CYTO-MEL); levothyroxine sodium (SYNTHROID); ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN LO) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers, vision blurred, body grew heavy feeling, clumsiness of movement. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date. Follow-up attempts are completed. No further information is expected.
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| 46 | 2021-06-01 | anxiety |
Felt dizzy immediately post vaccination (same thing happened after the first dose) Patient stated sh...
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Felt dizzy immediately post vaccination (same thing happened after the first dose) Patient stated she felt anxious about vaccine, felt dizzy and wanted blood pressure checked. Patient was given water, symptoms resolved within several minutes Discharged to home with son
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| 46 | 2021-06-01 | confusional state, feeling drunk, impaired work ability |
So immediately after the vaccine I felt like I was intoxicated. My head did not feel right. Withi...
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So immediately after the vaccine I felt like I was intoxicated. My head did not feel right. Within 6 hours of the vaccine all I wanted to do was sleep. I felt very sick, very fatigue and very weak. I was like that for 11 days. I went to my PCP 11 days after, he tested me for the Epstein Barr virus, and he did bloodwork. The results came back, and that the Epstein Barr virus was activated and my B12 was high elevated. The B12 was in the 1200 range. I went back to Dr. on February 10th. He gave me a steroid shot and B12 shot. I still felt fatigue and weak. I only work 5 days, 3-week frame. On February 17th, I saw another Dr. for headaches and tremors. I was extremely sick. On February 19th, I went to the ER. I went due to having left facial and upper body weakness and numbness. I was also very confused and was having tremors. They thought I was having a stroke. They did a CAT scan that did not show anything, so I had an MRI. I did a follow-up with my neurologist on the 29th of March. My lupus doctor also checked on me every other day. The last time I had any symptoms was the beginning of April.
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| 46 | 2021-06-01 | confusional state |
developed fever 102.6F, severe dizziness, nausea, tightness in chest, confusion, increased headache....
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developed fever 102.6F, severe dizziness, nausea, tightness in chest, confusion, increased headache. Large swollen redness at site injection.
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| 46 | 2021-06-01 | loss of personal independence in daily activities |
48 hrs after receiving the 2nd dose, the patient had nausea and vomiting. Could barely function, fat...
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48 hrs after receiving the 2nd dose, the patient had nausea and vomiting. Could barely function, fatigue/bodyaches. Currently, 4 weeks after receiving 2nd dose, the patient has achy hands esp. the left hand- their hands turn black and blue sometimes, not swollen. Her hands hurt but she plays tennis so has been taking advil to manage the pain. Did take anti-inflammatories before receiving the vaccine. We ordered labs for the patient to check for an underlying immune disorder which is flaring up. Advised pt to keep hands warm and to not overuse them and to continue on NSAIDs as needed for pain.
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| 46 | 2021-06-01 | panic attack, feeling abnormal |
Same day as vaccine, felt adrenaline rush, heightened level of energy the rest of the afternoon and ...
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Same day as vaccine, felt adrenaline rush, heightened level of energy the rest of the afternoon and evening. Two days following vaccine, I experienced some muscle coordination issues, dropping things, neurologically felt out of balance and slightly intoxicated. Explained to friends and family that I felt weird and not right in the head. Tiredness followed through next week, followed by extreme sensitivity to loud or high pitched noise. Started having multiple "brain zaps" or "brain fades" where I temporarily felt a rush of brief black, tunnel vision space, followed by panic attack ... left ear ringing at immediate onset. 10 days post vaccine, I had 6 hour episode of intense ringing in left ear. It subsided some and I slept well, very tired the next day. Scheduled appointments with my neurologist and ENT. Episodes resulted in tiredness/fatigue.
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| 46 | 2021-06-02 | feeling abnormal |
I got the hiccups! First time was about 11 am on date of 2nd vaccination. Second time was about 5:...
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I got the hiccups! First time was about 11 am on date of 2nd vaccination. Second time was about 5:15 pm on the date of the vaccination. Third time was about noon/12:15 on the second day. Each event was short lived and not what I would call "intense"...a casual to moderate hiccupping event. I have not had the hiccups since. I normally get the hiccups about two to three times a year. Otherwise my reaction to the second vaccine was a little fatigue...and feeling a little "off". nothing to really report...but the hiccups...LOL
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| 46 | 2021-06-02 | feeling abnormal |
Patient reports nausea, throat felt "funny", thick mucus feeling in mouth and throat. Around 3:50 s...
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Patient reports nausea, throat felt "funny", thick mucus feeling in mouth and throat. Around 3:50 symptoms began to improve. Around 4:00p patient reported dizziness. After sitting with feet elevated, patient began to report improvement in symptoms.
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| 46 | 2021-06-03 | confusional state |
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons...
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Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: <5 min post dose patient noted feeling short of breath, numbness, dizzy, sweaty, shaky and then lost consiousness. I was able to catch her head so she didnt hit a hard surface. Patient was unresponsive for 10 seconds. She started to seize and her eyes rolled to the back of her head. After she regained consciousness she was moved into the pharmacy and laid down. Pt was given a cool towel and water.1st BP (112/70 & HR74), 2nd BP 15min later (110/70 & HR 84). After 45 min pt left with family member
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| 46 | 2021-06-03 | feeling abnormal |
Brain fog; headache; tired; nausea; extremely hot feeling; itchy all over; face tightness; This is a...
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Brain fog; headache; tired; nausea; extremely hot feeling; itchy all over; face tightness; This is a spontaneous report from a contactable other HCP (patient reported herself). A 46-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, PFIZER, Solution for injection) via an unspecified route of administration, administered to her left arm on 05Mar2021 02:30 PM (Lot number: EL9267) as single dose for Covid-19 immunisation. The patient's medical history included high blood pressure (BP), chronic obstructive pulmonary disease (COPD) and post-traumatic stress disorder (PTSD). Known allergies: any caine medicine. Facility type vaccine: Public Health Clinic/Veterans Administration facility. Concomitant medications included lisinopril and tramadol (other medications in two weeks). On 05Mar2021 05:30 PM, the patient experienced brain fog, headache, tired, nausea, extremely hot feeling, itchy all over and face tightness. No COVID tested prior or post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 46 | 2021-06-07 | impaired work ability |
I began a very heavy and long menstrual period after receiving my second dose of the COVID-19 vaccin...
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I began a very heavy and long menstrual period after receiving my second dose of the COVID-19 vaccination. I began bleeding 4/7/2021 and didn't stop until 3 weeks after my endometrial ablation. The ablation was completed 5/11/2021 and the bleeding didn't stop completely until 6/2/2021. I had multiple CBC tests performed during this period of time and my HGB levels plummeted from 12.6 on 4/13/2021 to 8.4 on 5/14/2021. RBC count went from 4.48 on 4/13/2021 to 3.10 on 5/14/2021. I experienced severe anemia, was incredibly weak, missed multiple days of work, and required surgery to finally stop the bleeding.
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| 47 | 2020-12-31 | feeling abnormal |
Significant fatigue 24 hours after injection. Brain fog, need to sleep. Next am felt better Left arm...
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Significant fatigue 24 hours after injection. Brain fog, need to sleep. Next am felt better Left arm discomfort for week Day 4 after vaccine- nausea, mild congestion no fever Day 6 after vaccine mild congestion and significant headache
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| 47 | 2021-01-03 | feeling abnormal |
Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breat...
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Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breathing got worse, called 911, 1 Epipen given, she started to cough and talk to us, then couldn't breathe again, couldn't talk, paramedics arrived.
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| 47 | 2021-01-03 | insomnia | Temp, diarrhea for 4 hrs, malaise, bad headache , insomnia |
| 47 | 2021-01-04 | agitation, insomnia |
12/28 - 2 hours after injection - terrible arm pain. Could not raise arm and felt like a pulled musc...
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12/28 - 2 hours after injection - terrible arm pain. Could not raise arm and felt like a pulled muscle from my neck all the way down arm. This went on for 4 days. The pain woke me up at night for 2 nights. Just took Ibuprofen. This pain has resolved. 12/29 - body aches, chills, joint pain, fatigue, SOB on exertion, runny nose, and sneezing. These symptoms went on for 5 days. Mostly resolved - still some fatigue and SOB on exertion, runny nose, and sneezing. Again, treated with ibuprofen and rest. 1/31 - Extreme nausea, aggitatation, and fatigue. Took Zofran and went to bed at 7pm and slept until 9am. Felt much better. 1/2 - Completed a virtual visit. Advised to come in to clinic for covid test only. Not seen by physician. Negative results, and no F/U from a provider. 1/5 - All symptoms resolved except some fatigue and SOB on exertion, runny nose, and sneezing.
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| 47 | 2021-01-04 | feeling abnormal |
All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My ...
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All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My left arm started swelling, it started in fore arm and it started getting marks on it; pain in arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in her right arm on 21Dec2020 at single dose for covid-19 immunization. Medical history included Blood pressure high, Attention deficit hyperactivity disorder (ADD), depression and cancer four years ago and she didn't have any left node in left arm. Concomitant medications included losartan (LOSARTAN) for Blood pressure high, venlafaxine hydrochloride (EFFEXOR) as antidepressant, tamoxifen (TAMOXIFEN) for her cancer and it was hormone blocker, lisdexamfetamine mesilate (VYVANSE) for ADD. The patient received the vaccine last this last Monday on 21Dec2020, in her right arm, she was fine, on Thursday on 24Dec2020 like all of sudden she started feeling bad, she mean it just hit her. She had fever, she was very nauseous and her arm, her left arm started swelling, it started in forearm and it started getting marks on it. Anyway she went go and got tested for Covid yesterday 26Dec2020 because in middle of night, that night I felt so bad. She have got just headache on 24Dec2020, its most of that before then. Anyways she had just got her results back that was negative but so she didn't know that her arm, it was the opposite arm. The patient still experiencing pain in arm, she haven't had fever in last night and she haven't checked it today. She took Tylenol and she called her doctor yesterday and they made of me some antibiotics for her arms, probably the 7mg and the patient guess it is every 8 hours. The outcome of the event pain in arm was not recovered and the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-06 | impaired work ability |
Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative: left work a...
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Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative: left work at noon on 12/31/20
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| 47 | 2021-01-07 | excessive sleepiness |
excessive sleeping; Extreme fatigue; temp 100; sore throat; loss of balance; Muscle weakness; This i...
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excessive sleeping; Extreme fatigue; temp 100; sore throat; loss of balance; Muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration in the left arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. The patient's medical history included COVID-diagnosis from Mar2020 that resulted in blood clots and pneumonia both on 2020, and allergies to shellfish, eggs, peanuts. The patient was not pregnant. Concomitant medications included acyclovir [aciclovir], levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS), escitalopram oxalate (LEXAPRO), and bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Dec2020 06:00, the patient experienced extreme fatigue, temperature of 100, sore throat, loss of balance, muscle weakness, and excessive sleeping. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent other lab tests and procedures which included COVID test nasal swab was negative on 28Dec2020. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
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| 47 | 2021-01-07 | impaired work ability |
After 15 mins I felt like I couldn't breath. On the way home hour later hard to breath. I went to ER...
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After 15 mins I felt like I couldn't breath. On the way home hour later hard to breath. I went to ER gave me Steroids and Pepcid. Since then I have taken Benadryl. On 12/30 at 10am I was exp reaction again went back to the ER. They provided me with breathing treatment and was sent home on Prednisone. I contacted my PCP to inform her that I have to continue taking Benadryl to help with sob and my voice changes. It seems like my lungs are affected due to taking the vaccine. I'm currently off and not able to receive comp due to the vaccine being voluntary.
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| 47 | 2021-01-07 | sensation of foreign body |
Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside m...
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Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat. Then I began to have difficulty swallowing my saliva. And then the lump inside my throat started to feel larger and larger. By this time Dr had already injected me with Epipen and the pharmacist injected me with Solumedrol and I still felt as if I was having difficulty breathing and then I was taken to ER and I really can't remember too much after that. I was very groggy and then I was discharged from ED about 9:30 pm.
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| 47 | 2021-01-08 | feeling abnormal |
About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did...
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About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did not seem affected by the fatigue but my brain/head felt very "fuzzy". I had a hard time getting words out. Similar feeling to etoh intoxication. I was a bit off balance and dizzy. I remember shaking my head to try to clear it. I also had a very"plastic" taste in my mouth and felt nauseous. At the 48 hour mark (almost exactly) I felt better. At 60 hour mark brain/head symptoms completely resolved. Only experienced a very slight nauseated feeling.
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| 47 | 2021-01-08 | nervousness |
Arms started tingling immediately after injection but did not think it was a significant response. A...
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Arms started tingling immediately after injection but did not think it was a significant response. As I was driving home my throat began to swell, my heart was racing, my chest got red and I was very shaky - this occured appx 50 minutes post injection.
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| 47 | 2021-01-09 | feeling abnormal |
At 1700, felt malaise. .Woke up next morning on January 9th with 102 temp, 3cm lump at infection sit...
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At 1700, felt malaise. .Woke up next morning on January 9th with 102 temp, 3cm lump at infection site, body aches, chills, headache. Still feeling poorly on January 10th.
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| 47 | 2021-01-10 | feeling abnormal, sleep disorder, restlessness, insomnia |
Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of...
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Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous. Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities. Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness, "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea. Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness injection site.
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| 47 | 2021-01-10 | feeling abnormal |
3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went ...
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3 hours after receiving the vax. Got vax, went back to work and started feeling funny and then went home and had rash to stomach, thighs, tachycardia, pulse about 130, hypotensive, swelling to tongue, eyes. Called provider when she got home and took Benadryl. Provider advised Pepcid, Benadryl, steroids x6 days. She is feeling ok now.
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| 47 | 2021-01-10 | sleep disorder |
vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can o...
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vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can only say it is what I would imagine restless leg syndrome might feel like, weak and achy that disrupted sleep all night. 12/28/20 noticed enlarged lymph node on left side near clavicle tender to touch
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| 47 | 2021-01-11 | feeling abnormal |
tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole f...
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tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine. Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-11 | impaired work ability |
she had COVID symptoms; she had COVID symptoms; chills; low grade fever; muscle joint pain; muscle j...
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she had COVID symptoms; she had COVID symptoms; chills; low grade fever; muscle joint pain; muscle joint pain; exhausted with a headache/ She doesn't want to get up she is tired; exhausted with a headache/slight headache; muscle joint pain which is a stabbing pain all over her body; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, manufacturer: Pfizer), via an unspecified route of administration on 04Jan2021 14:00 at single dose for Covid-19 immunization. Medical history included ongoing childhood asthma, COVID 19 positive from 07Dec2020 to an unknown date. There were no concomitant medications. The patient felt like she had covid symptoms, chills, low grade fever, muscle joint pain, exhausted with a headache/ she doesn't want to get up she was tired, muscle joint pain, which was a stabbing pain all over her body, feeling unwell, all on 05Jan2021 05:00. The events were reported as non-serious. Caller had Sars-COV-2 infection diagnosed 07Dec2020. Received first dose of vaccine 04Jan2021 at 14:00. She was experiencing chills, low grade fever, muscle joint pain, exhausted with a headache. Asking for information on efficacy of second dose. She didn't have any side effects or anything initially. Then, 12 hours later at 5- 6 am she felt like she had COVID symptoms. She already had COVID so she known what it feels like. She was wondering how long would last. It was almost like having real COVID. She didn't have a prescribing doctor. She had COVID 07Dec2020. She was currently experiencing Chills, fever low grade, muscle joint pain which was a stabbing pain all over her body, and she was feeling unwell. She didn't want to get up she was tired. She has a slight headache. This all started at 5 am on 05Jan2021. Even with medication. She has been taking paracetamol (TYLENOL) and excedrin. She cannot work if she wanted to, but these effects are not serious. Her fever has went down. The chills have stayed the same. She was diagnosed with childhood asthma. Caller asked about interval information between the SARS-COV-2 infection diagnosed 07Dec2020 and her first dose of vaccine 04Jan2021 at 14:00. The outcome of events for felt like she had covid symptoms was unknown, for low grade fever was resolving, for other events was not resolved.; Sender's Comments: There is not a reasonable possibility that event suspected COVID-19 is related to BNT162B2. There is no test done to confirm whether patient got COVID-19 or not. And symptoms that were suspected by reporter as due to COVID-19 occurred one after the vaccination, when vaccine was not expected to achieve the effect.
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| 47 | 2021-01-12 | anxiety |
feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my ...
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feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart; Fast heartbeat; headache; blood pressure went down drastically; tachycardia; weak; looked pale; Anxiety; This is a spontaneous report from a contactable Other HCP (patient). A 47-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included patient was alergic to environmental or insect allergens. No food no medication''. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included loratadine. The patient receive other vaccines within 4 weeks prior to the COVID vaccine was immunotherapy vaccine against mold, insect, mites on 02Dec2020 on both arms. It was reported ''3mins post injection: warm feeling starting on my right arm going down to my left leg. feeling that I was going to pass out. faint. goes and come. I was feeling that I was going to pass out like 3 times , but I was in a wheelchair.. Thanks God and warm feeling from my right leg up to my heart. Fast heartbeat, and weak and sudden headache. Symptoms goes and come. it last 15 mins. Once I was brought to ER.. they estabilize my tachycardia and gave me benadryl. I did get better, but still weak. Stay 2 hours for observation. By the time I got to ER, I was a little better. Physician diagnoses as Anxiety event. because I got estabilize and never got a rash, difficulty breathing. I am 100%, my body for whatever reason it could be, did not welcome the vaccine. and blood pressure went down drastically...i looked pale as they told me.''. Adverse events start date was reported on 18Dec2020 10:03 AM. Case was non-serious. Treatment received for the adverse events included medicine for tachychardia and Benadryl. AE warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart and feeling that I was going to pass out. faint resulted in: [Emergency room/department or urgent care]. The outcome of the events ''warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart'' and ''feeling that I was going to pass out. faint'' was reported as recovered. The outcome of other events was unknown. Information about Lot/batch number has been requested.
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| 47 | 2021-01-12 | nervousness |
1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79...
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1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79, 125/78, O2 Sat 100%, placed supine position 1343: Felt shakey like low BG - got cookies, water, 80 HR, 128/88, 100% O2 1348: Felt like she wanted to sit up. 66 HR, 107/72, 100%, wave of dizziness and nausea 1349: HR 82, 123/86, 100% applied O2 8L Mask 1353: 92 HR 128/84, 100%, nauseated - coolw ash clothes applied - needed to transfer to a better chair that would lay back 1400: HR 72, 120/80, 100%, 36.7 - Felt warm but cool, wanted warm blankets - said she feels like she is sinking into the chair. HR 73, 118/78, 100% feeling better. 1409: 70 HR, 115/76, 100%, orthostatics taken. 1411: 69 HR 118/77, 100%, sat up 1414: 79 HR 123/87 99% took O2 off - felt ok. 1419 67 HR 121/83 100% standing felt okay, not dizzy.
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| 47 | 2021-01-13 | disorientation, impaired work ability, feeling abnormal |
Received 2nd dose on Friday, did not experience any issues until Monday. Began with tinnitus in lef...
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Received 2nd dose on Friday, did not experience any issues until Monday. Began with tinnitus in left ear, severe sound sensitivity, headache, then myalgia, fatigue, brain fog and disorientation, low grade fever of 99.6. Was sent home from work. Had COVID-19 testing and was negative. Worked from home the next day and still had myalgia and then had gastric issues of nausea and diarrhea, low grade fever.
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| 47 | 2021-01-13 | insomnia |
a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued a...
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a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued at 99.7 and her symptoms were 10 fold; Left arm soreness; Increased dry cough; Nasal congestion; Chills; Headache; Unable to sleep- tossing and turning; This is a spontaneous report from a contactable nurse reporting for self. This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: Apr2021) on 04Jan2021 around 10:30 AM at 0.3 mL single by injection in the left arm for COVID-19 immunisation. Medical history and concomitant medications were none. Prior to getting the vaccine patient had her temperature taken on unspecified date, which was 97.4. She had the injection in her left arm on 04Jan2021 around 10:30 AM. After she felt perfectly fine that day. She felt nothing. Then around 8 PM her side effects started. That night her left arm got sore, she had increased dry cough (reported as feels like a bronchial spasm that an asthmatic would have), nasal congestion, chills, and a headache. She went to bed unable to sleep- tossing and turning. She woke up around 2 AM or so. The next morning, 05Jan2021, she felt somewhat okay. She went to work. She had a normal temperature that morning at work. Then around 10 AM, her arm was still sore, she was not feeling quite well, she started to feel chills again, and had a fever of 99.5, along with a headache still. They sent her home. The next day, 06Jan2021, her fever continued at 99.7 and her symptoms were 10 fold. Then her fever broke around 10 AM. On 05Jan2021, she took a shower from all the sweating with her fever, and she did not notice any rash. She took another shower this morning (07Jan2021) and she noticed a weird rash on her left shoulder area. It does not itch, it is just there. She took a picture of it so she could monitor it. It is blotchy. For left arm soreness, she can now move it without feeling it, but then you touch it, it is sore and tender. The event fever broke yesterday around 10 AM. This morning (07Jan2021) her temperature was 98.6. Chills would come and go with the fever off and on. Treatment for all events included over the counter medications. Lab data included COVID test was negative on 28Dec2020 and 04Jan2021. Outcome of left arm soreness, increased dry cough, nasal congestion was recovering, outcome of chills, headache, unable to sleep- tossing and turning was recovered on 06Jan2021, fever was recovered on 06Jan2021 10 AM, outcome of rash was not recovered, outcome of other event was unknown. Relatedness of product to all events was reported as related, the reporter considered all events as non-serious.
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| 47 | 2021-01-14 | feeling abnormal |
approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to t...
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approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to take deep breath. Severe difficulty swallowing. Difficulty getting words out, then slurring of words/poor pronouncing of words. Foggy head. Poor balance.
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| 47 | 2021-01-14 | impaired work ability |
Debilitating lower back pain beginning mid-morning on the day following the vaccine administration. ...
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Debilitating lower back pain beginning mid-morning on the day following the vaccine administration. It came on quite suddenly. I left work early due to the pain. It feels like a deep twisting pain that seems to decrease strength in the back area.
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| 47 | 2021-01-14 | sensation of foreign body |
Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then i...
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Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat.; it felt like I had a lump inside my throat.; Then I began to have difficulty swallowing my saliva.; difficulty breathing; very groggy; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular in left arm on 20Dec2020 at a single dose for COVID-19 immunization. Vaccination was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included hypertension, overweight, and known allergies to bee stings and hair dye. The patient's concomitant medication included multivitamins. On 20Dec2020, within 15 minutes, the patient began feeling dry throat, then itching, then it felt like she had a lump inside her throat. Then she began to have difficulty swallowing her saliva. And then the lump inside her throat started to feel larger and larger. By this time, the doctor had already injected the patient with Epipen and the pharmacist injected her with Solumedrol and she still felt as if she was having difficulty breathing and then she was taken to ER and she really can't remember too much after that. The patient was very groggy and then was discharged from ED about 9:30 pm. The outcome of the events was recovered on an unknown date. Treatment for the events included epinephrine, methylprednisolone, diphenhydramine. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling dry throat, itching, felt like having lump inside her throat, having difficulty swallowing saliva, difficulty breathing and very groggy cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-01-14 | sleep disorder |
The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I f...
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The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I felt tired and chilled, without fever. After the third day, symptoms subsided and I was back to normal activity. On the 7th day following the vaccine, I began having pain in the armpit of the left side. It was painful to have pressure on the area and to raise the arm overhead. It progressed on the the 8th day with increased pain and tenderness to touch. On the 9th day, I had severe pain with palpation and could feel a lump in the armpit. I have no redness, heat, or rash in the area. I went to my physician with concern because I have had a double mastectomy two years ago.
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| 47 | 2021-01-14 | sleep disorder |
On the 26th I began to have itching all over my body that kept me up at night. I went back to taking...
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On the 26th I began to have itching all over my body that kept me up at night. I went back to taking Claritin and it worked I did get relief when the Claritin wore off I had more intense itching. I tool Claritin around the clock the 24 hours and it stopped after two days. It was a delayed reaction, caught me by surprise. I had no new foods, medications. I did call the after hours Dr to maybe get a steroid injection but he didn't feel it was the best choice and told me to continue the Claritin
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| 47 | 2021-01-15 | feeling abnormal, confusional state |
Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has s...
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Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has spread through shoulders and upper back; challenges in arms and legs?very little control, hard to even lift arm to eat, to type?like heavy weight pressing down on arms and shoulders, like filled with lead and extreme stiffness; still have floating feeling off and on; still have tingling in face, arms, and hands; dizziness; mental fog; headaches; heart palpitations; hands swelling--difficult to use. This has been ongoing for eleven days now. Other symptoms can be found in report made to Pfizer site: (1/12/2021 at 2:27 pm)
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| 47 | 2021-01-17 | anxiety, disorientation |
Caregiver reported onset of itchy scalp and headache approximately 7 hours after receiving dose. Sym...
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Caregiver reported onset of itchy scalp and headache approximately 7 hours after receiving dose. Symptoms progressed to disorientation, fatigue, cough, shortness of breath and anxiety.
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| 47 | 2021-01-18 | feeling abnormal |
I have slight soreness at the injection site and some fatigue, both of which I expected. However, I...
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I have slight soreness at the injection site and some fatigue, both of which I expected. However, I am also experiencing significant "brain fog". It is difficult to do my normal activities and I lose track of what I am doing. It feels like I have a cloud inside my brain. I have not gone to the doctor, but felt this should be noted.
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| 47 | 2021-01-19 | emotional distress |
Felt as though hips and elbows were dislocating- extreme pain that caused emotional upset for the da...
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Felt as though hips and elbows were dislocating- extreme pain that caused emotional upset for the day as well as pain throughout joints for several days.
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| 47 | 2021-01-19 | feeling abnormal |
Patient started feeling itchy at the injection site. Patient felt not okay, No SOB, lightheadedness,...
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Patient started feeling itchy at the injection site. Patient felt not okay, No SOB, lightheadedness, hives or numbness. Rapid Response was called and was advised extra observation time. No other intervention.
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| 47 | 2021-01-19 | loss of personal independence in daily activities |
Having severe headaches that is more severe from when I had the first dose. Currently feel heaviness...
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Having severe headaches that is more severe from when I had the first dose. Currently feel heaviness in my head that is affecting my activity performance. I am also experiencing more tiredness than in first dose that is worsening instead of getting better. I have been talking Tylenol with no relieve that I couldn?t sleep.
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| 47 | 2021-01-19 | sleep disorder |
At the time of the first injection on Dec 28th I noticed I began itching a few days later. I did no...
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At the time of the first injection on Dec 28th I noticed I began itching a few days later. I did not put the itching together with the injection due to the dry weather. As time went on I noticed the itching mainly on head and upper torso. I had pain by the injection site but lasted only 2 days and was not that bad. The itching improved over the past week but noticed after my second injection that the itching has started back full force. I wake up scratching during the night. The pain in the arm was worse this time and did interrupt my sleep. Today at work I noticed my arm being sore and increased itching and decided to check the site. I found the site to be sightly swollen, red and warm to the touch. Was advised by provider that I work with to take Benadryl which I cannot do at this time until I am off shift as it makes me drowsy.
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| 47 | 2021-01-20 | anxiety |
10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and f...
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10-20 seconds after administration of the COVID-19 vaccine (1st in series), patient became hot and flushed and experienced mild difficulty breathing. A rapid response was called, patient noted to have a swollen and red face and neck. 0.3mg IM Epinephrin given. HR 108, SpO2 98% on room air. Patient taken to the emergency department for follow-up. In the ED patient reported feeling anxious, nauseous, and having a dry mouth. Notes that she had never had a reaction to a vaccine before. Diagnosed with an allergic reaction to the COVID-19 vaccine. Benadryl, pepcid, and Solumedrol given.
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| 47 | 2021-01-20 | anxiety | POST VACCINATION- EXPERIENCED THROAT TIGHTENING, ANXIETY |
| 47 | 2021-01-20 | insomnia |
she had left arm pain as well; she is very sweaty now; had a migraine yesterday; she had achy joints...
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she had left arm pain as well; she is very sweaty now; had a migraine yesterday; she had achy joints all over yesterday; had achy joints all over yesterday, saying her neck hurt; felt sick with a runny nose; felt sick with a runny nose; the gland in her armpit (clarified as left armpit) area is swollen and very painful; the gland in her armpit (clarified as left armpit) area is swollen and very painful; hard time sleeping.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231, expiration date 30Apr2021), via an unspecified route of administration on 09Jan2021 11:50 at single dose (left arm) for COVID-19 immunization. Medical history included penicillin rash. There were no concomitant medications. The patient previously took diflucan 15 years ago and experienced extreme allergic reaction to diflucan; and amoxicillin and experienced rash. She stated she had a rash in the past to Amoxicillin and Penicillin. She received the COVID-19 vaccine on Saturday (09Jan2021), and the gland in her armpit (clarified as left armpit) area was swollen and very painful. She said she took Tylenol, and the Tylenol cut the pain. She stated she still has a little pain today. Her left armpit started feeling uncomfortable on Saturday night, and she had a hard time sleeping. She said when she woke up on Sunday morning, 10Jan2021, her left armpit area was extremely painful, clarifying she had left arm pain as well. She said the pain in her left arm has lessened today, but her left armpit area was still painful. Clarified she took a repeated 3 Tylenol 200 mg (600mg) dose over the past couple days for her left armpit pain. She took her first dose of 3 Tylenol 200mg tablets (600mg dose) at noon on Saturday, 09Jan2021, and another 3 Tylenol 200mg (600mg dose) at 5:00PM on Saturday evening and went to sleep. She said she woke up after her nap on Saturday evening, and was sweaty and had left armpit pain. She said she took another 3 Tylenol 200mg tablets (600mg dose) on Sunday, 10Jan2021, at 5:00PM. She said she took her last dose of 3 Tylenol 200mg tablets (600mg dose) this morning, 11Jan2021, at 7:00AM. On Saturday night, 09Jan2021, it was only her left armpit that was sore, but by Sunday, 10Jan2021 morning, her whole left arm was in pain and the gland in her left armpit was swollen. On 10Jan2021, the patient was very sweaty, and had a migraine. Clarified she felt sweaty now, like she just woke up from a fever. She said she was not overdressed, but maybe she was in a hot environment. She said she had no fever when she checked her temperature. She also had achy joints all over and her neck hurt on 10Jan2021. Patient reported that she had a PPD skin test administered 2 months ago and had no reaction to the PPD skin test. She felt sick with a runny nose on 10Jan2021, but she felt fine today, 11Jan2021. She said that after she received the COVID-19 vaccine, it was less than 24 hours when everything started happening. The patient had no history of all previous immunization with the Pfizer vaccine and no vaccines administered on the same date of the vaccine. The patient had no prior vaccinations within 4 weeks. Outcome of event hard time sleeping was unknown; she had left arm pain as well, had achy joints all over yesterday, saying her neck hurt, felt sick with a runny nose, was recovering; had a migraine yesterday was recovered on an unspecified date; and outcome of the rest of events was not recovered.
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| 47 | 2021-01-20 | loss of personal independence in daily activities |
Left deltoid pain severe for 9 days. Could sleep pt dress my self . Left ark in sever pain. Heat and...
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Left deltoid pain severe for 9 days. Could sleep pt dress my self . Left ark in sever pain. Heat and cold compress no relief. Went to employee health got X-ray Dr felt muscle tissue fiber damage . Rx of 600 mg of advil x3 a day still having pain
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| 47 | 2021-01-20 | loss of personal independence in daily activities |
I received the 1st dose of vaccine on 12/16/20 and on that date through 12/18/20, I had severe arm s...
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I received the 1st dose of vaccine on 12/16/20 and on that date through 12/18/20, I had severe arm soreness and body aches. On 12/20/20, I had a sore throat, headache, body aches, and nasal congestion that continued through 12/24/20. On 12/25/20, I had extreme body aches, fatigue, left arm and leg numbness and tingling, SHOB, temp of 100.6, and back pain. On 12/27/20, I went to the ER for my symptoms and to be tested for COVID-19, to which I tested positive. They also tested me for strep and flu, both were negative. I also developed intermittent and random tachycardia (HR 120-150's), palpitations, chest tightness and chest pain. I am a RN and monitored my O2 Sats and HR frequently. My symptoms finally resolved enough for me to return to work on 1/11/21.
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| 47 | 2021-01-21 | feeling abnormal | Extreme Fatigue, lethargy, arm soreness, headache, fogginess. |
| 47 | 2021-01-22 | sleep disorder |
6:00 pm onset of profound fatigue and moderate pain at the injection site 7:45 pm onset chilling/rig...
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6:00 pm onset of profound fatigue and moderate pain at the injection site 7:45 pm onset chilling/rigors lasting 90minutes, even under 5 blankets 9:15 pm fever up to 100.8, headache, bodyaches, unable to sleep 3:30 am 1/7/2021 took 800mg ibuprofen 4:00 am fever broke, went to sleep 6:30 am awoke with temp 97.4, tiredness and mild headache due to lack of sleep. Got up and went to work. -Fatigue, mild malaise, and injection site discomfort fully resolved after 72 hours with no further intervention.
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| 47 | 2021-01-24 | crying, insomnia |
right eye shut/she couldn't open the right eye, it was glued shut completely; right eye red/ right E...
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right eye shut/she couldn't open the right eye, it was glued shut completely; right eye red/ right Eye being Red; mucus from throat, clear mucus; Right eye weeping; Right eye pink; She was super congested/she couldn't breathe through the nose; barely being able to sleep; Right eye itching/Left eye itching; red and swollen eyes/right eye swollen; itchy throat/itching of the throat/scratching in the throat; runny nose, clear mucous (post nasal drip); This is a spontaneous report from a contactable Other HCP (patient). A 47-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Left arm, via an unspecified route of administration on 07Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Sinus infection, Kidney stones, pink eye when she was a kid. The patient's concomitant medications were not reported. She reports the following side effects: itchy, red and swollen eyes, itchy throat, runny nose, clear mucous (post nasal drip). The patient experienced Right eye itching, red and swollen eyes/right eye swollen, Right eye pink on 08Jan2021 with outcome recovering, right eye shut on 09Jan2021 with outcome of received on 09Jan2021, itching throat, mucus from throat, clear mucus, Right eye weeping on 08Jan2021 with outcome of recovered/resolved with sequel on 11Jan2021, Left eye itching on 08Jan2021 with outcome of recovered on 09Jan2021, runny nose, clear mucous (post nasal drip) on 08Jan2021 with outcome of recovered on 11Jan2021, right eye red/ right Eye being Red on 09Jan2021 with outcome of recovered on 09Jan2021. The patient got her First shot on Thursday morning at 7:30AM, then on Friday night 08Jan2021 at 7 in the evening her right eye was itching and weeping, it felt like something was in the eye but there wasn't. The right eye was swelling as well on Friday. On Friday the itching of the throat started. She is also having scratchiness in the throat. Her eye is scratchy also. When she woke up Saturday 09Jan2021 she couldn't open the right eye, it was glued shut completely and red. When she was a kid, in the past she has had pink eye, and there was green stuff coming out the eye but this was not like previously. She had to pull the eye lids apart, maybe this is viral. With her throat, she has had sinus infection in the past before in which she couldn't breath out of the nose, but with this she is experiencing Mucus that is clear and thin from the throat. Her left eye itching started Friday night, but it was only slight itchiness and by Saturday the left eye was normal. She is purely doing this report to help, in case other people have this happen. Early today, she did use a Neti pot and it did help a little, she has had horrible sinus infections in the past but this is not it. In the past, once you get a sinus infection you are prone to getting them, thankfully she has not had one in a few years, she would get thick crap in the sinuses, in this case her eye was draining going into her nose, therefore making her have a runny nose, and she also had scratching in the throat. She is breathing clearly through the nose. Itching in the right eye was ongoing but less intense. Right Eye Swollen: She was looking at mirror hates looking at herself but the eyelid was back to normal, however the white part of eye is still swollen. Right eye being Shut: It is open now, that was a one day occurrence. Itching in the throat: She noticed that today at noon around 1 is when she last had it, it is 5% still there where she feels something. Mucus from Throat: She used the Neti pot a couple hours ago, at about 1:30 PM. Since then she has had some drainage but it is 95% better. Her Right Eye ball is still pink looking like as if she was hung over. The Left eyeball is white. Right Eye Weeping: She left work because her right eye was weeping so much, going into her nose, and she is running at work, she has glasses, goggles, face shield, and so she cant wipe the liquid. She came home and iced her eye which helped. Right Eye Pink: On Saturday the right eye was red. Right now it is pink, like an eye lash is in the eye. The right Eye being Red was only for Saturday, like sclerosis, it was red and swollen. The left eye was swollen, but it is better now from this morning. She was super congested on Friday (08Jan2021), barely being able to sleep, she couldn't breathe through the nose. Weird, she barely slept but it wasn't a sinus infection. She couldn't sleep because of nose running and the eye running then Saturday into Sunday she was able to sleep with eye running. The runny nose got better with the neti pot. She is schedule for the 2nd dose on 28Jan2021. The outcome of other events was unknown. Information on the lot/ batch number has been requested.
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| 47 | 2021-01-24 | delirium |
Mild headache progressing to intense throbbing headache with flashes of white light, lasting for sev...
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Mild headache progressing to intense throbbing headache with flashes of white light, lasting for several hours, severe myalgias, high fever, episodes of delirium, right shoulder and right neck burning pain, chills, sweating, intense fatigue, rash on arms/stomach/back/thighs
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| 47 | 2021-01-25 | feeling abnormal |
Felt a little "weird" right after vaccine, after an hour she felt like she was suffocating. Went to...
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Felt a little "weird" right after vaccine, after an hour she felt like she was suffocating. Went to ED for SOB, felt like throat was closing. Given prednisone, benadryl. Questionable if she was given epinephrine in ED. Will follow up with allergist before second dose. HX of allergy to cats and grass. No hx of anaphylaxis.
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| 47 | 2021-01-27 | loss of personal independence in daily activities, feeling abnormal |
6 hours post vaccine, experienced fever, chills, body/muscle aches, fatigue, "brain fog" and runny n...
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6 hours post vaccine, experienced fever, chills, body/muscle aches, fatigue, "brain fog" and runny nose. Self treated with Tylenol, rest, fluids, Gatorade. Symptoms lasted 5 full days, missed work x 2 days. Fully recovered by 1/27/21.
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| 47 | 2021-01-28 | confusional state |
Woke up at 07:20 which chest tightness/pain and uncontrollable shaking. Temperature was 102 with h...
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Woke up at 07:20 which chest tightness/pain and uncontrollable shaking. Temperature was 102 with hospital grade temporal thermometer. Pulse rate of 140 and POX of 96. At 07:23 took 650mg Tylenol and 50mg oral diphenhydramine with 16 oz water. Chest tightness subsided around 10 minute mark and shaking stopped after one hour. Sleep from 10:00-16:00. Woke up with a headache and mental confusion.
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| 47 | 2021-01-28 | nervousness |
Patient is a 47 y.o. female that presents from employee health after receiving the COVID-19 vaccinat...
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Patient is a 47 y.o. female that presents from employee health after receiving the COVID-19 vaccination in her left arm. Within the 15-minute observation. She started developing a dry cough. She subsequently felt shaky, short of breath and felt a tingling in her throat. She states it feels funny when she swallows. She has noted tingling in her fingertips with associated discoloration. She has not noted any redness or swelling at the injection site. She has not developed a rash on her skin. She does have a history of COPD and uses inhalers and nebulizers. She has not tried an inhaler for the cough. She has had multiple medication allergies in the past including reactions to the Pneumovax and MMR. She denies chest pain. She has no abdominal pain. No nausea or vomiting. No leg pain. The patient presents to the emergency department after developing a cough, throat discomfort, shortness of breath and paresthesias following COVID-19 vaccination at 4 PM. She has no evidence of swelling of the lips, tongue or oropharynx on exam. She has no stridor or wheezing on exam. Her pulse oximetry readings are in the high 90s on room air. She received Benadryl, prednisone and a nebulizers treatment. She was observed in the emergency department for 2 hours and had improvement in symptoms. She was discharged in stable condition.
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| 47 | 2021-01-28 | sensation of foreign body |
Felt lumps in her throat, Tonsils closing up, started sweating, tightening of her throat, administer...
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Felt lumps in her throat, Tonsils closing up, started sweating, tightening of her throat, administered epi pen, gave oxygen, was able to converse and tell us what was going on, 911 was called and sent to the ER, spent several hours in the ER and then was sent home.
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| 47 | 2021-02-01 | feeling abnormal |
5 minutes after the shot was placed my heart rate increased to 120 and my blood pressure increased t...
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5 minutes after the shot was placed my heart rate increased to 120 and my blood pressure increased to 150/90. I felt weird, almost like I was under water. I remained under observation for 45 minutes. I was sent home and told to continue monitoring myself and to come back if I get worse.
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| 47 | 2021-02-01 | impaired work ability |
Employee reported that she had "flushing and felt very warm" for about 1 hour post Covid vaccination...
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Employee reported that she had "flushing and felt very warm" for about 1 hour post Covid vaccination at 2pm on 12/17/20. This dissipated after 1 hour. Employee then reports she "felt constipated and took some Dulcolax," and ate some food on the way home. At 1 am on 12/18, employee awoke with sore throat and began to experience intractable nausea, vomiting and diarrhea. At 5 am on 12/18, employee came to emergency department for treatment. She was given Zofran, dicyclomine and Tylenol # 3 and then discharged to home. Employee reports that nausea, vomiting, and diarrhea (with blood present), continued for several days and she was unable to work. On 12/22/20, employee still feeling ill, unable to eat with severe n/v/d. was given new prescription for Zofran as she reports she had used all of prior prescription from ER (was taking every 6-8 hrs). Employee began feeling better on 12/23/20 and returned to work. She reports she is not sure if reaction was from vaccine or not.
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| 47 | 2021-02-01 | sensation of foreign body | Nausea, dizziness upon standing, headache, feeling there was a lump in my throat |
| 47 | 2021-02-02 | disorientation, confusional state |
I was disoriented & confused the day after I got my last vaccine shot. I didn?t know how to even se...
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I was disoriented & confused the day after I got my last vaccine shot. I didn?t know how to even send a text message. I?ve had a headache since I got the last vaccine, dizzy, blurred or abstracted vision.
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| 47 | 2021-02-03 | hallucination, amnesia, feeling abnormal |
3 days after 1st dose- discharge from left nipple. 2nd dose vaccination: muscle pain and chills,...
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3 days after 1st dose- discharge from left nipple. 2nd dose vaccination: muscle pain and chills, memory loss, brain fog and (hallucinations, behaving like a 1o year old as per family)
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| 47 | 2021-02-03 | restlessness |
Immediately upon having the injection administered, my heart rate sped up. I sat down within the wai...
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Immediately upon having the injection administered, my heart rate sped up. I sat down within the waiting area for monitoring thinking that if I sat down for a bit, that it would maybe pass . Within about 7 minutes of that, I began to feel the back, left side of my throat go numb. I began to get very dizzy after that and I alerted one the pharmacy Nurses, that was on duty. She asked for me to open My mouth so that she could see if my throat was swelling & said that she didn?t see anything and I was told by her that it may just be anxiety that I was experiencing and she asked me to take a few sips of water and to try and relax a bit. She resumed helping others, while I continued to sit there. It was then when I experienced a heavy onset of chest tightness and the inability to breathe. The left side of my face and jaw went numb & that?s when I really knew something was wrong. I was taken outside for some fresh air and realize that I was so nauseous, more dizzy, very weak upon standing and I told the same nurse and another young lady that was assisting me that I felt like I was going to pass out and to please call EMS for me . At that time, I lost temporary feeling in all 4 limbs and I began to experience heart palpitations . I was having some trouble swallowing and I was laid down and. My blood pressure was taken. Blood Pressure was 235/130 and it was taken several times until emts arrived. It was then 200/120 and 180/112 by the time help arrived. Overall I experienced burning sensation in chest and abdomen, facial weakness and numbness left side fever loose stools weakness, shortness of brEath and chest tightness blurred vision felt like I?m out of touch with reality Malaise restless and the loss in feeling in my Limbs are slowly returning body And muscle and joint aches and pains and wheezing bouts
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| 47 | 2021-02-04 | agitation, restlessness |
getting jittery; tense; antsy; keyed up; blood pressure: 154/85; This is a spontaneous report from ...
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getting jittery; tense; antsy; keyed up; blood pressure: 154/85; This is a spontaneous report from a contactable pharmacist, reporting for herself. A 47-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via an unspecified route of administration on 14Jan2021 at 16:30 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included Stage IV endometriosis, AVNRT/SVT cardiac arrhythmia, survivor of clear cell renal cell carcinoma (treated 2010), allergies: Lupron (rash), environmental allergies (grasses, trees, weeds, molds, animal dander), all from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Drospirenone, ethinyl estradiol, betadex clathrate (YAZ), levonorgestrel (MIRENA), cetirizine hydrochloride (ZYRTEC), metoprolol succinate (TOPROL XL), and unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021 at 21:30, the patient starting getting jittery, tense, antsy, "keyed up". She took her blood pressure and it was 154/85. One hour later it was 148/89. Two hours later it was 158/88. The next day, on 20Jan2021 (day 6 post-vaccine), the blood pressure reading in the morning upon arising was 154/86. At 5 pm, it was 166/91. She doubled up on metoprolol succinate (TOPROL XL) dose, which didn't seem to alter the blood pressure at all, based on the home monitor readings. On day 7 post-vaccine (21Jan2021) it is as if the preceding day with the elevated blood pressure never happened; she felt perfectly fine and normal. Day 7 post vaccine, blood pressure resumed normal levels (115-120/70-80). The patient did not receive treatment for the events. The clinical outcome of getting jittery, tense, antsy, "keyed up", and blood pressure: 154/85 was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 47 | 2021-02-08 | insomnia, impaired work ability |
Light headed. Heart palpitations. Faint. Headaches. Weakness. Dizzy. Since vaccine. Been seen by u...
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Light headed. Heart palpitations. Faint. Headaches. Weakness. Dizzy. Since vaccine. Been seen by urgent care and doctors. Wearing heart halter monitor. Symptoms have not gone away. Insomnia worse. Started 12 hours after vaccine. All labs normal 5 days before and all labs normal now., but still having symptoms. Missing work.
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| 47 | 2021-02-09 | feeling abnormal | Headache, nausea, chills, body aches, sore joints, overall felt horrible |
| 47 | 2021-02-09 | sleep disorder |
A mild rash began to develop on chin and neck within 48 hours and beginning on day 3 post vaccine, t...
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A mild rash began to develop on chin and neck within 48 hours and beginning on day 3 post vaccine, the rash developed bumps over the chin and upper lip with intense itching. The rash worsened in severity over the next week resulting in constant burning and itching preventing sleep. It is now two weeks and the rash had not improved.
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| 47 | 2021-02-10 | impaired work ability, poor quality sleep |
her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; f...
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her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; fever; her right carotid on her neck felt swollen; right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt; tired and achy; tired and achy; feeling sick; muscle and joint pain; muscle and joint pain; cough; the back of her ribs hurt; Nausea; she is having shooting pains in different spots; This is a spontaneous report from a contactable nurse reporting for self. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number EL3249, via an unspecified route of administration from 25Jan2021 14:00 (at the age of 47 years old), Dose 2, as a single dose in the left arm for COVID-19 immunization. Medical history included she had her tonsils out on an unknown date. She was a nurse that works with COVID patients; she got tested twice last week (Jan2021), both were negative. She had no pre-existing medical conditions. She has never had a problem with vaccines. There were no concomitant medications. The patient previously received dose 1 of BNT162B2 on 04Jan2021 (Lot # EX9231) and experienced no reaction then. The patient had the second dose of the Pfizer vaccine around 2 PM yesterday (25Jan2021) and she kept moving around in bed and feeling sick last night. That night she was just tired and achy but she thought that could just be from working. She went to bed early and she woke up around 1:50 or 2 AM with chills so she went and got a thermometer. She woke up at about 2 AM (26Jan2021) with a 103 fever and chills and her right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt. Her skin just burns; she went to take a shower. With the skin burning she knew it was sore to touch but when she got in the shower, that was when she noticed it hurt. She was really achy; her legs were aching and she was having shooting pains in different spots. She commented that she called out today (26Jan2021), she never calls out; all she wanted to do was take a shower and she wondered if she needed to go to the doctor. Her skin burns even when she was showering; every part her skin burns. She was also having muscle and joint pain and cough and the back of her ribs hurt (Jan2021). The other thing was nausea (Jan2021). The fever and chills were persisting and were about the same. She was hoping for it to go down so she could go to work to tomorrow (27Jan2021). The clinical outcome of the fever, chills, and her right carotid on her neck felt swollen and hurt was not recovered. The clinical outcome of feeling sick, tired and achy, face feels swollen, skin burning, muscle and joint pain, cough, back of her ribs hurt, nausea, and shooting pains in different spots was unknown. The reporter states she thinks what she is reporting was directly related to the product.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-10 | loss of personal independence in daily activities |
It's the longevity of the side effects at a level preventing work and daily activities that is the b...
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It's the longevity of the side effects at a level preventing work and daily activities that is the biggest problem; fatigue; headaches; fevers; chills; dizziness; generalized pain; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL324, expiry date: not reported), via unspecified route of administration on 22Jan2021 05:00 PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccine in four weeks prior vaccination. Medical history included epilepsy and asthma. Concomitant medications included lamotrigine (LAMICTAL), escitalopram oxalate (LEXAPRO), riboflavin (VITAMIN b2), magnesium (MAGNESIUM), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10). The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL1284, expiry date: not reported), via unspecified route of administration on 02Jan2021 07:00 PM at a single dose on the left arm for COVID-19 immunization (age at vaccination: 47-year-old). Past drug history included known allergies to Parafon forte and Macrobid. The patient stated that it's the longevity of the side effects at a level preventing work and daily activities that is the biggest problem. She stated that she's 5 days post injection at the time of report (26Jan2021), and the fatigue, headaches, fevers/chills, dizziness and generalized pain are not going away (started on an unspecified date in Jan2021). Her doctor told me to report this to the manufacturer and get advice. No treatment was received. The patient did not have covid prior vaccination and was not tested for covid post vaccination. Outcome of the events was recovering.
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| 47 | 2021-02-15 | impaired work ability |
With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose ...
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With the first dose I felt sick for 1 day. I called out. The morning after receiving the 2nd dose I had severe fatigue, joint pain, my wrist and my armpit was budging, I noticed swelling my clavicle on my left side, chills, and dizzy. I had to miss work for 2 days. I had to lay bed in for 2 days. By 3rd it was much improved but I still feel weak. About 4 days after receiving the vaccine I was back to feeling my self. On 2/14-15/2021, my face was itching, I scratched it, and there is a small abrasion. My face started to swell, around 2AM this morning I had to go to the ER because my eyes were getting small, the swelling was getting worse. I also had bumps that looked like hives on my face, there was some fluid coming out of my face. I went to early this morning, The ER doctor said she thinks it is not infected she thinks it is inflamed. I did not mention that I had recently received the COVID vaccine and did not realize that it may be linked to the vaccine until later in the day. She prescribed Hydrocortisone 0.5 % cream and Mupirocin 2% cream. Since I have been home the ER the swelling has worsened. My face is painful, it feels like an orange peel when you touch.
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| 47 | 2021-02-15 | sleep disorder |
Arm was very achy the first 12-14 hours. Kept me awake that night. Injection site was very sore to...
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Arm was very achy the first 12-14 hours. Kept me awake that night. Injection site was very sore to touch. After 5 days, still have severe joint pain in left shoulder (side which injection was given) which is constant.
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| 47 | 2021-02-17 | disorientation, impaired work ability, sleep disorder, feeling abnormal |
I experienced a rash in my face. It looked like mosquito bites almost. The normal pain on the inject...
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I experienced a rash in my face. It looked like mosquito bites almost. The normal pain on the injection - red on outside. Whole arm was red and swollen. That lasted several days. Next day after vaccine, Inside of my arm, I noticed rash (looked like chicken pox/mosquito bites) and then it went to chest, abdomen and legs. The rash continued. My face was flushed and had a 99.9 fever. I had foggy brain and chest pain (started day after the vaccine). The chest pain would last about a minute - I monitored my heart rate. From sitting down my heart rate when up to 120 and down to 37. This occurred for four days - four - six times a day. By the 3rd day after vaccine, I started feeling worse. I experienced dizziness, nausea, couldn't think, was disorientated, rash on my body, no appetite, couldn't sleep well and had no energy and chest pain - was in bed for next three days. I didn't call my Dr right away, I was monitoring the chest pain while I rested. That resolved (chest pains) by Saturday. The rest continued. My Monday, I called Public Health and they advised to call my DR. Spoke to Dr. on 11th. On the 12th, I had a telehealth appt with him. On the 13th had an EKG done. Everything normal on EKG. I continued feeling dizzy and no energy. I didn't work until Jan 19th. On the 20th, I felt foggy brain and rash wasn't gone and I went back to my doctor on January 21 and he put me off work for another week. At this point, within the last few days, my energy is back and rash is gone - I do still have dark spots on back and legs from the rash. On January 25th, I got the second dose. (The rash kind of flared back after second dose but nothing as bad.)
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| 47 | 2021-02-17 | feeling abnormal, thinking abnormal |
**Note - reported wrong lot number on report #309074 - the correct lot number EL1284 (1st dose) - ...
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**Note - reported wrong lot number on report #309074 - the correct lot number EL1284 (1st dose) - 1st dose - forgot to state - needle sharp pain in the back of my neck and I felt it on my left side of my body - this occurred right away after the injection and it lasted for about 30 seconds.** 2nd dose report: was not as severe exp.; some swelling , pain and redness on arm around injection which lasted 2 days. I experienced hot flash like (face would turn red) - which lasted 5-10 min. When I had the hot flashes the rash would appear as more rash. It wasn't causing me a lot of itchiness. Second day, turning brown and kind of peeling skin off. This lasted for the first week (the hot flashes with the increased rash). The highest my fever went to 100. I had some foggy brain and overwhelmed with thinking. Symptoms resolved mostly within the first week. I was back to work by the 29th of January. I could think more clearly and every day I was getting more energy. I am usually someone who has a lot of energy and I exercise. I didn't have energy to exercise. For the whole month of Jan and the first two weeks of February, I didn't really exercise. Just starting to this week. Dr. visit in person on January 28 and he prescribed Triamcinolone 0.1%. Urine test - next month to recheck after testing prior to dose 2 of vaccine but after receiving dose 2 of vaccine.
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| 47 | 2021-02-19 | feeling abnormal |
2nd dose (1st dose received 1/22/21 Pfizer Lot# EL3247): Received 2nd dose 2/18/21 at 1900. 2/19/2...
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2nd dose (1st dose received 1/22/21 Pfizer Lot# EL3247): Received 2nd dose 2/18/21 at 1900. 2/19/21 woke up at 0700 with chills but afebrile. Went to work - felt fatigue and brain fog throughout the day. At 1000 experienced left arm soreness that resolved by 1900. At 2100 experienced headache, nausea & fatigue and fell asleep very early. Woke up at 0300 with increased headache and chills - remain afebrile. Menstrual cycle started 2/19/21 AM - very heavy flow which is unexpected, as cycles have been normal.
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| 47 | 2021-02-19 | impaired work ability |
Pt has IM phizer injection one day later developed fevers, headaches body aches that lasted ten da...
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Pt has IM phizer injection one day later developed fevers, headaches body aches that lasted ten days. Was not able to work. I called her up early February and she had recovered from these.
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| 47 | 2021-02-20 | irritability |
throat and tongue swelled, but not enough to cause breathing problem, just enough to make it hard to...
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throat and tongue swelled, but not enough to cause breathing problem, just enough to make it hard to talk. Resolved after a week. Developed red, bumpy, itchy rash on back of both hands and lower arms. Ended up scratching to point of bleeding. Rash resolved after 2 weeks and benadryl. Felt irritable for a full week. NEVER felt fluish, just the swollen throat and rash on back of hands and lower arms and irritableness.
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| 47 | 2021-02-21 | feeling abnormal |
~13 hours post vaccination, symptoms consistent with acute intermittent porphyria exacerbation (atta...
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~13 hours post vaccination, symptoms consistent with acute intermittent porphyria exacerbation (attack) developed: severe abdominal pain, nausea, brain fog. Porphyria symptoms responded to porphyria-specific treatment (IV infusion with hemin (Panhematin) on both 2/10/21 and 2/11/21; analgesics). Porphyria symptoms lasted until 2/12/21. -On 2/10/21 also typical COVID-19-vaccine side effects: muscle and joint pain, fever (101.2F), chills. These resolved within one day. Previous mild COVID-19 (8 months prior to vaccination). Infection is a known trigger of porphyria attacks. Vaccination does not usually trigger porphyria symptoms.
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| 47 | 2021-02-21 | feeling abnormal |
About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, stron...
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About 20 minutes after vaccination, lips and tip of nose went numb, tongue felt big and fuzzy, strong metallic taste in mouth, felt flushed and HR was elevated. Received 50mg of Benadryl.
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| 47 | 2021-02-24 | agitation, insomnia |
Extreme myalgia and paresthsias, Pain 9/10. Similar presentation patient experienced with past menin...
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Extreme myalgia and paresthsias, Pain 9/10. Similar presentation patient experienced with past meningitis event. Insomnia, vision changes, agitation. Prednisone is helpful in making pain bearable. Gabapentin started today. Labs pending.
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| 47 | 2021-02-25 | loss of personal independence in daily activities |
Rigors and severe back pain; Rigors and severe back pain; syncope; prolonged PT; Loss of work as a p...
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Rigors and severe back pain; Rigors and severe back pain; syncope; prolonged PT; Loss of work as a physician for 2.5 weeks; This is a spontaneous report from a contactable physician (patient) A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Jan2021 12:30 at single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease and allergies. The patient was not pregnant. Concomitant medication included lansoprazole (PREVACID). The patient experienced rigors and severe back pain, syncope, prolonged pt and loss of work as a physician for 2.5 weeks on 12Jan2021 with outcome of recovered with sequelae in Feb2021. The events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient was hospitalized due to the events for 2 days. The patient received steroids, pain meds, muscle relaxers as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile causality between event chills and syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be excluded. The events prolonged PT and loss of work as a physician for 2.5 weeks are attributed to intercurrent conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-27 | depression, crying | Exacerbated depression symptoms. Cried for 3 days after the second does. |
| 47 | 2021-03-01 | excessive sleepiness |
Low fever set in about 14 hours after vaccine, along with chills and fatigue. Slept a lot for about...
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Low fever set in about 14 hours after vaccine, along with chills and fatigue. Slept a lot for about 48 hours. Nausea and decreased appetite, dry heaving and minor vomiting. Nausea persisted for about 4 days after vaccine. Mild headache as well. Treatment was just rest and easily digestible foods. Recovering slowly.
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| 47 | 2021-03-02 | anxiety |
numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to ...
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numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); felt acutely short of breath and anxious; felt acutely short of breath and anxious; numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); This is a spontaneous report from a contactable physician. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 16:00 (at the age of 47 years old) at a single dose for covid-19 immunization. Medical history included known allergies: shellfish, seasonal allergies and psoriasis. Concomitant medications included several medications in two weeks. The patient is not pregnant. The patient had no other vaccine in four weeks. On 29Jan2021 23:45, after being asleep for approximately one hour, felt acutely short of breath and anxious, which lasted less than a minute and was then followed by numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE). These events resulted in emergency room visit. The patient underwent lab tests and procedures which included PCR/nasal swab on 29Jan2021 (post vaccination) which showed negative. Therapeutic measures were taken as a result of all the events which included diphenhydramine (BENADRYL), IVF. Outcome of all the events was recovering. Information on the lot/batch number has been requested.
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| 47 | 2021-03-02 | sensation of foreign body |
paramedic called for a 47 female here for first covid vaccination. no prior h/o reaction to other va...
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paramedic called for a 47 female here for first covid vaccination. no prior h/o reaction to other vaccines . pt followed by cardiology for unknown congential heart condition c/b episodes of tachycardia s/p "stress test " a few weeks but unable to complete the stress test. pt pt denies meds for her cardiac condition . approx 9 min after covid vaccine pt c/o substernal "indigestion type" chest tightness a/w sweating and globus sensation of the throat. pt did not have rash or hives or flushing or angioedema or shortness of breath or wheezing or dysphonia or stidor. exam pulse 84 bp 177/112 r 18 afeb pt did not appear in distress heent no angioedema cor rrr without murmur or gallop chest clr p&a. pt refused epinephrine but accepted oxygen. clinic did not have an ekg to assess cardiac status. but emt rhythm strip showed sinus tachycardia. pt transported ED without any medication intervention by emt
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| 47 | 2021-03-03 | insomnia |
Over night on the night following the vaccination, I had headache, body aches, malaise and insomnia....
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Over night on the night following the vaccination, I had headache, body aches, malaise and insomnia. Throughout the next day (1/13/21), I continued to have headache, body aches, and malaise as well as objective fever (up to about 101.5 degrees F), fatigue, dyspnea on exertion and lightheadedness. Later in the day (about 5:00pm) I developed significant shortness of breath at rest and chest pain. Later that evening I went to the Emergency Department because of concern over my extreme and persistent shortness of breath and chest pain. In the E.D. they did the following tests: EKG (normal), oximetry (normal), Portable Chest Xray (normal), rapid COVID test (normal), cardiac enzymes (normal), D-DIMER (ELEVATED), other bloodwork (normal). Because of the elevated D-dimer, a CT angiogram of the chest was performed to rule-out pulmonary embolism. The CT showed enlarged lymph nodes, but no evidence of pulmonary embolism. I was discharged home. By the next morning (1/14/21) I was feeling much better. And by the afternoon of 1/14/21 I was feeling completely back to normal without any symptoms.
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| 47 | 2021-03-04 | anxiety |
1005 Pt report dizzy. B/P 122/86, HR-74, R-18, 02 sat99% ra. Pt also reports some anxiety prior to v...
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1005 Pt report dizzy. B/P 122/86, HR-74, R-18, 02 sat99% ra. Pt also reports some anxiety prior to vaccine. 1010 reports dizziness getting better. 02 sat 99% ra, HR-72, 1021 Reports dizziness resolved. B/P 124/80, HR-79, 02 sat 100%, R-20. Pt discharged with husband and daughter. Instructed to f/u with MD as needed.
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| 47 | 2021-03-04 | feeling abnormal | heart racing, "just feeling wierd"- Evaluated by EMS-Cleared |
| 47 | 2021-03-07 | impaired work ability |
That same evening I began to be more short of breath and just didn't feel good. I had lethargy and g...
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That same evening I began to be more short of breath and just didn't feel good. I had lethargy and general malaise. I had pleuritic pain in my right upper back that was a sharp pain with inspiration. All of this continued to get worse over time and I developed pneumonia. I wasn't able to go back to work from 1/27/21 to 3/6/21.
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| 47 | 2021-03-07 | impaired work ability |
On Thursday February 18, 2021 around 9 am I began feeling chills, body aches, extreme nausea and exp...
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On Thursday February 18, 2021 around 9 am I began feeling chills, body aches, extreme nausea and experienced one of the worst headaches I have ever had in my life. I left work after a noon meeting and was on the verge of asking my husband to take me to the ER while I waited to hear back from my neurologist. I sent a message to my neurologist and inquired as to whether or not it was safe to take a dose of the regular migraine medication I have to treat this headache. The response I received from his office was that it was safe to take my abortive migraine medication which I did and within a couple of hours I began to feel better.
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| 47 | 2021-03-09 | feeling abnormal | Brain fog, muscle aches, fatigue, lasting about 36 hours |
| 47 | 2021-03-10 | confusional state, feeling abnormal |
03/05/2021: Sore arm at injection site, fever, severe headache, severe fatigue. 03/08/2021: Symptoms...
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03/05/2021: Sore arm at injection site, fever, severe headache, severe fatigue. 03/08/2021: Symptoms subsided except for moderate fatigue; new symptom: 'brain fog.' Current: Moderate fatigue continues; 'brain fog' with confusion is increasing in severity. Family is noticing that something is wrong. Examples: I did not know what medicines I was taking. I could not fill this form out within 20 minutes. I did not know how many pizzas to order for dinner. I signed the wrong name to a check. I had to look up how to spell the word signed. *Dates are accurate on v-safe if needed.
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| 47 | 2021-03-12 | confusional state |
The patient reported to the pharmacy counter after her 1st dose of the COVID19 (Pfizer-Biotech) vacc...
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The patient reported to the pharmacy counter after her 1st dose of the COVID19 (Pfizer-Biotech) vaccination within 5 minutes stating "Guys, I don't feel good." One of the pharmacists grabbed her chair and moved it to our check out window and sat down with her to ask her what she was experiencing. I grabbed the blood pressure cuff and returned to the patient. The other pharmacist reported to me that she felt light-headed, dizzy, and that her throat was itchy. We administered 25mg of diphenhydramine (oral tablet) and gave the patient some water. We then checked her BP and it was 68/40, which prompted us to call 911 for assistance. The other pharmacist stayed with her until the paramedics arrived (~15 minutes). About 5 minutes later we rechecked her BP and it jumped to 144/90. I tried to assess the patient's coherence, which began to diminish as she was very confused and could not understand the questions we were asking her. About 1 minute before they arrived, the patient said her throat was feeling worse and swelling, so we went to grab an epinephrine pen. EMT's arrived right as the dose was about to be administered, so we stopped to let them take over.
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| 47 | 2021-03-12 | disturbance in attention, confusional state | Fatigue, overall malaise, poor concentration, neck and body aches, confusion |
| 47 | 2021-03-13 | memory impairment, disturbance in attention, disorientation, confusional state |
I noticed I was unable to focus and becoming easily confused and disoriented on Wednesday, March 10,...
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I noticed I was unable to focus and becoming easily confused and disoriented on Wednesday, March 10, 2021. I found it difficult to navigate very familiar things like excel and navigating email communications. On Saturday, March 13, 2021, I was cooking with a couple of family members and I became confused and could not remember that I had something in the oven, what I was supposed to be cooking although I was whisking eggs at the time, who wanted what, etc. I became disoriented easily and almost burned my sister with hot grease, almost set the kitchen on fire when I set a dish towel on a still lit burner on the stove. Later on when playing scrabble, my favorite game, I had trouble adding up the points, I continuously counted over and over and then promptly forgot. I had trouble remembering who just went and constant wrote the scores under the wrong name. Could not remember the order of players and it was only three of us.
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| 47 | 2021-03-14 | feeling abnormal |
PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first sh...
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PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first shot, she complained of body soreness, weakness and headaches that did not go away until she had the stroke on 03/12/2021". Patient is now hospitalized and unresponsive.
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| 47 | 2021-03-14 | impaired work ability, feeling abnormal |
After my second vaccine, I developed severe right earache. It was inflamed and by the night my left ...
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After my second vaccine, I developed severe right earache. It was inflamed and by the night my left wrist had a rash that looked like shingles. I told my doctor about my symptoms and he suspected cellulitis. My doctor gave me ear drops and placed me on antibiotics. So my rash was still present and by the next day I experienced headaches and nausea and felt out of place. I called into work since I did not feel good. On Thursday 01-14-2021, I went back to work but now the same rash I developed on my left wrist was in my right ear. My ENT doctor did lab work and a culture test to check for herpes or shingles, both of these exams were negative and these symptoms lasted one week then they resolved.
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| 47 | 2021-03-15 | disorientation, crying |
Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; Felling Dizzy; Disoriented, Could not finish...
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Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; Felling Dizzy; Disoriented, Could not finish the drive home due to disorientation; Emotional; Crying; Nausea; Tired; Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 04Feb2021 10:30 am at a single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 on 12Jan2021 (at 04:30 PM, Right arm, dose 1) for covid-19 immunisation. The patient experienced felling dizzy (dizziness), disoriented, could not finish the drive home due to disorientation (disorientation), emotional (emotional disorder), crying, nausea, tired (fatigue); all on 04Feb2021 11:00 am and Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) on an unspecified date and (off label use) on 04Feb2021 10:30 am. No treatment received for the adverse events (felling dizzy, disoriented, could not finish the drive home due to disorientation, emotional, crying, nausea and tired). All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) and (off label use) was unknown and for all events, not recovered.
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| 47 | 2021-03-16 | confusional state, amnesia |
Seizure. Convulsions, lost consciousness, amnesia, high blood pressure, confusion. Numbness of lower...
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Seizure. Convulsions, lost consciousness, amnesia, high blood pressure, confusion. Numbness of lower lip, tingling in hands and feet, consistent headache, fatigue, memory problems, and filling out of my body are all still occurring five days later.
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| 47 | 2021-03-16 | feeling abnormal | Swelling red blotches burning feeling wierd shape tierd |
| 47 | 2021-03-16 | insomnia, feeling abnormal |
This is a follow up report starting from day after that first report was made -Report # 244159 - Sta...
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This is a follow up report starting from day after that first report was made -Report # 244159 - Starting with the 17th of January - I was still having facial numbness/tingling/pressure in my head/feeling like head was going to swell; arms were so heavy - couldn't lift my arms - like a heavy pressure on my chest; breathing was a problem; Swelling in my head caused eye issues. 18th - tingling started on back of neck; affecting my hearing and eyes (swelling in head); a lot of cognitive challenges. 1-20-2021 - heart racing; itchy all over; blood pressure spikes. Heart can feel like it's too fast and then going too slow. 1-21-2021 - legs burning from waist to hip; chest pain; heart racing; struggling to breath. 1/22 - chest pain and discomfort - pain shooting through arms; didn't sleep well. Arms wanted to pull into my chest. Stomach cramping on 1/23 - stabbing pain in wrists and hands; left side on heart pain. Pain was like having a beating. Left knee pain - January 24 - up all night with shooting pain in arm; fine motor pain skills shot - can't do what I need to do. January 25 - Elevated heart rate; elevated blood pressure. 1/26 - vision challenges; fuzzy. Heart racing; feet swollen; face feels puffy doesn't look puffy - pressure/tingly feeling in left cheek. Ongoing and Changing symptoms every day/week - with no let up. 3/11/ - buckling of legs started. Big thing now is my legs are buckling (happening from the hips) - when I try to get up or walk. I haven't fallen yet but I know it's coming. 3/12/2021 - heavy weight back in the arms. I still don't have the fine motor skills. I still can't drive and don't have control over my body and reflexes enough. Still having Pressure in chest and the face and head swelling - is unbearable and affecting my vision. I will see a neurologist next month. Dr is not sure what to do. Jan 12 - first ER visit. I have specific notes/log on all of my symptoms each day. If anyone wants to call - please call on Mondays or Wednesdays only( or Saturday or Sunday.) Also, Menstrual cycle is wonky. I had a normal period before the vaccine - 12/28-12/31/2020 - but didn't have one in January and I had one in February 10th - but just one day; 3/11/2021 - I had my next one and it was four days long and fourth day was very heavy then all the rest of the days.
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| 47 | 2021-03-17 | feeling abnormal |
Nausea; vomiting; abdominal pain; I felt light-headed. I had extreme fatigue - it felt like I had to...
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Nausea; vomiting; abdominal pain; I felt light-headed. I had extreme fatigue - it felt like I had to feel asleep for a year. I woke up and would feel like I hadn't slept. Those symptoms continued for over hours. I called the Dr on the 15th and she said didn't want to give me to Zofran; she wanted me to take Ginger but I didn't feel good enough to go out and get ginger. I was really feeling awful going to bathroom to bed. My fiancé gave me one of his Zofran and I took Tylenol too. After eight or nine hours the symptoms subsided. Except the fatigue - and that resolved about the 21st or so.
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| 47 | 2021-03-17 | nervousness |
Felt shaky and a warmth went from my feet to head causing a low grade headache. Shaking was internal...
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Felt shaky and a warmth went from my feet to head causing a low grade headache. Shaking was internal but then became external. I felt light headed as if my BP was low. The next day I have a rash on my neck with bumps on the side I received the vaccine. I also have had a headache all day as well.
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| 47 | 2021-03-18 | impaired work ability |
I had my vaccine shot at 6:50 in the afternoon, went home, felt sore and pain in my right shoulder w...
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I had my vaccine shot at 6:50 in the afternoon, went home, felt sore and pain in my right shoulder where I had the shot, sleep, took some advil pm so I can sleep, wake up today to get ready for work,(March 19), I cant move my right hand especially when im trying to lift it, causing too much pain, texted and called my company that i cant come to work because moving my right hand causing too much pain, called my doctor also
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| 47 | 2021-03-18 | insomnia |
Extreme dry mouth noticed around 7:30 pm the evening I received the vaccination. This lasted about 1...
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Extreme dry mouth noticed around 7:30 pm the evening I received the vaccination. This lasted about 16 hours. Insomnia the first night after receiving the vaccination.
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| 47 | 2021-03-19 | feeling abnormal |
I am really concern because since yesterday I had blurred vision that is getting worse now, feels li...
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I am really concern because since yesterday I had blurred vision that is getting worse now, feels like on and off I am looking through eyelashes. I would like to know if this one will be temporary or if I should call a Doctor. I am also a Dialysis nurse at medical facility. Please let me know.
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| 47 | 2021-03-19 | feeling abnormal | Nausea, stomach gurgling, out of sorts feeling |
| 47 | 2021-03-19 | feeling abnormal |
Symptoms began with headache immediately after received shot. A few hours after, experienced fatigue...
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Symptoms began with headache immediately after received shot. A few hours after, experienced fatigue and fogginess. The next day headache, fatigue, fogginess was worse. That night noticed slight muscle tremors, especially in legs. Also, woke up with night sweats. Although headache, fatigue and fogginess seemed to lessen significantly by day 4, muscle tremors increasing, especially at night. Also, night sweats remained. On day 6, muscle tremors worse.
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| 47 | 2021-03-19 | sleep disorder |
Severe leg cramps in left calf muscle overnight, strong enough to wake me from sleep between 3:00-4:...
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Severe leg cramps in left calf muscle overnight, strong enough to wake me from sleep between 3:00-4:00 AM, with lingering pain in that muscle and in hip joints still present at time of reporting approximately 24 hours later. Ongoing treatment with naproxen sodium and regular stretching.
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| 47 | 2021-03-21 | feeling abnormal |
7 days after 2nd shot began to develop 3 swollen lymph nodes under left arm. This is same arm as in...
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7 days after 2nd shot began to develop 3 swollen lymph nodes under left arm. This is same arm as injection. Swelling was red and painful. (I also became very sick after 2nd injection and was in bed for 2 days... had sweats, nausea, chills and brain was foggy.)
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| 47 | 2021-03-21 | impaired work ability, feeling abnormal |
The next day, I had a fever, chills, nausea, fatigue, dizziness, off balance and just not myself. It...
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The next day, I had a fever, chills, nausea, fatigue, dizziness, off balance and just not myself. It got worse during the day, so I had to leave work. I was out work for two days. It continued to get worse and I was starting to get weaker. I just got a lot of rest and took Advil. Consulted doctor by phone.
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| 47 | 2021-03-21 | impaired work ability |
By that evening, I started experiencing severe chills, headaches and I was very weak. I took Tylenol...
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By that evening, I started experiencing severe chills, headaches and I was very weak. I took Tylenol. I tried to go to work the next day, but I could barely move my feet. Then, the diarrhea started to where I was having very watery stool about 10-15 times a day. I couldn't eat anything. I had never been that sick in my life. I was in the bathroom every few minutes. On Saturday, I went to urgent care to get rehydrated since I had lost so much fluids. I was given meds to stop my stomach cramping along with another prescription, but I still couldn't eat at that point. For the next week, I was still extremely sick. I ended up losing 10lbs. I have to see my doctor tomorrow to be evaluated for surgery since this has caused issues with my hemorrhoids. I still experience diarrhea occasionally, so I have to be really careful what I eat. I don't have much of an appetite, so I eat very light.
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| 47 | 2021-03-21 | sleep disorder |
1st shot only moderate soreness next day. 2nd shot in approx 5 hours I had chills, headache, body ac...
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1st shot only moderate soreness next day. 2nd shot in approx 5 hours I had chills, headache, body aches, extreme exhaustion, swollen throbbing ears, fever, nausea, and stomach ache went to bed woke up a 9 pm 102.5 fever barely able to function. Took Vicks 44 tried to sleep completely miserable. Took Tylenol to try to get fever down. Still so miserable I couldn't swollen because my ear pain was bad. My friend drove me to the nearest minor med. I couldnt tolerate any light, barely walk, dizzy and hurting all over. My lymph nodes started swelling up all over my body. I am still in pain and hurting , exhausted 5 days later. I have kept a constant headache, still exhausted, and can rest with pain meds.
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| 47 | 2021-03-22 | anxiety |
Horrible headache. Bad muscle pain stiffness, pain in throat. Burning in throat and ears, severe an...
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Horrible headache. Bad muscle pain stiffness, pain in throat. Burning in throat and ears, severe anxiety
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| 47 | 2021-03-22 | loss of personal independence in daily activities |
Fatigue, significant, prevents daily activity Headache, significant, any use of prescription pain r...
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Fatigue, significant, prevents daily activity Headache, significant, any use of prescription pain reliver or prevents daily activity Reaction Intervention: prescription medication
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| 47 | 2021-03-22 | sleep disorder |
10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as...
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10:45am Injection, mild headache 11am slightly dizzy 11:30am Arm sore - cont. to get more painful as the day/night went on. Eventually, painful to lift. 12:30pm: Nauseous and not feeling well. Headache increasing. 7pm Migraine, chills, feeling awful, tired, muscle & joint pains, body aches, fever, left arm super painful. Slept restlessly Friday: Slept all day restlessly, chills, fever high of 102, tired, migraine, muscle & joint pain, no appetite. Sat: Migraine, some chills, muscle, joint, arm pain. Sun: Feeling much better, joint pains, arm sore, headache. Sun PM: Red, swelling, tingling on face around chin and mouth. - right side of face Mon: Rash on neck - right side of face Tues: Rash on torso
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| 47 | 2021-03-23 | anxiety |
After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe ...
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After about 30minutes of shot l had feeling of fullness on my face and slightly warm ears for maybe 30seconds and immediately after that I had feeling of sinking as if l am going to die for 30 seconds and I was alright after.
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| 47 | 2021-03-23 | memory impairment, feeling abnormal, disturbance in attention | became foggy, forgetful, lose thought, couldn't articulate thoughts |
| 47 | 2021-03-24 | nervousness, anxiety |
Dizziness, anxiousness, nervousness, generalized weakness. Patient given a bottle of water, seated, ...
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Dizziness, anxiousness, nervousness, generalized weakness. Patient given a bottle of water, seated, encouraged to relax, calm down.
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| 47 | 2021-03-24 | sleep disorder |
Since the time of receiving the vaccine I have had the following: Almost three days of extreme pain ...
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Since the time of receiving the vaccine I have had the following: Almost three days of extreme pain in my arm. I was not able to sleep the first two nights, because I was in so much pain. Shortly after, I had symptoms resembling that of the flu to include body aches, chills, headache, nausea and vomiting. I have had a headache everyday since receiving the shot. I have been nauseous since receiving the shot.
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| 47 | 2021-03-27 | depression |
Rash that looks almost like a chemical burn under arms around the armpit area and lower part of ches...
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Rash that looks almost like a chemical burn under arms around the armpit area and lower part of chest under breasts, also at top bend of one leg. Itching and burning rash. Started evening of 3/26 and has not gone away. Taking Benadryl and Pepcid per a nurse?s suggestion.
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| 47 | 2021-03-28 | impaired work ability |
After first dose on 07-MAR-2021 I felt injection site pain, redness and swelling. It was mild and la...
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After first dose on 07-MAR-2021 I felt injection site pain, redness and swelling. It was mild and lasted a few days. After the 2 nd dose on 28-MAR-2021 about 3 hours later I developed a headache. About 12 hours after the vaccine I developed a headache, muscle aches, joint pain, fatigue and a fever of 100.1. The headache body aches and fatigue were severe, joint pain moderate and fever low grade. I was unable to work a full day and did end up staying in bed for most of the day.
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| 47 | 2021-03-29 | feeling abnormal, abnormal dreams |
On the day after the shot, I had a headache and fatigue, which I was expecting. 3 days after, I was...
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On the day after the shot, I had a headache and fatigue, which I was expecting. 3 days after, I was having some feeling of being a little out of it - spaciness and some light headedness. Although I would NOT classify it as a brain fog, I am switching words around regularly. Very randomly. My dreams are INCREDIBLY vivid.
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| 47 | 2021-03-29 | sensation of foreign body |
At 11:50 am patient received COVID 19 Pfizer vaccine, asked to remain in waiting area for 30 minutes...
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At 11:50 am patient received COVID 19 Pfizer vaccine, asked to remain in waiting area for 30 minutes due to a severe allergic reaction to Phenergan in the past. At 12:10 pm she stated she felt a lump in her throat. No hives or swelling noted at this time. Benadryl 50 mg administered PO. PA & physician came and assessed, patient stated the symptoms were getting worse and she felt her throat closing. Administered Epinephrine 0.5ml at 12:25 pm. 991 was called. Second dose of Epi was given at 12:40pm EMS arrived at 12:41pm and transported to Emergency Room. Observed in ED for 2 hours and then discharged home, no additional symptoms or treatment noted.
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| 47 | 2021-03-30 | anxiety | c/o of increased HR and seems anxious. P=124; O2=98. resolved. P=89 |
| 47 | 2021-03-30 | anxiety | palpitations, anxiety. |
| 47 | 2021-03-30 | feeling abnormal |
Bad Hot Flash when first getting the vx also was sweating, Now I have hot flashes every night I have...
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Bad Hot Flash when first getting the vx also was sweating, Now I have hot flashes every night I have to change my pajamas during the night. I also have Brain Fog. It has not gotten better. Did NOT have this issue until after the Covid vx. FYI, I had a hysterectomy when I was 32yrs old.
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| 47 | 2021-03-30 | feeling abnormal |
it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria...
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it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria); it triggered an exacerbation (attack) of my underlying genetic disease (acute intermittent porphyria); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain); This was characterized by severe abdominal pain; headache; extreme dizziness; chest pain; brain fog; numbness in feet; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received bnt162b2, via an unspecified route of administration, in left arm on 03Mar2021 09:00 (second dose, Batch/Lot Number: EN6203), via an unspecified route of administration in left arm on 09Feb2021 12:45 (first dose, Lot number: EC(L?)8982) both as single dose for covid-19 immunization. Medical history included acute intermittent porphyria, migraine, hypertension (HTN), dermatitis contact (Known allergies: adhesives (contact dermatitis)), COVID-19 (If COVID prior vaccination: Yes) all from unknown date and unknown if ongoing. Concomitant medications included givosiran sodium (GIVLAARI); lisinopril; hemin (PANHEMATIN DRY); zolmitriptan taken for an unspecified indication, start and stop date were not reported. The patient experienced after each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain), it triggered an exacerbation (attack) of her underlying genetic disease (acute intermittent porphyria), this was characterized by severe abdominal pain, headache, extreme dizziness, chest pain, brain fog, numbness in feet all on 03Mar2021 20:00. After each vaccination, 12 hours later typical side effects developed (low grade fever, chills, muscles pain) and it triggered an exacerbation (attack) of her underlying genetic disease (acute intermittent porphyria). This was characterized by severe abdominal pain, headache, extreme dizziness, chest pain, brain fog, numbness in feet. She received treatment for the attack and symptoms resolved after several days. The treatment included: Intravenous treatment with hemin (PANHEMATIN). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was resolved. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID tested post vaccination.
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| 47 | 2021-03-31 | feeling abnormal | At 24 hours after the shot, exhausted and ?loopy.? Then, intestinal pains for 36 hours. |
| 47 | 2021-03-31 | sleep disorder |
Headache prior to shot but increased in intensity around 7 hours after injection, continued througho...
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Headache prior to shot but increased in intensity around 7 hours after injection, continued throughout night, disrupting sleep, severe the following morning, then began to recede in intensity about 24 hours after injection
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| 47 | 2021-04-01 | feeling abnormal | pt started to feel funny, numbness in the jaw, arm pain, leg pain |
| 47 | 2021-04-03 | feeling abnormal |
I woke up with a headache and a sore arm. As the day progressed I started to feel terrible. Very tir...
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I woke up with a headache and a sore arm. As the day progressed I started to feel terrible. Very tired and generally just felt yucky.
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| 47 | 2021-04-04 | agitation, restlessness, sleep disorder |
5/25 Received vaccine at 9:30 a.m. at the hospital. Sore arm developed about 3 hours later. Later th...
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5/25 Received vaccine at 9:30 a.m. at the hospital. Sore arm developed about 3 hours later. Later that afternoon, had muscle aches and tiredness. 5/26 10:30 a.m. noticed a couple hives on my upper thigh and inside forearms. Realized they were there before I got to work, but didn't make note of it. 12:00 felt very tired, muscle aches, especially in neck, felt like mild flu. noticed hives/rash getting worse in the afternoon. They were not itchy. 8:00 p.m. Called on call doctor due to worsening rash/hives. "Breathing seemed fine. Dr. called back and advised 10 ml Benedryl along with nightly Zyrtec. Took 10 ml liquid Benedryl. 9:00 p.m. noticed breathing got a little easier, less constricted. Made sure my son's epi pen was available if needed. Saturday, March 27 Had chills in the middle of the night, turned on electric mattress pad to get warm, making hives worse. 4:00 a.m. 10 ml Benedryl. Didn't notice breathing getting better, or not lasting very long. Contemplated ER if got worse. 8:45 a.m. 10 ml Benedryl. Temp is 98.8 10:00 took Zyrtec and ibuprofen Called Dr. in the morning, who suggested medrol dose pack of steroids. Due to past history with hives, requested 10 day course of steroids. 11:00 6 prednisone 1:30 p.m. 10 ml Benedryl possible less internal agitation 5:45 Benedryl 11:00 p.m. Zyrtec, temp 98.2. Hives continued to spread, but at much slower rate. Felt on face, ears and back of head. More prickly sensation form the hives. Some spots so many hives it is just one large red spot. Felt very hot. Tried to use ice pack to cool down and ease tingling irritation from hives. Sunday, March 28 1:10 a.m. Benedryl for restlessness (especially in legs), chamomile tea 4:00 a.m. magnesium, which finally settled the restless legs. 11:30 prednisone Called Dr. back since hives didn't seem to be dissipating, and feeling very agitated internally. We both agreed it was time to go to urgent care. Saw Dr. at Urgent Care. She offered steroid shot, but stated it would further decrease the effectiveness of the COVID vaccine. Observed that my back was looking better from the hives. Opted to try famotidine and hydroxyzine hcl for allergy and agitation. 2:45 took hydroxyzine and famotidine within an hour, started to have relief from the intensity. That night, I was finally able to rest and sleep. Over the next few days, the hives continued to go away, and I wasn't bothered internally by them again.
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| 47 | 2021-04-05 | anxiety |
1245:Pt c/o SOB, Anxiety, Dizzyness,BP:122/74, P:99, T:98.1, Spo2 99% RA. Pt given water and observe...
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1245:Pt c/o SOB, Anxiety, Dizzyness,BP:122/74, P:99, T:98.1, Spo2 99% RA. Pt given water and observed for additional time.1255:Pt stated feeling much better, Pt instructed to get hydrated and call PCP for concerns. Pt released.
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| 47 | 2021-04-05 | loss of personal independence in daily activities |
She got her vaccine, started feeling more and more as the day progressed that her arm was hurting an...
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She got her vaccine, started feeling more and more as the day progressed that her arm was hurting and then as the day progressed she felt like her last 2 fingers in her left hand were tingling, and that extends up towards her forearm. This morning they hurt extremely bad, she cannot open a container, and having ulnar nerve pain, cannot do anything as she cannot use the entire hand due to the pain and has weakness in that hand. She is not having any other pain. She has not taken anything for her symptoms.
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| 47 | 2021-04-05 | sleep disorder |
Had expected fatigue and chills and bad headache on day two after vaccination. Lasted about 18-20 h...
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Had expected fatigue and chills and bad headache on day two after vaccination. Lasted about 18-20 hours. Sore arm progressed over a few days to throbbing aching left shoulder. It kept me up at night for days. Shoulder got tighter and achier, peeking at about 2 weeks post vaccination. I continued to use arm normally (I am a swim coach with lots of overhead demonstrations) until I was in acute pain three weeks after vaccine. At which point I sought care. Had X-ray and MRI done. Received oral steroid dose-pack which helped greatly after 3-4 days. I have started PT to return range of motion and address findings on MRI. (Rotator cuff and bicep tendon itis) PT has discovered neck inflammation and loss of motion and is focusing on return of neck motion to start. She is considering if post-vaccine neck nerve compression is actually the root of my pain.
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| 47 | 2021-04-07 | anxiety, feeling abnormal |
At 1025 patient alerted observation nurse LVN to a sensation of itching and difficulty swallowing. P...
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At 1025 patient alerted observation nurse LVN to a sensation of itching and difficulty swallowing. Patient requested water. Patient tolerated water well, no shortness of breath, lung sounds clear. Vitals BP 140/91, Pulse 81, Respirations 21, Temp 97.0, SaO2 97%. Patient appears anxious and tearful. 1040 Benadryl 25 mg PO given due to patient stating itchiness and difficulty breathing. 1045 patient stated it was easier to breath and felt comfortable, patient tolerated water well. Vitals 135/92, Pulse 73, Respirations 21, SaO2 98%. Charge Nurse alerted to patient status. Patient visibly comfortably lung sounds clear, mild itchiness to throat that patient stated was improving. Charge Nurse educated patient to the signs and symptoms of an adverse reaction, patient states understanding. Patient drove alone so nurse advised patient to call for family to come pick her up from site and not be alone. Educated to call 911 or go to ER if symptoms return. Patient agreed to wait in observation with LVN while she attempted to call for family. Patient tolerated standing. 1052 Vitals BP 125/117 Pulse 70, SaO2 97%, Resp 20, Temp 97.2. Vitals reassessed at 141/93, pulse 77, Respirations 20, SaO2 98% Temp 97.3. Nurse present with patient at all times. At 1122 patient once again complained of itchiness in her throat and was in visible distress. Charge Nurse alerted. EPI Pen 0.3 mg administered by nurse to Right thigh, 911 called by charge nurse. BP 161/100, HR 91, SaO2 94%, Temp 96.8. Patient stated she felt some relief after Epinephrine administration. 1127 Vitals, BP 165/98 HR, 94, SaO2 97% but patient still stated she felt ?like something is stuck?. 1129 paramedics arrived and attended to patient. 1131 patient was taken in stretcher with belongings.
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| 47 | 2021-04-08 | anxiety |
1230 sitting in general observation area and is itching right arm. States she did not have any probl...
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1230 sitting in general observation area and is itching right arm. States she did not have any problems with the first dose. States she has her EPI pen with her for anaphylaxis reaction to bee stings. States she is not having any trouble breathing. Tongue examined and not swollen. Taken to private observation area. Noted red blotchy flat rash on right arm, neck, and front of chest. Itching constantly. 1232 gave Benadryl 25 mg, two tablets by mouth for itching. Husband is present. 1235 noting rash is progressing to left arm. 1240 HR 91, BP 166/88; O2 sat 99% on room air. Denies throat discomfort or itching in throat. Drinking water without difficulty. 1245 gave ice for itching. Mild redness noted bilateral thighs. 1255 BP 162/93; HR 72. No throat or tongue swelling. Respiration even/ regular. Redness of rah subsiding, still itching but less. States she is anxious as well and thinks her BP may be from anxiety. Husband present and will be driving. Patient states this is nothing like her anaphylaxis and feels well enough to go home. Ambulated without difficulty to POV Rash redness subsiding
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| 47 | 2021-04-08 | feeling abnormal |
Itching, swelling, redness, and injection site. Severe nerve pain shooting down all limbs, severe ch...
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Itching, swelling, redness, and injection site. Severe nerve pain shooting down all limbs, severe chills, fuzzy brain, all over joint pain, exhaustion
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| 47 | 2021-04-09 | anxiety | chest pain, palpitations, dyspnea, anxiety |
| 47 | 2021-04-09 | feeling abnormal |
I was given the vaccine in the right upper arm. I picked that arm due to PHN in my left trigininal ...
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I was given the vaccine in the right upper arm. I picked that arm due to PHN in my left trigininal nerve from shingles. They gave me the vaccine and I proceeded to move my car to the 30 minute waiting area. I put the car in park and suddenly I felt dizzy. Like I was looking through a magnifying glass backwards. Since I have a reaction to Xolair in 12/15/2021 I had been extra cautious. This hit my quickly. It felt like I had a ton of weight on my chest. It progressed quickly to where I felt like I couldn't breath. The staff was watchful. They called an ambulance. They monitored me there but it was like I could not wake up. I wanted to fall asleep. My blood pressure was higher than normal at one point during my ER visit I looked up and my blood pressure was 137/91. I felt like I had when I had a many stroke in 2019 my speech was slower I couldn't get the words out. My toes and finger were cold. They transported me to the ER for observation. It was that that the head ache only in my right frontal lobe started and my arm and neck on the right side began to hurt. Within about 1.5 hours I began to wake up from the fog and my speak cleared up. While laying on the bed my fingers were curling up. As the speech returned that hands warmed up.and my fingers began to release. The staff at the clinic had given me benadryl within about 20 minutes of the vaccine. Upon release I was droggy and like a huge adrenal rush had worn off. I had slight stuffy nose and like I had a severe hay fever reaction that I was coming down from last night. This hit me quick and hard. The ER said I had a stress reaction and a head ache of unknown cause as all of my blood work came back normal. But honestly at one point I felt paralyzed. Even today I feel stuffier than I normally do. Like I have a slight asthma attack. I know my blood oxygen was 97 % at one point and I can tell when it drops even a precent
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| 47 | 2021-04-09 | feeling abnormal |
Immediate taste and tickly/tingly feeling in back of throat that left tongue and back of throat feel...
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Immediate taste and tickly/tingly feeling in back of throat that left tongue and back of throat feeling a little numb. This all lasted a couple of days. Face and neck were itchy for a couple days. Face became red and splotchy 7 hours later but only lasted 30 min. Felt generally off for a couple days (tired, achy, nauseous, pain at injection site). Itchy rash and pain at injection site started 1 week later and lasted 3-4 days.
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| 47 | 2021-04-10 | sleep disorder, panic reaction, excessive sleepiness, disorientation | Suddenly onset exhausted and disoriented. 13 hour nap. Frequent wakings with arm pain and panic. |
| 47 | 2021-04-10 | sleep disorder | Fever of 101.8, severe body aches so painful they prevented me from sleeping |
| 47 | 2021-04-11 | depression, feeling abnormal |
I was starting my period (light spotting) and it just stopped after the first dose. That was Mar 9, ...
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I was starting my period (light spotting) and it just stopped after the first dose. That was Mar 9, 2021. I have not gotten my period since. According to the doctors as well as my menstruation cycles prior there were no signs or peri menopause or menopause. Additional symptoms: After the first dose: (lasted for 3 weeks) Extreme fatigue. (Sleeping 20 hours a day) Swollen joints. (Radiating pain from the occipital ridge downward through out the spine & the right knee). Constant pain in my neck, shoulders, hips. Brain fog. Blurry vision/vision changes and things looked like they were vibrating/jumping Numbness in my face Tasted metal in my mouth Nausea Diarrhea Loss of appetite Depression After the second dose (lasted 10 days) Entire left arm was in pain Swollen and stiff from left arm, base of my occipital ridge/top of spinal column , neck shoulders, all the muscles between my shoulder blades the day after. Starting on day 3, all the areas up and down my spinal column felt swollen, stiff and in pain. Dissipated after 10 days. I lost mobility in my hip joints. Swollen right knee ( I am still experiencing these 2 symptoms, 4/12/21). Fatigue Brain fog. Diarrhea. Nausea Loss of appetite
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| 47 | 2021-04-11 | panic attack, anxiety, loss of personal independence in daily activities |
The day after the second dose of the vaccine with chills and a low grade fever. I had a cold sweat a...
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The day after the second dose of the vaccine with chills and a low grade fever. I had a cold sweat and shortness of breath. It felt like something was restricting my airway. My blood pressure felt like it was elevated. My fever chills and sweats lasted about five days. The blood pressure feeling with anxiety and panic attacks lasted for five weeks. I also had fluid in my lungs. During this time I felt extremely fatigued. I developed a horrible lower back pain about three weeks after the vaccine and I was congested with a horrible sinus headache. I have never had back problems before, I could not sit down, and this lasted for six weeks. It is slightly better now but still present. It was severe for I got some physical therapy. I am currently have a lot of GI issues and I am scheduled with a GI Specialist. I have lower GI pain. I visited the ER 04/02/2021. I am also very congested with headache in the forehead area.
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| 47 | 2021-04-12 | feeling abnormal, depression |
I started vomiting 12 hours from when I received the shot. Hot and cold sweats. Stomach cramping. As...
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I started vomiting 12 hours from when I received the shot. Hot and cold sweats. Stomach cramping. As the next few days went on, I was feeling foggy, unmotivated and extremely depressed.
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| 47 | 2021-04-12 | feeling abnormal, sleep disorder, feeling drunk |
It wouldn't let me add this, but it was my first Pfizer shot. I started feeling dizzy within the fir...
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It wouldn't let me add this, but it was my first Pfizer shot. I started feeling dizzy within the first 30 minutes, and didn't think much of it. Went home and just under 3 hours later, started to feel strange. I felt almost drunk, like my brain was fuzzy. Even more dizzy. Then my tongue swelled. I then had palpitations and felt my heart jump. The palpitations came and went a few times through the night. I couldn't sleep and experienced some slurring. I then took aspirin and tried to drink a lot of water. I felt scared so asked my parents to call every hour to make sure i was alive. I didn't think to call 911 because I felt so out of it. I had a mild headache that went from my forehead to the back, but it felt more strange than anytthing. The next morning my tongue had several bites all along the edges and top of the edges. I then got hives on my face, on Sunday, April 11. I took benadryl and put cortizone cream on. I took benadryl again on 4/12. I'm still dizzy and slightly short of breath. i have an appointment with an immunologist for thursday.
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| 47 | 2021-04-12 | insomnia |
I started having left abdominal pain under my ribs (spleen and liver) on the afternoon of Friday, Ap...
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I started having left abdominal pain under my ribs (spleen and liver) on the afternoon of Friday, April 2 that lasted though Sunday, April 11. I went to the ER at 1am on Sunday, April 4 because the pain would not improve and kept me awake. I was admitted to the hospital for two days with a host of CT scans, blood work, Xray and ultrasounds for a diagnosis of splenic infarction and inflammation of the liver which I have never had before. No other clots were found, just evidence of spleenic infarction and inflammation of the spleen. Labor shows evidence of the diagnosis and I have now been put on low dose aspirin 81 for blood clot concerns and preventative by the advise of Hemotologist.
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| 47 | 2021-04-13 | disorientation |
W/n hour I was very lightheaded and dizzy. I was sporadically disoriented and extremely exhausted. F...
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W/n hour I was very lightheaded and dizzy. I was sporadically disoriented and extremely exhausted. From the following morning (Sunday) through Thursday of the same week I had severe back pain and pain and aches in my joints down my arms into my hands. Dizziness also during that time period.
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| 47 | 2021-04-13 | feeling abnormal |
I woke up a little after midnight Friday morning with significant arm pain, nausea, diarrhea, fever ...
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I woke up a little after midnight Friday morning with significant arm pain, nausea, diarrhea, fever and intense body aches. The body aches continued for the rest of the night and throughout the next day. Started to feel better on Saturday, but then developed stiffness on the left side of my neck in the afternoon. Sunday night I woke up in the night with the feeling that the room was spinning, but I had no nausea. I continue to have fatigue, brain fog and a feeling of vertigo.
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| 47 | 2021-04-13 | sleep disorder, restlessness |
Feels very cold and restless with no fever. She is currently in bed and we are waiting to see if if ...
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Feels very cold and restless with no fever. She is currently in bed and we are waiting to see if if passes soon. She didn't sleep well and now is very restless and on the verge of tears.
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| 47 | 2021-04-14 | feeling abnormal |
Painful and very stiff neck. Symptoms got progressively worse over 72 hours. Very difficult to make ...
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Painful and very stiff neck. Symptoms got progressively worse over 72 hours. Very difficult to make movements up and down of my head and side to side hurts as well. Feels like the pain is deeper and closer to the back of the head than typical muscular pain/strain. Don't know if it is related to the vaccine, but it's a very strange feeling and not something I have ever experienced before.
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| 47 | 2021-04-14 | feeling abnormal | Fatigue, dizziness, numbness in toes, shakes, brain fog |
| 47 | 2021-04-15 | agitation |
Day 1 Nausea Dehydrated Headache Fatigue Felt heavy, freeze/stabbing pitch fork headache all day D...
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Day 1 Nausea Dehydrated Headache Fatigue Felt heavy, freeze/stabbing pitch fork headache all day Day 2 Headache Fatigue Arm pit itch Teeth pain and clinching (neurological uncontrollable) vertigo/dizzy Stiff neck sore muscles and joints Day 3 Fatigue Headache Day 4 Fatigue Ankles got really swollen Out of breath on just a walk Headache Shooting Pain in legs and feet Pain at past mohs surgery site Day 6 Agitated Nauseous Dizzy Headache Bells palsy like symptoms right side of my face
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| 47 | 2021-04-15 | anxiety | APPREHENSION, CHOKING SENSATION, AND CHEST TIGHTNESS |
| 47 | 2021-04-16 | confusional state |
3 minutes after injection, mild tongue and lip swelling, running nose, itchy throat, red splotches a...
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3 minutes after injection, mild tongue and lip swelling, running nose, itchy throat, red splotches and hives on chest and arms, mental confusion, and sudden extreme fatigue
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| 47 | 2021-04-17 | confusional state |
During observation period member had what appeared to be a seizure lasting less than 1 minute - head...
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During observation period member had what appeared to be a seizure lasting less than 1 minute - head fell back, rolled eyes, trembling. Confused when episode ended for about 15-20 seconds then became oriented and answering questions appropriately. Patient vomited face became very pale, complained of feeling hot and "not right' transported to ER via EMS
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| 47 | 2021-04-17 | confusional state |
while sitting right arm went numb, then couldn't get words out to speak and was confused; was taken...
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while sitting right arm went numb, then couldn't get words out to speak and was confused; was taken to hospital and given tests (MRI, CT scan, COVID test, echocardiogram, chest X-ray); numbness went away first day, MRI showed TIA/mini strokes on left side of brain and insula part of brain; had aphasia for two days; admitted to hospital for observation and released after 3 days; given Lipitor and aspirin and heparin shots for treatment; no lasting effects from stroke; doctor says cholesterol, blood pressure and family history normal;
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| 47 | 2021-04-17 | hallucination, depressed mood |
I felt dizzy and threw up Severe nausea Fever Chills Body aches Dizziness Emotional- sadness Halluc...
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I felt dizzy and threw up Severe nausea Fever Chills Body aches Dizziness Emotional- sadness Hallucinations Extreme tiredness
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| 47 | 2021-04-20 | anxiety |
pt stated her mouth tingly, VS taken and WNL. Pt self administered epi pen. Rapid Response team call...
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pt stated her mouth tingly, VS taken and WNL. Pt self administered epi pen. Rapid Response team called. O2@2L given to patient to help calm her down. RRT transferred pt to ER for further treatment.
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| 47 | 2021-04-21 | anxiety |
1st Day - Extremely tired, Nauseous 2nd Day - Fatigue, Nauseous, Ribs hurt, body hurt 3rd Day - same...
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1st Day - Extremely tired, Nauseous 2nd Day - Fatigue, Nauseous, Ribs hurt, body hurt 3rd Day - same as day 2 4th Day - felt better 6th Day - Rapid heart rate / anxious 7th Day - Pain in my neck and found large Lymph Node in neck/clavicle 8th Day - Couldn't get out of bed, felt like a truck hit me, Lymph Node still enlarged in neck and also under left underarm. Went to Doctor she confirmed it was Lymph Nodes - 5 CM in my neck with 4 -5 of them enlarged, and 3 - 4 under my left arm. Also behind my knee 9th Day - Lymph nodes still the same size and very painful, now in my groin area. Still exhausted. Went for Chest X-Ray, negative 10th Day - Still the same, trouble walking 11th Day (today)- Still the same, more pain
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| 47 | 2021-04-21 | feeling drunk, depressed mood, insomnia |
High/Drunk feeling within 1 hour of shot, Not able to sleep at night for first 72 hours (2 hrs 1st ...
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High/Drunk feeling within 1 hour of shot, Not able to sleep at night for first 72 hours (2 hrs 1st night, 4 hours 2nd night, 4 hours 3rd night), Very low mood and wishes I would die on 4/15 morning as pain/discomfort was so great. Severe Chills (shaking, needed 3 blanket) from late afternoon to early morning hours during the 1st 72 hr post injection, Severe night sweats 1st 3 nights - body was soaking wet and soaked through pajamas, Joint and muscle pain in arms, legs, face/jaw starting the 1st night after injection and continuing for 4 days after injection, Swollen, painful lymph nodes in under arm/neck - continues to this day (started night 1 and now 9 days after injection), Occasional dizziness when standing and sitting starting 4 days after injection and continuing for 48 hours, Blurred vision, people looks like they were swaying starting day 5 through day 6, Very Heavy vaginal bleeding started on day 7 (4/20), got worse on day 8 (4/21), and the same on day 9 (4/22): soaking through pad every 2-3 hours on day 8 and day 9. bleeding continues at time of this report. NOT like a period, or timing of my period. My period is not due to start until 4/25 and I have been regular my entire life - 36 years! Cough and left arm pain started on day 8 (4/21) - I went to ER after calling my OBGYN and talking with the nurse. NEVER had a fever, NEVER had cramps.
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| 47 | 2021-04-24 | insomnia, feeling abnormal |
I felt fine the first 12 hours after the shot other than a little bit of brain fog. 12-36 hours aft...
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I felt fine the first 12 hours after the shot other than a little bit of brain fog. 12-36 hours after the shot, I felt terrible. I was achy, sweaty, had chills, no appetite and two waves of nausea. I had trouble sleeping. I ate very little during this time (toast, banana, soup), and threw up once. I had to rest all day. My left arm hurt and my lymph node by my left armpit hurt. (I have had ultrasounds over the past couple of years of my left breast/armpit taken due to an enlarged dense lymph node discovered on a mammogram. The ultrasounds have showed no increase in growth, and no signs of cancer.) I started feeling better 36 hours after the shot. It's now just over 48 hours post-vaccine. The lymph node pain remains and if I try to do anything even mildly strenuous I get flushed and tire easily, so I have been mostly resting. This was my second shot.
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| 47 | 2021-04-24 | sensation of foreign body |
Pt called call center on 4/22/21with c/o rapid heartbeat and feeling of something stuck in pt's thro...
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Pt called call center on 4/22/21with c/o rapid heartbeat and feeling of something stuck in pt's throat. Pt said, she received pfizer vaccine from location on Monday, 4/19/21. Pt said on her drive home, she got itchy which went away after 2 days. Informed pt she needed to go to an ED ASAP. Pt verbalized understand and said she has someone to take her to the ED.
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| 47 | 2021-04-25 | crying |
Three days after first immunization shot, developed severe PMS for 1.5 weeks (severe breast pain, se...
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Three days after first immunization shot, developed severe PMS for 1.5 weeks (severe breast pain, severe abdominal cramping), followed by extremely heavy menstruation and days of pain. This was significantly more painful and heavy than any menstruation of my entire life. I was doubled over in pain crying for days. Took Advil to reduce pain.
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| 47 | 2021-04-25 | sleep disorder |
Worsening of tinnitus, keeps me up at night, ears have been swollen after vaccine, unable to comfort...
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Worsening of tinnitus, keeps me up at night, ears have been swollen after vaccine, unable to comfortable wear hearing aids since vaccine. Have an appointment with hearing doctor on the 28APR2021 to try to get relief. Do not feel I will be able to complete the vaccine series due to this reaction.
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| 47 | 2021-04-26 | disorientation |
1st time shot - after 5 minutes I had disoriented issues, hot flushes for about 5 minutes where I to...
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1st time shot - after 5 minutes I had disoriented issues, hot flushes for about 5 minutes where I took my shoes off in the car and mentally felt like I was having an anxiety attack so the ?attendant lady? said it was normal to have a #panicattack . Two weeks later I went to my 2nd shot, and thinking it was a previous ?anxiety attack? this time would be better. Same timing, same feelings happened that lasted about 3 minutes and it was extremely scary.
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| 47 | 2021-04-26 | feeling abnormal |
The following events were only described to the author of this report 3 weeks after the events happe...
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The following events were only described to the author of this report 3 weeks after the events happened: A few minutes after the shot, the patient (pt) felt tightness in throat but still was able to breath. The pt then started feeling weird and a little dizzy in her head. This passed after about 15 minutes. The next day the pt woke up with nerve pain and soreness in the upper, inner part of her arms just above the elbow. The pt also reported nerve pain in the palm of hand below the thumb. The pt also reports having bad shin pain & muscle soreness. The shin pain lasted 4 days even after she took her regularly scheduled Celebrex along with Tylenol. Arm & hand pain only lasted a day.
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| 47 | 2021-04-27 | anxiety |
4/28/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ...
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4/28/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: rapid heart rate. Assessment : Time of assessment 1336. Alert and oriented, and anxious. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Water given, VS at 1336- BP- 148/92. P-136, O2- 100%, recheck at 1346- BP- 128/90, P- 90, O2- 100%, patient reports anxiety Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/28/2021 1:12 PM 0.3 mL 2/25/2020 Intramuscular
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| 47 | 2021-04-27 | anxiety |
10:42: Patient complained of scratchy throat and mild anxiety and claims to have history of anaphyla...
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10:42: Patient complained of scratchy throat and mild anxiety and claims to have history of anaphylaxis with penicillin and Aleve allergy. Patient's initial blood pressure at 148/91, 98% O2 sat, 74 HR, RR 16. Patient requested and was given 25 mg/1 tab of benadryl PO. Patient with no labored breathing or respiratory distress and no swelling at vaccine left upper arm injection site. 10:57: Vitals retaken. BP 136/84, hr 70, 96% RR 18. At this time, patient decided to go AMA. Risks and benefits explained. AMA form signed by patient. Pt in stable condition with steady GAIT and able to exit facility with no issues.
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| 47 | 2021-04-27 | impaired work ability |
Systemic: Nausea-Severe, Systemic: Vomiting-Medium, Additional Details: extreme tiredness from the d...
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Systemic: Nausea-Severe, Systemic: Vomiting-Medium, Additional Details: extreme tiredness from the day of vaccine which didnot go away even after 4 days and patient complains of not able to go to work
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| 47 | 2021-04-27 | impaired work ability |
4/25, 4pm, 2nd dose of Pfizer. Mass vax scheduling second dose 17days from 1st shot. 7pm, fatigue,...
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4/25, 4pm, 2nd dose of Pfizer. Mass vax scheduling second dose 17days from 1st shot. 7pm, fatigue, mild sore arm. 4/26/21 - 7am SEVERE BONE PAIN started in vertebrae, hip, coccyx, knees, ankles, completely unmitigated by 1000mg Tylenol and 800mg ibuprofen, FEVER - w/ meds still 99.7, CHILLS - moderate, DIARRHEA/NAUSEA - mild, fatigue - moderate, headache - mild, mitigated by meds. Would have gone to hospital if I thought they could do something. ABDOMINAL PAINS - intermittent, HEART FLUBBING - mild. 7pm, BONE PAIN reduced to moderate by 9pm, fever broke. 4/27/21 - felt like I had the flu - FATIGUE, CHILLS, NAUSEA, - all tolerable and mild-moderate, ABDOMINAL PAINS - intermittent, HEART FLUBBING - mild. 4/28/21 - FATIGUE - moderate (worse), ABDOMINAL PAINS - moderate, not gastro-related, HEART FLUBBING - mild. Third day missed of work. Heading to doctor.
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| 47 | 2021-04-28 | sleep disorder, feeling abnormal |
It's 7 days later and I am still not well - face swelling, hot to the touch (similar to when I had s...
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It's 7 days later and I am still not well - face swelling, hot to the touch (similar to when I had staph infection) Nausea is new as of today, migraine has come back (was present up until yesterday afternoon and started to dissipate and now back in full force). I have had 17 concussions in my lifetime so it feels like that a bit, foggy, can't stand for long, fatigue. Here are my symptoms by days. Would have sent this sooner but couldn't function or look at screen- really sick. I am still sick and not sure if this is normal or I should be going to the ER or some type of doctor. 4/22/21 ? 2nd Shot at 10:35 am - @ 1:45 pm arm really started to get soar and hard to lift. Chills. Drossy. 4/23/21 ? After I awoke from the 1st night, I couldn't move my entire body's left side, I was dragging my left leg with me and couldn't lift my arm from my body or move it. exhausted felt drugged, like hangover, migraine and getting in car accident all in one. Kept dozing off. Slept a lot. Head felt similar to concussion. Unable to really walk. 4/24/21 ?Slept a lot during day. Arm and leg mobility better and I could finally feel my left fingers. So much pain so I finally took my 1st Tylenol muscle 8 hr at 9:38 am. Took another at 10:30pm. It helped for about 5 hours and then woke up with sharp pains again. At night, shooting pains in legs especially back of legs and burning I?m in a lot of pain so while I can now feel my left side and move my arm a bit better my legs are still in a constant state of shooting spasm and I can?t lay down, sit up, recline or anything. Nothing brings comfort. It?s like taking an electrical prod to my body. Arm still hurts (NOT at injection site) but can move it better now still feels like sinus infection. It?s like muscles are pizza dough and someone is pulling them, stretching them painfully with electrical current when you aren?t moving. Massive spasm all over back of legs hips from bottom down. Eyes really swollen. Did Sinus Rinse. Under my arm put and beside/behind my breast rib cage sore. 4/26/21 - Pain wakes as usual throughout the night but it?s 4:40am and the Tylenol has worn off. Pizza dough pulling and spasms in the legs. I?ve taken more Tylenol in the last 4 days than I have taken in the last 40 years. I felt like I didn?t have a headache when I got up but my legs were still streaming so I took another Tylenol and I have a headache and don?t feel good. I now am able to move arm but extremely painful like a log, I can lift it only 1.5 inches from my body which is more than I could before so it must be getting better. Head still feels similar to concussion with migraine. The headache is causing me to clinch teeth and the headache is not at the level it was but still pretty bad. None of this pre -2nd shot. When I was about 12yrs old I had Rheumatoid arthritis (or that was the drs explanation) and this is what it felt like, I couldn?t move my legs or my arms then. I did not take any Tylenol tonight. Shoot pains only wake me up 3 times although they are constantly there just the strength differs Dr?s have always said I have extremely high threshold for pain. I was finally able to brush my hair, afterwards my arms were shaking muscle wise and fatigued. Rash inside my ear and face blotchy. 4/27/21 ?No real change in symptoms except now I am seeing my face swell and eyes are still burning and painful. My face only on the left side more than right looks like a cabbage patch doll- swelling. Eyes sore and front of head hurts. Stuffy nostril only left one ? so I do another sinus rise today. Still feel drugged. Body is sore. Hard to move neck. Still in pain take Tylenol at 9:20pm. The pain woke me up multiple times and kept me up. It?s like someone is pulling my muscles like pizza dough. It is so painful. No position is comfortable. Woke up at 10:30, 11:45, 12:15, 2:21, 3:52, 4:05 and that was it couldn?t get back to sleep because of this pain. Don?t have a foam roller here but maybe an olive oil bottle I could use in the same manger or a tennis ball. I have to do something I can?t take this pain. 4/28/21 ? 8:32 am having trouble lifting my arm, very heavy fingers numb fatigued like I just lifted something really heavy by myself. I was finally able to move arms enough to was the dishes. Left side of face still swollen. Under my arm put and beside/behind my breast rib cage still sore. Finally, was able to take bath. Not hot because I didn?t want any more swelling. 4/29/21 ? Only woke up a couple of time and slept better so thought I would try to go for a walk outside today. My headache I thought was pretty much gone. I didn?t last more than 8 mins. I felt like I couldn?t stand, exhausted, not strong enough and needed to sit down. My migraine is back and I feel nausea, not hungry, face is swollen still. I have lymphedema and use my machine every night, but it?s almost like the shot increases inflammation all over my body, find the places that have been affected before and gets in there. I only drink water, no coffee, tea or juice and no alcohol since 3 days before my 1st shot and was planning to continue that until 2 months after my 2nd shot.
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| 47 | 2021-04-28 | sleep disorder |
It started with body ache and then terrible headache, chill, nauseous, tiredness, and overall weakne...
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It started with body ache and then terrible headache, chill, nauseous, tiredness, and overall weakness. Not so much fever (about 100) but felt cold. I was Covid positive in November 2020, and felt the symptoms were very similar to what I had back then. It lasted two full days and especially the headache was persistent and went on the morning on the 3rd day. Spent two full days in bed. Took Advil on the 1st day and 2nd day but it took 3-4 hours to start feeling the effect. I switched to Tylenol on the night of the 3rd day, but didn't feel it worked. Felt almost normal in the afternoon of the 3rd day, but the headache came back the same night and couldnt sleep. Finally felt recovered in the morning of the 4th day but minor headache. The 4th day afternoon was fine.
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| 47 | 2021-04-29 | feeling abnormal | severe brain fog lasting 2+ days, body aches 2+ days, headache |
| 47 | 2021-05-03 | confusional state |
After receiving her vaccine, client states she felt dizzy and confused, then lost consciousness. Vi...
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After receiving her vaccine, client states she felt dizzy and confused, then lost consciousness. Vital signs BP 136/84, O2Sat 99%, HR 100. Client was alert and awake. Client advised to be transported to the ER. Client refused. Client went home.
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| 47 | 2021-05-09 | loss of personal independence in daily activities |
Woke up, got out of bed and by the time I reached the foot of the bed, the room spun and my body spu...
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Woke up, got out of bed and by the time I reached the foot of the bed, the room spun and my body spun and fell to the ground. I couldn't get up, walk and ease the dizziness and nausea. I went to the ER since it was sudden and extreme - never had any problems with vertigo in my past - and am a healthy, avid daily runner/walker. I passed the neurological tests and left with anti-dizziness and anti-nausea meds.
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| 47 | 2021-05-10 | disorientation |
Sore arm the next morning; Headache; Disorientation; general tiredness/fatigue; This is a spontaneou...
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Sore arm the next morning; Headache; Disorientation; general tiredness/fatigue; This is a spontaneous report from a contactable consumer (Patient). A 47-years-old female (non pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:00 (at the age of 47-years-old) (Batch/Lot number was not reported) as 1ST dose, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient did not have any known allergies and no allergies to medications, food, or other products. Concomitant medication (within 2 weeks of vaccination) included doxepin (DOXEPIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 03Mar2021 at 02:00PM, the patient experienced sore arm the next morning; general tiredness, sore arm the next day, headache, fatigue and disorientation. There was no treatment received for the adverse event. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 47 | 2021-05-18 | feeling abnormal |
Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling...
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Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling across face just above upper lip; face and neck turned red and swollen/ arms turned red under sleeves; face and neck turned red and swollen; dizzy; brain fog; Existing Tinnitus in left ear is louder; This is a spontaneous report from a contactable consumer reported for herself. This 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 15:15 (Batch/Lot Number: Unknown) as single dose (at 47 years old) for COVID-19 immunisation. Medical history included fibromyalgia from (previously diagnosed as Rheumatoid Arthritis). Concomitant medications included fenofibrate, escitalopram, hydrochlorothiazide, losartan potassium (LOSARTAN/HCT), herbal sup, all taken for an unspecified indication, start and stop date were not reported. The patient previously took monosodium glutamate and experienced allergy, hydroxychloroquine sulfate and experienced allergy. On 27Apr2021 15:15, the patient experienced anaphylaxis, vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen/ arms turned red under sleeves, dizzy, brain fog, existing tinnitus in left ear is louder, all with outcome of not recovered (as reported). Therapeutic measures were taken as a result of the events included Diphenhydramine, Epinephrine, Famotidine, Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that: "Sent to ER via ambulance: Diagnosed with Anaphylaxis. Vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen, arms turned red under sleeves, dizzy, brain fog. Existing Tinnitus in left ear is louder, and as of 04May2021, I still have the headache". Seriousness criteria of the events was reported as serious due to disability. The information on the Lot / Batch number has been requested.
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| 47 | 2021-05-23 | sleep disorder |
Severe stomach pain that kept me up all night on April 30th followed by a dull stomach pain througho...
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Severe stomach pain that kept me up all night on April 30th followed by a dull stomach pain throughout the weekend. Severe stomach pain started up again on Monday, May 3rd. I went to a walk-in clinic who sent me to the ER. At ER, they took a Cat Scan and determined I had appendicits. I had laparascopic surgery to remove my appendix on May 4th.
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| 47 | 2021-05-25 | excessive sleepiness, loss of personal independence in daily activities, mental status changes |
After first dose her mental status become slightly altered and she leaned to the left a bit when sta...
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After first dose her mental status become slightly altered and she leaned to the left a bit when standing up and walking.. From the day of second dose my sisters appetite decreased. She started sleeping more, got weaker to the point I had to bathe her, she had to start using a wheelchair. Mental status much more altered. She was to weak to go to dialysis on Monday March 22 2021 hospice was called in Tuesday March 23 2021 and she passed away at approximately 4:00 P.M. March 24th 2021.
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| 47 | 2021-05-26 | disorientation |
I experienced dizziness, nausea, disorientation and fainted while standing. I hurt my head, knee an...
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I experienced dizziness, nausea, disorientation and fainted while standing. I hurt my head, knee and thumb, but was otherwise ok. I don't know how long I was out and woke up on the floor. :(
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| 47 | 2021-05-26 | disturbance in attention |
joint pain in one of her legs; muscle and joint pain in one of her legs; So tired; Difficulty to con...
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joint pain in one of her legs; muscle and joint pain in one of her legs; So tired; Difficulty to concentrate; Sweats/sweats a lot; Headache; always cold; shaking/her hands are shaking; always cold and shaking; Not feeling well; Her head is heavy; Feels chilly; This is a spontaneous report from a contactable consumer (Patient). A 47-years-old female patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution of injection, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in Arm Right on 30Jan2021 as 1st dose, single for covid-19 immunisation. Medical history included breast cancer from 2018 and ongoing. She has it in her neck, treatment is almost over. Radiation was over two years ago, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included tamoxifen (TAMOXIFEN) taken for breast cancer started almost two years ago. A low dose, she was started on 20mg, but had a very bad side effect, was reduced to 5mg.20mg: NDC, lot, expiry unknown. LEVOTHYROXINE taken for thyroid disorder was started about 15 years ago from an unspecified start date and ongoing. The patient experienced headache, always cold on 31Jan2021, muscle pain in one of her legs on 03Feb2021, shaking/her hands are shaking and always cold and shaking on 31Jan2021, joint pain in one of her legs, muscle and joint pain in one of her legs, so tired, difficulty to concentrate on 03Feb2021, sweats/sweats a lot on 31Jan2021, not feeling well on 2021, her head is heavy on 2021, feels chilly on 2021. Question: Patient experienced headache, chills, and body weakness after getting the 1st dose of PFIZER-BIONTECH COVID-19 VACCINE last 30Jan2021-She wants to know if it's normal to have these symptoms - Took Tylenol to manage headache - According to her she already reported the side effects to (name). Question: "Can I skip the 2nd shot if I can't bear the pain. Additional Context:Calling about COVID vaccine. Had it on Saturday, she was ok on Saturday, since Sunday afternoon, she had a very bad headache, and Sunday night she started shaking, when she sleeps, she sweats, it is so bad that she needs to change, she is all wet, always cold and shaking, and she has muscle and joint pain in one of her legs, she is so tired and shaking, her hands are shaking, she cannot hold anything, is having difficulty to concentrate, do her job, she is not feeling well. She doesn't know if she should have the second one, or hold on, will the second be worse. The patient received treatment for the event headache with Tylenol. The Reporter stated the events as Non serious. Outcome of the headache was recovered on 01Feb2021, always cold was unknown, , muscle pain in one of her legs was unknown, shaking/her hands are shaking was recovering, always cold and shaking was recovering, joint pain in one of her legs on was recovering, muscle and joint pain in one of her legs was recovering, so tired was not recovered, difficulty to concentrate was not recovered , sweats/sweats a lot was not recovered , not feeling well was unknown , her head is heavy was unknown , feels chilly was unknown. Follow-up (04Feb2021): This is a Follow-up spontaneous report from a contactable consumer. Follow-up attempts are completed. No further information is expected.
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| 47 | 2021-05-26 | feeling abnormal |
In a little more than 24 hrs after the injection I began to have mild Migraine, and strange feeling ...
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In a little more than 24 hrs after the injection I began to have mild Migraine, and strange feeling as if I am coming down with a cold which subsided after taking Motrin. Then later in the evening my right leg from knee to my foot began to feel numb with a desensitization feeling. I took a hot shower, massaged the leg, the feeling did not go away. I have began stretching moving about more, getting up and down walking. The feeling and desensitization only began after the injection, only in this one leg, and has not ceased. It was intermittent, as it was coming and going, it was happening in the evening, now it is happening all during the day, even as I type this note, I am experiencing this weird feeling, I am not sure what to call it, it's not total numbness, some kind of desensitization feeling. It's very weird and scares me. I am not sure if I should even get the second dose. feel like a guinea pig with this vaccine.
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| 47 | 2021-05-26 | impaired work ability |
Heart Palpitations and fluttering - strong pressure and felt like a baby kick. This is happening qu...
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Heart Palpitations and fluttering - strong pressure and felt like a baby kick. This is happening quite often - daily and last anywhere from 1-30 minutes. The episodes come and go at all times of the day. It takes my breath away and can cause me to cough. I am exhausted and it's impacting my work and home life. I did a video doctor appointment on 4/15/21 with, PAC. We determine at that time to let it "play out" and see how I felt. After the 2nd vaccine on April 19 the symptoms increased. It was at that time she had me come into the office. We ran tests and she put me on a 24-hour heart monitor. Those results were 'normal' With the continued symptoms, she referred me to, DO at the Heart and Vascular Center. I saw him on 5/21 and he put me on a different heart monitor. I had an echocardiogram on 5/27.
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| 47 | 2021-05-26 | impaired work ability |
each time I started with a strong headache and head pressure within 2 hours of the vaccine, and felt...
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each time I started with a strong headache and head pressure within 2 hours of the vaccine, and felt "off" for 24 hours (a little dizzy, a little nauseous, exhausted)
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| 47 | 2021-05-27 | sleep disorder |
Very achy "vaccine" arm one week after second shot. Painful enough to wake me up in the middle of th...
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Very achy "vaccine" arm one week after second shot. Painful enough to wake me up in the middle of the night
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| 47 | 2021-05-28 | feeling abnormal |
facial swelling( Eyes,Lips,Cheek); Itching; swelling wheal; redness on face/chest /neck; arm pain at...
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facial swelling( Eyes,Lips,Cheek); Itching; swelling wheal; redness on face/chest /neck; arm pain at injection site; menstrual period flowing hard (came early); menstrual period flowing hard (came early); arm numbness; feeling like something running up my neck; dizzy; throat swollen; headaches; felt weird right after; fatigue; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on left arm on 07May2021 12:45 (Batch/Lot Number: EW0169) as 1st dose, single dose (at the age of 47 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced facial swelling( Eyes,Lips,Cheek), Itching, swelling wheal, redness on face, chest, neck, arm pain at injection site, menstrual period flowing hard (came early), arm numbness, feeling like something running up my neck, dizzy, felt weird right after, throat swollen, headaches and fatigue on 07May2021. The patient received treatment: steriods/ stomach anticid, antihistamine. Prior to vaccination, patient was not diagnosed with COVID-19 and not been tested for COVID-19. The patient had emergency department visit. The outcome of the events was recovering.
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| 47 | 2021-05-28 | feeling abnormal | Tremor, dyskinesia, brain fog, tachycardia |
| 47 | 2021-06-02 | feeling abnormal |
Patient reported itching throat altered sensation in mouth and throat. Benadryl 25 mg administered. ...
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Patient reported itching throat altered sensation in mouth and throat. Benadryl 25 mg administered. reassessed half hour later. Patient was fine and able to drive home. no shortness of breath nor respiratory distress.
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| 47 | 2021-06-03 | nervousness, anxiety |
D-EMS was dispatched to the COVID vaccine clinic for a pt whom received her vaccine and was now havi...
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D-EMS was dispatched to the COVID vaccine clinic for a pt whom received her vaccine and was now having a reaction to it. C-Allergic reaction to COVID vaccine. H-Pt had her first dose of the COVID vaccine at 1630 and was sitting in the evaluation line. She stated that she began breaking out into hives and called the paramedic. The pt began to feel tingly all over felt as if her mouth was swelling. Paramedic obtained a set of vital signs; placed her onto the 3lead monitor which revealed sinus tach and obtained IV access to administer 50mg of benadryl and 40 mg of pepcid PO. They called for Medic 6 to transport the pt to the ER. A- We found the pt sitting upright a&oX4 skin P/W/D. At the time of our arrival there was no more hives noted on the pt. The pt was nervous and stated that her lips and nose were tingling. She denied shortness of breath or trouble breathing but stated that it was hard for her to swallow. There was no noted swelling to the pts tongue. The pts lung sounds were clear and bilateral. The pt had already recieved a dose of benadryl and pepcid as previously stated. Rx-We obtained a baseline set of vital signs. Paramedic switched the pt from Paramedic 3lead to our own, which revealed sinus tach. We assisted the pt as she stood and sat onto the cot. We secured the pt to the cot per SOGs in the semi fowler position. We loaded the pt into the ambulance. T-We transported the pt routine traffic to TRH via Medic 6. While en route to TRH we continued to monitor the pts vital signs. The pt stated that it didnt feel like she was having trouble breathing but she felt as if she couldnt take a full deep breath. Lung sounds remained clear and bilateral with a o2 sat of 100% on room air. Paramedic administered 125mg of solu medrol. The pt remained stable. The pt denied any other new or worsening symptoms. Once we arrived at TRH we placed the pt into the ER bed in room 7 via 2 person sheet pull. Report was given to the RN. Medic 6 was cleaned and restocked and we returned to service. History of Present Illness This is a 47-year-old Caucasian female who presents to the emergency department by EMS due to symptoms resulting after receiving Pfizer COVID-19 vaccination today. It was her first shot. She developed some tingling in her lips as well as some difficulty swallowing. She did not have any respiratory difficulty. EMS gave her Pepcid, Benadryl, Solu-Medrol prior to arrival. Upon arrival she is still having some symptoms of difficulty swallowing. She is quite anxious. She states that she was feeling fine prior to the vaccination. Imported information including vital signs, nursing notes, allergies, past medical/social/family/surgical history reviewed Routine PPE including gloves if indicated, face mask, eye protection worn during the patient encounter ssessment: Possible adverse reaction to vaccine versus anxiety. Patient was initially seen by Dr. and had medical screening exam performed. He had ordered epinephrine and 0.5 mg of lorazepam. The patient remains tachycardic and states she feels like she is having problems swallowing. On exam there is no stridor. She is able to swallow her secretions. I do not appreciate any neck swelling. Chest is clear. No focal neurologic findings. EKG My EKG interpretation: Sinus tachycardia with a ventricular rate of 110. No acute ST elevation, T wave inversion, ST depression Reexamination/Reevaluation Reevaluation: Patient's potassium is 3.2. CO2 is 19. That is consistent with hyperventilation. Other labs are normal except for glucose of 229. Soft tissue neck x-ray was obtained and that showed some possible airway inflammation and therefore CT scan will be done to more effectively characterize the findings. Patient received potassium replacement as well as additional Ativan. She will also be given some IV fluids since she remains slightly tachycardic. That could be lingering effects of the epinephrine The patient's D-dimer was normal. She felt better after Antivert and Lopressor. Heart rate remained below 100 and but other vital signs were normal. Dizziness was better Diagnosis/Disposition Adverse reaction to vaccine Patient Instructions Drink plenty of fluids. Watch for worsening symptoms of difficulty swallowing, shortness of breath, facial swelling. Antivert for dizziness. Work note for tomorrow. Recheck with your doctor sometime within the next 3 weeks to see if you should get the second dose of the vaccine. Return to the emergency department if worse or new symptoms. RX Given meclizine: 1 tab, PO, TID, dizziness/motion sickness, # 20 tab, 0 Refil(s)
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| 47 | 2021-06-04 | insomnia |
Fever of 100.4 degree; I was not able to really sleep I kept waking up; feet hurting; Body aches; ha...
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Fever of 100.4 degree; I was not able to really sleep I kept waking up; feet hurting; Body aches; having a lot of phlegm in the back of my throat / coughing up a lot of phlegm; having a lot of phlegm in the back of my throat / coughing up a lot of phlegm; Back hurting; Pain in my joints in my arms and my elbow; Pain in my joints in my arms and my elbow; Pain in my joints in my arms and my elbow; I still have this 'throbbing' (not clarified further) in my big toe that will not go away like I'm like in extreme pain in my right foot in my big toe.; I feel like this is gout or something it's driving me crazy, because my big toe is hurting so bad; I'm like in extreme pain in my right foot in my big toe. But, the other issue that I was dealing with is the fact that, it was in my left foot and then it went to my right foot; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 47-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on an unspecified date around 2 O'clock in the afternoon (Batch/Lot Number: EN6206) as unknown, single dose for covid-19 immunisation. Medical history included multiple sclerosis. Concomitant medications included patient take medication for her thyroid and she also take an infusion for her multiple sclerosis. She also stated that she had blood work in the last 3 weeks in February 12th may be. On an unknown date when patient got home, she experienced a fever of 100.4 degree. She started drinking some water to bring the temperature down she took 3 Tylenol (as an event treatment) to bring the temperature down and I finally dropped the temperature down to 98.7. further, last night she did not have and she was not able to really sleep and kept waking up, she did not have chest pains or anything like that, but last night her feet started having issues as her feet hurting, her big toe was throbbing which she was not clarified and also had body aches. In morning, patient started having a lot of phlegm in the back of her throat, had coughing up a lot of phlegm. she took a Benadryl and, also took two more Tylenol, because she started having body aches again and Tylenol was not helping her alone because of lot of pain, her back hurting and started having pain in her joints, arms, and elbow. Patient still experienced throbbing (not clarified further) in her big toe that would not go away like in extreme pain in her right foot and in big toe. It was reported that patient had other issue that she was dealing with her left foot and then it went to her right foot which she did not understand why. The outcome of all events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 47 | 2021-06-05 | feeling abnormal |
In observation post vaccine within 15 minutes c/o tired and "loopy" and when being evaluated continu...
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In observation post vaccine within 15 minutes c/o tired and "loopy" and when being evaluated continued to have a drop in BP with and Increase in HR= became unresponsive and 911 called. NO resp issues or hives
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| 47 | 2021-06-06 | anxiety |
"Pt w/ hx of anxiety. Pt c/o dizziness and swelling of the throat ""a little"". 8:58AM BP 163/94, ...
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"Pt w/ hx of anxiety. Pt c/o dizziness and swelling of the throat ""a little"". 8:58AM BP 163/94, HR 79, RR 16, 99% RA -- > 152/78, 73, 16, 99% RA -- > 149/87, 80, 16, 100% RA -- > 9:38AM laying 142/79, 69, 16 & standing 160/90, 80, 99%RA. Pt given 25mg PO Benadryl. No airway edema, no neck lymphadenopathy, no rash, airway clear. A&O x4 No obvious signs of allergy to Pfizer. Most likely anxiety. Pt stable and released from the vaccination site w/ husband. Pt had steady gait, verbalizing thanks, speech clear. Recommended pt f/u with their healthcare provider. F/u instructions provided."
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| 47 | 2021-06-07 | feeling abnormal |
Over the course of two weeks after vaccination and present, I have no feeling of heart functioning. ...
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Over the course of two weeks after vaccination and present, I have no feeling of heart functioning. My heart is functioning good though. I can't feel any normal heart patterns such as when exercising, or adrenaline increases, I can't feel my heart rate increase. Which is dangerous. I also can't feel my heart strings when I get emotional in my heart. When I get sad, I can cry but no longer feel it in my heart. I had an EKG and full panel blood tests done on 6/72021, all came back normal. This all started after the last vaccination. There is a disconnect to my heart.
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| 47 | 2021-06-07 | sleep disorder |
I woke up panting, with a very fast heartbeat, and very dizzy, all day long. It came back for many d...
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I woke up panting, with a very fast heartbeat, and very dizzy, all day long. It came back for many days.
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| 47 | 2021-06-09 | insomnia |
Fever; Muscle contractions; couldn't sleep; Major headache; This is a spontaneous report received fr...
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Fever; Muscle contractions; couldn't sleep; Major headache; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 12Mar2021 at 15:30 (at the age of 47-year-old), as single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 19Feb2021 at 15:15 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021, the patient experienced high fever(39C) for more than 24 hours, muscle contractions which were painful, could not sleep and major headaches. The patient did not receive any treatment for the reported adverse event. The clinical outcome of the event high fever(37C), muscle contraction, sleeplessness and major headaches were recovered. Information about lot/batch number cannot be obtained. No further information is expected.
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| 47 | 2021-06-10 | anxiety, feeling abnormal |
feeling a little bit sick; feels a little bit funny once she got the vaccine; her head is hurting, H...
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feeling a little bit sick; feels a little bit funny once she got the vaccine; her head is hurting, Headache; shoulder is hurting; a little bit of trouble breathing; also feels in her stomach; sometimes like it is Anxiety attack; She started to fall asleep, she started to have Shivers; Dizzy; gas problems reappear; This is a spontaneous report from a contactable consumer or other non hcp (patient's son). A 47-years-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0179; Expiration Date: 31Aug2021) via an intramuscular route of administration arm left on 04Jun2021 as 1st dose, single dose for COVID-19 immunization. Medical history included some gas problems from an unknown date and unknown if ongoing while taking Simethicone. Patient has not had any vaccine in 4 weeks prior COVID vaccinations. Concomitant medication(s) included simeticone (SIMETHICONE, 125 mg; twice a day, one in the morning, one in the night; Chew Capsule), indication for Simethicone, Reporter stated, well it's also related to her symptoms because she feels, well she used to have the symptoms before she spoke to the doctor and she told her that it was some gas problems and the doctor told her that she could take this medication. But after she started taking it and then she stopped feeling it but then after she got the shot, she had started to reappear all the symptoms again. And now she has started to take the Anti-gas medication and the Aspirin pill. On 04Jun2021, the patient experienced feels a little bit funny, head is hurting, her shoulder is hurting and she had a little bit of trouble breathing, she also feels in her stomach, headache, feels sometimes like it is Anxiety attack, maybe and she feels them almost like in period, started to fall asleep, she started to have shivers, dizzy and on an unspecified date in Jun2021, experienced gas problems reappears. Reporter stated, calling for mom, she was feeling a little bit sick. She was feeling, well we got our Pfizer Vaccine on Friday and ever since then caller's mom had been telling me that she feels a little bit funny once she got the vaccine. It was like her head was hurting, her shoulder was hurting and she has a little bit of trouble breathing. She said that she also feels in her stomach. Reporter stated, she was still concerned about the side effects that she has, that she was feeling right now. The patient underwent lab tests and procedures on an unspecified date in Mar2021 she did not receive the test because her doctor told her that everything was fine and that everything was under regulation. Therapeutic measures were taken with 81 milligrams for the Aspirin and for the Ibuprofen it is its 220 milligrams. She says that the Aspirin she took it on the night that she had the vaccine. She is telling me that whenever she started to fall asleep, she started to have Shivers and she started to feel a little bit Dizzy. And for the Ibuprofen, she had it on the morning after, so June 5th and on the night of the June 5th and today morning. The outcome of the events was not recovered.
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| 48 | 2020-12-31 | crying, feeling drunk, feeling abnormal, sleep disorder |
After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, the...
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After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, then I headache started. A minute later fatigue hit and I was starting to fall asleep at the wheel. I live 1 mile away so I made it home. Now my head was getting fuzzy. Called a co-worker to tell her what was happening and she said my speech was slurring. I felt drunk and hungover at the same time. I went to bed and slept for an hour. I woke up and felt very fatigued. I finally went to bed for the night then was awoken with severe arm pain. My entire upper arm felt so tight but I it was soft upon palpation. I fell asleep and awoke to terrible arm pain again. I started crying in bed but fell asleep again. I woke up in the morning with severe upper arm pain and minor headache. I couldn't rotate my arm back to put my bra on so I took some ibuprofen. That had immediate relief for my arm and headache. I ran one errand and was wiped out. The fatigue hit again. The arm pain came back so I took another ibuprofen with relief. I had no energy so laid around for the rest of the day. I woke up on Sunday and finally felt normal with just pain at the injection site. The 2 other medical people that have had similar reactions like mine with dizziness and feeling light-headed have one thing in common with me...we are all vegetarians. I don't know if that makes a difference with protein metabolism or other enzymatic activity, but we are the only 3 that I know of out of all of our co-workers who have received the vaccine to react like this.
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| 48 | 2021-01-04 | anxiety |
Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: em...
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Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: employee with an adverse reaction to the Covid vaccination. Reported to RN 10 minutes post vaccination Lips numbness/ tingling, throat fullness and slightly anxious. NP assessed employee and 50mg of IM Benadryl given in the opposite arm (right). No SOB or wheezing noted. VS pre treatment 158/99, 98%-RA, 98-HR, 18-RR. Ten minutes post treatment Lip tingling and throat fullness improving. At 20 minutes post treatment all S&S of adverse reaction resolved VS taken throughout even with 60 minutes of observation time total VS 139/84, 99%-RA, 81-HR, 14-RR. She is feeling tired and will consider calling for a ride to go home as advised by staff.
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| 48 | 2021-01-04 | nervousness |
15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throa...
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15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throat irritation. She states she feels " a bit shaky inside ". Given juice and crackers. BP 143/84. heart rate 89. O2 sat 99%. She was moved into another quieter observation area. She claims she felt better. Given H20 to drink. States she had a bit of chest discomfort but this was nothing new to her. She has been having chest discomfort for the past 1-2 weeks periodically. Upon observing patient for 40 minutes, patient states, she felt better. BP 115/78, heart rate 80. Patient was then released. She states this is the first time this has happened while taking an IM injection.
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| 48 | 2021-01-04 | sensation of foreign body |
30 minutes after receiving the vaccine I had developed a welt and itchiness on an ear. About 45 minu...
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30 minutes after receiving the vaccine I had developed a welt and itchiness on an ear. About 45 minutes to 1 hour after the receiving the vaccine I developed some additional spots on my face and my throat felt like something was stuck in it. I purchased some oral Benadryl from the Outpatient pharmacy took 50mg and in 30 minutes my symptoms were resolving.
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| 48 | 2021-01-05 | feeling abnormal |
they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis s...
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they suspect that I have rheumatoid arthritis; this is like abnormal I mean anybody with arthritis should not be a part of these trials; Never felt this kind of joint pain in my life/these are hitting my every joint in my hand, I can barely move; I have never been in as much pain in my life; I am really bad nauseous; soreness in your arm; This is a spontaneous report from a contactable consumer (patient) (Food service worker in the hospital). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history included Meniere's disease (reported 'Meniere's disease in my left ear'). The patient's concomitant medications were not reported. Consumer stated, ''I just took the COVID 19 vaccine I work at (institute name), (city name), I took it yesterday around 1 and all through the night; they suspect that I have rheumatoid arthritis I got an injection in one of my hips, my right hip and both my shoulders I can inject in cortisone injection and I have never felt this kind of joint pain in my life, I can barely move, I had been calling and I let my director know and anybody that has any kind of arthritis on these trials, I have never been in as much pain in my life and I am really bad nauseous.'' When offered for the website consumer stated, ''I just wanted to report the side effects, I am really nauseous and I can barely move; this is like abnormal I mean anybody with arthritis should not be a part of these trials.'' When probed if vaccine was prescribed by Physician, Consumer stated, ''No it was voluntary, it was not mandatory it was given my hospital administration.'' Product details for vaccine (LOT#, Expiration date, NDC#, UPC#): Consumer stated, ''EH9894, I think for the last number.'' Treatment for adverse events: Consumer stated, ''I don't have anything for nausea, I did take, they told to me take Ibuprofen my doctor said that it would help with the soreness in your arm, I take my Ibuprofen every six hours because it is prescribed to me, but I could barely move my, I can barely move; these are hitting my every joint in my hand.'' Expiry Date of Ibuprofen: 16Jul2021. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.
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| 48 | 2021-01-05 | feeling abnormal |
Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested posi...
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Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020; Tested positive for COVID/positive via Nasal Swab test/fever/body aches/headaches/She was very very weak, almost lethargic/felt really bad/fatigued; gas; bloated; the weight last week she was 167 and this week she was 180; This is a spontaneous report from a contactable nurse reporting for herself. A 48-year-old female patient received her first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) Lot #EH9899, via an unspecified route of administration on 16Dec2020 at single dose by injection in the right deltoid for COVID-19 immunisation. Medical history included borderline hypertension from 2018 and ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) from 2018 and ongoing for borderline hypertension. The nurse reported that she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020. She said this kinda weird. She received the COVID vaccine on 16Dec2020. She tested positive for COVID on 24Dec2020. Obviously she was exposed to COVID prior to the vaccine. She was scheduled to have the 2nd dose on 05Jan2021 but her hospital deferred it to 23Mar2021. She was asking if this was what's recommended.She said this was another weird thing, regarding the weight last week she was 167 and this week she was 180 (in Dec2020). She was very bloated in Dec2020, it was bizarre. He husband did not receive the vaccine and had symptoms on 24Dec2020. She had normal seasonal allergy symptoms. She did not think much of it. She took her Xyzal and her normal things.She took her husband to get tested and he tested positive, so she got tested, and was positive. She worked at (address withheld), and all of her patients were immunocompromised. She was shocked. She did not think this had anything to do with the vaccine. If anything, it has helped her fight the virus.By Christmas day 25Dec2020 her fever was 102, she had body aches, she went into overdrive. She had headaches and lots of gas in Dec2020.She went into overdrive from partial recognition from the vaccine.She was very very weak, almost lethargic. Her O2 saturation have stayed good around 98% in Dec2020. She has done really well. Yesterday or the day before she felt really bad again. She did a virtual visit with (name withheld), and the doctor started her on steroids and gave her an inhaler just in case she needed it. She felt better on 30De2020. On 29De2020 she was so bad and bloated, she only had one dose of the steroids, but had unusual weight gain. Then 2 pounds were gone this morning on 30De2020.She had no pitting edema or edema period. She was very fatigued, but had more energy this morning, probably because of the steroids. She had the vaccine, even though day 7 post-injection, instead of day 10, which was about 50%, her body reacted more so than her husbands because her body recognized it. The outcome of the events was unknown. She was unsure of the outcome. It was up and down. She has felt worse and she has felt better. The reporter considered the event Tested positive for COVID was Not serious and unrelated to the BNT162B2.; Sender's Comments: While reporter causality is noted, a possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.
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| 48 | 2021-01-05 | mental impairment, disturbance in attention |
12/22/2020 2:50pm Shortly after the vaccine was administered experienced SOB and wheezing. Albutero...
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12/22/2020 2:50pm Shortly after the vaccine was administered experienced SOB and wheezing. Albuterol MDI utilized and symptoms subsided. 3:30pm Mild Headache and back pain. Fatigue and lethargic. Pain scale 3-4 5:15pm Headache increased intensity. Fatigue and lethargic. Back pain still the same, took Motrin 600mg-OTC Wheezing, used Albuterol-MDI 7:30pm Headache and back pain increased intensity 12/23/2020 4:54am Woke up with wheezing, headache and back pain. Pain scale 6 Albuterol-MDI utilized 7:42am Wheezing and SOB, Albuterol utilized and symptoms subsided 3:00pm Headache increased intensity throughout the day. Difficulty focusing and multitasking. Loosing train of thought. Fatigue and lethargic. Pain scale7. Motrin OTC 800mg taken with evening medications and went to sleep. 12/24/2020 7:23am Woke up with severe headache and anosmia. 12/25/2020 Headache and anosmia 12/26/2020 Headache and anosmia 12/27/2020 COVID test-Negative result Headache and anosmia 12/28/2020 Headache and anosmia 12/29/2020 Headache and anosmia. Doctor's appointment. Headache treated with Tramadol 12/30/2020 Headache and anosmia. Pain scale 6 12/31/2020 Headache and anosmia Pain scale 3-4 01/01/2020 Headache and anosmia Pain scale 2-3 01/02/2020Headache and anosmia Pain scale 0-2 01/03/2020 Headache and anosmia Pain scale 0-1 01/04/2020 Anosmia 01/05/2020 Headache and anosmia Pain scale 2-3 01/06/2020 Headache and anosmia Pain scale 3-4
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| 48 | 2021-01-06 | feeling abnormal |
Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patie...
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Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patient reports feeling short of breath but no noted drop in oxygen saturation. Oral diphenhydramine 50mg administered.
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| 48 | 2021-01-07 | feeling abnormal |
Pfizer-BioNTech COVID-19 vaccine: Extremely sorry injection site, chills, sweating, body aches, stuf...
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Pfizer-BioNTech COVID-19 vaccine: Extremely sorry injection site, chills, sweating, body aches, stuffy nose, headache, feeling "foggy".
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| 48 | 2021-01-07 | panic attack, excessive sleepiness |
Initial event was soreness at site which resolved on its own within a few days. 2 days after receiv...
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Initial event was soreness at site which resolved on its own within a few days. 2 days after receiving vaccine, I began having an allergy reaction to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed. I have been experiencing chills then profuse sweating. I also so fatigued, I sleep much of the day. I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.
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| 48 | 2021-01-08 | impaired work ability |
Fever of 101 for three days. Around 8 pm on January 1st sever vertigo anytime changing position. Wen...
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Fever of 101 for three days. Around 8 pm on January 1st sever vertigo anytime changing position. Went to open MD who recommended epley maneuver . Was told to do this for "several days" and then come back if it did not go away. Maneuver was done for three days before vertigo went away, but constant dizziness for another three days, and then intermittent dizziness still ongoing. Called into work.
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| 48 | 2021-01-09 | anxiety |
Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach quea...
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Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach queasiness. HR was 156, sats were 100 % on room air. Seemed to subside after 30 minutes . However throughout the rest of the day, waves of similar symptoms recurred predominantly tachycardia and GI along with skin sensitivity. Overnight did ok, but the following morning, again re urged with sustained tachycardia at which time sought ED evaluation. Had one episode in ED with HR in 151, other vital signs maintained. Received solumedrol and Benadryl. After treatment and monitoring without recurrence, discharged home on prednisone , Benadryl. Ativan if needed.
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| 48 | 2021-01-09 | sleep disorder |
Woke up in middle of night with fever and chills and body aches. Arm very sore and hard to lift. T...
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Woke up in middle of night with fever and chills and body aches. Arm very sore and hard to lift. Tylenol taken with not too much relief. Slept most of the day. Second day arm is much better and can move more. Body is still achey.
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| 48 | 2021-01-10 | feeling abnormal |
After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, an...
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After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, and "didn't feel right". Patient was laid flat on a couch, but then passed out and was not responsive to sternal rub. After a code was called, the patient woke up. At no time was there a loss of pulse or SOB. Patient was transported to the ER and was subsequently discharged same day. Patient did report that prior to the vaccination, she ran 13 miles in the morning, which may have had something to do with the reaction.
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| 48 | 2021-01-10 | impaired work ability | sore throat, headache, earache. called in sick to work. |
| 48 | 2021-01-11 | feeling abnormal | patient complained of metallic taste, body felt heavy, eventually subsided |
| 48 | 2021-01-11 | feeling abnormal |
mild brain fog-feeling "stupid" and struggling with connections, like not picking up on humor immedi...
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mild brain fog-feeling "stupid" and struggling with connections, like not picking up on humor immediately, trying to put things away in the wrong place/ "stupid" with brain fog that I called in; mild fatigue; mild intermittent headache; mild intermittent headache/ only mild joint ache in knees; This is a spontaneous report from a contactable other health care professional. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 04Jan2021 11:30 at single dose at right arm for COVID-19 immunization. Medical history included non-Hodgkins lymphoma from 1995, invasive ductal carcinoma 2009 with breast reconstruction; phrenic nerve paralysis left side; cardiomyopathy. Concomitant medications included beclometasone dipropionate (QVAR), and metoprolol. On 04Jan2021 15:30, noted starting around 4 hours after vaccine, the patient experienced mild fatigue, mild intermittent headache, mild intermittent ache in knee joints. The patient was unsure if they were vaccine related but became a little more intense as the evening went on (next 5 hours) but still overall were mild, but enough for the patient to determine they seemed related to the vaccine. Also noted about 6 hours after vaccine, on 04Jan2021 17:30, mild brain fog-feeling "stupid" and struggling with connections, like not picking up on humor immediately, trying to put things away in the wrong place. The patient went to bed about 8-9 hours after vaccine (8pm). The patient usually gets up at 4:45-5am. She was so tired the next morning and "stupid" with brain fog that she called in. She wasn't uncomfortable per se, no headache the next day, only mild joint ache in knees, fatigue and brain fog. No serious reactions. The outcome of the events was recovered on an unspecified date in Jan2021. The patient did not receive treatment for the events. Information about lot/ batch number is requested.
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| 48 | 2021-01-11 | hallucination |
I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt littl...
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I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt little bit sick and I picked up food and I started to feel sick. I went to work and my symptoms got worse and I sat in my desk and I felt like fainting. I just felt so sick and I thought it was my diabetes. A coworker saw me and told me i looked deathly pale and felt fainting and they took me to a ER room. They gave me Benadryl and IV fluids. I started seeing the floor and ceiling warped out, I was hallucinating. My legs felt numb as well. My eyes were twitching constantly. My blood pressure 147/95 and pulse was 112. I went home, ate and went to sleep. On Saturday I felt better and went back to work 12-28-2020, I felt weak and stayed working at my shift. On Tuesday I worked 1 hour and still felt super weak. Today I am starting to feel like myself again. I will not get my second dosage due to my symptoms I have experienced.
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| 48 | 2021-01-11 | impaired work ability |
Developed muscle aches and chills in the middle of the night post vaccine. unable to report to work...
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Developed muscle aches and chills in the middle of the night post vaccine. unable to report to work the following day. symptoms resolved at this time
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| 48 | 2021-01-11 | impaired work ability | patient developed a fever unable to return to work the following day. |
| 48 | 2021-01-11 | insomnia |
Difficult time sleeping last night; Woke up with all joints achy; Aching all up my spine; sort of we...
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Difficult time sleeping last night; Woke up with all joints achy; Aching all up my spine; sort of weird headache; body aching; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. Medical history included depression, had hip surgery last year (from 2020) and anxiety. Concomitant medication included escitalopram oxalate (LEXAPRO) for anxiety and depression. esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), on regular basis naproxen sodium (ALEVE) and paracetamol (TYLENOL) because of her hip. Patient was calling because she was vaccinated yesterday, 03Jan2021. Patient was a nurse and she got the COVID Vaccine yesterday. she wanted to go into the symptom checker or whatever because she was having, she woke, she wasn't (incomplete sentence). she had a difficult time sleeping last night. She woke up like with all her joints start just achy and she did not have a great time. she wanted to report her symptoms. patient have other things. No really big co-morbidities, like, she had depression. she had some body issues like she had a "torn labor" and stuff like that but that needs to be repaired but not like blood pressure, diabetes, none of those things. she had hip surgery last year. she took two Aleve in the morning and two 500 Tylenol. And she took one more Aleve in the evening and two more Tylenol. As of causality, patient stated she believe so. It's much more intense than it was, than she was feeling yesterday. she definitely could feel it after she had the vaccination. she got like this aching all up her spine and sort of the weird headache for about (incomplete sentence). it was for the rest of the day about an hour after she got the vaccination. She was a little too un-tuned with her body aching. Consumer stated, "Is there, I mean, more I was calling to register with that CDC thing or whatever to report, you know just what's happening. I figured it was probably, kind of part of the research study or whatever for symptoms and tracking and all that. Is that what I am doing as well too by doing this or is that something separate?" When probed if reported through CDC questionnaire, consumer stated, "No, I went onto the website and it said that on CDC website the worst thing and it said that you needed a code or something a key code to get into the program and I don't. Is this where the reporting is going or how do I register with the (app Name) or whatever? Is that what I did by telling you what's going on?" When informed about the role of Pfizer Drug Safety, consumer stated, "I did not understand that safety report or I figured that we were like also assisting in some kind of research trial type thing too. Are they going to call me or no? Is this the last time I'm hearing from anyone?" No investigation assessment. No Lab Work. No Treatment. Outcome of the events was unknown.
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| 48 | 2021-01-11 | sleep disorder |
Bad headache, real tired, did not feel all that well sort of sick to my stomach. Also I could not ...
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Bad headache, real tired, did not feel all that well sort of sick to my stomach. Also I could not sleep on my left side that evening. ( that was the side I got vaccine in)
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| 48 | 2021-01-13 | anxiety |
About 10 minutes after vaccination, patient began to experience heightened anxiety with no other sym...
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About 10 minutes after vaccination, patient began to experience heightened anxiety with no other symptoms. Evaluated by a paramedic on staff and symptoms quickly resolved.
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| 48 | 2021-01-13 | anxiety |
pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of ...
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pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of upper extremities/tingling; sore throat; shortness of breath; anxiety; malaise; This is a spontaneous report from a contactable Nurse (patient). A 48-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: EL1284), via an unspecified route of administration in left arm on 04Jan2021 05:15 at single dose for COVID-19 immunization. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient had no Known allergies. Concomitant medication included zinc, vitamin d3, quercetin and sambucus nigra (ELDERBERRY) received within 2 weeks of vaccination. The patient reported that 12 hours after the injection she experienced severe headache, nausea, chills, temp 102, tingling of upper extremities, sore throat, shortness of breath, pressure in her chest on 04Jan2021 17:15. The fever/chills lasted about 12hrs. Chest discomfort, tingling and shortness of breath were transient (possibly anxiety related). Day 2 post vaccine in Jan2021 moderate to severe HA (headache) persisted and malaise. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 48 | 2021-01-13 | anxiety |
About 10 minutes after vaccination, patient began to experience heightened anxiety with no other sym...
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About 10 minutes after vaccination, patient began to experience heightened anxiety with no other symptoms. Evaluated by a paramedic on staff and symptom quickly resolved.
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| 48 | 2021-01-13 | confusional state |
knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition ...
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knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition issues; dizziness
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| 48 | 2021-01-13 | impaired work ability |
got vaccine yesterday. 4 am this morning staff wake up with warm and chill, injection site so painfu...
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got vaccine yesterday. 4 am this morning staff wake up with warm and chill, injection site so painful, headache and body ache. Took a day off today.
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| 48 | 2021-01-13 | sleep disorder |
Fever. T 101 F; The flu like symptoms lasted about 36 hours; headache; chills; Tiredness; Went to sl...
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Fever. T 101 F; The flu like symptoms lasted about 36 hours; headache; chills; Tiredness; Went to sleep early; This is a spontaneous report from a contactable Nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 14:00 for the 2nd dose at single dose, intramuscular on 18Dec2020 11:00 for the 1st dose at single dose for covid-19 immunisation. Medical history included I am allergic to pollen, dust mite. The patient experienced Four hours after 2nd shot, headache, chills. Tiredness. Went to sleep early. The next day still tiredness, headache , chills and fever. T 101 F. The flu like symptoms lasted about 36 hours. All events were non serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolved. No follow up attempts are possible; information about lot/batch number cannot be obtained.
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| 48 | 2021-01-14 | anxiety |
Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a co...
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Uneasiness; tingling; tachycardia; Some abdominal queasiness; This is a spontaneous report from a contactable Physician (Patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EK9231), via an unspecified route of administration on 07Jan2021 13:15 at single dose in Left arm for COVID-19 immunization. Medical history included hypothyroidism, breast cancer and severe local/regional reaction to bee sting. The patient previously took tamoxifen for breast cancer (9-10 years before 10Jan2021). There were no known allergies. Concomitant medications which the patient received within 2 weeks of vaccination included levothyroxine, tamoxifen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced uneasiness, tingling followed by tachycardia within couple of minutes, some abdominal queasiness on 07Jan2021 13:15. Heart rate (HR) was 156. Seemed to subside over a period of 30 minutes. However slow waves of similar episodes occurred throughout the rest of the day, predominantly tachycardia and Gastrointestinal tract. Next day symptoms recurred and sustained a little longer. Sought evaluation. In Emergency department (ED), Labs unremarkable. One episode in ED with HR 151. Blood pressure (BP) maintained. Electrocardiogram (EKG) showed sinus tachycardia. Treated with steroids and Benadryl. On pulse dose steroids and Benadryl with overall improvement. The events resulted in Emergency room/department or urgent care. Treatments Solumedrol and Benadryl were received for the reported events. The outcome of the events was Recovering. This case reported as non-serious.
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| 48 | 2021-01-14 | feeling abnormal |
positive for Covid; positive for Covid; This is a spontaneous report from a contactable healthcare p...
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positive for Covid; positive for Covid; This is a spontaneous report from a contactable healthcare professional (patient). A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiration date unknown), via an unspecified route of administration in right deltoid, on 18Dec2020 07:15 at a single dose for Covid-19 immunization. Medical history included ongoing hypothyroidism and hysterectomy. Concomitant medications included estradiol (taking after hysterectomy) and levothyroxine for hypothyroidism, both ongoing. The patient has no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient stated that she received the Covid vaccine mid- Dec2020. She stated she was supposed to receive the 2nd dose 2 days ago, 06Jan2021. On 03Jan2021, she started feeling bad the day before testing positive, went to urgent care to be tested, thought she had the flu. She tested positive for Covid on Monday 04Jan2021, so she has been in quarantine. She was unable to receive her 2nd dose because she was in quarantine. She wanted to know if it's ok to delay the second dose or if she needs to re-start the series. The reporter assessed the event relatedness was unknown, patient stated that she doesn't know the causality, she has not been in contact with anyone that was known to be positive, but she is a healthcare worker who sees multiple patients a day, so one of them could have been asymptomatic. Outcome of the events was not recovered.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
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| 48 | 2021-01-14 | sensation of foreign body |
Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed...
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Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed at about 25 minutes. Feeling winded at about 30 minutes, lips very slightly blue-ish. Vitals were all normal and no treatment was given. Approx six hours later I experienced a "lump in my throat" for about two to three hours - took Benadryl, which resolved it. Also around five or six hours later ordinary side effects began - fatigue, aches, headache, sore arm. These all resolved by the following morning.
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| 48 | 2021-01-15 | sensation of foreign body |
L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation res...
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L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation resolved following benadryl. tingling still present at 14 hours but has improved.
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| 48 | 2021-01-16 | sleep disorder |
@1106 on 1/16/21 experienced arm tenderness at injection site. @1400 on 1/16/21 experienced head...
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@1106 on 1/16/21 experienced arm tenderness at injection site. @1400 on 1/16/21 experienced headache and took ibuprofen and headache resolved about 1 hour later @2130 on 1/16/21 began to experience chills and general malaise and another headache, took ibuprofen. @0130 on 1/17/21 woke up sweating, with a headache, continued malaise, and chills, took ibuprofen @0730 on 1/17/21 woke up with headache, took ibuprofen @1300 on 1/17/21 fatigue, chills and malaise returned. Still present at time of this submission. Rest and ibuprofen have provided minimal relief.
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| 48 | 2021-01-17 | disorientation, excessive sleepiness |
The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went ...
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The left side of my lip began to twitch, then my lips went completely tingly and numb, my face went numb, and I became a little bit disoriented while driving home. I also noted a pain in the left side of my chest. I got feeling back in my lips in my face approximately half an hour to 45 minutes later. I did take an Allegra allergy pill when I got home. I had already taken one Allegra allergy pill that morning. I slept for 12 hours on the following Friday night and Sunday night, whereas I typically only sleep approximately 6 to 7 hours per night. I noted significant stuffy nose and fatigue for the 3 to 4 days following the vaccine continuing until today.
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| 48 | 2021-01-19 | feeling abnormal |
10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. S...
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10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. She reported throat tightness. , nausea and dizziness. 2 MDs were in the Observation area. They assessed her, gave her 25 mg Benadryl IM and 3 puffs of Albuterol inhaler. Heart rate 110, Resp Rate 12, O2 sat 98% on room air. Pt continued to fell warm and "weird." MDs wanted her to go to hospital but pt refused. Her employer offered to drive her to the ER but she refused. The MDs remained with her, monitoring for another hour. Pt was feeling better and chose to have her husband pick her up.
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| 48 | 2021-01-19 | impaired work ability |
Chills, Fever 100.6, Joint/Muscle Pain, Fatigue, Injection Site Arm Pain, Abdominal Pain, Unable to...
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Chills, Fever 100.6, Joint/Muscle Pain, Fatigue, Injection Site Arm Pain, Abdominal Pain, Unable to work.
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| 48 | 2021-01-20 | feeling abnormal |
Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain...
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Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain & swelling at injection site and up my neck; pain & swelling at injection site and up my neck; worst patient have ever felt, felt like body had been poisoned; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686 and expiry date: unknown), via an unspecified route of administration on the left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included heart disease, diabetes and allergies to sulfa antibiotics. Patient's concomitant medications were not reported. The patient received the first dose on 21Dec2020 (lot number: EH9899) on the left arm. The patient experienced fever 100.5, chills, joint pain, nausea, headache, tachycardia, shortness of breath, dizziness, chills, pain & swelling at injection site and up my neck, inability to lift even a water bottle without having pain on 10Jan2021. In summary it was the worst patient have ever felt, felt like body had been poisoned. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow up attempts are possible. No further information is expected.
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| 48 | 2021-01-20 | feeling abnormal |
Severe headache; chills; body pain; intermittent nausea; extreme fatigue; brain fog; arm pain at inj...
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Severe headache; chills; body pain; intermittent nausea; extreme fatigue; brain fog; arm pain at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 48-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer BioNTech COVID VACCINE; lot number: EL3249; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 16:00 at a single dose for covid-19 immunization. Medical history included asthma, pain and allergies to sulfa drugs. Concomitant medication included montelukast sodium (SINGULAIR), estradiol, meloxicam and fexofenadine (FEXOFENADINE). The patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer BioNTech COVID VACCINE; lot number: EJ1685) via an unspecified route of administration left arm on 19Dec2020 04:45 PM at a single dose for covid-19 immunization. The patient has not received other vaccines in four weeks. The received her vaccine in a hospital. On 08Jan2021 5:30 PM, the patient experienced severe headache chills, body pain, intermittent nausea, extreme fatigue, brain fog and arm pain at injection site. No treatment was received from the adverse events. The patient was not diagnosed with Covid prior to vaccination and has not been tested for Covid post vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 48 | 2021-01-20 | feeling abnormal |
Dizziness; brain fog; achy; chills; sore arm; This is a spontaneous report from a contactable other ...
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Dizziness; brain fog; achy; chills; sore arm; This is a spontaneous report from a contactable other HCP(patient). A 48-year-old female patient received first dose BNT162B2, via an unspecified route of administration at Arm Right on 30Dec2020 10:00 at the 48 years old at single dose for COVID-19 immunization. The medical history included Rheumatoid arthritis and Depression. The concomitant medications were hydroxychloroquine phosphate ( PLAQUENIL ), leflunomide(ARAVA), desvenlafaxine succinate(PRISTIQ). The patient previously took Methotrexate and experienced allergies. On 31Dec2020 11:00, the patient experienced Dizziness, brain fog, achy, chills, sore arm. Mild for maybe 6 hours and a couple hours were moderate. Woke the next day on 01Jan2021 feeling fabulous. There was no treatment received for all the adverse events. There was covid tested post vaccination. There was no other vaccine in four weeks. The patient underwent lab tests and procedures, which included Nasal Swab on 30Oct2020 Negative. The outcome of the events was recovered on 01Jan2021. Information about lot/batch number has been requested.
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| 48 | 2021-01-22 | feeling abnormal |
Around the 18 minute mark began having an odd facial sensation. There was intermittent tightening ...
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Around the 18 minute mark began having an odd facial sensation. There was intermittent tightening feeling at eyebrows and across forehead that would then flutter/spasm, subside, then repeat. The episodes would last 1-3 seconds intermittently for 25-30 mins. No treatment was sought, it did not affect any daily functions.
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| 48 | 2021-01-25 | feeling abnormal |
headache; tiredness/overwhelming feeling of tiredness; nausea; feeling "funny" in the head; a funny ...
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headache; tiredness/overwhelming feeling of tiredness; nausea; feeling "funny" in the head; a funny taste in the mouth; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 13Jan2021 07:50 at a single dose on Left Upper Arm Muscle for COVID-19 immunization. Medical history included thyroid disorder and antidepressant therapy. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder, duloxetine hydrochloride (CYMBALTA) as Antidepressant and multivitamins. The patient stated that she is calling about the COVID Vaccine, she just had the shot at 7:50AM this morning. After getting the shot she heard that she is not suppose to get the shot if she had tested positive for COVID before the vaccine. She wanted to know if this was true or a rumor. Back around Nov2020 she did test positive for COVID. It was the week before the holidays on Wednesday 18Nov2020 when she lost taste and smell, she then got tested on 19Nov2020 Thursday then got results Friday or Saturday morning, the weekend before the holidays that she was positive. The test was a nasal swab. The girls in the office said she was not suppose to get the shot if it had not been 3 months. When she had COVID shot they didn't tell her if she could take it or not. This morning she woke up everything was fine, she drove over to get vaccine, after they put the vaccine in, they made her wait 15- 30 minute, while waiting she was getting a headache, then the headache went away and she then felt funny in the head. She was a little nauseous then that went away. Then she had this overwhelming feeling of tiredness like she could go to bed. She felt bad a little bit. When she then drove back to work at the school she had this funny taste in the mouth. Her boss wanted to call and see if this is all normal. The date of first dose was 13Jan2021, all the symptoms she experienced occurred within half hour of receiving the vaccine. She thinks she is fine. At the moment she does not have the taste in mouth any longer and her headache left. She still feels funny in head as well as she just feels bad inside, she has the feeling of overwhelming tiredness, she just feels like something is coming on, like she knows she is getting sick. She has no Lot or Expiry to share, she vaccine CDC card is outside in the car and not physically with her. Her drive to get the vaccine was an hour away to a Hospital and all the medication was taken an hour before. She went to the hospital to have the vaccine administered. Then she drove to work at a school. She has had an antibody test, in which they draw blood, it was negative but that was even before she caught COVID, it was back in Aug2020 or Sep2020. She has had no issues with vaccines in the past. The outcome of the event headache, a funny taste in the mouth, and nausea was recovered on 13Jan2021, tiredness/overwhelming feeling of tiredness was unknown, feeling "funny" in the head was not recovered. The events were assessed as non-serious. Information about lot/batch number has been requested.
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| 48 | 2021-01-25 | excessive sleepiness |
extreme fatigue. I slept for two days following both vaccines, decreased energy. Sore arm which afte...
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extreme fatigue. I slept for two days following both vaccines, decreased energy. Sore arm which after the second dose remains a dull ache now at two weeks and 3 days after the second dose. Still have severe fatigue. I want to sleep all day.
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| 48 | 2021-01-25 | sensation of foreign body, feeling abnormal |
Presents to Er c/o feeling like "I was falling" approx w/in 5 mins after receiving her second covid ...
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Presents to Er c/o feeling like "I was falling" approx w/in 5 mins after receiving her second covid vaccine. Slight substernal chest tightness w/ feeling like there is a lump in her throat. No sob/tongue swelling/nausea/vomiting or rash reported. Was given benadryl w/ mild relief.
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| 48 | 2021-01-25 | sleep disorder |
Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night...
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Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night had difficulty sleeping and new onset neck pain as well. Finally took tylenol at 3AM. Woke up at 9:15 and walked from bedroom to kitchen at which time had severe orthostatic hypotension with near sycope that did not progress to full syncope due to lying down quickly. Continued with tachycardia for several days and mild shortness of breath for two days. That evening, had new onset RUQ abdominal pain for 2-3 hours that resolved.
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| 48 | 2021-01-26 | feeling abnormal | Extreme fatigue, foggy mind, for 48 hs starting six days after vaccination. |
| 48 | 2021-01-26 | feeling drunk |
a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar b...
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a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; feelings of like disconnection; Feelings of like of being drunk; another larger bulge under her right axillary and that one was causing off and on under the armpit, she was getting some shooting pain; Fatigue; This is a spontaneous report from a contactable Nurse. This 48-year-old female Nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant drugs included lisinopril for blood pressure/hypertension, omeprazole and vitamin supplements. Historical vaccine included the first dose of BNT162B2 (lot# EK5730) on 21Dec2020 for COVID-19 immunization and having a swollen lymph node along her collar bone on the left side which was on the side where she got the shot and it didn't really change much, it just kind of stayed the same size and it remained there for whole three weeks. Nurse stated then she got the second dose of the vaccine and thought that what she was having were a bunch of swollen lymph nodes, and that lymph node was now larger and she had a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary (12Jan2021) and that one was causing off and on under the armpit, she was getting some shooting pain and her lymph node was larger now as well, the lymph node along her collar bone. Nurse further stated she also had some intermittent fatigue that she expected and also off and on feelings of like disconnection or feelings of like of being drunk. But that's not very bothersome, that's just once in a while since 11Jan2021. But she was concerned about the swelling of lymph nodes. No treatment was received for events. Outcome of events was not recovered. Nurse believed that swollen lymph nodes, fatigue and feeling drunk were due to the Covid 19 Vaccine.
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| 48 | 2021-01-26 | sleep disorder |
My right shoulder had intense deep muscle and surface soreness around the injection site that kept ...
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My right shoulder had intense deep muscle and surface soreness around the injection site that kept me awake the first night of receiving the first vaccination. The site was slightly swollen and warm to the touch with a few red dots that did not itch. I did use 500mg of Tylonal to help alleviate the pain. Within 35 hours of the first injection, my arm was not as tender or sore to the touch and did not keep me awake at night. Although still sore, 48 hours later, there is no more swelling and the redness and red spots are gone.
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| 48 | 2021-01-27 | anxiety |
Shortly after receipt of the first dose of the Pfizer-BioNTech Covid-19 vaccine, this patient began ...
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Shortly after receipt of the first dose of the Pfizer-BioNTech Covid-19 vaccine, this patient began complaining of palpitations, "warmth" radiating from the center of chest, and anxiety while in the observation area. She was moved to a quieter portion of the vaccine area where she was asked to lay supine on a bed. She did not have any difficulty breathing or swallowing and also did not have any visible rashes or hives. Her vital signs were as follows: 3:00 PM- BP: 148/85 mm Hg, HR: 144 beats/minute, SpO2: 100% 3:05 PM- BP: 148/85 mm Hg, HR: 156 beats/minute, SpO2: 100% 3:11 PM- BP: 120/76 mm Hg, HR: 127 beats/minute, SpO2: 100% 3:17 PM- BP: 120/76 mm Hg, HR: 120 beats/minute, SpO2: 100% 3:22 PM- BP: 130/77 mm Hg, HR: 132 beats/minute, SpO2: 100% Emergency medical services was called. She stated she felt better around 3:17 pm onwards, however, it was suggested that she visit the Emergency Department due to her ongoing tachycardia. She was subsequently transferred to the Emergency Department for observation and work up. She is awaiting work up currently in the Emergency Department, without any complaints asides from anxiety.
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| 48 | 2021-01-27 | feeling abnormal |
Received vaccine at 3:10. At 3:20 reported feeling a little dizzy. Checked VS BP176/102 HR 84 Pulse...
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Received vaccine at 3:10. At 3:20 reported feeling a little dizzy. Checked VS BP176/102 HR 84 Pulse Ox98% Temp 98.2. Patient reports she has high blood pressure and her PMD has told her to take a second dose of her BP medication if her pressure is elevated. Patient felt well enough to walk back to unit (escorted by RN) to take her medication, at 3:30PM. Re-checked BP at 3:50 178/106, pulse 85 Re-checked BP at 4:10 165/95, pulse 82 After consulting with NP and patient 50 mg oral Benadryl given at 4:15. Patient would not wait in vaccine unit after this and insisted on returning to her unit, instructed her to return or go to ER if symptoms worsen or do not improve. She still felt a little "off" and slightly dizzy but dizziness was not worse when walking and she reports that she did not feel faint.
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| 48 | 2021-01-27 | feeling abnormal |
Severe muscle pain across upper back (felt like muscle was being pulled off bone, unable to sit up f...
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Severe muscle pain across upper back (felt like muscle was being pulled off bone, unable to sit up for longer than 10-15 minutes at a time without leaning on desk or needing to lay down), general muscle pain (not as severe) throughout the rest of my body. Headache, fatigue (exhausted), brain fog, muscle tightness (unable to take a deep breath due to tightness...not short of breath). Swollen lymph nodes in right armpit, overall feeling exhausted. Treatment: I just slept a lot, took Tylenol. I have a doctors appointment today. Outcome: Slowly getting better. Still have brain fog , fatigue (not exhausted anymore), muscle weakness (not the severe pain anymore).
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| 48 | 2021-01-28 | depressed mood |
24 hours after vaccine, both arms began to hurt very bad, felt hot and tingly. Shooting pains in bot...
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24 hours after vaccine, both arms began to hurt very bad, felt hot and tingly. Shooting pains in both wrists and left knee. Became very dizzy. The pain lasted for about 8 hours then moved into both legs with shooting pains in both ankles. The leg and ankle pain lasted for about 8 hours. Now I am just very sore in all extremities and joints. Moving very slowly compared to my usual. Feel very run down. Also had very itchy arms about 8 hours in only for a few minutes, no rash.
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| 48 | 2021-01-28 | feeling abnormal, excessive sleepiness |
Hours 18-30 after the 2nd dose of covid vaccine, I had bad headache (sensitivity to light), body ach...
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Hours 18-30 after the 2nd dose of covid vaccine, I had bad headache (sensitivity to light), body aches, nausea, and very tired. Slept all day, got up for dinner, then went back to bed. Woke up the next day and felt 100% good. I. Other words, had the 2nd dose on Monday morning, Tuesday felt awful, Wednesday felt perfectly fine.
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| 48 | 2021-01-28 | impaired work ability | fever, body aches. called in sick to work. |
| 48 | 2021-01-28 | impaired work ability |
In the evening I went swimming and felt really tired so I cut it short. Next morning I went running ...
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In the evening I went swimming and felt really tired so I cut it short. Next morning I went running and I felt exhausted, so I cut it short as well, as the day progressed I called in at work because I was extremely tired. My body was generally achy and I started with a headache. By noon I took some Tylenol and Motrin and took a nap by 2PM I felt fine. I might have had a slight fever no thermometer available, unable to check. Mostly was chills and the extreme fatigue my main symptoms.
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| 48 | 2021-01-29 | disorientation |
Malaise and severe joint pain, nausea, frequency in bowels, stomach pain, dizziness, headache that s...
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Malaise and severe joint pain, nausea, frequency in bowels, stomach pain, dizziness, headache that started about 12 hours post injection in the night. Arm pain radiating into axilla and down arm from injection site. A bit disoriented upon waking, pushed fluids and OTC meds with some relief of pain but GI symptoms persisted.
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| 48 | 2021-01-29 | sensation of foreign body |
After ten minutes my throat began to feel swollen, a feeling of a lump in my throat. After around 2...
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After ten minutes my throat began to feel swollen, a feeling of a lump in my throat. After around 20 minutes I also began to feel more light headed/dizzy. I was moved to be observed by a nurse for another 20 minutes and when symptoms did not subside I was moved to the Emergency Department where they administered Epinephrine at 9:27am, Pepcid, 9:24am, Solu-medrol 9:24-10:50am. Diagnosis: Anaphylaxis. Dr. wanted to prescribe Benadryl IV but I declined as I needed to drive home and the facility was far from home. I was discharged around 1:00pm. A prescription for an Epi Pen was made by Dr. and filled that day at pharmacy. and spoke to my Dr. at another healthcare organization at 4:30pm. Benadryl OTC was then rx'd by my primary care doctor at 4:30pm-50mg every 6 hrs moving to 25 mg every 6 hours the next day. Symptoms of swollen throat continued into the next day and have not yet abated but also have not worsened. Due to continued throat swelling I have taken 50mg of Benadryl the next day as well. Dr. my primary care Dr. scheduled an allergist appt for Feb. 3, 2021 and advised I should not get the second dose of the COVID19 vaccine until I speak with an allergist and have a treatment plan developed.
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| 48 | 2021-01-30 | sleep disorder, nightmare |
Around 5pm (12/28): chills, arm soreness on site of injection Trouble sleeping as sleep cycles inter...
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Around 5pm (12/28): chills, arm soreness on site of injection Trouble sleeping as sleep cycles interrupted by nightmares, also fever (101), chills and muscle/ joint aches 12/29: nausea/ vomitting with worsening joint/muscle aches. Sent home without finishing workday. Fever continue all day and all night with syncopal episode on friday night. My husband gave me ice bath to break the fever which was 102 ( according to him). *unable to got to the bathroom unassisted from Friday afternoon and all day Saturday* 12/30: fever, muscles, joiny aches and headaches persisted but lesser in severity 12/31: first day fever free ( last and only dose of tylenol at 6am). Mild headache at time of filling up this report(8:51pm) Able to go the bathroom unassisted all day.
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| 48 | 2021-02-01 | anxiety, nervousness |
Felt anxious and nervous 5 minutes after Pfizer vaccine. Patient drank 2 bottles of water and rested...
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Felt anxious and nervous 5 minutes after Pfizer vaccine. Patient drank 2 bottles of water and rested. BP 119/80, pulse 77, O2 sat 100%. Patient started feeling better. No new anxiety and nervousness. No other symptoms. Stable to go home.
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| 48 | 2021-02-01 | confusional state, sensation of foreign body, agitation |
Immediate dry mouth and agitation - drank water to try to combat dry mounth 1 minute marker - tightn...
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Immediate dry mouth and agitation - drank water to try to combat dry mounth 1 minute marker - tightness in throat, difficulty swallowing and slight confusion begins - drank more water and began to suck on lollipop 5 minute marker - confusion, tightness in throat worsens and lump in throat begins - I alerted medical staff who attended to me and gave me a cold compress. 10 minute marker - Drank water, self administered 2 children's dissolvable Benadryl 20mg - remained at hospital for one hour under observation. 50 minute marker - throat still tight, lump subsided, difficulty swallowing persists, confusion lessens, extreme dry mouth persists, tingling in extremities comes and goes - self administered 2nd Benadryl 25mg 60 minutes - left clinic 90 minutes - called primary care physician and left a message 3 hours - primary care responded to take prednisone 20 - 40 mg every 6 hours for 2 days. 3 hours 20 minutes - all symptoms described above subsided. Prednisone was taken for 36 hours as tightness in throat, issue swallowing and lump came back when I tried to stop the Prednisone at 48 hours.
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| 48 | 2021-02-01 | impaired work ability |
I began noticing 2 days after receiving the second vaccine joint stiffness and aches. At the end of ...
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I began noticing 2 days after receiving the second vaccine joint stiffness and aches. At the end of my 9 hour shift I was very stiff in all of my lower joints from the hips down as well as uncomfortable from the achiness. I walked slowly and stiffly as I was leaving work. I felt extremely tired that night and decided to work a shorter shift the next day - 8 hours rather than 9 hours. I took ibuprofen prior to my second shift. I was still achy and stiff but it was a little better witht he ibuprofen. The next day at home on the weekend I was again achy and stiff and took ibuprofen. I woke up on 1/25 with swollen hands that were painful and stiff. I have since had daily swelling of both hands and achiness in wrists non
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| 48 | 2021-02-03 | anxiety |
Patient states she was waiting in post vaccination area when she began to become very anxious. Her h...
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Patient states she was waiting in post vaccination area when she began to become very anxious. Her heart was racing, felt hot, rash on chest, and felt throat feel thick. EMS was on site and took vital signs. Transported patient to Emergency Department via ambulance. Benedryl and Prednisone were administered IV. Patient was monitored for 4 hours at Emergency Department. Followed up with patient today. She is continuing to take Benedryl. Feels much better.
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| 48 | 2021-02-03 | feeling abnormal |
Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/di...
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Right eyelid feels heavy; She slept all day Sunday; Extreme fatigue; Flushed feeling; lightheaded/dizzy; lightheaded/dizzy like she was going to pass out; Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on; Had a heavy feeling in her chest; Tingling sensation on her lips; Tingling sensation on the right side of her face, and cheek; Severe burning in her right ear; Sore throat on the right side; When she was speaking it sounded like she had a thick tongue; Tongue feels swollen; Pain at the base of her skull on the right side; Pain on the right side of her forehead; Pinpoint pain that went down the right side of her spine; Metallic taste in her mouth; felt off; Pain at the injection site; It was so bad that it would wake her up if she rolled over; This is a spontaneous report from a contactable Nurse reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL3248), via an unspecified route of administration on 15Jan2021 at single dose (Once by injection in the right arm) for COVID-19 immunisation. The patient medical history was not reported. Historical vaccine included Hepatitis B vaccine. There were no concomitant medications. On 15Jan2021, after 15 minutes of monitoring she was fine. 5 minutes later or so (after 20 minutes), she had a flushed feeling and was lightheaded/dizzy like she was going to pass out. She returned to her office. She had someone check her blood pressure which was fine. It was 110/60. Normally it runs low in the 90s. Again, she thought she looked flushed. It was reported she had a heavy feeling in her throat and chest and on her face. She had removed her mask but it still felt like she still had it on. She had brought Benadryl with her, as she has had a reaction to the Hepatitis B vaccine before. She took the Benadryl since she felt off. She thinks this first part of what she experienced triggered everything else. By the time she got home, she had a tingling sensation on the right side of her face, on her lips and cheek. She had severe burning in her right ear. She also had a sore throat on the right side. Heaviness in her throat and chest- resolved late Saturday to early Sunday (Jan2021). Her husband noticed on Friday evening (15Jan2021) when she was speaking it sounded like she had a thick tongue. Saturday morning it was more normal. Her tongue does feels swollen. She also developed pain at the base of her skull on the right side. This started about 2 hours after the vaccine. She had pain on the right side of her forehead. She had pinpoint pain that went down the right side of her spine. She also developed a metallic taste in her mouth. She had pain at the injection site. It was so bad that it would wake her up if she rolled over. On 17Jan2021, she slept all day Sunday and also had extreme fatigue. On 18Jan2021, her right eyelid feels heavy on 18Jan2021. She does not think any of these are serious, but stated they are concerning. Vaccination card does not have the NDC or expiration date on it. Patient asked is getting the second dose of the injection recommend. She is leaning towards no but wanted to see what was recommended. She has reached out to her primary care about this. Outcome of the events flushed feeling, lightheaded/dizzy, lightheaded dizzy, like she was going to pass out was recovered on 15Jan2021. Outcome of the events when she was speaking it sounded like she had a thick tongue was recovered on 16Jan2021; Outcome of the events pain at the base of her skull on the right side, pain on the right side of her forehead, pinpoint pain that went down the right side of her spine, extreme fatigue, pain at the injection site was recovered on 17Jan2021; Outcome of the events Had a heavy feeling in her throat and chest/Had a heavy feeling on her face- had removed her mask but it still felt like she still had it on, and Had a heavy feeling in her chest was recovered on Jan2021. Outcome of the events severe burning in her right ear, sore throat on the ride side, tingling sensation on her lips, tingling sensation on the right side of her face and cheek was recovering. Outcome of the events tongue feels swollen, metallic taste in her mouth, right eyelid feels heavy was not recovered. Outcome of the events it was so bad that it would wake her up if she rolled over, she slept all day Sunday, and felt off was unknown. The reporter considered the events as non-serious. Causality assessment for events for felt off, she slept all day Sunday, It was so bad that it would wake her up if she rolled over was not reported. Causality assessment for all other events was reported as related.
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| 48 | 2021-02-03 | nervousness, anxiety, insomnia |
she woke up her hands and feet were very cold; her hands and feet started feeling cold clammy and sw...
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she woke up her hands and feet were very cold; her hands and feet started feeling cold clammy and sweaty; hands and her feet have been sweating; feeling jittery; has not been able to sleep; feeling very nervous and anxious; feeling very nervous and anxious; she can feel cold air through her skin easier now/ under hot water her fingers and feet feel more sensitive to hot water; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on 11Jan2021 17:30 at a single dose on left arm for COVID-19 immunization (COVID-19 vaccination). The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 23Dec2020 at a single dose for COVID-19 immunization. The patient said that she got the second shot on Monday 11Jan2021 about 17:30 in the evening. On Tuesday 12Jan2021, when she woke up, her hands and feet were very cold. Her hands and her feet have been sweating. Her hands and feet started feeling cold clammy and sweaty the next day on Tuesday 12Jan2021 while she was working from home. She is also feeling jittery and she has not been able to sleep and she is feeling very nervous and anxious (onset date for feeling very nervous and anxious also reported as 13Jan2021, pending clarification). She said that she can feel cold air through her skin easier now it feels like, and also said that even under hot water her fingers and feet feel more sensitive to hot water than they did before. She has never had these symptoms (feel nervous and anxious) before. It made her nervous thinking that maybe the shot caused her hands and feet to feel cold and sweaty. The outcome of the events was not recovered.
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| 48 | 2021-02-04 | anxiety |
-increased anxiety, had redness on left forearm and right forearm. After two days redness was gone. ...
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-increased anxiety, had redness on left forearm and right forearm. After two days redness was gone. -took Tylenol that night which helped.
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| 48 | 2021-02-04 | feeling abnormal |
it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left ton...
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it looks and sounds like she has Bell palsy; mental fog; Nauseated; left side of face numb; left tongue felt numb and fat as though I got injected at the dentist; Then medicine taste in my mouth and some slurring; Then medicine taste in my mouth and some slurring; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old female patient received first dose of BNT162B2 (Lot number and expiry date not available), via an unspecified route of administration on 21Jan2021 10:45 at single dose in the left arm for COVID-19 immunization. Medical history included Hypo thyroid (medication not needed at this time). The patient had no known allergies. Concomitant medication included cefixime (FLEXERIL) and ibuprofen (IBU). On 21Jan2021 11:00, after 15 minutes of getting the vaccine, the patient felt nauseated. Then it continued to get worse from there left side of face numb, mental fog, left tongue felt numb and fat as though she got injected at the dentist. Then medicine taste in her mouth and some slurring. Stated that her boss which is doctor side it looks and sounds like she has Bell palsy. She was prescribed Methylprednisolone and she feel somewhat better. Still waiting to feel completely myself. It's been now about 8 hours since her vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included methylprednisolone. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 to the onset of reported events Bell palsy and mental fog occurred 15 minutes after getting the vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-02-07 | anxiety | dizziness, anxiety, metallic taste |
| 48 | 2021-02-08 | feeling abnormal |
Rapid heart rate over 143, high blood pressure 247/100 and something, hard to catch my breath and fe...
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Rapid heart rate over 143, high blood pressure 247/100 and something, hard to catch my breath and felt weird. Onset within 5 minutes. Lasted greater than 30 minutes.
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| 48 | 2021-02-08 | loss of personal independence in daily activities |
This ADR was self-reported via the hospital ADR reporting system. In the patient's own words, "Recei...
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This ADR was self-reported via the hospital ADR reporting system. In the patient's own words, "Received the 2nd shot on 2/3/21 @ around 08:00. Left feeling fine. At around 15:00 started experiencing sore throat. Then switched to chills, with body pain and aches along with low fever and massive headache. Experienced such symptoms during Thursday, February 4th with requesting a day off to recover. On Friday, still had a headache, tiredness, aches and pain, but returned to work".
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| 48 | 2021-02-09 | sleep disorder |
All over body / muscle aches - unable to sleep well due to extreme discomfort. Pain started around 8...
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All over body / muscle aches - unable to sleep well due to extreme discomfort. Pain started around 8pm and intensified through the night. Started to abate early afternoon next day. Did take extra strength Tylenol 4 times between 8pm 2/8/21 and 2pm 2/9/21. As of today, 2/10/21, still have joint pain in right hand knuckles and mid back / right shoulder blade and at injection site.
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| 48 | 2021-02-11 | sensation of foreign body |
After receiving her 2nd COVID-19 vaccine at 1448. The employee reported at ~ 7-8 minutes after rec...
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After receiving her 2nd COVID-19 vaccine at 1448. The employee reported at ~ 7-8 minutes after receiving the vaccine her eyes, ears, head and chest began to itch. o2sat was 100% on ra, b/p 113/51, 67 bpm and RR 16. The employee denied any SOB, no swelling in the throat and no swelling of the tongue. The employee's chest was red. She stated she felt she had "ball of phlegm in throat" . Benadryl 50 mg po x 1 . The employee spoke in clear concise sentences and had no sign of distress. After 40 minutes of observation the symptoms improved.
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| 48 | 2021-02-12 | disturbance in attention |
Neck stiffness, pain, Severe headache/ migraine overnight the night of receiving vaccine 1. Followin...
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Neck stiffness, pain, Severe headache/ migraine overnight the night of receiving vaccine 1. Following 2 days chills, fever 101.5, nausea, headache, joint pain, neck stiffness/pain, dizziness, difficulty concentrating. Swelling like a golf ball at injection site, purple skin and painful arm for 10 + days. Can feel a solid border of about 3 inch diameter around where the golf ball type knot was . Still sore when touched and visible bruise today.
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| 48 | 2021-02-12 | sleep disorder |
Rising blood pressures and severe headache that wakes me from sleep. Blood pressures continued to ri...
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Rising blood pressures and severe headache that wakes me from sleep. Blood pressures continued to rise until 2 days after when BP medication was switched to spironolactone. 3 days later, I presented to ER and additional medication was added to lower my blood pressure. Remains higher than baseline and headache persists although less intense
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| 48 | 2021-02-15 | anxiety |
Patient started complaining of cold sweats, chills, and sweating. She states she suffers from anxiet...
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Patient started complaining of cold sweats, chills, and sweating. She states she suffers from anxiety and thinks she is having an attack. Patient then escorted to the post vaccination area and asked to remove jacket, and given water. After 10 mins of observation she states she is feeling better. Patient then escorted to her car without any incident
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| 48 | 2021-02-16 | feeling abnormal |
Noted after first injection on 1/6/2021 within three hours, extreme fatigue, excessively sore arm an...
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Noted after first injection on 1/6/2021 within three hours, extreme fatigue, excessively sore arm and following morning significant brain fog and loss of energy. Noted after second injection on 1/27/2021, not much in the way of symptoms until about 3:15 a.m. on 1/28/2021 when was awakened from a sounds sleep with tremendous body aches, chills, fever, fatigue and headache. Took about 7 full days to completely recover. During weekly healthcare PCR testing, tested positive for COVID 19 on 2/10/2021. Two weeks later to the day. Week prior test was negative.
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| 48 | 2021-02-17 | impaired work ability, feeling abnormal |
By 8 am, I recognized I realized I felt different - headache and foggy and tired. By 12 pm my headac...
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By 8 am, I recognized I realized I felt different - headache and foggy and tired. By 12 pm my headache became really severe - even when walking or chewing. My face was really hurting me; very tender by left eye. I felt so tired. I had to go home from work at 2:30. Felt very cold and I put on really warm clothes and got under three 3 blankets and I slept for three hours. I felt better by that evening, I slept normally that night. Face was very swollen under my eyes - two days after vaccine. (I have filler under my eyes - it's been a year since I had that put in.) Benadryl every six hours. It took 12 hours for pain to go away and for it to decrease. But it did help. Everything resolved.
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| 48 | 2021-02-18 | feeling abnormal |
I received my 2nd vaccine at 3:24pm. Around 3:30, I had a bitter taste in my mouth in the back of my...
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I received my 2nd vaccine at 3:24pm. Around 3:30, I had a bitter taste in my mouth in the back of my throat. I didn?t associate this with the vaccine. I left the facility around 3:45pm and started driving home. The right side of my face started to feel funny and felt numb. By the time I got home at 4:20, the whole side of my face felt numb. I could smile and talk. It felt like I had received Novocain from the dentist. I immediately started looking for phone numbers to call and tried to figure out what was happening. I left a message with a nurse hotline and left a message with the answering service at my primary care doctor?s office. Doctor FaceTimed with me for 7 minutes at 5:04 and said to go to the hospital.
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| 48 | 2021-02-18 | insomnia |
Employee received the second dose of the Pfizer COVID vaccine. Employee felt deep bone and muscle p...
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Employee received the second dose of the Pfizer COVID vaccine. Employee felt deep bone and muscle pain right after injection. The next day she was unable to move arm away from her body. Took Tylenol and ibuprofen and range of motion improved. Over time pain increased to a constant pain. On 2/14/21 the pain increased to 7 out of 10 while she was laying down and the pain would wake her up at night. Employee reports pain was bad regardless if she was sleeping on right arm or not. Employee reports one day (2/7/21) she experienced numbness in right arm down to fingers tips. Employee was seen on 2/18/21 and was diagnosed with rotator cuff tendonitis and prescribed physical therapy and given a steroid injection: methylprednisone acetate.
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| 48 | 2021-02-18 | sleep disorder, restlessness |
I don't know if this is related, but shortly after getting the shot my sleep patterns have been disr...
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I don't know if this is related, but shortly after getting the shot my sleep patterns have been disrupted. My bedtime is between 10-11pm and my wakeup time is 6:30am. For the last three weeks, since getting the shot, I wake up between 2:30-4:30am and as much as I try to fall back asleep, stay in a restless state until my alarm goes off. There have been no diet or medicine changes or stressful/traumatic events. The only change is getting the vaccine. Is this related?
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| 48 | 2021-02-21 | confusional state |
I am diabetic and my blood sugar dropped in the middle of the night; I am diabetic and my blood suga...
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I am diabetic and my blood sugar dropped in the middle of the night; I am diabetic and my blood sugar dropped in the middle of the night; Sleeping a lot; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 48-years-old female patient received bnt162b2 (BNT162B2, Lot Number Unknown) via an unspecified route of administration on an unspecified date (at 48 years of age) as a SINGLE DOSE for Covid-19 Vaccination , insulin (INSULIN) 'regular Insulin for sliding scale' Lot Number Unknown 'number under the bar code C:1011:1030310691833329. via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , insulin detemir (LEVEMIR) Lot Number 310018652576, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , insulin aspart (NOVOLOG) Lot Number 374934031098, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , semaglutide (OZEMPIC) weekly, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose, weekly for diabetes mellitus. Medical history included hypertension. Concomitant medication included lisinopril (LISINOPRIL). The patient reported I am diabetic and my blood sugar dropped in the middle of the night, so my husband had to get up and give me something (Unspecified Medication) and then I am sleeping a lot and I do have some confusion on an unspecified date. The patient underwent lab tests that included blood glucose: dropped on an unspecified date. Treatment was given for diabetic and blood sugar dropping. Consumer also stated, No, it is not that severe The clinical outcome of the events diabetic, blood sugar dropped in the middle of the night, Sleeping a lot and Confusion was Unknown. The action taken in response to the event(s) for insulin was unknown, for insulin detemir was unknown, for insulin aspart was unknown, for semaglutide was unknown. The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.
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| 48 | 2021-02-24 | anxiety, nervousness, emotional distress |
Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she bega...
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Patient received her first COVID vaccination today at 8:30 pm. Within 15 min of injection, she began to look distressed and reported sensations of tingling in her elbows and behind her knees. No SOB, facial swelling, or heart palpitations. It was felt she may be nervous and she was given water and monitored closely. Vitals taken with O2 100%, HR 58, BP 134/89 Pt received Benedryl 25 mg when she began to note mild erythematous blotching on neck 10 min later vitals stable with bp 138/82 and pulse 62 Pt was given a second 25 mg dose to take if any symptoms worsened on way home- she was driving therefore I did not want to give her another dose at the time. She understands to call for emergency care if any SOB, facial swelling, or any distress Pt confirmed at 10 pm that she made it safely home with some improvement in her symptoms. I will follow up with her in the morning as well and will complete a VAERS report. I have educated her that at this time CDC would recommend not receiving the second vaccination, given potential allergic reaction within first 4 hours. We will review this again tomorrow I communicated with patient morning of 2/25/21- she states still mild tingling of arms but no new or worsening symptoms. She feels this is more consistent with anxiety and hesitant to not receive her second dose. I suggested she discuss with her primary care provider before her next visit and if she were to proceed with her second vaccination, I would suggest someone being with her to drive and she take 50 mg of benedryl 1 hr prior to vaccine. She was appreciative.
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| 48 | 2021-02-25 | feeling abnormal |
Stabbing abdominal pain for 18 hours, brain fog, fatigue, headache, sinus congestion, mild pain at i...
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Stabbing abdominal pain for 18 hours, brain fog, fatigue, headache, sinus congestion, mild pain at injection site. Symptoms started 2.5 hours after injection and lasted 30 hours.
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| 48 | 2021-02-26 | anxiety |
Patient reported feeling anxious and warm after receiving the vaccine. Her heart rate was 130 at th...
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Patient reported feeling anxious and warm after receiving the vaccine. Her heart rate was 130 at the time. Subsequent readings: BP 160/110 O2 Sat 95% HR 119 BP 196/120 O2 Sat 96% HR 125 Patient was transported to the hospital.
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| 48 | 2021-02-28 | sleep disorder |
Severe pain and swelling of lymph nodes under the right armpit and right side of breast. Pain level...
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Severe pain and swelling of lymph nodes under the right armpit and right side of breast. Pain level was a 9 on a scale of 10. Feels like a golf ball is there but not to the touch. I barely slept the first night. I thought I was imagining the swelling but took pictures to compare left and right arm. Swelling is definitely noticeable. I didn't have Tylenol in the house so I used a wet wash cloth underneath my right arm pit to ease the pain. Helped a little bit but not much. The next night I used a refrigerated Gatorade bottle underneath my arm which worked much better. 3rd night I finally was able to get Tylenol and that seemed to help more so but I am still swollen and painful but now more tolerable.
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| 48 | 2021-03-01 | loss of personal independence in daily activities |
2/26 9:30 am: cold sweats, nausea, stayed home from work 2/27, 2/28: unable to perform normal ellipt...
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2/26 9:30 am: cold sweats, nausea, stayed home from work 2/27, 2/28: unable to perform normal elliptical cardio, could only do a few minutes than had to lay down due to extreme fatigue and shortness of breath 3/1: too fatigued to shower, change, or cook a meal. Stayed home from work. 3/2: Went to work. Too short of breath to walk across campus without sitting and taking breaks. Went to urgent care at noon, took PCR test for Covid, was negative.
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| 48 | 2021-03-03 | anxiety |
Approx 3 minutes after receiving the vaccine she became very anxious. She started dry heaving into ...
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Approx 3 minutes after receiving the vaccine she became very anxious. She started dry heaving into the trash can. She also has hypoglycemia and her BS was 100. She was able to calm herself down without medications. Her doctor told her next time to eat more before she goes.
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| 48 | 2021-03-03 | anxiety |
PT COMPLAINS OF "PROBABLE" ANXIETY ATTACK. SYMPTOM CONSISTANT SLIGHTLY ELEVATED RES. NO OTHER OBVIOU...
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PT COMPLAINS OF "PROBABLE" ANXIETY ATTACK. SYMPTOM CONSISTANT SLIGHTLY ELEVATED RES. NO OTHER OBVIOUSE SYMPTOMS. PT MOST COMFORTABLE IN TRIPOD POSITION. BP 148/82 HR 75 O2SAT 99 SKIN WARM AND DRY AT 1420 PT PLACED UNDER OBSERVATION. PT STATED SYMPTOMS CONSISTENT WITH MILD ANXIETY ATTACK PREVIOUSLY EXPERIENCED. ONSET PRIOR TO VACCINATION. 1435 BP 120/82 HR 77 RESP 12 O2SAT 99 SKIN WARM AND DRY CAP REFIL LESS THAN 2 SEC. RESPIRATORY BREATH SOUNDS CLEAR BILATERALLY. FOLLOW UP TREATMENT OF REASSURANCE.
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| 48 | 2021-03-04 | feeling abnormal, memory impairment |
I ran fevers ranging from 103.7 to 102 for 5 days. I had muscle aches, malaise, headaches and dizzin...
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I ran fevers ranging from 103.7 to 102 for 5 days. I had muscle aches, malaise, headaches and dizziness. I am still having "brain fog" to this day. Once I was afebrile I learned there were several days for that time period I did not remember. I am still experiencing headaches and brain fog.
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| 48 | 2021-03-04 | feeling abnormal |
tongue felt numb, and then started to swell as well as throat. Felt very weird swallowing. Pharmac...
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tongue felt numb, and then started to swell as well as throat. Felt very weird swallowing. Pharmacist gave me benedryl and made me stay there longer.
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| 48 | 2021-03-04 | sensation of foreign body |
About 10 mins post vaccine my throat started to feel tight and almost numb.....then I was having dif...
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About 10 mins post vaccine my throat started to feel tight and almost numb.....then I was having difficulties swallowing, as if there was a lump in my throat......a few mins later my inner ears felt like they were burning and I felt pressure. I asked staff if symptoms were a side effect of vaccine at 15 minute mark from waiting period. They had me sit back down for another 15 mins and paramedic come see me. I told him I felt fine other than my throat feeling like it was as getting tighter and the difficulty swallowing. He offered to take my stats and I asked him to wait to see if symptoms would dissipate. After approx 49 mins of waiting from initial shot dose, my heart felt like it was racing and my throat felt tighter and I was now having a much harder time swallowing and I felt lightheaded. They took me back and hooked me up to get my vitals. About 7 mins later they brought an EPI Pen and I administered the shot in my leg. After approx 10mins +/- I began to feel my throat loosening a little. Then over the next 10 mins or so I felt almost normal with little trouble swallowing. They told me that I needed to go to the ER for further Eval. I arrived at ER approx 15 mins later and they gave me 2 Benadryl and 2 steroid pills and monitored me for the next 4 hrs - I was released shortly after - and again no other pain or side effects after EPI Pen and meds they administered. Sent home with EPI Pen and Steroids and instructions on what to watch for.
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| 48 | 2021-03-05 | feeling abnormal |
9pm: nauseous, chills, fever, soreness, headache, extreme fatigue 11pm: Took 15ml NyQuil 8AM: took ...
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9pm: nauseous, chills, fever, soreness, headache, extreme fatigue 11pm: Took 15ml NyQuil 8AM: took 2 800mg tylonal 9am 3/5/2021: chills subsided All symptoms lasted until 11pm on 3/5/2021 3/6/2021: lymph node on left side swollen and sore, mild headache and mild fatigue and fogginess
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| 48 | 2021-03-05 | irritability |
Acute onset of fatigue approximately 48 hours after receiving the vaccine on 30/Jan/2021. Fatigue ha...
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Acute onset of fatigue approximately 48 hours after receiving the vaccine on 30/Jan/2021. Fatigue has worsened and persists to this day. Acute onset of palpitations 48 hours after vaccine and lasting approximately 20 min., headaches lasting 3 days and severe heartburn lasting 3 days. Coarse fasciculations of left pectoralis muscle onset 50 hours after vaccine. This progressed over ensuring days to involve other muscles both above and below the diaphragm including gluteals, gastronemius muscles, abductor hallucis longus, left first dorsal interosseous, deltoids, triceps, various abdominal and spinal muscles, and more recently the left masseter. The fasciculations persist to this day. Muscle pains started 2 days after onset of the fasciculations and are moderate-severe and worsened by exercise. I experienced tingling at the lower limbs on 6 occasions and transient disorientation one day on my way to work. My vision has been a bit blurry at times. i have been moody and short-tempered at times.
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| 48 | 2021-03-07 | depression | What felt like a chemically induced depression + fatigue. Lasted for 3 days |
| 48 | 2021-03-09 | anxiety |
Patient felt tigling in left arm the injection arm. Patient has Anxiety issues . Anxious wanted to b...
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Patient felt tigling in left arm the injection arm. Patient has Anxiety issues . Anxious wanted to be checked.
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| 48 | 2021-03-09 | feeling abnormal |
Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakne...
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Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakness Requires emergency room visit or hospitalization Shortness of Breath, Myalgia
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| 48 | 2021-03-09 | impaired work ability |
I became fatigued that day. Hi progressively became more ill feeling over the weekend. On Sunday mor...
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I became fatigued that day. Hi progressively became more ill feeling over the weekend. On Sunday morning I awoke with massive diarrhea. I developed a 3° above normal temperature throughout the day. I had chills, nausea, dry heaves, headache, loss of appetite, fatigued. This lasted about 24 hours. I was a little bit better on Monday. I tried to go to work on Tuesday. I left early from work on Tuesday because of nausea, extreme headache, vomiting. It is now Wednesday and I have diarrhea again, no fever. I haven?t had the fever since Monday around noon. I still have a headache, nausea, fatigued.
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| 48 | 2021-03-09 | nervousness, anxiety |
Pt was feeling light headed and experiencing and blurry vision. Staff talked to the pt and took vita...
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Pt was feeling light headed and experiencing and blurry vision. Staff talked to the pt and took vitals. Vitals were as followed: P: 98, BP: 149/106, SPO2: unattainable. Pt reported having a history of hypertension and dextrocardia. Pt was breathing well and was able to speak clearly. Pt was AnOx4. Pt stated she has had no food or drink yet today and was nervous for the vaccination. Vaccination site was not raise, inflamed, or warm to touch. Staff concluded pt was most likely experiencing dehydration and anxiety. Staff told pt to monitor symptoms and if any were to return or worsen, to call insurance nursing hotline or 911.
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| 48 | 2021-03-10 | amnesia, confusional state | Episodes of confusion/memory loss, fatigue, headaches |
| 48 | 2021-03-11 | impaired work ability |
Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Im...
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Patient reported swelling of face and tingling of lips within 4 hours of second COVID-19 vaccine. Immediately afterwards, patient was dizzy, flushed feeling, tingling of my lips, and swelling of the right side of my face. These symptoms were not enough to seek medical attention but were there. After that, I had swelling down my arm and into my right hand, up my neck and face, up and down the right side of my back. I have been extremely tired and weak feeling. Some improvement but I am still really sore and the RSD is starting to act up. I have called into work, been eating well, drinking a lot or water, moving as much as I can, and using Advil and Tylenol for pain management. Called into work for three days.
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| 48 | 2021-03-13 | anxiety |
Tingling in roof of mouth, tongue. Patient showed anxiety - emotional about death of cousin. BPs 155...
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Tingling in roof of mouth, tongue. Patient showed anxiety - emotional about death of cousin. BPs 155/95 (pulse 79), 136/90 (pulse 79). Given water and rested.
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| 48 | 2021-03-13 | loss of personal independence in daily activities |
Relatively immediate onset of chest pain with elevated blood pressure above normal. Longer term res...
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Relatively immediate onset of chest pain with elevated blood pressure above normal. Longer term response was palpitations and irregular pulse limiting regular activity for just over one month. Cough and fluid accumulation in lungs began day 5 (similar to my presentation of Covid-19 infection but less intense). Regular exercise was able to resume approximately 2/26/21
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| 48 | 2021-03-14 | anxiety, feeling abnormal |
out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported ...
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out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported sleeping more heavily than usual; woke with her hair wet as if had experienced a fever overnight; anxious; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient started received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient has known allergies to sulfur and penicillin. Concomitant medications were not reported. The patient received first dose of vaccine on 03Feb2021. Immediately following injection, felt as if her heart rate increased; felt as if it remained out of rhythm through Thursday evening eventually returning to a more regular rhythm. She also experienced shortness of breath, impaired vision and some dizziness noted in Feb2021. She also been sleeping more heavily than usual woke with her hair wet as if had experienced a fever overnight. She stated she felt better, but still not at what she would consider her normal self and was anxious about receiving the second dose and wanted to speak with someone to further discuss her concerns. Outcome of anxious was unknown while recovering for the remaining events Information on the Lot/batch number has been requested.
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| 48 | 2021-03-14 | feeling abnormal |
nausea; vomiting; headache; feeling feverish (no fever); Feeling beat up; dizziness; fatigue; This i...
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nausea; vomiting; headache; feeling feverish (no fever); Feeling beat up; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm, on 05Feb2021 at 11:45 (at the age of 48-years-old) at a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included fingolimod hydrochloride (GILENYA), baclofen (MANUFACTURER UNKNOWN), mirabegron (MYRBETRIQ), bupropion hydrochloride (WELLBUTRIN), and hydroxyzine hydrochloride (HYDROXIN). The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies and ibuprofen (MANUFACTURER UNKNOWN) and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced dizziness and fatigue on 05Feb2021 and nausea, vomiting, headache, feeling feverish (no fever), and feeling beat up on 06Feb2021 at 13:30. The events were reported as non-serious. The clinical course was reported as follows: Within one to two hours (as reported), on and off, the patient felt dizziness and fatigue. After 26 hours (as reported), the patient felt nausea, vomiting, headache, fatigue, feeling feverish (no fever) and feeling beat up. The feeling beat up lasted 12-14 hours and the headache lasted 2 days. The patient did not receive any treatment for the events. The clinical outcome of dizziness, fatigue, nausea, vomiting, and feeling feverish (no fever) was recovered on an unspecified date, feeling beat up was recovered on 07Feb2021, and headache was recovered on 08Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 48 | 2021-03-14 | loss of personal independence in daily activities |
severe dizziness and palpitations with any change in posture- Postural Orthostatic Tachycardia Syndr...
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severe dizziness and palpitations with any change in posture- Postural Orthostatic Tachycardia Syndrome. was severe for 4 weeks but is still intermittently present 6 weeks later. I had to move a recliner to my clinic office to be able to get through my work day. could not stand for more than 5minutes without feeling that I would fall down. nausea x 2 weeks severe fatigue limiting activity x 4 weeks chest pain x 4 weeks (intermittent associated with tachycadia, no association with activity or food, pleuritic in nature, lasted 5-30 minutes at a time, no chest pressure, no sweating with it) I am better but not fully recovered.
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| 48 | 2021-03-15 | anxiety, panic attack |
Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes...
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Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes of injections.
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| 48 | 2021-03-16 | nervousness | Shaky, felt faint, hyperventilated Rash on neck Emt checked vitals Heart racing all else good |
| 48 | 2021-03-17 | feeling abnormal |
sx started 5-10 min later-shoulder pain started in L shoulder, vaccine location, went across to othe...
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sx started 5-10 min later-shoulder pain started in L shoulder, vaccine location, went across to other shoulder. next day, walking to garage-could not breathe, chest pain, heartrate elevated, 104 fever. ED-chest xray, EKG, blood work. 3-4 hrs. waiting for heart rate to go down. sent her home 103 fever. felt bad for 4 days after that-heart rate, fever. no Rx. otc Tylenol for fever. Doctor told her she should not have had vaccine since she recently had Covid.
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| 48 | 2021-03-17 | impaired work ability |
Patient received COVID-19 vaccine on 1/4/2021. Later that day developed chills/sweats, body aches, ...
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Patient received COVID-19 vaccine on 1/4/2021. Later that day developed chills/sweats, body aches, cough, nasal congestion, sore throat and shortness of breath. She continues to have shortness of breath and has not been able to return to work.
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| 48 | 2021-03-17 | insomnia |
loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with...
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loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with swelling; severe pain under arm in armpit with swelling; hot feeling on skin; extreme fatigue; had some itchy skin and redness an hour after shot, especially on both arms; had some itchy skin and redness an hour after shot, especially on both arms; Extremely nausea/Often nauseous; insomnia; mild diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809; expiration date not provided), via an unspecified route of administration (anatomical location: arm right) on 09Feb2021 18:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included asthma and known allergies to sulfa drug both from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date not provided) on 19Dec2020 02:30 pm (vaccination location: left arm) and experienced dizziness, extreme itchy skin, headache, and fatigue reported as 'After 1st shot had dizziness and extreme itchy skin 1 hour after shot for approx 2 hours before it ended, then headache and fatigue for 1-2 days. However, after 48 hours all effects from the 1st shot were gone'. The patient experienced spontaneous bleeding under skin by right eye on 14Feb2021. Patient's clinical course is as follows: After 2nd shot, patient had some itchy skin and redness an hour after shot, especially on both arms that lasted a couple hours (started at 7PM and stopped at 9PM). Patient also had extreme fatigue everyday since 11Feb2021, as well as insomnia especially during the first 48 hours. Also had total loss of appetite the past 8 days (17Feb2021), extremely nauseous and mild diarrhea everyday since immediately after 2nd shot until now (8 days later) with no improvement. Often nauseous until close to the point of vomiting. 2 days after 2nd shot started having severe pain under arm in armpit area with swelling and hot feeling on skin. Developed some spontaneous bleeding under skin by right eye about 5 days (14Feb2021) after shot which has now gone away. Fatigue and health is poor with no improvement; most effects seem to be getting worse instead of improving each day. Patient was not COVID tested post vaccination. It was reported that no treatment was provided for the events. Outcome of the event 'had some itchy skin and redness an hour after shot, especially on both arms' was recovered on 09Feb2021; outcome of the event 'spontaneous bleeding under skin by right eye' was recovered; outcome of the remaining events was not recovered.
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| 48 | 2021-03-17 | sensation of foreign body |
Adverse reaction after receiving the COVID-19 vaccine in Vaccine Clinic. Medications: Fludrocort...
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Adverse reaction after receiving the COVID-19 vaccine in Vaccine Clinic. Medications: Fludrocortisone 0.1mg (pt took med prior to vaccine) No current outpatient medications on file. Allergies: Pt reports anaphylaxis x2 as a child after receiving vaccine (varicella and MMR) Not on File Medical history: "low blood pressure" per pt No past medical history on file. This was vaccine dose 0.3ml Pfizer Lot# ER2613 given @ 2:55pm Describe adverse reaction: Per pt "itchy throat" and "knot in my throat" Tachycardia to 110's Hypertension 120-150/80' Employee was monitored for 30minutes. Vaccine @ 1455 and pt started to c/o "itchy throat" @ 1515. Pt requested water and was able to swallow w/o difficulty. C/o feeling dizzy and warm. VS continued to be taken while pt sat on gurney. MERT called @ 1527 and arrived @ 1534. Pt taken to ED. AOD present @ 1530 and escorted pt via gurney to ED w/ MERT @ 1540. A/O x3, following commands, RR 20's. No difficulty breathing. 15:21 128/86 100% RA HR107 RR20 15:27 157/84 100% RA HR100 RR20 15:33 125/85 100%RA HR114 RR20 Anaphylaxis symptoms: Per pt "itchy throat" and "knot in my throat" Tachycardia to 110's Hypertension 120-150/80' Anaphylaxis plan: Anaphylaxis kit within reach. Pt also brought her own Epi pen. Not used. MERT called. Vasovagal symptoms: Dizziness Vasovagal plan: Pt remained seated and gurney brought to clinic. Administration error: NONE MERT called YES @ 1527 Transferred to ED VAERS report number: Email sent to OHS and patient documented in adverse reaction log.
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| 48 | 2021-03-18 | disorientation |
Yesterday on March 17, I was supposed to get my 1st COVID Pfizer vaccine from facility but because o...
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Yesterday on March 17, I was supposed to get my 1st COVID Pfizer vaccine from facility but because of nurse negligence and human error she overdose me and injected two shots of vaccine one after the other at the same time. Right after the incident they shifted me to emergency and kept me under observation there for almost 10 hours. I am a healthy person of no underline issues but still went through physical and mental trauma. Right after the dose I got dizzy, disoriented, my BP shot up, my heart rate was on the lower side now I am moved to home but have severe body aches, headaches, ear pain and allergic rashes itch on both arms and neck . I am scared if this would affect my health in future.
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| 48 | 2021-03-21 | anxiety |
I'm paralyzed; Anxiety; chills; Shaking but not fever; This is a spontaneous report from a contactab...
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I'm paralyzed; Anxiety; chills; Shaking but not fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. Medical history included hypertension, brain injury (doesn't have a good memory), menopause and menopausal problem. The patient is on a lot of medications (unspecified medication) for her Brain injury. The patient previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient had her second dose on 06Mar2021 and had been having bad like chills and shaking too but not fever. The patient was shaking bad (not clarified) there but she doesn't know if it's part of her menopausal problem from my menopause (as reported) but she was shaking. The patient mentioned that she was paralyzed. The patient stated that she was taking some Ativan for anxiety, she has been so anxious; and she had been taking Benadryl. The outcome of the events was unknown.
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| 48 | 2021-03-21 | sleep disorder |
Received vaccination dose 1 at 5pm. Woke in middle of night with abdominal pain and thirst. Day 1 ...
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Received vaccination dose 1 at 5pm. Woke in middle of night with abdominal pain and thirst. Day 1 woke at 6am extremely tired, woozy, nauseous (no fever). I was able to work from home a little but napped several times. Day 2 on a tired but functional, continued abdominal pain turning late in day to diarrhea (about 48 hours post vaccine). Day 3 morning abdominal pain, diarrhea and tired. Day 4 mostly back to normal. I had covid 90 days prior to the vaccination. I'm scared to get the second dose.
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| 48 | 2021-03-22 | disorientation |
Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarr...
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Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarrhea, chills, disorientation, difficulty breathing
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| 48 | 2021-03-23 | anxiety |
Client received 1st Pfizer Covid Vaccine (Lot # ER8732, Exp 3/24/21) approximately 1545. Client was ...
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Client received 1st Pfizer Covid Vaccine (Lot # ER8732, Exp 3/24/21) approximately 1545. Client was sitting in post vaccine waiting area when she alerted EMT she was feeling lightheaded and dizzy. RN joined and began to assess client. Vitals at 1600: blood pressure 126/80 pulse 84, respirations 18. Alert and oriented. No swelling noted. Client denied shortness of breath. Per client no history of allergies or reaction to vaccines in the past. Client asked for water. PHN joined team, client instructed to take small sips of water. Client mentioned she had not ate yet and thought maybe it was related to that. Client informed she would be observed another 15 mins due to current symptoms. 1608 client stated feeling warm, anxious, and still lightheaded. PHN offered client benadryl and client accepted. Per client husband came with her and was going to drive her home. Benadryl 50mg was given orally at 1609. Vitals: blood pressure 144/90, pulse 76, respirations 18. Client informed staff she felt hands were shaky and body was warm. Client alert and oriented, no swelling noted. Vitals at 1616: 140/90, pulse 60, respirations 16. At 1622 client stated feeling better, did not want to wait rest of remaining time. Client was advised to consult primary provider prior to receiving second dose Pfizer. Client also given ER precautions. Husband was waiting in parking lot and was going to drive client home. Client left facility with a steady gait at 1630.
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| 48 | 2021-03-24 | abnormal behaviour, fear |
I had a psychotic episode. I literally thought I was going to drive my self and my nephew to Heaven....
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I had a psychotic episode. I literally thought I was going to drive my self and my nephew to Heaven. I was going to Heaven and I was going to take him with me. I left the house without a phone and drove all the way to where my vehicle ran out of gas. I was apprehended by the highway patrol and taken to the local hospital. They ran all types of test and found nothing. The entire night I was out of my mind. My family came and I treated them badly. I refused to eat, drink, sleep, because I was fearful they would poison me or hurt me. It was awful. After they finally got me to take some sleeping pills, I woke up in my right mind. Why didn't you all have psychosis as a possible side effect? I would have never taken this vaccine had you all put this on the sheet of paper. Only thing you all had was "feeling unwell." What the heck is that? I was out of my mind and I was this hospital's third patient. You all are dead wrong and psychosis should be added to the list ASAP. Who is going to pay this hospital bill plus two ambulance rides?
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| 48 | 2021-03-25 | feeling abnormal |
Patient received vaccine at 14:15 and was in the observation room when at 14:30 reported feeling diz...
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Patient received vaccine at 14:15 and was in the observation room when at 14:30 reported feeling dizzy, warm, hear raising and not feeling right. A team alert was called and at 14:30 healthcare team arrived to provide assistance. Patient's blood pressure was up and was taken by team to medical office for further evaluation.
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| 48 | 2021-03-25 | sleep disorder |
Patient woke up in the middle of the night due to her chin quivering and then noticed facial numbnes...
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Patient woke up in the middle of the night due to her chin quivering and then noticed facial numbness, specifically the left side of her chin and lip. The left side of her jaw was numb and tingling. When she woke up this morning, she noticed that her arm felt heavy, numb, and somewhat tingly. As of late morning today, her arm is still a little tingly and numb. This sensation goes from the top of her arm to her fingertips, specifically her 4th and 5th fingers. She does not notice any facial paralysis or drooling and she was able to suck out of a straw this morning. She will notify her doctor and seek follow-up care if it does not improve.
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| 48 | 2021-03-26 | sleep disorder |
Immediate pain at the injection site, less than with the first dose. 12 hours later at 4:30am 3/26/...
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Immediate pain at the injection site, less than with the first dose. 12 hours later at 4:30am 3/26/21. I woke up with a fever of 99.9, extreme body aches, skin hurt to touch, horrible headache, bad arm pain, wasn't able to sleep much after that due to all of the pain. Got up at 8am but in too much pain and went back to bed. Fever continued all day and fluctuated between 99.9 to 101.6. Headache, body aches, joint pain, arm pain was so intense I couldn't get comfortable lying down but could not stand very long and couldn't sit up due to extreme fatigue. Headache, body aches and joint pain started to diminish enough that I could sit up around 8:00pm 3/26/21. Showered at 8:00pm. Ate at 9:00pm. In bed again by 11:00pm with fever at last check 99.9. Woke up to fever breaking at 1:00am 3/27/21 Slept through the night without waking up due to pain. Woke up at 8am 3/27/21 some low grade fatigue but not in pain, no headache, and no fever. Feeling wiped out, arm still tender but not painful, feeling pretty great all things considered. Will likely have an autoimmune reaction/flare, but when I get sick or get a vaccine it usually comes a few days after.
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| 48 | 2021-03-27 | anxiety |
Severe jerking and shaking intermittently for 18 hours. Also extremely tired for 7 days. Anxiety at...
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Severe jerking and shaking intermittently for 18 hours. Also extremely tired for 7 days. Anxiety attacks prevalent still happening.
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| 48 | 2021-03-27 | feeling abnormal |
feel like I have a chest cold.; feeling like I had the flu; trouble breathing; fatigue; throat has b...
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feel like I have a chest cold.; feeling like I had the flu; trouble breathing; fatigue; throat has been a little sore; cough; feel like allergies all flared environmental and food; nausea; felt horrible; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ENG199), via an unspecified route of administration in the left arm on 04Mar2021 at 17:30 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis, vestibular migraines, allergies to all tree nuts, sunflower oil 25 very high, milk and egg whites, environmental allergy, the patient was recently vegan due to an anaphylactic attack. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included hydroxychloroquine, varenicline tartrate (CHANTIX), escitalopram oxalate (LEXAPRO), lisdexamfetamine mesilate (VYVANSE), metronidazole (TRIAM). There was no other vaccine administered within 4 weeks of the vaccination. On 05Mar2021 at 00:00, the patient woke up feeling like she had the flu. She had trouble breathing and felt like she had a chest cold. She felt fatigue and horrible. This reminded her of how she felt when she had strep throat. Her throat had been a little sore, she had a cough and nausea. She also felt like her environmental and food allergies flared. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "feel like I have a chest cold", "feeling like I had the flu", trouble breathing, fatigue, throat has been a little sore, cough, "feel like allergies all flared environmental and food", nausea and felt horrible was resolving.
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| 48 | 2021-03-27 | impaired work ability |
Starting next day 2/27/21 fever 99-102.8 F, body muscle and joint aches, headache, extreme fatigue c...
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Starting next day 2/27/21 fever 99-102.8 F, body muscle and joint aches, headache, extreme fatigue continuing to present 3/28/21 - seen in doctor office, urgent care and ER. Treatment - had to stay home from work approximately( every time I had a fever) 3 weeks all together. I am an RN - working as a covid tester - so covid testing weekly, and temperature checks 5 days/week. Other than rest, drinking fluids and tylenol and lots of test to rule out other illnesses - no further treatment.
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| 48 | 2021-03-28 | confusional state |
dizziness, confusion, facial flushing, accelerated heartrate, hives and itchiness in throat. Followe...
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dizziness, confusion, facial flushing, accelerated heartrate, hives and itchiness in throat. Followed by two days of soreness to arm and redness at injection site.
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| 48 | 2021-03-30 | anxiety | lightheaded, anxious / resolved. |
| 48 | 2021-03-30 | impaired work ability |
After 1st Dose (2/26/21, 3:50pm)- Pain in left arm appeared about 8 hours after injected and lasted ...
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After 1st Dose (2/26/21, 3:50pm)- Pain in left arm appeared about 8 hours after injected and lasted for about 1-2 days. After 2nd Dose (3/22/21, 3:35pm)- Pain in left arm, fever (100.6 F), chills, headache, nausea, body aches (Severe pain in lower back and hips. Knees and elbows ached too. I assume the aches were associated with the fever b/c this often happens to me with fevers). All of these symptoms started around 3:30am 3/23/21 and lasted through 4-5 pm on 3/23/21. Only treatment was Acetaminophen Extra Strength, 2 pills taken around 2:30 pm on 3/23/21. Symptoms started improving 20 minutes after taking medication. I stayed home from work on 3/23/21, but was able to return to work on 3/24/21. Felt great on 3/24/21. No symptoms.
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| 48 | 2021-03-31 | confusional state |
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo...
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Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Systemic: Vomiting-Severe, Additional Details: none
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| 48 | 2021-03-31 | nervousness |
"Pt complained of blurry vision. VS obtained. BP 167/112; HR 76; O2 Sats 98% on RA; Temp 98.0; pt ...
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"Pt complained of blurry vision. VS obtained. BP 167/112; HR 76; O2 Sats 98% on RA; Temp 98.0; pt noted hx of hypertension, has not taken medication since 2019. Visual field test. On site MD notified, pt transferred to ER for further evaluation. ED summary: symtoms resolved and pt discharged home. Pt was primary nervous! Upon arrival at ED, BP 141/103; HR 71; blurred vision persists "
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| 48 | 2021-04-01 | feeling abnormal | foggy feeling, sweaty palms |
| 48 | 2021-04-01 | excessive sleepiness, loss of personal independence in daily activities |
The morning after the second dose, I woke up with 104 F temperature, chills, massive headache and pa...
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The morning after the second dose, I woke up with 104 F temperature, chills, massive headache and pain at the injection site. Took Tylenol every 4 hours all day long - fever, chills and headache did not stop. Had to spend all day in bed, could not eat, had to get someone to take care of my children - literally could not stay awake or function. Next day I woke up feverish and with a mild headache, Tylenol worked and I was able to function although I did not feel completely well. At night the fever came back and also pain in the back of the neck. Fever was not as bad as the day before. Today, Woke up with headache, tylenol worked and I am functional. No fever. The pain at site injection is reseeding; it was sore and lymph nodes of arm pit are still swollen but it does not bother me. The other symptoms were scary.
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| 48 | 2021-04-01 | excessive sleepiness |
On 3/31/21 patient was observed for 15 minutes following vaccination and reported no change to healt...
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On 3/31/21 patient was observed for 15 minutes following vaccination and reported no change to health status, so was cleared to leave the clinic area. Patient called the next day (4/1/21) to report that approximately 40 minutes following her vaccination, while driving home, she experienced sudden shortness of breath, muscle spasms, and increased heart rate. Patient reports that she pulled her car over to the side of the road, and then "blacked out". Pt does not know how long she was "out", but upon waking she vomited and called a family member for a ride home. Patient reports that when she got home, she slept for 14 hours. Woke up the next day (4/1/21) and felt sore and exhausted. Vomited a few more times throughout the day, and was on the toilet and she "saw spots" and "blacked out" again. Patient say she did not fall over or collapse. Family member observed this "black out" to last about 30 seconds. As of 4pm that day, more than 24 hours post-vaccination, she was still feeling unwell and not able to keep food down. Patient denies hives, itching, fever, congestion, swollen lips/face. Patient was advised to drink water or electrolyte-drink, rest, and call 911 or her PCP if she experienced another episode of SOB, "black out" period, prolonged vomiting, or new symptoms. Patient agreed to suggested course. Patient has no health insurance, doesn't want to come to a medical clinic for evaluation.
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| 48 | 2021-04-01 | impaired work ability |
I started with a very itchy scalp as I was driving to the office after my shot. Shot was at 9:45, I ...
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I started with a very itchy scalp as I was driving to the office after my shot. Shot was at 9:45, I arrived at the office around 10:23 and felt very itchy. I took two Tylenol when I arrived as advices for soreness. I felt hives/rash on the back of my neck around 12:15 or so. Then in my underarm, back of my knee and inner elbow area. I started feel nausea. I drank plenty of water and had a few bites to eat. My hives/rash were popping up and I was using topical Benadryl. Soon after, I took on 25 mg Benadryl. I called my doctor?s office for guidance around 4: 10 pm and then started throwing up. I had someone drive me home. No fever. I developed red hives around my hairline and around eyes. Felt very tired. Next day, I stayed off work and drank plenty of water and slept a lot. Rash had cleared but the red hives around my hair line and eyes were visible. Called doctors office and was told to continue Benadryl.
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| 48 | 2021-04-01 | loss of personal independence in daily activities, sleep disorder |
The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain beca...
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The day after receiving the shot I developed pain in my entire arm from armpit to fingers. Pain became severe by day 3. Pain spread to my right breast, neck, back, and right scapular area. I have had numbness in my fingers on right side. Today is 16 days. The pain increased every day for about 10 days. Decreases slightly and is now holding. I'm am in terrible pain. I didn't sleep for 6 days when the pain was at is peak and still can barely sleep. It's the worst pain of my life. It feels like my arm is in fire and in a meat grinder. My arm and neck pain worsens when I use my arm or change positions. I am also getting flushed heat feelings on my face intermittently. Since this vaccine I have had allergic reactions to ibuprophen and prednisone which sent me to the ER. Two medications I have received before with no problem. I also felt I was reacting to gargling with listerine which I have used before without issue. I eat eggs regularly and got a small sensation of throat swelling with that too and have not eaten them again. My doctor is having trouble treating me since I am now having so many allergy symptoms to different things. I have been advised by my doctor not to continue with this vaccine or any vaccine in the future. I am still in terrible pain that is limiting me from participating i. my normal life activities. I did not develop any rashes or obvious swelling at the injection site. Twenty minutes after receiving the shot I did get a bit flush feeling and some redness in my face and my ears felt hot and then cold. That resolved within about 45 minutes.
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| 48 | 2021-04-03 | feeling abnormal |
1st shot just had sore arm the next day for a few hours. 2nd shot side effects 6hrs after: sore arm,...
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1st shot just had sore arm the next day for a few hours. 2nd shot side effects 6hrs after: sore arm, muscle aches entire body, extreme fatigue, body feels really heavy (like being pulled down), chest feels thick (like full of cotton), headache, alot of nausea, taste and smell are muted (still have both but not as intense as normal). My doctor thinks I was an undiagnosed covid case, early on in the pandemic (had been exposed unknowingly to someone who had traveled 3mths overseas at the pandemic outbreak, the tests they ran came up unknown but all my symptoms were what would turn out to be covid symptoms including complete loss of taste and smell.
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| 48 | 2021-04-03 | feeling abnormal |
Weakness, fogginess in head - not thinking clearly, chills even a week later, no energy, exhaustion,...
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Weakness, fogginess in head - not thinking clearly, chills even a week later, no energy, exhaustion, funny feeling on left side of face, loss of appetite, general feeling of unwell and not feeling like myself.
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| 48 | 2021-04-03 | sleep disorder |
Joint pain. Swollen lymph nodes. Pain in lymph nodes under right arm. I had some lymph nodes removed...
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Joint pain. Swollen lymph nodes. Pain in lymph nodes under right arm. I had some lymph nodes removed from under my right arm in 2010 as treatment for breast cancer. The remaining lymph nodes were extremely sore after the second Pfizer Covid-19 vaccine. I have not had trouble with these lymph nodes since some were removed. It hurt so much I couldn?t sleep. This lasted for about a week. The doctor prescribed pain medication, but I chose not to take it. Just took Tylenol instead.
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| 48 | 2021-04-04 | feeling abnormal |
After 1st: swollen node in throat, breast pain on right side After 2nd: (shot at 4:30pm) sore arm, ...
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After 1st: swollen node in throat, breast pain on right side After 2nd: (shot at 4:30pm) sore arm, then next morning, aches thorughout body - muscles and joints all day. exhuastion. Chills started around 2 pm 4/2; then fever began about 30 minutes later lasting into early morning hours of 4/3 and spiking to 105.5 - with Motrin and Tylonal every 3 hours it held b/t 102.8 - 103.8. 4/3, no fever but hurt, tired, foggy brain. 4/4, muscle aches, not feeling right, headache 4/5 (today) headache, body "off" - don't feel right - body feels slow and heavy, bad headache still
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| 48 | 2021-04-04 | sensation of foreign body |
Chest clear to auscultation oropharynx without edema. BP 119/94 mmHg, HR 82 BPM, 98% RA Around 10 mi...
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Chest clear to auscultation oropharynx without edema. BP 119/94 mmHg, HR 82 BPM, 98% RA Around 10 mins after receiving vaccination, she reported sensation of lump in throat, chest tightness/dull pressure and hives on the back of her tongue, without facial/lip/tongue swelling, hoarseness, SOB, dysphagia or pruritic. Apart from the chest tightness, she reports similar reactions in the past to shellfish, corn, and iodine contrast, but resolved after receiving Benadryl 25 mg capsule with subsequent improvement in the lump sensation, but also reported the chest pressure was not going away. She and her husband were advised to go to the ED via EMS, but they declined and stated they would seek emergent evaluation if symptoms worsened or didn't improve fully/resolve, and husband said he is an EMT. They were again advised that we should call EMS and have her go to the ED, but they again declined
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| 48 | 2021-04-06 | anxiety |
Approximately 40 minutes after administration of the medication, general statement to another staff...
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Approximately 40 minutes after administration of the medication, general statement to another staff member that she was feeling itchy. This other staff member reported it to me. I assessed staff member and her complaints were that her throat was feeling tight and that her arms were itchy and she felt anxious and hot. No rash noted. Staff member was given a fan to cool off and she kept insisting that she was fine. Benadryl 50mg was given po at her request at approximately 50 minutes after vaccine. About 75 minutes later, she states she feels like it may be getting worse. I phoned NP and called EMS. Staff member had her own Epi pen (states she asked for it when she had a reaction to Amoxicillin a while back). While on the phone with EMS dispatcher, and staff member was answering questions, it was decided to have staff member to go ahead and do her Epi pen auto inject. It was injected by herself in her Right outer thigh. Almost immediately staff member states that she felt better. EMS arrived a short time later, approximately 12 minutes, staff member states felt better, with no further feelings of her throat being tight or itchy. BP was elevated at 170/90 as per EMS. Staff member refused to go to ER to be evaluated as she states "I am much better now." Staff member continued to stay at work for another 30 mins and allowed a fellow staff member to follow her home. I also checked on her at 745pm via phone and she states that she is just sleepy.
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| 48 | 2021-04-06 | confusional state |
SOB, numbness and tingling in lower extremities. Confused, did not know where she was . BP 170/100 ...
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SOB, numbness and tingling in lower extremities. Confused, did not know where she was . BP 170/100 HR 135 EKG- PVCs. transported to Hospital
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| 48 | 2021-04-06 | insomnia |
Bouncing off the walls with energy. I felt like I was on meth, I didn't have any jitters or shakes, ...
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Bouncing off the walls with energy. I felt like I was on meth, I didn't have any jitters or shakes, just days and days of energy I haven't had since I was a kid. I couldn't sleep, I couldn't sit still, I literally was amazed at how much energy I had. And since I have not heard about anyone with these symptoms, I thought I should advise someone. In 1 week I did more work than I have in years and I'm disabled, I hardly do anything. It lasted only a few days, and now I'm back to being lethargic, hardly doing anything. It was a nice change of pace. There were no other side effects.
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| 48 | 2021-04-06 | sleep disorder, disturbance in attention |
On 3/15/21 approximately 4 hours (8PM) after receiving the second vaccine I noticed a loud ringing i...
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On 3/15/21 approximately 4 hours (8PM) after receiving the second vaccine I noticed a loud ringing in my ears. This has continued since at varying tones and volumes. It is centered in the middle of my head, not in one ear or the other. It ranges from the sound of a running toilet to the sound of cicadas. It is constant, varying in intensity throughout the day. Occasionally the intensity seems to cause difficulty breathing , difficulty focusing, and fatigue. Additionally, it seems to be disrupting my ability to sleep.
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| 48 | 2021-04-07 | sleep disorder |
At about 6pm, started feeling run down and not good; had a fever of 100; Could only sleep off and on...
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At about 6pm, started feeling run down and not good; had a fever of 100; Could only sleep off and on; chills; This is a spontaneous report from a contactable consumer. A 48-Year-Old female non-pregnant patient (consumer) received second dose BNT162B2 (Solution for injection, EN5318, COVID19, Brand: Pfizer) via an unspecified route of administration in right arm on 18Feb2021 at 10:00 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (COVID19, Brand: Pfizer, Lot number: EN5318) on right arm on 28Jan2021 at 10:00 AM for COVID19 immunization. On 18Feb2021, at about 6pm, started feeling run down and not good. Took 2 Advil Liquid Gels. Woke up at about 2am and took temperature and had a fever of 100. Could only sleep off and on, had chills and fever persisted until about 7am. No covid prior vaccination and no covid tested post vaccination. Outcome of events was recovering.
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| 48 | 2021-04-09 | sleep disorder |
Approximately 12 hours (around 2am) after the 2nd dose, my upper body felt very achy, especially my ...
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Approximately 12 hours (around 2am) after the 2nd dose, my upper body felt very achy, especially my arms and "core" body. I also felt cold, and had a headache. I did not sleep well; however, I was too tired and muscles too sore to get up in the morning. I slept until around 1pm the next day . At approximately 1pm the next day (about 23 hours after the 2nd dose). I felt well enough to get out of bed and move around, but still very tired and went to bed early in the evening. After the second night of sleep, I woke-up refreshed the next morning and did not have any more symptoms.
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| 48 | 2021-04-10 | feeling abnormal |
I immediately had a sore throat, a burn/blister spot on roof of my mouth and an instant headache. I ...
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I immediately had a sore throat, a burn/blister spot on roof of my mouth and an instant headache. I felt like I was developing hives and felt odd. The shot also burned as it entered my arm.
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| 48 | 2021-04-10 | memory impairment, feeling abnormal |
My first on 03/19/2021 went smoothly, just sore area of shot. They had me wait 15 minutes after just...
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My first on 03/19/2021 went smoothly, just sore area of shot. They had me wait 15 minutes after just in case adverse reaction. On 04/09/2021 came back for second round. The nurse gave me my 2nd shot and said they don?t make patients wait after injections, I left the facility and by the time I reached my car my tongue had swollen up, went home and later that night my husband and kids asked what was wrong with my eyes - both my eyes were bloodshot red and swollen. On 4/10, my left eye was better but not my right. I have had brain fog, not being able to remember short memories all weekend. I plan to call my doctor in the morning. As a woman, I felt morally obligated to share my side effects.
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| 48 | 2021-04-11 | sleep disorder, feeling abnormal |
Within an hour or so, became severely congested; was like sinuses filled with cement. Could only bre...
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Within an hour or so, became severely congested; was like sinuses filled with cement. Could only breathe through mouth, and felt short of breath as result. Later developed cough which lasted for several days. Felt as though my seasonal allergies had been turbo-charged. Some fatigue. The next night had low fever (99F; but I usually run a little over 97F). Injection site hurt upon movement for 48 hours. Resolved, but several nights later (day 4 or 5) had tingly pain at injection site that woke me from sleep, and persisted into next day.
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| 48 | 2021-04-13 | irritability |
Soreness at injection site-started 4 hours after injection, lasted about 36 hours Fatigue- started n...
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Soreness at injection site-started 4 hours after injection, lasted about 36 hours Fatigue- started next morning 9am. Lasted off and on about 48 hours Hot flashes- started about 6 hours after injection. Totally random times lasting 5 minutes to 30 minutes each without fever over the next 84-96 hours Headache- 48 hours after injection. Off and on over next 48 hours Irritability- started 30 minutes after injection. Has been 105.5 hours and is still occurring.
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| 48 | 2021-04-14 | feeling abnormal | Dizziness, brain fogginess for 45 minutes after shot. Symptoms slowly decreasing. |
| 48 | 2021-04-14 | feeling abnormal |
About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both...
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About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both arms, hands and right legs. I first noticed my symptoms as I had been walking for about 2 miles and I felt my right leg becoming weak all of a sudden and I felt dizzy, dizzy as in feeling like collapsing. I did not collapse but felt o the verge of it all the way back to my house. I had to concentrate real hard to walk back to my neighborhood without passing out. It happens on two other walks. I have now stopped all walks since week 3 of my vaccine. Into my second dosis and it is worse. Other symptoms include feeling lethargic as if I had a serious disease tired after just washing a plate kind of fatigue. I can feel my heart beat very strongly in my right breast, in my throat or in the back of torso by the end of the day. My arms are always numb but with different intensity, especially if I walk around a bit, with my arms facing down. I am feeling extremely dizzy as unstable and having to concentrate to walk very straight if I am out side. My legs feel like they are not reliable (never have had that feeling at my age). It is more than feeling like a zombie, it is feeling too weak to do anything and my head is sometimes spinning. The numbness can be painful as a sudden thrust in an arm ( this does not last more than a few seconds). It has now been going on since week 3 of my first dosis and today is day 7 of my second dosis! I had 0 symptoms on the first 2 weeks of my vaccine, dosis one. Now, I don't see any progress, rather a slight worsening of all the symptoms above. It is freakish not knowing what I have, of course. One can imagine, so stress adds to the mix sometimes during the day. I would not dare to even go walk my dogs now. A short grocery store visit at the most.
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| 48 | 2021-04-14 | panic reaction |
post vaccine pt reported funny taste in mouth and began to panic. Pt evaluated in tent and recovered...
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post vaccine pt reported funny taste in mouth and began to panic. Pt evaluated in tent and recovered.
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| 48 | 2021-04-15 | agitation |
She felt like she couldn't breathe; Oxygen level was low; Adrenaline rush/Felt agitated; Heart was b...
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She felt like she couldn't breathe; Oxygen level was low; Adrenaline rush/Felt agitated; Heart was beating fast; Blood pressure was up; This is a spontaneous report from a contactable consumer (Patient herself). A 48-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown, Expiration date: Unknown) via unspecified route of administration in the right arm on 28Jan2021 13:20 as SINGLE DOSE for COVID-19 Immunization. The patients medical history included ongoing Hashimoto's disease (for about 20years), Breast cancer (had her five year clearance recently) and AFib (She had AFib two years ago because she was on too high of a dose) from an unknown date. Concomitant medications included ongoing Levothyroxine Sodium (Tirosint) at 175ug daily for hashimoto's disease and Liothyronine at 5ug daily for hashimoto's disease. Family history included her son had a reaction to a vaccine, but she is not sure which vaccine it was. His arm was swollen, red, hot, and painful after the vaccine. The patient has not tested for COVID-19 prior to vaccination and not since vaccination. The has not taken any Pfizer vaccine previously and not taken any other vaccine on the same day. The patient experienced adrenaline rush, heart was beating fast, blood pressure was up and felt agitated from 01Feb2021. She had the Pfizer vaccine on 28Jan2021 and four days later at work she felt like she had an adrenaline rush that lasted for 3 hours. It felt like her heart was beating fast, her blood pressure was up, and she felt agitated. It was unusual. It seemed to stop and she went to sleep at 20:00. She woke up at 22:00 and her heart was beating out of her chest and she felt like she couldn't breathe. Her Apple watch showed her heart was beating at 140 sitting still. She went to the hospital. It stopped after 45 minutes, maybe an hour. Her oxygen level was low when she got to the hospital. It was 92 and her blood pressure was up. She has just a higher level of agitation. She is not sure if that is the immune system. She snapped at someone at work and she has never done that. Her heart rate and blood pressure have resolved completely. The agitation is still there. She went to the ER on 02Feb2021. It resolved in the ER, so she was not admitted. She had no more racing heart that day. Her blood pressure was up in the ER. The agitation comes and goes. She gets that way when her adrenaline is going, if her blood pressure is up, or if she takes a steroid. Any kind of adrenaline reaction. She hasn't used them for so long. She did not reacting well to it. They checked her thyroid level. She had AFib two years ago because she was on too high of a dose. She was on the same brand of Tirosint, but higher dose. The dose may have been 200mg but she is not sure. She is not absolutely sure what dose she was on at that point. She wasn't on Liothyronine at that time. The patient visited the emergency room as she thought she was having a heart attack. It scared her. she is going to talk to her cardiologist to make sure it is ok for the second dose. The outcome of the events heart was beating fast and Blood pressure was up recovered, the outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 48 | 2021-04-15 | confusional state |
Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t qu...
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Tremors shaking hot cold sweats elevated blood pressure fatigue confusion blurred vision couldn?t quench my thirst dry mouth unsteadiness
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| 48 | 2021-04-15 | depression |
Extreme debilitating depression for approximately 4 days post vaccine.; This is a spontaneous report...
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Extreme debilitating depression for approximately 4 days post vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number EL9264) via an unspecified route of administration, in left arm on 02Feb2021 at 22:00 as single dose for Covid-19 immunization. The patient was not pregnant. The patients medical history included coeliac disease, autoimmune thyroiditis, fibromyalgia and hypertension. Concomitant medications included hydrochlorothiazide, lisinopril, liothyronine sodium (T3), levothyroxine sodium (T4). The medical history include allergy to Compazine, Wellbutrin and Midrin. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 04Feb2021 the patient experienced extreme debilitating depression for approximately 4 days post vaccine. The patient did not receive any treatment for the event. The clinical outcome of the event was recovering. No follow-up attempts are possible. No information is required.
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| 48 | 2021-04-15 | feeling abnormal, loss of personal independence in daily activities, impaired work ability |
About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both...
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About 3 weeks after my first dosis of the Pfizer vaccine, I started having constant numbness in both arms, hands and right legs, dizziness, pins and needles, extreme fatigue, lethargy, feeling the pulse of my heart rate in various part so my body in an opressive kind of way like in my throat, under my right breast, in my back on the ribs usually. All these symptoms never subsided and became noticeably worse a few days after my second dosis on April 8th. My arms are always numb when I get up and become worse when hanging down, of course, but with different intensity. I am feeling extremely dizzy as I walk around and unstable. Walking feels like the ground is further than it is in a way. I do notice a slight shortness of breath but more of an oppression in the rib cage than panting. I have been avoiding walking far or walking my dogs all together. I am not seeing any improvements even after my visit to the Urgency Care where nothing wrong was found on blood work and EKG. I was told to reduce inflammation with dietary supplement and some vitamins. I cannot work of course and what is a bit frightening now is that I am not improving on day 8 of my second dosis! Same rotation of weird symptoms all day (feeling my blood not circulating normally if that can be described even, numbness, pins and needles in arms, and right leg. Sometimes it affects my right cheek. Dizziness and unstability to walk around. Vision is lower as well. Too weak to do anything constructive. My legs feel like they are not reliable (never have had that feeling at my age). It is more than feeling like a zombie, it is feeling too weak to do anything and my head is sometimes spinning. The numbness can be painful as a sudden thrust in an arm ( this does not last more than a few seconds). It has now been going on since week 3 of my first dosis and today is day 7 of my second dosis! I had 0 symptoms on the first 2 weeks of my vaccine, dosis one. Now, I don't see any progress, rather a slight worsening of all the symptoms above. It is freakish not knowing what I have, of course. One can imagine, so stress adds to the mix sometimes during the day. I would not dare to even go walk my dogs now. A short grocery store visit at the most.
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| 48 | 2021-04-15 | feeling abnormal |
Systemic: tingly/fuzzy feeling around nose and upper cheek area-Mild, Systemic: Tingling (specify: f...
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Systemic: tingly/fuzzy feeling around nose and upper cheek area-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt had tingly/fuzzy feeling around nose and upper cheek area. She sat in observation for a total of 30 mins, pt was given Allegra and after 30 mins, said she was feeling back to normal
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| 48 | 2021-04-15 | feeling abnormal |
I started out with a sore neck about 12 hours after the injection. As the day went on, fatigue, sev...
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I started out with a sore neck about 12 hours after the injection. As the day went on, fatigue, severe joint pain, general achiness set in. As the day went on I experience brain fog, chills and occasional dizziness. 24 hours after the injections I experience severe chills and night sweats. 36 hours after the injection, most of the pain subsided, but slight fatigue and brain fog remained. I took Tylenol the help with symptoms of pain soon after they began.
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| 48 | 2021-04-15 | impaired work ability | Headaches for 2 1/2 days and needed to be out of work |
| 48 | 2021-04-15 | insomnia |
Started to have body aches, head aches and neck pain from next day morning and keep on progressing t...
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Started to have body aches, head aches and neck pain from next day morning and keep on progressing the symptoms even after 4 weeks. So tested for Covid on 2/23/21 and was positive. Also tested positive on 11/2/2020 and recovered in 3 weeks. My allergies increased in frequencies and intensity during last 12 weeks and had a severe anaphylactic shock 3 weeks ago which required calling 911 and ER treatment for stabilization. Till today, I have body aches, neck pain, insomnia and head aches and I am doing everything in my knowledge to improve my health. Multiple doctors and specialist appointments, are still continuing for treatment .
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| 48 | 2021-04-15 | insomnia |
Pfizer-BioNTech COVID-19 Vaccine EUA Tinnitus Began day after injection, off and on for two days. T...
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Pfizer-BioNTech COVID-19 Vaccine EUA Tinnitus Began day after injection, off and on for two days. Third day through now, the 6th day, constant tinnitus all day and night. Causing difficulty sleeping. Causing some dizziness.
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| 48 | 2021-04-18 | excessive sleepiness |
Immediately after receiving the shot, my tongue became numb and tingly, lasting almost two minutes. ...
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Immediately after receiving the shot, my tongue became numb and tingly, lasting almost two minutes. I was just about to call for the nurse when it seemed to subside. I felt fine that afternoon, but the following day I had no energy and slept for 12 hours.
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| 48 | 2021-04-18 | loss of personal independence in daily activities, impaired work ability |
Shot received at approx. 10:45 am on 4/17/2021. Started feeling very tired in afternoon, by 6pm on s...
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Shot received at approx. 10:45 am on 4/17/2021. Started feeling very tired in afternoon, by 6pm on same date, completely exhausted, achy and headache, sore arm, started having chills on and off 4/18/20 - woke up at approx. 4am crying in excruciating pain. I literally hurt from my hair to my toe nails and everything in between. More than regular muscle aches, could barely function. At some point during the day, I developed a fever. Several times checked thru the day, maintained around 100. Complete exhaustion 4/19/20 - woke up approx. 6am. The excruciating pain had moved to extremely sore muscle, still exhausted, no longer have fever. Notice swollen lymph nodes on left side. I have a welt about the size of a baseball located next to my armpit towards my left breast. VERY swollen and painful. Injection site is still sore and very hot. Fatigue is still keeping me from working. I had to call out sick to work today.
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| 48 | 2021-04-19 | feeling abnormal, anxiety |
"48 y/o c/o feeling light headed w/ left arm tingling within a few minutes of receiving second vacci...
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"48 y/o c/o feeling light headed w/ left arm tingling within a few minutes of receiving second vaccine dose. Pt states she feels anxious and "" unexplainable"" ? Feels like heart is racing.States there are too many people in here. Denies CP NO SOB Pmhx - Unremarkable Meds- None VS : 136/87 HR: 87 RR : 17 Pt A & O x 3 Appears visibly anxious, jittery, speech coherent but speaks fast Plan: Transfer to ED - symptoms resolved on arrival to ED, patient goes home "
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| 48 | 2021-04-19 | feeling abnormal |
Pfizer 1st dose on 4/11/21 (lot # ER8731) ? on LD?.. On 4/13/21 Patient main complaints of dry cough...
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Pfizer 1st dose on 4/11/21 (lot # ER8731) ? on LD?.. On 4/13/21 Patient main complaints of dry cough, chills, body aches, tight chest. She received her first Covid vaccine on 2 days ago and then shortly thereafter she started feeling bad. Per provider diagnosis, these symptoms likely was due to side effects of COVID vaccine. Report this for record keeping.
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| 48 | 2021-04-19 | feeling abnormal |
1122: SPC notified this RN about this pt's ADRs. Upon arrival, pt stated, "my tongue feels tingling,...
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1122: SPC notified this RN about this pt's ADRs. Upon arrival, pt stated, "my tongue feels tingling, numb and back of my throat feels like I have phlegm. It feels weird when I swallow." Pt stated she has epi pen for bee sting, and the s/s she is having is similar as with Bee sting. Pt with her daughter in car, and her husband in another vehicle next to her. 1125: V/S obtained. BP 113/69, 98O2 RA, Resp: 18. Frequent throat clearing, c/o closing up airway at back of throat but no SOB. EPI pen administered over clothes immediately to left superior thigh region. 1130: BP 120/80, 98O2 RA, Resp 18. MAJ informed, and at site.
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| 48 | 2021-04-19 | loss of personal independence in daily activities |
Since my 2nd pfizer covid vaccine, Ive had joint pain and stiffness in my left shoulder where admin...
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Since my 2nd pfizer covid vaccine, Ive had joint pain and stiffness in my left shoulder where administered. I expected it to lessen over the weeks but it is slowly becoming worse, The pain makes it difficult to do daily activities some days and causes me to take ibuprofen every day which does help temporarily. I've waited to report this because its not a severe or life threatening reaction, and I wanted to see if it got better. Please advise if I should be concerned about this.
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| 48 | 2021-04-20 | anxiety |
patient experienced multiple syncope episodes after her second dose of the pfizer vaccine, she menti...
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patient experienced multiple syncope episodes after her second dose of the pfizer vaccine, she mentioned she was pretty anxious before the vaccine.
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| 48 | 2021-04-20 | feeling abnormal |
On Saturday April 17th I woke up at 6 in the morning with sever vertigo. I was extremely sick and co...
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On Saturday April 17th I woke up at 6 in the morning with sever vertigo. I was extremely sick and could not stand up straight. Room was spinning and I got sick with diarrhea. Was extremely nauseous and the feeling only passed when I was lying down. Eventually the severe symptoms subsided after 2.5 hours and I was able to mostly function with the use of motion bands on my wrist. It was so scary, I paid 200 to rejoin One Medical Group and booked a same day in person appointment. The doctor said my ears were inflamed and did the Epley manuever with me. However, the symptoms are still lingering.I'm dizzy and my ears feel clogged. I can't seem to get them unplugged. It still feels at times as if the room is spinning around me and I'm woozy in a bit of a brain fog. I've been keeping the motion bands on at most times to try to keep the symptoms at bay.
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| 48 | 2021-04-21 | feeling abnormal |
Dull headache (persistent, now Day 6 that won't go away and is troubling me); Fatigue (continuous, n...
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Dull headache (persistent, now Day 6 that won't go away and is troubling me); Fatigue (continuous, now Day 6, Can't keep my eyes open). Both headache and fatigue persist almost a week out. Symptoms 24-48 hours following the vaccine included: Low-grade fever 100 degrees F Sharp menstrual cramps (I am in menopause) Dark bruising on top of right foot (below 3rd finger and pinkie) Nausea Shoulder soreness surrounding the site of injection Feeling in a daze Fatigue (see above) Dull headache (see above)
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| 48 | 2021-04-21 | insomnia, disturbance in attention |
chills, fever, sweating, all over aches, weakness, loss of appetite, nausea, tired but difficulty sl...
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chills, fever, sweating, all over aches, weakness, loss of appetite, nausea, tired but difficulty sleeping, heart racing at times, sensitivity to light, hard to do anything for long (sleep, read, watch TV...)...tough to focus. Pain at injection site, too. Came on about 6.50 hours after getting the 2nd dose. Started with tingles and increased pain in injected arm. Worsened through the night. In middle of night was freezing but my back was completely sweaty and sheets covered in sweat. Was miserable like that through the next day. Was better the day after, and better again day 3, but now on day three still have dull headache, difficulty focusing, am exhausted, and have nausea despite pushing fluids, taking ibuprofen, and resting. Pain in left armpit (injected arm) started yesterday and still have it.
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| 48 | 2021-04-22 | excessive sleepiness |
Ice cold sensation on upper left arm, gradually extended across upper back. Also extremely drowsy, ...
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Ice cold sensation on upper left arm, gradually extended across upper back. Also extremely drowsy, taking multiple naps during day, 4/23. Can't find any information regarding this symptom with the vaccine.
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| 48 | 2021-04-23 | sensation of foreign body |
Within 5-10 I felt symptoms. Symptoms- Lump in throat and lump/tightness in chest. Swelling felt ...
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Within 5-10 I felt symptoms. Symptoms- Lump in throat and lump/tightness in chest. Swelling felt in ear right ear. I took 25mg of benadryl prior to shot and took liquid Benadryl after aymptoms happened. Blood pressure was taken it was WNL.
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| 48 | 2021-04-24 | feeling drunk |
First dose. Immediately spiked heart rate. High blood pressure with bottom over 100. Rash Flushed....
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First dose. Immediately spiked heart rate. High blood pressure with bottom over 100. Rash Flushed. Physical chills (could be seen) head to toe felt drunk. Nausea. Dizzy. Chest pains. Since the first dose I have been getting these tremors and spasms when I sit or lay to relax. My neck arm etc jolts. Second dose. Spike in heart rate and elevated blood pressure bottom 98 Dizziness. Rash. Arm pain and rash (and now heat and 3? bruise on arm site with rash) Chest Pains. Had twitches on the left side in my neck and head.
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| 48 | 2021-04-25 | amnesia |
Head on left side gradually got heavy, vision went blurry, left side weakness, and headache. I had ...
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Head on left side gradually got heavy, vision went blurry, left side weakness, and headache. I had been having memory loss and searching for words a few weeks before and just thought it was because I was getting older. Similar symptoms as a TIA. I was driving and more worried about pulling my car to the right and back over from crossing the line.
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| 48 | 2021-04-26 | impaired work ability |
Had my first shot on 03/26/21 at pharmacy and the second on 04/16/21 LOT#ER8731 at pharmacy. With th...
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Had my first shot on 03/26/21 at pharmacy and the second on 04/16/21 LOT#ER8731 at pharmacy. With the first shot I was hot but that symptom went away in the 15 minute wait time, I had acetaminophen and an allergy medication before coming to the pharmacy. With the second shot I had neither before arriving but took them as soon as I arrived home. I work for a bus company and have been driving the same sets of children since January 2021, on last week approx. Wednesday I started to sweat but put it down to the changing weather. Saturday, April 23,2021 I was sweating profusely and thought to drink a lot of water. By Sunday I was experiencing a lot loose diarrhea and thought it would be better to not attend work on Monday, April 26, 2021. I should also mention that the previous week at work my stomach was bothering me and could barely make it to the restroom. The end result is that from Saturday through today Tuesday I have had headaches in the weirdest places the back of my head where the spine meets and in the top of my head. The middle of my forehead and the lower portions of my temporal lobe. I tended to lay down because I would get dizzy and the nausea was getting to be a bit much. No vomiting but I did purchase some Citrus Twist ( similar to Sprite) and that calmed down the nausea. Upon going to the Clinic today I was given a COVID Test and the Clinician suggested a follow up with my Primary, She also suggested that above might be Gastro in nature. Made an appointment and am reporting to VAERS about the possible Adverse Recation.
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| 48 | 2021-04-26 | loss of personal independence in daily activities |
I had Covid-19 back in November so I had a strong reaction to the first dose for 24 hours. I had joi...
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I had Covid-19 back in November so I had a strong reaction to the first dose for 24 hours. I had joint pain in my knees which was very painful. It lasted for eight weeks and my doctor was unsure whether to get the second shot and decided not to. I had some joint pain in my elbows and ankle on some days. The joint pain in my knees was different in severity as the eight weeks went on. It ebbed and flowed on different days. I used Biofreeze and it helped a little but I am usually in good shape and exercise 7-10 hours a week. I had to modify my activities to avoid pressure on my knees. It is better now after twelve weeks.
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| 48 | 2021-04-27 | confusional state |
About 15 minutes after my vaccine my lips, tongue, gums, and inside of mouth were itching. I notifie...
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About 15 minutes after my vaccine my lips, tongue, gums, and inside of mouth were itching. I notified the nurse immediately. By the time I was administered a shot of 50mg Benadryl, I had started a slight itching on my arm and legs. My oxygen saturation level (read with meter on finder) was 99%. The nurse listened to my breathing to ensure I was not wheezing. My throat did not swell and neither did my tongue. I was monitored for about 30-45 minutes longer and released with instruction to take Tylenol as needed and Benadryl if needed again. I was instructed to call 911 with any sign of anaphylaxis. I napped during the day but have had no other symptoms other than a mild headache. I had some slight confusion on the way home but that occurs with any dose of Benadryl I take, so the shot of Benadryl could have caused that.
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| 48 | 2021-04-27 | feeling abnormal |
Client reported a feeling of blood rushing through body, lightheaded, and heart palpitations. Vital...
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Client reported a feeling of blood rushing through body, lightheaded, and heart palpitations. Vitals taken at 1202: HR87, O2 95%, BP 166/99. No difficulty breathing. client denies any swelling in throat or mouth. Itching in hands and feet. Zyrtec 10 mg given at 1217. Continue monitoring client. At 1240 client reported mild throat tightening and flushing in neck, hands, feet, and top of head. Denies any difficulty breathing. Epi pen 0.3 mg given at 1244. Vitals at 1246. HR94, O2 93%, BP 181/100. Clients son decided to take client to ER. I don't know which hospital. Client left at 1305.
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| 48 | 2021-04-27 | impaired work ability, memory impairment, mental impairment, feeling abnormal |
By the afternoon of the first dose, I was tired. At night in bed, I experienced dry mouth, brain fog...
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By the afternoon of the first dose, I was tired. At night in bed, I experienced dry mouth, brain fog, faint ringing in ear, tingling in hands and feet, dry eyes, some dizziness. Sensations in muscles, stomach, and bones. It felt like something is circulating around This continued each day 2-4 following this dose. I am concerned about the brain fog and tingling in hands and feet. I am on day 6, and I am experiencing more brain fog, inability to think or remember some things, pain in rib cage, collar bone, and sensitivity in lymph nodes in breasts and throat. I know experiencing longer than average side effects than others. I have seen my doctor on Monday and he is monitoring me for 2 weeks. I am a school teacher. I am concerned. I have had to take 3 consecutive days out this week and need to be at the school to administer state testing by next week. I don't understand why I was not given a good 2 weeks to overcome my effects of vaccination by the school dept. to protect myself, students, and my own family. I took the first dose because others had said that their side effects were minimal lasting only a few days. I had mine done last Thurs of the school vacation. I feel held back from doing my job as a teacher.
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| 48 | 2021-04-28 | anxiety |
After first dose 21 days prior, pt reported some tingling in mouth. After this second dose pt develo...
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After first dose 21 days prior, pt reported some tingling in mouth. After this second dose pt developed tongue/throat tingling, itching, clearing throat, anxiety, and diaphoresis. Pt given Benadryl and Epipen and was sent to ED.
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| 48 | 2021-04-28 | feeling abnormal, memory impairment |
Nerve pain, tingling. Felt like bee stings. Started in left quad area and spread through out body. ...
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Nerve pain, tingling. Felt like bee stings. Started in left quad area and spread through out body. Still happening but getting better 2 months later. Also , after second dose experienced extreme brain fog and memory issues.
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| 48 | 2021-04-28 | feeling abnormal |
Itching in fore arm of injection arm that evening Fatigue for day and a half Brain fog for about 4-5...
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Itching in fore arm of injection arm that evening Fatigue for day and a half Brain fog for about 4-5 hours 48 hours after injection
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| 48 | 2021-04-30 | amnesia |
Dizzy; Seizure; lost consciousnesses; don't remember any of it; apparently lost consciousnesses and ...
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Dizzy; Seizure; lost consciousnesses; don't remember any of it; apparently lost consciousnesses and drove slowly and hit a pole; "positional vertigo"; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EP8737) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Mar2021, the patient developed positional vertigo after the first dose. On 06Apr2021, the patient apparently had seizure with no history of seizures. The patient also had lost consciousness and drove slowly and hit a pole. They had to break the window to get the patient out of the car. The patient did not remember any of it. The patient stated that it was less than an hour that she was out; from the time recorded on the incident report and waking up in the emergency room (ER) and looking up at the clock in the room, it was under an hour. On an unspecified date, the patient experienced dizzy. The patient lab work and stuff done when she was in the ER after she had the seizure. The outcome of the events was unknown.
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| 48 | 2021-04-30 | feeling abnormal |
breakthrough bleeding; sweats without fever; bad headache,migraine did not respond to benadryl; Cram...
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breakthrough bleeding; sweats without fever; bad headache,migraine did not respond to benadryl; Cramping; hot flash; Body aches; chills; it feels like I am about to have a period.; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 13Apr2021 11:00 AM (Batch/Lot Number: ER8727) (at the age of 48-years-old) as single dose for covid-19 immunisation. Medical history included eczema, beef allergy, allergies: Sulfa, on birth control pills from an unknown date. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included BNT162B2, dose 1, administered in arm left on 23Mar2021 10:30 AM (Batch/Lot Number: EW0151) (at the age of 48-years-old) for covid-19 immunisation and experienced first shot just a sore arm like tetanus shot. The patient did not receive other vaccine in four weeks. The patient did not get Covid prior vaccination and did not receive Covid tested post vaccination. The patient stated after second shot, bad headache starting about 12 hours after shot on 13Apr2021 23:00. On 13Apr2021 10:00 PM, body aches, chills/sweats without fever. Similar to having flu on 13Apr2021 10:00 PM. Migraine did not respond to benadryl (usually benadryl or phenergan helps). Headache took about 36 hours to go away. Cramping and breakthrough bleeding the day after shot on 13Apr2021 10:00 PM and continuing today, two days after. She was on birth control pills (for hormones) and was on active row of pills. It's like she forgot to take a pill - hot flash, bleeding, even headache were all things that happen if she was missing progesterone. Headache and most aches gone except it felt like she was about to have a period. Treatment received for event Migraine included Benadryl and no treatment received for the other events. The outcome of the events breakthrough bleeding and Cramping was not resolved, of the event headache was resolved in Apr2021, of the event it feels like I am about to have a period was unknown and of the other events was resolving.
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| 48 | 2021-05-04 | feeling abnormal |
Chills; FEVER 99.8; Foggy Brain; Fatigue after 12 hours-slept 20 hours (extreme); This is a spontane...
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Chills; FEVER 99.8; Foggy Brain; Fatigue after 12 hours-slept 20 hours (extreme); This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL2302), via an unspecified route of administration, administered in Arm Left on 23Jan2021 12:30 as single dose for covid-19 immunization. The patient medical history was not reported. The patient concomitant medication included Levothyroxine (LEVOTHYROXINE) (MANUFACTURER UNKNOWN) taken for an unspecified indication from 2000 and ongoing; Dulera (FORMOTEROL FUMARATE, MOMETASONE FUROATE) (MANUFACTURER UNKNOWN) taken for an unspecified indication from 2018 and ongoing; salbutamol (ALBUTEROL HFA) (MANUFACTURER UNKNOWN) taken for an unspecified indication from 2017 and ongoing; omeprazole (PROTONIX [OMEPRAZOLE]) taken for an unspecified indication from 2016 and ongoing; alprazolam (XANAX) (MANUFACTURER UNKNOWN) (Do not take day before or week after) taken for an unspecified indication from 2000 and ongoing. On 23Jan2021, patient experienced severe fatigue after 12 hours slept (total fatigue was 5 days (with initial being worst)). Patient experienced Chills, foggy brain (4 days) on an unspecified date. Patient experienced fever 99.8 after each dose, side effects were twice as bad after 2nd dose, but didn't start until after 12 hours. No admission to hospital due to the event, No Any treatment received. The outcome of the event Fatigue after 12 hours slept, Chills was recovered. The outcome of the events Chills and Foggy Brain were unknow.
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| 48 | 2021-05-04 | loss of personal independence in daily activities, insomnia |
This is a spontaneous report from a contactable physician. A 48-year-old female patient received BNT...
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This is a spontaneous report from a contactable physician. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 48-year-old, dose 2 via an unspecified route of administration on 17Mar2021 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included Huntington's disease diagnosed in 1995, due to this her voice crackles a bit. The patient's concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EL9263) at the age of 48-year-old, for COVID-19 immunisation and she experienced 4 days of severe nausea, vomiting, couldn't get out of bed, couldn't eat, and diarrhea. The patient got her second dose on 17Mar2021 and had worsening of nausea, vomiting and fatigue on an unspecified date. The patient couldn't keep food down, can't sleep and keeps falling down, and he states "that really concerns me, she's going to knock her teeth out or bleed in her brain, that's not good". She's barely able to get around, doesn't leave unless she has a doctor's appointment. The problem is this, it's not the vaccine, it's the genetic modification this patient has Huntington's disease she was told it was safe, but don't think they took into consideration that it's a genetic modification and she has Huntington's which was also the genetic modification, don't know what to do at this point. He mentions that her nausea and dizziness was getting worse now that were a month out. She's falling down more than before. He wants to help her keep down food because she lost approximately 10% of her body weight. She's dizzy and weak, he states "she's wiped out, not sleeping". He also mentions that she's had hospitalizations. The reported was asking what do to next and if there was an on-staff physician for special cases. Patient reports going to the hospital 8 days after the second shot, she wasn't eating or sleeping. The second shot of Pfizer COVID vaccine was on 17Mar2021, patient began having severe vertigo, falling down, breathing hard, afraid she was going to knock her teeth out or break a bone, insomnia on an unspecified date. Patient reports she took a sip of water and threw up all over the side of the car today 20Apr2021. The Doctor states that this was not normal for her. Patient and reporter stated that the patient has lost between 10-15 lbs, about 10% of body weight. Reporter states that Ivermectin comes in custom lozenges and that it gets rid of inflammation so that it doesn't hurt the whole body. Ivermectin can make the GI upset. Caller states that it was not actually a vaccine that Pfizer was offering, reporter explains that Huntington Disease was when there was a repetitive code in the DNA, to the point it effects muscles and nerves and renders you. What Pfizer and Moderna was offering was a genetic modifier, mRNA was a genetic modifier, not a vaccine. In a Vaccine, they take a piece, make sure its dead, expose it to you and your body makes an antigen, that's a typical vaccine but this is not. Patient says Friday Saturday and Sunday she was stuck in the house. She cannot do anything. Reporter says the patient needs professional help. Her voice fluctuates so people take her seriously. (institute name), told the patient it would be ok to take the Pfizer COVID vaccine, but they didn't take into consideration is it was a genetic modifier. This was not a typical vaccine. Reporter states that he needs help escalating this please help with escalating this, needs help to know what to do for this patient because of the MRNA genetic modification. The mRNA may have affected the Huntingtons. The events resulted to hospitalization except for vertigo and breathing hard. The outcome of the events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 48 | 2021-05-07 | anxiety |
spotting / menstrual cycle when it was not supposed to be; getting psycho; This is a spontaneous rep...
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spotting / menstrual cycle when it was not supposed to be; getting psycho; This is a spontaneous report from a Pfizer-sponsored program . A contactable 48 years old female consumer reported that she received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. Since 05Feb2021 the patient started having spotting after an hour (also reported as coup of hours) after receiving the vaccine and getting psycho. She had a menstrual cycle when it was not supposed to be. She had a regular menstrual cycle. She was on her full cycle as of 08Feb2021. The patient recovered on 07Feb2021. Information on the lot/batch number has been requested.
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| 48 | 2021-05-12 | insomnia |
stiffness of joints; Didn't sleep at all last night.; Back pain; can't walk; Knee pain; right and le...
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stiffness of joints; Didn't sleep at all last night.; Back pain; can't walk; Knee pain; right and left arm pain/legs hurt/hands were also hurting; not as hard of a pain but it is in the muscles below the knee and in the back of the calf.; neuropathy; whip lash in shoulders and neck; feel radiation or heat; uncomfortable; shoulders became sore; tired; Eyes hurt; vasculitis pain flare up; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in right upper arm, at age 48 years, on 12Apr2021 13:00 (Batch/Lot Number: 9R8732) as second dose, single, for COVID-19 immunization. Relevant medical history includes two autoimmune diseases and two lung diseases further reported as ongoing Post-traumatic stress disorder (PTSD) diagnosed in 2017 because of trauma from vasculitis because both her arms looked like sleeves of nothing but broken blood vessels; Chronic obstructive pulmonary disease (COPD) from unspecified dates; ongoing bronchiolitis from unspecified date that does not go away; ongoing Hepatitis B contracted after vasculitis had gotten back together with her baby daddy and contracted it that way; ongoing small cell vasculitis (CSVV) from Oct2017 is her main disease; immune system weaker than her mom; body is weak; has weak muscles; generalized anxiety disorder; depression; she had fell on both arms, she's had a knee surgery; and she can barely walk because she pulled a back muscle before, her back and her having an injury from 2 years ago in 2019. Patient also usually gives blood at her primary care. Family history includes arthritis, her mom has it. Concomitant medications included tenofovir alafenamide fumarate (VEMLIDY) taken for antibiotic therapy from an unspecified start date and ongoing; meloxicam taken for joint swelling from an unspecified start date and ongoing; alprazolam (XANAX) taken for generalised anxiety disorder from an unspecified start date and ongoing; quetiapine fumarate (SEROQUEL) taken for post-traumatic stress disorder from an unspecified start date and ongoing; pantoprazole taken for ulcer from an unspecified start date and ongoing; sertraline taken for depression from an unspecified start date and ongoing; promethazine taken for prophylaxis of nausea and vomiting from an unspecified start date and ongoing; albuterol sulfate taken for an unspecified indication from an unspecified start date and ongoing; and budesonide taken for lung disorder, start and stop date were not reported. Patient historically took first dose of BNT162B2 (injection, Batch/lot number: EN6202) in the left upper arm at age 47 years on 19Mar2021 at 1:40pm at a clinic for COVID-19 immunization and experienced no adverse event; and an unspecified flu shot last Oct2020 (also reported as last winter). Patient has some 5 or 6 doctors there as specialists or prescribers. She has a liver specialist and a vasculitis specialist, whom she has not seen since the flare up because of her insurance, a main primary that saved her and brought her into remission is not covered with her insurance, and a GI doctor as well. She also reported that her immune system is probably weaker than her mom's because of her own 2 diseases. She also said that she was supposed to be in lung therapy but her body is weak. She stated that every time something hurts, it may be neuropathy. She has weak muscles and they haven't been this weak. She could move around and do things before. Patient was tired from the autoimmune and lung disease, she has had to stop and rest. Patient clarified that she had these prior to COVID coming. Patient wanted to get the vaccine to have more immunity so she could go out. She didn't want to get the Corona virus. The doctors said she wouldn't make it. It was her choice but the doctors recommended it. It was reported that patient has completed vaccination. About a week ago (13Apr2021), started experiencing a lot of pain from a vasculitis flare up. It is as if it just happened and was having a lot of pain in various parts of the body. Patient stated that it didn't start until like the second day (13Apr2021). Patient was not disgruntled, believes in the vaccine. She has an appointment with the tele doc this week and with another doctor at the same office since doctor was not in this week, because of her back and her having an injury from 2 years ago, X-rays, and can't walk right now, is in a lot of pain. She did not know if she can take pain pills, with all her other stuff. Patient stated that both her legs hurt and she can't walk. Her hands were also hurting with it in Apr2021. Patient had knee pain on 19Apr2021, leg pain was still there but getting better and was still hurting when she walks. It is not as hard of a pain but it is in the muscles below the knee and in the back of the calf in Apr2021. On 21Apr2021 or 22Apr2021, right and left arm just hurts all the way down started. They are the same and are still hurting and staying persistent. On 26Apr2021, back pain was added and stated that she got it for complaining about her arm. It started About 3 days after the shot, around 14Apr2021 or 15Apr2021, patient had whiplash in shoulders and the neck. It started in the back of the head and was like she could feel radiation or heat. It would be so uncomfortable, her shoulders became sore. When she looked left or right, it felt like whip lash. It has gotten better. For her arm, she wanted to revert to ice/heat but she hasn't done anything yet. Patient called her primary in hopes that he would give her something for the pain, she was not in pain management but it is hurting so bad. Since the injection, she has been so tired, so she has not been taking her XANAX. She takes them as needed for generalized anxiety disorder and her anxiety has not been up. A lot of the time she does not have to take them. The diseases make her tired and fatigued. If her mind is too racy, she will take to keep as calm as possible, especially with the small cell vasculitis or then she could have a flare. Her main objective is to keep calm. She was already taking 1 XANAX a day when diagnosed with PTSD but they just raised it because then came her PTSD and depression from the vasculitis. Has muscle relaxer cyclobenzaprine hydrochloride (FLEXERIL) at 100mg once a day which she doesn't take. Did not normally take these but has been taking them since this happened. She is in so much pain. Does not generally have high tolerance for pain. Does not like taking opioids because they make her throw up. She can only take them with Phenergan. Does not take if she does not need them because they do not sit well with the liver. She has an inhaler that keeps the lungs dilated for 10 hours, is not Pulmicort but something else. Eyes hurt on Apr2021 and can't read the label because its so little. She has bronchiolitis which is another rare disease with the airways in her lung and medication keeps the lungs dilated. Haven't seen the doctor yet so no tests yet. Since this happened, she can't walk. On 26Apr2021, when she went back down she couldn't walk since. It is her lower back on the right side, above her hip. She had pulled it 2 years ago (2019), above the hip on the right side. She recognized this feeling from a couple of years ago. It seems to be the place where she feels over winded. It may be neuropathy problems, wondering if it's not neuropathy since it's not her muscles (Apr2021). Everything that was wounded has come back and hurts as bad as it does. For can't walk, the pain just hurts. She didn't sleep at all last night (26Apr2021). Tries to turn and get up and if she is on either of her arms. Other than the neck, shoulders and back of her head, she never got a fever. When it started she thought that it was normal. Then, it started hitting in all of these other places and she was barely moving. Patient had the normal feeling like when she would breathe. On an unspecified date, she was having stiffness of the joints, as if they were traveling, then taking a vacation to every place that she has ever hurt itself. She had fell on both arms, she's had a knee surgery and its like going to that. The knee surgery was on the right knee. Like right now its in her back, and she can barely walk because she pulled a back muscle before. She stated that she will enjoy it if she can walk again and she just wanted to make it through this. The adverse events did not require emergency room visit or physician's office visit but was definitely at the point where she will go see the primary or go to the ER. The outcome of the event vasculitis pain flare up, right and left arm pain/legs hurt/hands were also hurting, and ?can't walk was not recovered; for knee pain, whip lash in shoulders and neck, feel radiation or heat, uncomfortable, and shoulders became sore, it was recovering at the time of report; for the other events, it was unknown. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-05-14 | feeling abnormal |
This is a spontaneous report received from a contactable consumer (patient) . A 48-year-old female ...
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This is a spontaneous report received from a contactable consumer (patient) . A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8735), in Arm Left on 21Apr2021 at 15:15 (at 48 years) at single dose for covid-19 immunisation. Medical history included urinary tract infection (UTI) and history of low blood pressure (not ongoing). She biked and hiked and eat healthy. Family history included high blood pressure in her dad and in her sister.Previously on 24Mar2021 (at 48 years) the patient received the first dose of the vaccine (lot ER8730) in right arm for covid-19 immunisation. Concomitant medication included ciprofloxacin taken for urinary tract infection from 10Apr2021 to 16Apr2021 (She just came off antibiotic a week prior to the second shot). On 21Apr2021 at 10:05 PM her heart rate was "extremely accelerated" (had accelerated heart rate) and patient stated that her chest, neck, and head felt "super hot" (her chest, neck, and head were hot) and also stated that she was feeling "weird" and "floaty". She stated these symptoms lasted about 15 seconds and went away but had another episode right after that she stated was "not as intense but pretty intense still."She had a couple of those situations and she kept getting a wave of like this floating feeling or sensation all over her body.She reported going to the emergency room (ER) on 21Apr2021 where she had a few more incidents like this and stated that she also got "real hot" and had a "sensation" all over her body all at once that she cannot describe (she states that it's different than a "pins and needles" feeling) that made her dizzy and caused her heart to race. She stated these symptoms continued for a couple of days. She reported that on 24Apr2021 she woke up and felt fine but on 24Apr2021 at night stated that the symptoms returned but worse, her muscles started "trembling and jerking" and reported having a hard time talking and walking; she got that all over sensation again all over her body, her heart was racing, her chest was tight and hot and her muscles were tremoring and her leg muscles started jerking and she had trouble talking and walking, her throat and neck were feeling tight and closing.She reported she took 2 Benadryl and drank some sugar 2 teaspoons of sugar water but her symptoms worsened so she went back to the ER. She stated that by the time she got to the emergency room, her symptoms had subsided except her legs were "still trembling"/ her legs were just shaky. At the ER they checked her heart and did a blood panel. They said everything was good, they sent her home. On 25Apr2021 and on 26Apr2021 she was dizzy, weak, shaky, and had other incidents of her heart racing that she stated weren't extreme and then started to feel better on 27Apr2021. She reported that on 27Apr2021 night she woke up and her chest was tight again, it was hot and tight on the left side, she had that floaty feeling again all over. She had left side chest pain from 23:00 until 5:40 in the morning then it stopped, everything stopped and she was fine all day.On 29Apr2021 afternoon she felt better but still had some slight dizziness "almost like vertigo" but on 29Apr2021 night she was back at the ER, she had that all over feeling again, that sensation all over, her leg muscles were jerking, she couldn't talk again, she took Benadryl and drank sugar water again because it worked before she really does not know if that was what worked but it calmed down after that the time before. She went back to the ER they checked her in and this time the sensation, the feeling that was all over stayed in the right arm and leg but it subside on left side, her heart was racing a couple more times. It was right when her legs muscles started tremoring, they were having minor jerks, not as bad but every time that happened her heart rate would go up, her resting was 59 or 61 and it got up to 101. Her neck and chest would get hot. On 29Apr2021 night she was in the ER for quite a while, it subsided they sent her home with some Ativan for tremors and palpitations and told her to follow up with a cardiologist. Patient went to the cardiologist, she had blood and labs done and she had 2 conferences on the phone with her doctor.On 30Apr2021 morning she was super dizzy and weak and shaky and light headed and nauseous. She went to a cardiologist on 30Apr2021 and has been hooked up to a 7 day heart monitor. She reported that she still felt "real trembly" she has started feeling a little dizzy and floaty feeling. Event accelerated heart rate was ongoing, it just popped up whenever on and off. Dizziness was ongoing, patient said it was on and off but it was more on than off; she said sometimes it was worse or it was less but it had never left. Chest pain recovered on 28Apr2021 at 05:40.Outcome of the other events was unknown.Events heart rate increased , feeling hot, floating sensation and dizziness are reported as serious per hospitalization in 2021.
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| 48 | 2021-05-14 | loss of personal independence in daily activities |
she started to have shortness of breath in the evening; She realized she couldn't do as much as she ...
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she started to have shortness of breath in the evening; She realized she couldn't do as much as she normally does. She said she tried; Tested positive for Covid-19 after both doses of Covid-19 Vaccine; she tested positive for the COVID-19 Virus on 05May2021; Now she had zero taste and smell; Now she had zero taste and smell; she had congestion; This is a spontaneous report from a contactable other-HCP. A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1284 and expiration date was not reported), via an unspecified route of administration in deltoid left on 11Jan2021 as 2nd single dose, for COVID-19 immunization. Medical history included hypertension from 2015 and ongoing, hyperthyroidism from Aug2019 and ongoing, ongoing seasonal allergy stated she has had seasonal allergies since she was a kid. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number-EH9899 and expiration date was not reported), via unspecified route of administration on 20Dec2021 for COVID-19 immunization. On 05May2021 the patient experienced tested positive for COVID-19 after both doses of covid-19 vaccine. Upon follow-up received on 07May2021, she tested positive for the covid-19 virus on 05May2021. The patient now she had zero taste and smell (ageusia) (medically significant) the patient the patient with outcome of not recovered, On May2021 the patient experienced now she had zero taste and smell, she said she had congestion and couldn't taste and smell. She said on 06May2021 she started to have shortness of breath in the evening. She said because she was a cardiopulmonary specialist, she thought her shortness of breath was mild, but her family members thought she sounded winded. She said yesterday, she realized she couldn't do as much as she normally does. She said she tried to mop the floor yesterday and couldn't finish mopping the floor because she was short of breath. She said she doesn't feel sick. She realized she couldn't do as much as she normally does. She said she tried to mop the floor yesterday and couldn't finish mopping the floor-Activities of daily living impaired. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05May2021, sars-cov-2 test positive: positive on 05May2021. Therapeutic measures were taken as a result of now she had zero taste and smell (ageusia), now she had zero taste and smell (anosmia), she had congestion (nasal congestion), she started to have shortness of breath in the evening (dyspnoea), she realized she couldn't do as much as she normally does. she said she tried (loss of personal independence in daily activities). The outcome of event was Not recovered. Follow-up(07May2021): New Information received from the contactable consumer includes updated events and dates, Past drug events and allergy and questions regarding events. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Vaccination failure,Covid19,loss of smell,taste. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 48 | 2021-05-19 | sleep disorder |
Fatigue, headache, severe pain at injection site, chills, elevated heart rate (especially at night),...
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Fatigue, headache, severe pain at injection site, chills, elevated heart rate (especially at night), difficulty sleeping,, chest tightness. Symptoms lasted about 1 week post-vaccination. Also, Period came 1 week early, lasted 10 days and was very light. Very unusual
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| 48 | 2021-05-23 | excessive sleepiness |
three test on 5/4 antibodies both negative then positive for PCR from same day results came Thursd...
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three test on 5/4 antibodies both negative then positive for PCR from same day results came Thursday evening 5/6 retested Friday per employee 5/7/2021 on review of activities noted PAPR had turned off 4/21 in COVID + room, believed to be the source of my COVID exposure. ER Visit 5/7 then again on 5/14 resulting in admit with discharge Sunday, received betamethasone two injections 24 hours apart. Continue to be sick, cough, headache, severe fatigue-sleeping more than 1/2 the day.
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| 48 | 2021-05-23 | panic attack, anxiety |
Complained of tightness in throat and chest, heart racing, anxiety after vaccine. Went to Urgent c...
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Complained of tightness in throat and chest, heart racing, anxiety after vaccine. Went to Urgent care and was seen by PA-C. Patient was given a Benadryl shot with a weird panic attack noted before she received it. Legs shaking and couldn't stand. Felt better after she received the shot/
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| 48 | 2021-05-24 | disturbance in attention | headache, difficulty concentrating, nausea. Given water and observed for additional time |
| 48 | 2021-05-25 | disturbance in attention |
migraine , blurry vision,drop foot,leg pain, Concentration problems, numbness, weakness, all still e...
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migraine , blurry vision,drop foot,leg pain, Concentration problems, numbness, weakness, all still effecting me
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| 48 | 2021-05-25 | insomnia |
Immediate extreme migraine; Severe neuralgia flare up; Can't sleep due to muscle pain; Can't sleep d...
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Immediate extreme migraine; Severe neuralgia flare up; Can't sleep due to muscle pain; Can't sleep due to muscle pain; Breakthrough bleeding; Cramps; 1st dose : 15Apr2021, 2nd dose: 15Apr2021; 1st dose : 15Apr2021, 2nd dose: 15Apr2021; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 15Apr2021 09:30 (Batch/Lot Number: ER8735) as 1st dose, single, and via an unspecified route of administration, administered in right arm on 15Apr2021 (Batch/Lot Number: EW0176) as 2nd dose, single for COVID-19 immunization, in an urgent care center. Medical history included chronic migraine, occipital neuralgia, and Penicillin allergy from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL); and zonisamide, both taken for an unspecified indication. On 07May2021, the patient experienced immediate extreme migraine, severe neuralgia flare up, she can't sleep due to muscle pain, breakthrough bleeding, and cramps. The patient has not recovered from the events.
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| 48 | 2021-05-25 | loss of personal independence in daily activities |
developed sinus symptoms on 1/11/21, they progressed to coughing and wheezing. Treated with Prednis...
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developed sinus symptoms on 1/11/21, they progressed to coughing and wheezing. Treated with Prednisone and antibiotics, symptoms improved and returned 3 times over the next 4 months. Eosinophils raised to 1700 and IgE to 665. Previously diagnosed with Eosinophilic Esophagitis. No previous diagnosis of allergies or asthma. Developed asthma so severe requiring albuterol nebulizers, Flonase, singulair, Symbicort, and could not continue activities of daily living. Once off steroids symptoms progress approximately 7-10 days off with nasal congestion, coughing and wheezing.
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| 48 | 2021-05-26 | disturbance in attention, sleep disorder |
Tinnitus after the first shot - went away in a few days Constant Tinnitus after the second shot, it'...
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Tinnitus after the first shot - went away in a few days Constant Tinnitus after the second shot, it's heavily affecting my sleep and ability to concentrate. Fatigue, Dizziness Swollen Lymph nodes - on left arm, it was the size of half an egg. Lymph nodes are smaller after 6 weeks but still sensitive.
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| 48 | 2021-05-26 | feeling abnormal |
after about 5 minutes she came and said she was starting to itch and roof of mouth was feeling funny...
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after about 5 minutes she came and said she was starting to itch and roof of mouth was feeling funny , I gave her 2 Benadryl 25 mg and she stated she was feeling better after about 15 to 20 minutes
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| 48 | 2021-05-26 | insomnia |
High fever; chills; body and joint aches; body and joint aches; severe headache; difficulty sleeping...
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High fever; chills; body and joint aches; body and joint aches; severe headache; difficulty sleeping; diarrhea (1st dose only); lose of taste and smell; lose of taste and smell; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: E49899, dose 1 via an unspecified route of administration in right arm on 22Dec2020 at 15:15 as 1ST DOSE, SINGLE for covid-19 immunization (48-years-old at the time of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. The patient relevant medical history included asthma, back injury, drug hypersensitivity, allergies: NSAIDS, mushroom allergy, seafood allergy, (Allergies to medications, food, or other products: Yes, sodium benzoate, ASA, NSAIDS, mushrooms, seafood). The patient concomitant medications included Multivitamin, D3, Iron, Mg Citrat and flax seed oil. The patient previously took sodium benzoate and experienced drug hypersensitivity, ASA, and experienced drug hypersensitivity. On 04Jan2021, the patient experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, diarrhea (1st dose only), and loss of taste and smell. No treatment received for the adverse event. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. On 05Jan2021, the patient underwent lab tests and procedures which included sars-cov-2 test was negative (Covid test type post vaccination was Nasal Swab). Follow-up attempts are completed. No further information is expected.
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| 48 | 2021-05-28 | excessive sleepiness |
Eye lids were puffy; Slept for about 15 hours; Achy; This is a spontaneous report from a contactable...
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Eye lids were puffy; Slept for about 15 hours; Achy; This is a spontaneous report from a contactable consumer. A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on right arm on 07May2021 16:30 (Batch/Lot number was not reported) as 2nd dose, single dose (at the age of 48 years old) for COVID-19 immunisation. Medical history included ongoing migraine, seasonal outdoor allergies and COVID-19 from 26Feb2021. Concomitant medications included sumatriptan (SUMATRIPTAN) taken for migraine. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, at 16:45 on the right arm on 15Apr2021 for COVID-19 immunisation The patient stated, "the next morning and couple days following, my eye lids were puffy. I took BENADRYL. 24 hours after the shot, I was achy and slept for about 15 hours. Overall, the 2nd dose reactions were better than having COVID". The outcome of the events was recovered on May2021. Information on the lot/batch number has been requested.
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| 48 | 2021-05-31 | disturbance in attention |
Slight pressure like ears and eyes; Slight headache but it had become so bad that I never had; Did n...
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Slight pressure like ears and eyes; Slight headache but it had become so bad that I never had; Did not feel well; Vision was blur; Hard to open eyes; it is like a pressure; Still I had at back of my head like a pressure little bit; concentration, everything was gone within like so fast; This is a spontaneous report from a Contactable consumer (patient). A 48-Years-old female consumer received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on 28Jan2021 as an 1ST DOSE, SINGLE for COVID-19 immunization (age a vaccination 48-Years-old). Medical history and concomitant medications of the patient were none. On 28Jan2021 around one hour after vaccination, the patient had slight pressure like ears and eyes, slight headache but it had become so bad that she never had, hard to open eyes; it was like a pressure, did not feel well, vision was blur, concentration, everything was gone within like so fast, Still I had at back of my head like a pressure little bit. Clinical course was provided as follows: She had her first dose and started having some symptoms right like within an hour or so. It was a slight pressure like ears and eyes and little like slight headache but then it had become like at the end of the day, it was so bad that she never had, (intensity was more than before). It was sudden, and she could not keep her eyes open. It was to that point like hard to open her eyes and it was like a pressure. She went back to the site and checked blood pressure, she recorded it was fine, '100.2 and over' (not further clarified), pulse and everything was fine, but she did not feel well. Even she felt like her vision was blur her concentration, everything was gone within like so fast." She did not receive any medication, but she had sat down and was laid on until she felt normal. Follow-up attempts are completed. No further information is expected.
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| 48 | 2021-06-01 | feeling abnormal, loss of personal independence in daily activities |
A few weeks after my vaccine, the first reaction was dizziness was in the morning for about 6 days. ...
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A few weeks after my vaccine, the first reaction was dizziness was in the morning for about 6 days. Then I started to have nausea and not being able to stand without assistance. Then I went to see my PCP. Then I was prescribed Meclizine, but it was making the symptoms worse. I stopped after 24 hours taking, I only took 2 doses of the medication. I then saw a specialist and they suggested that my symptoms were related to the COVID-19 vaccine. My symptoms were still bothering, and I couldn?t work for two weeks. My other PCP referred me to physical therapy. I was on physical therapy for two months. I feel like my symptoms have not gone away, I still need assistance to get out of bed and I cannot bend down unless I am holding on to something. I cannot even walk with without a feeling of pounding in my head. I do not have dizziness anymore I am just off balance.
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| 48 | 2021-06-01 | feeling abnormal |
This is a spontaneous report from a contactable consumer (patient). This is one of the 3 cases from ...
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This is a spontaneous report from a contactable consumer (patient). This is one of the 3 cases from same reporter. A 48-years-old female patient received second dose of bnt162b2 (COVID-19 mRNA VACCINE, Solution for injection, Lot /Batch Number: ER8736 and expiry date was not reported) via an unspecified route of administration in left deltoid at left upper shoulder on 17May2021 (at age 48-years-old) as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. No relevant family medical history was reported. No Prior Vaccinations within 4 weeks. No additional vaccine was administered on same date. Patient had previously received first dose of vaccine (LOT: ER8733; EXP: unknown) in left upper shoulder on 26Apr2021 and experienced fatigue. On 18May2021 (1 day after vaccination), patient was just tired (fatigue) and arm hurt really bad/ Her arm was really sore. She had gotten it in the left arm. She didn't throw up or anything. She was also dizzy and nauseous. Around lunch time, around noon, it really picked up and she got the chills for a short period of time, low grade fever and body aches. On an unknown date in May2021 (reported as the for the next day) She felt lousy. By around noon the next day she was back to normal. She worked half the day and ended up taking the rest of the day off and the next day off to recover. She wasn't scared or worried. No Treatment was received. Patient did not visit emergency room or physician office. Reporter seriousness for all events was unspecified. On an unspecified date in May2021, the patient resolved from the event "felt lousy". The outcome of other events was unknown. Additional information has been requested.
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| 48 | 2021-06-02 | sensation of foreign body |
within 15 minutes of receiving vaccine, PT complained of swelling of throat and something stuck in t...
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within 15 minutes of receiving vaccine, PT complained of swelling of throat and something stuck in throat. PT was administered 50 mg of Benadryl, 0.3 mg of epinephrine. 911 was called and pt. transferred to ED.
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| 48 | 2021-06-03 | impaired work ability, excessive sleepiness |
Major fatigue the next day. It kept me from working. I slept majority of the day. Pain and swelling ...
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Major fatigue the next day. It kept me from working. I slept majority of the day. Pain and swelling at injection site lasting for 2 days. Bad headache lasting two days.
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| 48 | 2021-06-03 | irritability |
Pain in arm and armpit; Pain in arm and armpit; Sore neck and jaw; Sore neck and jaw; Tongue very se...
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Pain in arm and armpit; Pain in arm and armpit; Sore neck and jaw; Sore neck and jaw; Tongue very sensitive and still sensitive; Now I have a knot in my armpit that is very tender; Now I have a knot in my armpit that is very tender; Headache; tired; irritable; My back hurt for days; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 18Feb2021 at 16:30 (at an age of 48-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. She had known allergies and had other medical history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in arm right on 28Jan2021 at 16:15 as 1st dose, single dose for COVID-19 immunisation. She did not take other vaccine in four weeks. She had taken other medications in two weeks. Patient not had COVID prior vaccination and not had COVID tested post vaccination. On 18Feb2021 at 18:00, the patient experienced pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days. The patient did not receive any treatment for the events. The clinical outcome of the pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days were resolving. No follow-up attempts are possible. No further information is expected.
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| 48 | 2021-06-06 | feeling abnormal, memory impairment |
Within 3 days of the vaccine, I was off balance/dizzy, fatigued, brain fog, short term memory issues...
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Within 3 days of the vaccine, I was off balance/dizzy, fatigued, brain fog, short term memory issues, nausea and no appetite, left inner ear swollen with fluid, tinnitus/ear ringing constantly. These issues lasted 4 weeks. Tinnitus and a little imbalance still happening.
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| 48 | 2021-06-06 | excessive sleepiness | Extreme fatigue. Slept for 18 hours after receiving the vaccination. |
| 48 | 2021-06-08 | confusional state |
Almost immediately following patient's second Covid vaccine, she felt dizzy and started sweating. A ...
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Almost immediately following patient's second Covid vaccine, she felt dizzy and started sweating. A few minutes later, she started shaking/trembling. Her blood pressure was a 185/128 and pulse was 109. Patient sat for about 20 minutes and drank a couple ounces of orange juice. She then developed some mild confusion and difficulty with speech. Her blood pressure at this time was 196/135 and pulse 107. A ambulance was contacted at that time. EMT assessed the patient and recommended triage to the hospital, which the patient refused.
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| 48 | 2021-06-08 | feeling abnormal |
The same day around 4:00 pm extremely tired didn't do anything for the same day diarrhea. For the fi...
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The same day around 4:00 pm extremely tired didn't do anything for the same day diarrhea. For the first day i felt i was drunk. It went away after a day. Swore on the arm. Menopaused after the first shot.
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| 48 | 2021-06-08 | feeling abnormal |
Bell's palsy; The left side of her face was completely paralyzed; It started with her left eye, she ...
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Bell's palsy; The left side of her face was completely paralyzed; It started with her left eye, she stopped blinking, but she did not know it. She just felt like something was in her eye; She then realized her mouth was crooked. She could not move the left side of her mouth, she could not move the entire left side of mouth at all; She just felt like something was in her eye; This is a spontaneous report from a contactable consumer (patient). The 48-years-old female patient received bnt162b2, dose 2 via an unspecified route of administration on 20Mar2021 10:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization at the age of 48 years old. Medical history included Nebulizer and rescue inhaler for asthma for sudden symptom. This report was not related to a study or programme. No additional Vaccines Administered on Same Date of the Pfizer. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations was None. Family Medical History Relevant to AE was None. The concomitant drug was Nebulizer and rescue inhaler for asthma for sudden symptom. The patient previously received bnt162b2, dose 1 via an unspecified route of administration in Left arm on 27Feb2021 10:15 (Lot Number / Expiry Date: EN6202) as SINGLE DOSE for covid-19 immunization at the age of 48 years old. The patient experienced bell's palsy, the left side of her face was completely paralyzed, it started with her left eye, she stopped blinking, but she did not know it. she just felt like something was in her eye, she then realized her mouth was crooked. she could not move the left side of her mouth, she could not move the entire left side of mouth at all, she just felt like something was in her eye, all on 08May2021. Reported as: She was calling to report that she got Bell's Palsy from the vaccine. The adverse event started 08May2021, but she could not be seen by her doctor until Monday 10May2021. That is when she was officially diagnosed with Bell's Palsy. The event started slowly on 08May2021. The left side of her face was completely paralyzed. It started with her left eye, she stopped blinking, but she did not know it. She just felt like something was in her eye . It took her a while to realize it. She then realized her mouth was crooked. She could not move the left side of her mouth. She didn't realize the full effect until sometime between 4:00-5:00 , but it had initially already started early in the day, but she was not thinking anything of it. By 4:00-5:00 she could not move the entire left side of mouth at all. Treatment incldued Five days of steroid medicine. She was checked for all the tic born illnesses and negative for those. She had a CAT scan to make sure nothing is odd in the brain. They asked if she had a virus or head cold, but she has not had as much as a sniffle in two years. They checked everything and ruled everything else out and determined the vaccine caused. The AE(s) require a visit to Emergency Room and Physician Office: At first she thought she was having a stroke. She went to the ER first, but was in the waiting room for a three hours. The more she sat there she was reading up on the side effects. She saw details about Bell's Palsy and determined it was Bell's Palsy and not a stroke. Therefore, she left the waiting room and went to the doctor on Monday. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-06-09 | poor quality sleep |
Excessive bleeding & cramps, even though it was Day 3 of period. 3 tampons & 3 pads each hour for se...
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Excessive bleeding & cramps, even though it was Day 3 of period. 3 tampons & 3 pads each hour for several hrs. In 2 1/2 days, I've used 55 Super tampons & 33 large pads. This caused fatigue, low BP 98/48, 103/56, 106/53, dizziness, and onset of sleep w/ painful wake cycles. I used no pain meds, just grape molasses mixed with tahini as well as plain yogurt, salt & water mix to replenish electrolytes. 3rd day: the flow is down to 1 tampon + 1 pad / hour. Cramps increased.
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| 48 | 2021-06-10 | amnesia |
I had the pain under the bottom of my left foot like fire that would not go out, that pain was so un...
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I had the pain under the bottom of my left foot like fire that would not go out, that pain was so unbearable; I could not walk, the bottom of foot was swollen; I could not walk, the bottom of foot was swollen; Weakness; My mind went blank I couldn't remember something I do all the time I just went blank; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration in deltoid right on 24May202 (Batch/Lot Number: EW0187; Expiration Date: unknown) (at the age of 48-year-old) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date in the year 2020 to an unknown date in the year 2020. The patient's concomitant medications were not reported. The patient reported that she got the vaccine on the 24May2021 (Monday), by the 24May2021 (Monday night) "i had the pain under the bottom of my left foot like fire that would not go out, that pain was so unbearable" and that was the very same pain she had when she got the COVID the last year (2020), she had to be on round the clock medicine she could not walk, the bottom of foot was swollen just like she had the COVID last year, and there was a weakness. When I called to the doctor, the pain she was in, the doctor wanted her to go to the emergency room but she could not go to the emergency room it was so bad. When there was the weakness, she was so weak she just felt better this past Sunday (30May2021), that's how many stage it took me to come back to herself. The patient reported when the very day she got the vaccine she was at work and my mind went blank I couldn't remember something I do all the time I just went blank" and I could not remember. It was just that one shot to space the time and she was struggling couple of days after there was some struggle just remembering things all of that scary enough, but it was very concerning to the point where I could not want to take the second vaccine, that's how scary the whole experience for her. The outcome of the events was unknown. Was requested for additional information
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| 49 | 2020-12-31 | feeling abnormal |
12/26-Had the vaccine, 27th evening felt nauseated, woke up in the middle of the night with head tig...
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12/26-Had the vaccine, 27th evening felt nauseated, woke up in the middle of the night with head tightness(headache), rigors, hot flashes.28th feeling off and fatigued, continued to feel better as the days went on and on the 31st had diarrhea, rigors, temp of 99.3F, hot flashes, muscle aches now.
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| 49 | 2021-01-02 | nervousness |
2:37 pm 10 minutes after receiving vaccine pt reports feeling dizzy and nervous. She has a history o...
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2:37 pm 10 minutes after receiving vaccine pt reports feeling dizzy and nervous. She has a history of anxiety and has been seen before for anxiety attacks. Pt denies chest pain, shortness of breath or pain. 2:45 pm pt evaluated by EMS BP 138/78, Pulse 98. pt reports feeling better. 2:55 pm pt declined transport to ED, signed out AMA. Pt was escorted out to car.
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| 49 | 2021-01-03 | confusional state, feeling abnormal | headache, weakness, brain fog, confusion, dizziness. weakness in limbs |
| 49 | 2021-01-03 | feeling abnormal |
12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit ...
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12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit to wrist. All over fatigue, joint pain, brain fog, and temp of F. Nausea and headache. 12/30 - Pain in left worse, incressed pain, redness, and swelling at injecition site. Painful swollen area in left armpit. Pain with any movement of left arm. Headache, fatigue, nausea, and muscle weakness. 12/31 - Continued pain in left arm, but improved. Continue to have pain swollen area with warmth and redness size of an orange. Headache and fatigue. 1/1 - fatigue, arm sore. Bilateral arm weakness. 1/2 - headache throughout day, not responsive to Tylenol or Advil, fatigue 1/3 - Vertigo, fatigue 1/4 - Left arm slightly sore to touch, fatigue.
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| 49 | 2021-01-03 | insomnia |
Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. S...
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Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. Symptoms are ongoing. Also, complaints of insomnia (ongoing), joint pain (day after vaccination), right lower quadrant pain (first night after vaccination), weakness (for 3 days after vaccination), moderate muscle pain at injection site (resolved after 48 hours), night sweats (ongoing).
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| 49 | 2021-01-04 | feeling abnormal, mental impairment |
difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; ...
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difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering. Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-04 | excessive sleepiness |
By evening I began running a fever (101-102), headache, body ache, general malaise. I went to bed ar...
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By evening I began running a fever (101-102), headache, body ache, general malaise. I went to bed around 10 pm, I woke the following day around 4pm. This is very unusual for me. Confined to not feel well into the next day , but by that evening I felt better.
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| 49 | 2021-01-05 | anxiety |
bp 100/54 synocopalepisode; experienced nausea, was anxious prior to injection; states this has happ...
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bp 100/54 synocopalepisode; experienced nausea, was anxious prior to injection; states this has happened with another injection in past. is now awake, alert and oriented; 911 called-evaluated by ems; refused transport; observed an additional15 min. s/s resolved; denies sob, rash, edema, etc.
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| 49 | 2021-01-05 | fear, feeling abnormal |
I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was si...
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I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was sitting on my arm and very heavy at the site. I went to the waiting area and the last 5 minutes and I started feeling weird, kind of getting dizzy and my heart started racing really fast. Am I can tell I was getting really hot and my face was flushed and my heart was racing and my hands started shaking, trembling almost like I couldn't control it. I've never experienced something like this. The part that really scared me was my heart racing like it was going to come out of my chest. They called a code, put me in a wheel chair and took me to the ER (where I work). They took my blood pressure which was really high, they did EKG, blood work and urine test. They kept me there for about five hours, while watching me. And the last weird thing that happened at one point I felt like liquid was running thru my body and my feet were really cold for several hours, It felt like someone was pouring liquid over me. I kept asking the nurse if this is normal and no one knew what to tell me. After everything started slowing back down and it had been a couple hours and the next day i felt like I had a slight head ache and felt out of it, kind of like I had a hangover and of course my arm was really sore. The Doctor in the ER did advise me not to get the second dose as it will be worse than the first one.
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| 49 | 2021-01-05 | feeling abnormal |
Patient experienced dizziness, "brain fog", and elevated blood pressure 15 minutes post vaccine admi...
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Patient experienced dizziness, "brain fog", and elevated blood pressure 15 minutes post vaccine administration
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| 49 | 2021-01-05 | feeling abnormal |
Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat w...
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Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat was fast; Felt like she had to throw up; Pain in right arm; Does not feel good; It felt like there was oil in her mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 30Dec2020 10:45 at single dose in right arm for COVID-19 immunization. The vaccination was given in hospital, not a military facility, at 10:45 and left hospital at 11:05 on 30Dec2020. Prior vaccinations within 4 weeks was none. Additional vaccines administered on same date of the Pfizer suspect was none. Medical history included ongoing migraine and family medical history included mother has high blood pressure and father has diabetes. Concomitant medication included verapamil from Oct2020 at 40 mg twice daily by mouth for migraine. Additional Information for concomitant products Verapamil included 1 for one week, 2 for second week 3rd week 3 and after 3 months, then came back down to 2. The patient experienced does not feel good at 11:30 on 30Dec2020. She was driving and did not feel good. She felt like she had to throw up at12:00 on 30Dec2020 and had it all night until she went to bed. Eyes were red when she woke up at 23:30 on 30Dec2020, that's when she first noticed. Heartbeat was fast around 12:30 on 30Dec2020. Tiredness and needed to sleep extra at 17:00 on 30Dec2020. Pain in right arm at 12:00 on 30Dec2020. When she went to drink something, she noticed her arm was painful. No ER or physician's office required. Received call from patient regarding the COVID vaccine. She received it on 30Dec2020 (yesterday) and was a healthcare worker. She later stated she works in patient transportation in a hospital. She did not feel good. Yesterday, she felt like she had to throw up. When she slept, she felt very tired and when she woke up, her eyes were red. She washed her face when she woke up around 11. Then she noticed her heart beat was kind of fast. She took another medication she takes all the time. Her doctor said that she can take it with it but she was not sure. She did not feel herself. Yesterday after she took it, she had to wait there for 15 minutes. It felt like there was oil in her mouth. She just drank water and came home. When she came home, her heart beat was fast. She had to sit down. She liked to eat spicy food, and she needed to sleep. Her kids said she never slept like this. Both eyes were red, red like blood. Her daughter told her to go look at them in the mirror. There was no pain or nothing in her eyes, they were just red and they improved today. If she goes to bed now, she can sleep, but she just wakes up and drinks tea and wants to wake up. She didn't want to sleep, but she felt like she could. Regarding the pain in her right arm, she had to hold her shoulder when she first woke up. It was worse then, but it's better now that she keeps moving it. She has 3 more weeks to get the next dose of the COVID Vaccine. Hopefully it will be this shot only and she can go back to work. She planned on going back to work on Saturday. She would like to know if she can continue to take Verapamil. She will call her pharmacy to find out. The outcome of the events does not feel good and tiredness and needed to sleep extra was not recovered. The outcome of the events felt like she had to throw up, eyes were red, heartbeat was fast and pain in right arm was recovering. The outcome of the other event was unknown. Information on Lot/Batch Number has been requested.
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| 49 | 2021-01-05 | impaired work ability |
UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to...
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UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to a previous flu vax reaction 2 years. She did consequently have a migraine headache upon awakening this AM which prevented her from working. Treated with Benadryl 25mg PO in the ER, monitored via cardiac monitor and then she was discharged with 25mg of Benadryl that she took when she got home at 1630.
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| 49 | 2021-01-05 | sleep disorder |
Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did ha...
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Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did have a hematoma and bruising, No fever On Jan 1st, I started feeling fatigued again and noticed round reddening approximately 2 inch in diameter appear about a inch under vaccination location which is still bruised. There is no pain or itching at reddened site. Jan 2, 3 and 4th-Fatigue worsened and developed low grade temp never surpassing 100. My throat developed allergy reaction feeling, same reaction I get with nuts. Throat did not swell and benedryl managed the reaction on Jan 3rd. My eyes began swelling and I could not stop sneezing. Developed laryngitis from the post nasal drainage. I was up whole night but still went into work as normal on Jan 4th. Struggled through the days but swelling and itching subsided. I experienced the muscle aches on the 3rd and 4th. On Jan 5th, started feeling better and rested. Still have reddened reaction on arm but is fading. It is faintly visible today on Jan 6th, I feel better, just have the sneezing currently and a mild headache. Benedryl is the only medication besides daily meds I took during the past several days. I did not want to interrupt the immune system's work.
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| 49 | 2021-01-06 | feeling abnormal, disorientation |
Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the l...
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Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the lft side, especially on the cheek, coming from neck. Back of head. numbness and tingling feeling on the back of the head and both arms and the hands. Patient reports headache as well. Also feeling fatigued
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| 49 | 2021-01-06 | feeling abnormal |
Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad...
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Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad (Still having some of these problems)
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| 49 | 2021-01-06 | feeling abnormal |
felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, al...
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felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, also hands flushed feeling over neck facial numbness on the left check headache dizziness neck pain throat pain numbness and tingling on right arm fatigue feels unwell
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| 49 | 2021-01-06 | feeling abnormal |
a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This ...
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a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This is a spontaneous report from a contactable Nurse(patient). This Nurse reported for similar events for 6 patients. This is 1st of 6 reports. A 49-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at the 49 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The registered nurse and 5 other registered nurses she worked with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after she was injected with the COVID-19 Vaccine. She had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. The patient said she had no other symptoms after receiving the COVID-19 Vaccine. The reporter said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. The reporter said stated the registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter stated she did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. The patient works at a hospital but didn't received any medical treatment. The patient just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. Case will be reevaluated based on follow-up information ,Linked Report(s) : US-PFIZER INC-2021001363 same reporter/drug/event, different patient.;US-PFIZER INC-2021001364 same reporter/drug/event, different patient.;US-PFIZER INC-2021001195 same reporter/drug/event, different patient.;US-PFIZER INC-2021001204 same reporter/drug/event, different patient.;US-PFIZER INC-2021001329 same reporter/drug/event, different patient.
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| 49 | 2021-01-06 | feeling abnormal |
This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vacci...
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This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vaccine recipient reported that after 10 minutes of receiving the 2nd vaccine they developed a headache that felt like a migraine. The vaccine recipient took Advil, then a few minutes later started sweating, felt clammy, and hot. The symptoms started to pass 15 minutes later. That night they reported that their chest felt tight but it went away before bedtime. This morning 1/7/2021, vaccine recipient reported feeling tired and mind felt foggy. They were able to continue to go to work.
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| 49 | 2021-01-06 | irritability |
throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallo...
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throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallowing; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1685) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 06:00 for COVID-19 immunization. Medical history included fibromyalgia, asthma, prediabetes, and carpal tunnel syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no previous allergies to vaccines. The patient allergies to medications which included: doxycycline, medroxyprogesterone acetate (DEPO-PROVERA), metoclopramide (REGLAN), gluten. The patient initially had headache, dizziness and irritability, throat tingling, throat swelling, and difficulty swallowing started around 12 hours after injection, event onset date reported as 29Dec2020 18:00. The events resulted in emergency room/ department or urgent care. The events were reported as non-serious by HCP. Treatment received for the events included diphenhydramine and hydroxyzine embonate (HYDROXYZINE PAMOATE). The outcome of the events was recovering.; Sender's Comments: The reported pharyngeal swelling together with other symptoms was likely related to the single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 49 | 2021-01-06 | panic reaction |
Tachypnea Panic Narrative: Employee experienced panic response w/tachycardia up to 105 BPM. BP stab...
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Tachypnea Panic Narrative: Employee experienced panic response w/tachycardia up to 105 BPM. BP stable 144-147/84-90 throughout response. Benadryl 50mg admin @1650. Code team arrived assessed employee and took to ED
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| 49 | 2021-01-07 | confusional state |
Left sided parentheses and numbness sensation which then spread to right side. Strong headache initi...
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Left sided parentheses and numbness sensation which then spread to right side. Strong headache initially then resolved, rapid heart rate, confusion, dizziness, high blood pressure,
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| 49 | 2021-01-07 | insomnia |
Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12...
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Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12 hours. All symptoms resolved. Patient Included the following information: 1 st dose Phizer EH 9899 2nd Dose Phizer EK 9231
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| 49 | 2021-01-07 | insomnia |
100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is ver...
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100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is very painful; migraines; she felt warm; joint pain; dull headache; tenderness at the injection; chills; as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it; fatigue/joint pain and fatigue are getting worse; This is a spontaneous report from a contactable consumer. A 49-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on the left arm on 30Dec2020 10:40 at single dose for covid-19 immunisation. Medical history included from Feb2020 and ongoing she is currently a breast cancer patient/she had breast cancer, has lymphedema in the right due to breast cancer and on 31Oct2020, she tested positive for COVID and that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. Had joint pain and fatigue ever since her COVID-19 diagnosis in October. There were no concomitant medications. The patient previously took H1N1 shot and her arm got really big and they watched for cellulitis discomfort. The patient stated on Dec2020, "received the COVID-19 vaccine on 30Dec2020 and is reporting 100.7 temperature, dull headache, tenderness at the injection, chills, joint pain and fatigue. She reported that she has had joint pain and fatigue ever since her COVID-19 diagnosis in October. The patient contacted COVID, she tested positive on 31Oct2020, and still has no taste or smell, and the biggest thing right now, that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. She wants to know, where it has gone into the joint, the arthritis has flared from it, from her testing positive, it will be 9 weeks tomorrow since she had COVID, and she is not 100%, and yesterday she had the COVID vaccine, her first dose, and she was up all night, her joints and muscles were in a lot of pain, but she had been like that, and this morning she took her temperature and it was 101.7. Does it mean can't have the shot in 3 weeks? She has had health issues this year, she had breast cancer, and her oncologist wanted her to have the vaccine, but it concerns her with all the pain in her joints swelled, and wanted to know if it is a side effect due to COVID. States she is still coughing, she wants to know if Pfizer thought this was a side effect of COVID, since she tested positive in October, will she have to live like that? It is very painful. Her shot went fine at 10:40 yesterday morning, fine, but she has been experiencing stiffness and joint pain, and she contacted COVID in October, thinks this doesn't have to do with the shot, this has been this way since October, and her husband said to ask- will it be like this since she contacted COVID, and the only thing, this morning she had a headache, but she didn't sleep and she gets migraines it she doesn't sleep, and she took her temperature, she felt warm and it was 101.7. Her temperature was 101.7 about a half hour ago (31Dec2020), she takes her temperature now, states it is now 100.8. Stated that she probably needs to speak to her doctor for her questions. Got up a 1am and took Ibuprofen. Her joints were so sore from when having COVID and so she went back to sleep and slept off and on. Got up at 4am this morning with the dull headache, it was not enough to be considered a migraine, so she took another 800mg Ibuprofen. Headaches: states it is just a dull headache, she hasn't taken Ibuprofen yet this morning, she is not a big medicine person, she is trying to see if it will go away, but if it is worse she will take migraine medicine". The outcome of "as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it", "she was up all night/she didn't sleep", "It is very painful", "migraine" and "she felt warm" were unknown. Other events was not recovered.
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| 49 | 2021-01-07 | sleep disorder |
12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand ...
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12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand and face swelling, swelling and tenderness around injection site, general flu-like symptoms making it difficult to sleep. I was able to go to work the next morning despite symptoms. Symptoms, other than mild soreness in arm where injected, resolved 36 hours after onset.
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| 49 | 2021-01-08 | anxiety |
mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vo...
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mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vomiting, diarrhea, itching This started at minute 13 after the vaccine administration. I have had several infusion reactions before to biologics to treat my autoimmune disease and this is how it always starts. There was nothing available at the administration place so I left and took zyrtec, benadryl and pepcid. The symptoms stopped in about 25 minutes.
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| 49 | 2021-01-08 | feeling drunk |
After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light ...
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After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring. I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest. Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure
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| 49 | 2021-01-09 | feeling abnormal |
1st & 2nd day extreme /Joint & musculoskeletal pain, head ache, fatigue , short of breath, Cough...
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1st & 2nd day extreme /Joint & musculoskeletal pain, head ache, fatigue , short of breath, Coughing, runny nose, congestion, fever, ringing in ears, 3rd day musculoskeletal & joint pain, inner ear pain, fatigue, cough, throat pain This is 3rd day and I am still miserable
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| 49 | 2021-01-09 | insomnia |
Felt achy and trouble sleeping all night post 2 nd injection. Woke up at 3 am with fever 100.5. Head...
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Felt achy and trouble sleeping all night post 2 nd injection. Woke up at 3 am with fever 100.5. Headache, chills, sweating, low grade fever 99.5 all day until about 10:00 pm on 1/8/21. 80% better on 1/9/21 just lower back soreness and mild headache. 100% better on 1/10/21. This was my second vaccine.
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| 49 | 2021-01-09 | sleep disorder |
The patient received the vaccine in the left deltoid at 07:45 on 1/7/21. The patient reports that o...
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The patient received the vaccine in the left deltoid at 07:45 on 1/7/21. The patient reports that on 1/8/21 at around 0200, she was awoken with a sharp pain in her left arm followed by complete paralysis of her left hand for about 15 seconds. Did not re-occur. Did not seek treatment. Reported to Dr. and no further issues seen.
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| 49 | 2021-01-10 | nervousness, loss of personal independence in daily activities, feeling abnormal |
her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all ...
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her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all sick, cold, sick and experiencing terrible side effects; Fatigue; Muscle ache; Nauseous; Felt awful; Can't eat all the day, no appetite; phobic something to drinking water; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. The patient experienced getting all sick, cold, sick and experiencing terrible side effects, fatigue, muscle ache, nauseous, cannot do anything, felt awful, cannot eat all the day, no appetite, phobic something to drinking water. The patient has been sick for three days now. The patient was a "senior" (not clarified) care giver at the nursing home. Everybody at nursing home at the nursing home got the shot and now everybody has cold and sick. She has only one day of work and she has to come into her job to take care of elderly people. As since current everybody is experiencing the terrible adverse, terrible side effects, everything. Fatigue, muscle ache everything. The bosses at her nursing home cannot give them three days or even seven days off of work after receiving a contract to give them shot. It was confirmed that the patient received the COVID vaccine. The patient also stated that they are off of that side effects. They are not interrupted not just the "arm" (not clarified) been there. The patient said she getting everything. She was getting all the side effects. So when they had this Pfizer drug shot "they didn't get seven days off of" (not clarified) work. If a person gets a shot, they are feeling fatigue, nauseous (incomprehensible voice). They can't do anything. They should be allowed to stay home from work. Right now everybody in the nursing home is feeling the adverse effect. The entire building. So, she was telling Pfizer to report the report is that all of sudden that the nursing home "seniors" (not clarified) and nurses they got the shot, they can't even get to work. The effects are so bad that they can't do anything. The patient also stated that fatigue, she had fatigue all day. The first day she got the shot her nerve was bad but the second day was everything fatigue. She felt awful, she could not eat, she had no appetite. She was phobic something to drinking water, she cannot eat all the day. "Fruit or something 5 I can eat" (incomprehensible voice)." When probed for the LOT#, the reporter stated, "No they did not give me anything. All they did is I think 037 I think it looks like a 'K' 20A. (further not clarified) like it says (further not clarified) 037K20A that's (further not clarified)." The outcome of the events was unknown. Information on lot number/batch number was requested.
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| 49 | 2021-01-11 | confusional state |
painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nau...
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painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nausea vomiting shortness of breath headache some periods of confusion
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| 49 | 2021-01-11 | feeling abnormal |
1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins We...
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1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins Wed, Thursday neck shoulders blades hurt, and achy. Friday Chills, no fever, hurt to the bone all over, sick to stomach, noticed some lips swollen, felt foggy in head. Headache constant top of head. 10:45am spots and vision blurry. Felt very sick. Laid head down then woke black spots. Sat occasionally in sun saw black spots. /sun off not looking at computer did not see black spots. Monday increase black spots. Saw an eye doctor.
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| 49 | 2021-01-14 | anxiety | PT presents with respiratory difficulty, anxiety. |
| 49 | 2021-01-14 | feeling abnormal |
FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAI...
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FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAIN JOINTS,FEVER,NAUSEATE,FEELING BAD.
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| 49 | 2021-01-14 | impaired work ability |
Employee received the first vaccine on 12/18 with no problems. Developed "sinus symptoms" which bega...
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Employee received the first vaccine on 12/18 with no problems. Developed "sinus symptoms" which began on Dec 28, was rapid tested on 12/30 and read as positive. Did well and was due to come back to work when received the second dose of Pfizer vaccine on 1/6. She was symptomatic at the time. The day following the second vaccine, developed temperature, body aches and generalized malaise. Has been out of work since that time. Did see nurse practitioner on Wednesday.
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| 49 | 2021-01-15 | impaired work ability |
dizzy, nausea, headache, myalgia, fatigue, arthralgia, then on 1/14 fever 10.3 headache continued a...
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dizzy, nausea, headache, myalgia, fatigue, arthralgia, then on 1/14 fever 10.3 headache continued arm sore, did call out of work 1/14 took Tylenol and motrin
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| 49 | 2021-01-15 | impaired work ability | Headache, Myalgia, Fever, Fatigue Narrative: missed work 1/14/21 |
| 49 | 2021-01-16 | feeling abnormal |
Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. ...
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Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. Had a feeling of being in a fog and not quite myself. Taste and smell felt distorted and could not fully taste and smell my coffee. Took 2 max strength tylenol which helped bring temp down to 98.F and remained steady till the afternoon when temp went up to 102F. Had feeling of body aches and chills. Took a hot shower and another dose of tylenol and went to bed. Next morning felt much better with no fever symptoms. Left arm was sore but better than day before. Woke up with a vertigo feeling and hot flashes but not enough to interrupt daily activities. Treated with meclizine
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| 49 | 2021-01-16 | impaired work ability |
Sig stomach and gut cramps to the point of near syncope. Missed half day work. Nausea, lack of appet...
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Sig stomach and gut cramps to the point of near syncope. Missed half day work. Nausea, lack of appetite. Lasted over 4 hs severe, 12 hs moderate
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| 49 | 2021-01-18 | anxiety |
Patient reported having "itching" day after 1st dose, no hives or airway issues, no other s/s. Pati...
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Patient reported having "itching" day after 1st dose, no hives or airway issues, no other s/s. Patient self admitted to feeling anxious about 2nd dose, however wished to proceed. Approximately 20-25 minutes post vaccine, patient felt dizzy upon standing. VS checked, BP 130/80, HR 80s, SPO2 99% RA. Patient speaking in full sentences. Oriented. Felt fine otherwise. Patient held until 1615, symptoms did not improve, but did not worsen. Suggested patient go to Hospital for evaluation, or at the least have family pick her up. Patient met by family at 1700 and situation described as well as recommendations. F/u 1/18 - Patient had dizziness through the next day. Dizziness improved and she then had low grade symptoms from injection including fatigue / aches / HA that also went away and felt fine 1/18/21. She did not seek additional medical care.
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| 49 | 2021-01-18 | anxiety | Rash, Anxiety, Flushed |
| 49 | 2021-01-18 | feeling abnormal |
Woke up shivering at 1 A.M. Saturday so bad that my husband thought I was having a seizure, took my...
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Woke up shivering at 1 A.M. Saturday so bad that my husband thought I was having a seizure, took my temp it was 104. Took Tylenol, held cool compress on my forhead, the next day had bad chills, throbbing headache, and temp never dropped below 100. I was very weak, every muscle in my body ached, couldn't eat, yet my blood sugar was high all day. Kept checking my temp. It was avg. 102 . Read about the side effects, seemed like I just had it worse than others. Then into Monday morning, still felt awful, but had woke up in a pool of sweat, temp finally fell to 99 . Seemed like the worst was past, was able to eat a little breakfast, but then the diahrea started! I called in sick again, and went to Urgent care. The Dr. said I had a severe adverse reaction to the second vaccine. I asked for a Covid test just in case. Now Tuesday, felt better today, still a bit tired, temp has been avg. of 98 today, got results from test, negative.
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| 49 | 2021-01-18 | impaired work ability |
Later in day intense headache and now two days later still intense headache, muscle aches/soreness(m...
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Later in day intense headache and now two days later still intense headache, muscle aches/soreness(mostly arms neck back), very tired, chills, low grade temp. flu like). Even had to miss work.
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| 49 | 2021-01-18 | impaired work ability |
Persistent fever >101, vomiting, severe headache, severe joint pain, anorexia, started 12 hours aft...
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Persistent fever >101, vomiting, severe headache, severe joint pain, anorexia, started 12 hours after vaccine and persisting now Day 3 since vaccine. Unable to function for work. Had Covid illness 3/2020. Antibodies still present on blood work one week prior to vaccine. No hx of vaccine reactions in the past.
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| 49 | 2021-01-19 | impaired work ability | Increased fever to 99.6 degrees F. Achy - muscle. Chills Headache. Missed work. |
| 49 | 2021-01-19 | impaired work ability |
I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level ...
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I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level was 8 out of 10. When I tried to get out of bed, I was dizzy and had to hold to the walls to make it to the bathroom. I had severe dry mouth, nausea, muscle weakness, loss of appetite and chills. I was unable to go to work. The symptoms did not begin to subside until later in the evening the next day around 6:30pm. Today I am still weak but making it. Still having chills, and some minor muscle aches and spasms.
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| 49 | 2021-01-19 | loss of personal independence in daily activities |
fever; extreme body/ muscle aches; extreme body/ muscle aches; headache; sore throat; I can't get ou...
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fever; extreme body/ muscle aches; extreme body/ muscle aches; headache; sore throat; I can't get out of bed; extremely tired; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EL3248), via an unspecified route of administration in the right arm on 09Jan2021 at single dose for COVID-19 immunisation. Medical history was none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EK5730) on 19Dec2020 at 11:30 AM in the left arm. The patient's concomitant medications were not reported. On 09Jan2021 10:00 the patient experienced fever, extreme body/ muscle aches, headache, sore throat, can't get out of bed, extremely tired all with outcome of not recovered. The patient received no treatment due to the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
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| 49 | 2021-01-20 | anxiety | anxiety, tachycardia, palpitations. all symptoms resolved during observation period of 30 minutes. |
| 49 | 2021-01-20 | impaired work ability, insomnia |
Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vo...
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Jan 17: 9pm nausea, then chills, fever of 101-102; dizziness, shaking uncontrollably from chills; vomited at 5am on jan 18; Jan18 fever and chills continued, no apetite all day; dizzy; weak; severe body aches; confined to bed all day; severe head ache; very sensitive to light; could not sleep for more than 15-45 minutes at a time; food tasted like chemicals or sickeningly sweet; only rice tasted normal; very sensitive to and repelled by odors. Jan 19: nausea abated, started to eat a few things but eveything still tasted terrible except for rice; got tested: covid negative, flu A &B negative, RSV negative; body aches were much worse; difficult to walk due to shooting pain in feet and back; stayed in bed all day; Jan 20 fever broke, now have right side sore throat; still achy and dizzy; Jan 21 still have headache and mild body aches, not confined to bed but too weak and achy to work
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| 49 | 2021-01-22 | feeling abnormal |
I did not administer the vaccine. Pt was treated by doctor over the phone following the event and fo...
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I did not administer the vaccine. Pt was treated by doctor over the phone following the event and followed up in person 2 days later. She reported a numb/ strange sensation in her lips and tightness in her face that resolved with taking Benadryl.
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| 49 | 2021-01-24 | anxiety |
positive for Covid; positive for Covid; pneumonia; fever; This is spontaneous report from the Pfizer...
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positive for Covid; positive for Covid; pneumonia; fever; This is spontaneous report from the Pfizer sponsored program, IBCC (Inbound Call Center for HCPs) via a contactable nurse (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EKS730), via an unspecified route of administration in deltoid left on 22Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Patient received the first dose of the vaccine on 22Dec2020 and a week later she was tested positive for COVID on 29Dec2020. She was due for the second dose the day before the time of the report. She was concerned about the immune system before getting the second dose. She got a significant pneumonia on 29Dec2020 with COVID infection that her coworkers did not get and she was worried about the condition of her lungs and getting the second dose of the vaccine. She had done her research and read what the CDC said about waiting longer for the second dose. Patient had a fever on 26Dec2020, 4 days after getting the vaccine, she was scheduled to get the second dose on 12Jan2021, but she did not go in, since she couldn't get straight answers from anyone about the second dose, her question was: when could she get the second dose? Patient was feeling better, she didn't get a repeat chest X-ray, but she felt, like she didn't have fevers, she felt like much better. Her fevers started 4 days after the vaccine on 26Dec2020, and lasted 5 days, maybe 2 days into the antibiotics it stopped. She had recovered completely from fevers. Stated her first test, she tested negative, on 27Dec2020, then tested positive on 29Dec2020. She had no test since then, since one could shed the virus for months, and she didn't feel the need to retest, she was past the point on quarantine. Lab data included Chest X-ray: Pneumonia on 29Dec2020, COVID 19: Negative on 27Dec2020, COVID 19: Positive on 29Dec2020. Outcome of event fever was resolved, and of other events was unknown. Causality: She couldn't say for sure no, but she questioned if put her in a more vulnerable state.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported "positive for Covid" and pneumonia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-25 | impaired work ability | Fever, headache, very bad body aches, chest pressure, dizziness and missed two days of work |
| 49 | 2021-01-25 | insomnia |
12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TO...
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12/21/2021 HIVES AT THIGHS WITH ITCHING AT SITE ITCHING -RT SAME DAY 01/12/2021 HIVES AND ITCHING TORSO AND THIGHS- SITE OF ARM- LT SAME DAY UP TO 4TH DAY-WORST OM 1/16/2021 WITH RESTLESS NIGHT WAKING UP EYE MATTED-WAKING UP ITCHYAT SITE/TORSO/THIGHS/LT EYE SWELLING AND RT EYE WITH WATERY LUNG FEELING SEEN AT THE ER AND ORAL STEROIDS CAUSE SOME SWELLING AT OTHER EYE BUT BETTER AFTER 30 MIN.AFTER A NAP RT EYE WAS SWELLING W/O ITCHING PRETTY BAD.AND ORAL MEDROL PACK LAST DOSE 1/19/2021 AND FORGOT THE DOSE ON 1/21/2021 AT WORK HAD EYE SWELLING LT EYE FIRST THEN WENT TOOK A DOSE THEN HAD ON THE RT EYE. SWELLING WITH TORSO AND SITE ITCHING TOO SO TOOK ANOTHER STEROID GETTING BETTER WITH PO BENADRYL 50 MG- FATIGUE BUT PRETTY GOOD.YESTERDAY TIRED TOWARDS THE END OF SHIFT AND THIS AM AFTER 9 HRS WAS FEELING TIRED-FATIGUE- STARTED LATE AND THIS PM SWELLING ON THE LT AND THEN RT (SAW CHIROPRACTOR 1/23/2020). IM DEXAMETHASONE 8 mg IM NOW BETTER AFTER 30 MINUTES BETTER.
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| 49 | 2021-01-26 | impaired work ability, sleep disorder |
I received the shot in the morning on Jan. 21, 2021 and had no issues until 12:20am (Jan 22)when I w...
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I received the shot in the morning on Jan. 21, 2021 and had no issues until 12:20am (Jan 22)when I woke up sweating profusely and had major chills. My body ached all over and had a hard time sleeping due to all of this the entire evening. I woke up and tried to get ready but quickly realized I was weak, my joints hurt, body ached, headache and couldn't do it. This continued throughout the morning and part of the afternoon. Then around 2pm, I was still tired and achy but my joints didn't hurt as bad and I was able to manage the headache with ibuprofen. The body aches continued through most of the next day (Jan. 23) as well. By Jan. 24th I was perfectly fine and back to normal. I had covid early in the year on Nov. 6 which kept me out of work for almost 3 weeks. These few days were very similar to how I felt when I had covid but not as intense.
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| 49 | 2021-01-27 | agitation |
Headache; body aches; fever; dizziness; sore arm; drowsiness; loss of balance; agitation; skin ach; ...
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Headache; body aches; fever; dizziness; sore arm; drowsiness; loss of balance; agitation; skin ach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date not provided), via an unspecified route of administration in the left arm on 15Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID, and allergies (unspecified). The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included unspecified medication. The patient experienced headache, body aches, fever, dizziness, sore arm, drowsiness, loss of balance, agitation, and "skin ach" on 15Jan2021 21:00. Treatment was not provided in response to the events. The patient has not undergone COVID test post vaccination. The outcome of the events was recovered with sequel on an unspecified date in Jan2021.
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| 49 | 2021-01-28 | feeling abnormal, feeling drunk |
Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my enti...
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Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my entire right arm. I was only able to lift my arm up to my shoulder. Very fatigue, body aches, dizziness and drunken feeling. Day 3: less arm soreness. Very fatigued and dizzy. Body aches, joint and muscle pain. Pain in my body. Day4: muscle and joint pain, still very fatigued and my vision began to become blurry. Day 5: fatigue, joint pain, headache and blurred vision has worsened. Day 6: fatigue joint pain, sever headache, dizzy, vision is still bad. I contacted the ophthalmologist and Optometry to schedule an appointment.
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| 49 | 2021-01-31 | crying |
woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; head...
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woke up writhing in pain; had chills so bad my teeth were chattering; had fevers through night; headache 6/10 /My head hurt so bad 10/10; thought I would throw up; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; My arm was dead weight, I couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch; muscle and bone aches; muscle and bone aches; I was just crying; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3302, intramuscular in the left arm on 18Jan2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 vaccination. Medical history included hyperthyroidism from an unknown date. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included Levothyroxine, Liothyronine, CoQ10, McIntyre Vit D, and Probiotics all from unspecified dates for unspecified indication. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, intramuscular in the left arm on 28Dec2020 at 09:00 as a single dose for COVID-19 vaccination. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2021 at 12:30, the patient experienced writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch. This morning just muscle and bone aches and headache 6/10. The patient did not receive treatment for the events. The clinical outcome of the events writhing in pain and had chills so bad her teeth were chattering. She had fevers through night. From 12:30-4 am. Her head hurt so bad 10/10 she was just crying and thought she would throw up. Her arm was dead weight, she couldn't move it and it was hypersensitive, like if you touched it it was excruciatingly painful and hot to touch were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 49 | 2021-01-31 | feeling abnormal |
Felt weird agt 15min end time of observation. Needed to take a deep breath. Got up: lost footing/s...
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Felt weird agt 15min end time of observation. Needed to take a deep breath. Got up: lost footing/stumbled. Feels weird, very tired.
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| 49 | 2021-01-31 | loss of personal independence in daily activities |
Mainly I couldn't lift my arm and I couldn't pick up my children that lasted 24 hours and the next d...
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Mainly I couldn't lift my arm and I couldn't pick up my children that lasted 24 hours and the next day I put a heating pad on it, I had a headache and I was tired so I took a nap. All symptoms lasted 24 hours
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| 49 | 2021-01-31 | sleep disorder, impaired work ability, excessive sleepiness |
Sick; woke up 12 hours later and had a temp of 102 and arm pain/ temp gotten as high as 103 degrees ...
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Sick; woke up 12 hours later and had a temp of 102 and arm pain/ temp gotten as high as 103 degrees Fahrenheit; arm pain; sweating; she was really tired; This is a spontaneous report from a contactable nurse. This 49-year-old female nurse reported for herself that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982) at single dose for Vaccination on 14Jan2021. The vaccine was injected to left deltoid/shoulder about 2:15 pm. Relevant medical history included ongoing uterine fibroids since Dec2019, ongoing obesity since Oct2000 and COVID-19 from Dec2020 to Dec2020. Relevant concomitant drug was unknown. The patient had surgical procedures when she had her first child. No Family Medical History Relevant to AE(s). Her mother got the shot a couple of days before caller did and she had no problems. The patient was administered her first dose of Pfizer BioNTech COVID-19 Vaccine on 14Jan2021. She reported that she became sick (Medically significant) about 12 hours later on 15Jan2021. The patient Went to sleep and woke up about 12 hours after she got the Pfizer-BioNTech COVID-19 Vaccine with a body temperature of 102 degrees Fahrenheit and arm pain. She could not really go back to sleep. When she got up it went away. She tried to go to work that day, and did go to work but she was really tired. When she finally got home she got in the bed and really had not been out of bed since then except for today she was sitting in a chair; so she thought maybe she had improved a little bit at on the reporting day. She had maintained a constant fever since 15Jan2021 that had gotten as high as 103 degrees Fahrenheit. At the reporting time her temp was 100.5. She had alternated Tylenol and Motrin for the fever. She was sweating profusely so it may be the temperature trying to break, but she had been struggling since she had it. This was so unlike her, she did not just stay in bed. She could not kick it. She had been unable to work since 15Jan2021 and she had to work tomorrow. She believed this was medically significant because she cannot work. The patient did not have vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No Additional Vaccines was administered on Same Date of the Pfizer Suspect. Relevant Tests was None. The patient did not visit the emergency Room nor Physician Office due to the events. The outcome of event being sick was resolving. The outcome of event temperature had gotten as high as 103 degrees Fahrenheit was not resolved. The outcome of other events was unknown. The patient thought the causality was yes 100% because her COVID-19 symptoms were not even this bad; she never had a fever with COVID-19; and she had never before had a fever this high for this long.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the event; causality therefore cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-02-01 | amnesia, impaired work ability, depression |
Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, ...
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Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, loss of appetite, diarrhea. Missed 5 days of work
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| 49 | 2021-02-01 | feeling abnormal |
COULD NOT LIFT LEGS TO GET INTO BED, OR HARDLY WALK IT WAS SO PAINFUL AND LOW BACK PAIN, MIGRAINE, F...
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COULD NOT LIFT LEGS TO GET INTO BED, OR HARDLY WALK IT WAS SO PAINFUL AND LOW BACK PAIN, MIGRAINE, FUZZY HEAD, DIZZY, LACK OF APPETITE, FATIGUED (SLEPT ALL DAY STARTING AT 3 PM DAY OF VACCINE TO ALL WAY NEXT DAY AND NIGHT), VERY ACHEY, COULD NOT LIFT MY RIGHT ARM, BRUISE WHERE INJECTION WAS GIVEN ALONG WITH A KNOT. TODAY IS 2.2.21 AND STILL FEEL FUZZY HEAD AND ACHEY.
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| 49 | 2021-02-01 | nervousness | dizziness, rapid heart beat, shortness of breath, shaky |
| 49 | 2021-02-02 | feeling abnormal, disturbance in attention | Fatigue, injection site soreness, difficulty concentrating (foggy feeling) for 36 hours |
| 49 | 2021-02-02 | feeling abnormal |
Took BP meds first thing this morning, normally have no issues, was fine. Went to get 2nd dose and ...
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Took BP meds first thing this morning, normally have no issues, was fine. Went to get 2nd dose and 2 hours after dose, felt very swimmy in my head, took BP and with meds it is 130/99. Not extremely high but I did take my meds at 8 am this morning.
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| 49 | 2021-02-02 | excessive sleepiness |
Had intense headache for 72 hours straight where I could not withstand any light - the best way I co...
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Had intense headache for 72 hours straight where I could not withstand any light - the best way I could describe it is my migraine had a migraine. Would get dizzy when I stood up. Nauseous and extreme fatigue for 3 days. Slept for 16 hours within 24 hours of receiving the vaccine, day 2 slept for 12 hours but then was up due to vomiting/diarrhea (for 6 hours) about 56 hours after injection and then slept another 12 hours on day 3 after injection. Had a slight sore throat as well. By day 4 all symptoms had resolved.
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| 49 | 2021-02-03 | feeling abnormal |
Left lower quadrant pain; Nausea; Fatigue; arm pain; she felt like she caught ' a bug' or 'flu-like ...
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Left lower quadrant pain; Nausea; Fatigue; arm pain; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; This is a spontaneous report from a contactable healthcare professional (patient herself). A 49-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 at 0.3 ml, single for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced arm pain on 08Jan2021, fatigue on 09Jan2021, nausea on 10Jan2021, left lower quadrant pain on 11Jan2021. The patient said that she felt like she caught "a bug" or "flu-like symptoms" after her first dose of the COVID vaccine. She would like to know if she should get the 2nd dose of the COVID vaccine after experiencing flu-like symptoms after her first dose. Therapeutic measures were taken as a result of nausea and left lower quadrant pain that included ciprofloxacin and metronidazole. Clinical outcome of arm pain was not recovered; for fatigue and nausea was recovering; for left lower quadrant pain was recovered on an unspecified date; while for the other events was unknown.
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| 49 | 2021-02-03 | feeling abnormal |
Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painf...
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Weakness; fatigue; small breathes like slightly short of breath; body aches/ severe tender and painful lymph nodes-to neck and groin and around sides; low grade fever; abdominal pain one day; all days lymph nodes pain /neck lymph node aches/ severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness, especially around the side rib cage and waist area; tenderness especially around the side rib cage and waist area/ severe tender and painful lymph nodes-to neck and groin and around sides; feeling really bad like i want to cry; slight headache; night sweats; rapid heart rate; increased blood pressure; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; severe tender and painful lymph nodes-to neck and groin and around sides, under ribs; tenderness to flank area; difficult to turn in bed and lie on right side; Itchiness but no visible rash; first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration at the right arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included taking medication for focus (adult adhd?); perimenopausal. She also has known allergies: sulfa; shrimp, strawberry/raspberry flavored foods or candies. The patient was not pregnant at the time of vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for focus, perimenopausal. The patient previously received the first dose of bnt162b2 intramuscularly at the right arm on 28Dec2020 at 2:30 PM at the age of 49 years for COVID-19 immunization (Lot number: EL3249). On 15Jan2021, the patient experienced weakness, fatigue, small breathes like slightly short of breath/ short of breath, body aches, low grade fever, abdominal pain one day, all days lymph nodes pain and tenderness especially around the side rib cage and waist area, more on right side then left, neck lymph node aches, feeling really bad like the patient wanted to cry, slight headache, night sweats. Lymph node pain and tenderness is the worse along with body aches and weakness. Also, on 15Jan2021, patient experienced rapid heart rate, increased blood pressure, severe tender and painful lymph nodes-to neck and groin and around sides, under ribs and tenderness to flank area. Mainly right below right ribs and right waist, right flank painful and difficult to turn in bed and lie on right side. There were also Itchiness but no visible rash. According to the reporter the events started on 15Jan2021 at 1AM. The patient received the first dose of bnt162b2 on 28Dec2020 and second dose on 12Jan2021. The patient had nasal swab, rapid on18Jan2021 result was negative and nasal swab on 20Jan2021 result was negative. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering except for abdominal pain one day which recovered on 16Jan2021.
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| 49 | 2021-02-03 | impaired work ability |
101.9 -highest fever got; body aches; a little bit of joint pain and dry heaving (didn't have anythi...
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101.9 -highest fever got; body aches; a little bit of joint pain and dry heaving (didn't have anything in me); diarrhea. Headache. It lasted until about 6 in the morning and then started getting better. By 4:00 pm on 20th I felt better. Just tired. I called in sick on the 20th. No treatment.
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| 49 | 2021-02-04 | anxiety |
Pfizer-BioNTech COVID-19 Vaccine EUA She has h/o anaphylaxis to flu vaccine and 5 minutes after CO...
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Pfizer-BioNTech COVID-19 Vaccine EUA She has h/o anaphylaxis to flu vaccine and 5 minutes after COVID vaccine she experienced SOB, throat and tongue itching, flushing, very anxious, her BP 144/102, HR 120s, RR 20. She had Epi-pen and we injected it for her per her request. She transferred herself to a wheel chair and went to ER with Crisis Nurse. Symptoms resolved. Patient discharged from ED.
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| 49 | 2021-02-04 | anxiety |
Rash; Fever of 101; Anxiety; more anxiety each day after the shot; Anxiety was reported as worsened;...
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Rash; Fever of 101; Anxiety; more anxiety each day after the shot; Anxiety was reported as worsened; Rash at injection site; This is a spontaneous report from a contactable consumer, the patient. This 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EJ1685), single dose via intramuscular route of administration in the left arm between 5:30-6pm on 15Jan2021 (at the age of 49 years-old) for COVID-19 vaccination. Relevant medical history includes ongoing nervous bad anxiety attacks, spinal stenosis (diagnosed 2-3 years ago), two stomach surgeries, so she had problems going to the bathroom and experienced bloody discharge, hiatal hernia surgeries (one surgery was 4 years ago and the other was 3 years ago), appendix taken out 3 years ago, ongoing insomnia diagnosed 10-11 years ago, shellfish allergy to lobster, pinched nerve and nerve issues and took Krill pills and had an allergic reaction. Relevant drug event included increased anxiety and her hands would fall asleep when she took trazodone and quetiapine (SEROQUEL). The patient did not receive any concomitant medications. On 17Jan2021, the patient experienced rash at the injection site. On 18Jan2021, the patient experienced a fever of 101 and more anxiety each day after the shot. Anxiety was reported as worsened. On an unknown date the patient experienced rash. The patient was treated for rash with diphendydramine (BENADRYL). The clinical outcome of fever was recovered on 19Jan2021, recovering for rash at injection site, unknown for rash and not recovered for anxiety.
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| 49 | 2021-02-05 | confusional state, amnesia |
pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt prese...
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pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22. pt presented to my office on 1/25/21 she had confusion, memory loss, labial bp, relative hypotension, bradycardia, severe fatigue, muscle pain and weakness, barely able to rise from a chair or walk, also reported HA, diarrhea, hiccups,decreased O2 sat to a low of 91%-her baseline is 98-100%, she developed a rash after her appointment with me.
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| 49 | 2021-02-05 | disorientation | Aches fatigue nausea somewhat disoriented |
| 49 | 2021-02-05 | feeling abnormal | Headache, brain fog, diarrhea, and exhaustion |
| 49 | 2021-02-10 | disturbance in attention, feeling abnormal |
Started with brain fog, unable to focus, fatigue, chills and body aches. Continued to progress to t...
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Started with brain fog, unable to focus, fatigue, chills and body aches. Continued to progress to temp 101.8, shaking chills, EXTREME arm pain, upper back pain, chest pain, wheezing, SEVERE headache, nausea, vomiting, diarrhea, EXTREMELY swollen axillary lymph nodes enlargement. Symptoms started approx 2 hours after injection and proceeded for 6 days then started to slowly improved then resolve.
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| 49 | 2021-02-10 | feeling abnormal |
Patient states that from her ears to her throat feels tight, she is hot and ear ache as well, feels ...
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Patient states that from her ears to her throat feels tight, she is hot and ear ache as well, feels yucky all of sudden. My tongue and throat feel fat and weird. Exactly like when she eats shrimp
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| 49 | 2021-02-10 | impaired work ability |
I woke up about 4am on the 8th I had fever and chills and shaky, temp was 100.5 nauseous, weak, diz...
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I woke up about 4am on the 8th I had fever and chills and shaky, temp was 100.5 nauseous, weak, dizzy, I called into work, I assumed the shot was working. I called my physician to let her know I was having a reaction, I diarrhea for 3 days . I just took some tylenol and after the 3 days I started feeling better
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| 49 | 2021-02-11 | impaired work ability |
I received my first COVID vaccination on 12/23/2020. Within 24 hours I had a very painful arm at the...
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I received my first COVID vaccination on 12/23/2020. Within 24 hours I had a very painful arm at the injection site & flu like s/s such as HA & myalgias. This continued & on 12/29/2020 I began to have an irritated bronchial & even stayed home from work this day. Each day the s/s progressed & by Monday 1/4/2021 I was beginning to have wheezing and chest congestion, productive cough, & SOB, diarrhea, & abdominal pain. The last symptom I have had was the horrible mouth lesions. I worked on Monday 1/4/2021 sick but then was off on 1/5, 1/6, 1/7, 1/8, & Monday 1/11/2019. Throughout my time of not feeling well I never ran a fever. On Friday 1/8/2021 I had a negative COVID test through the respiratory clinic. I did a round of antibiotics & even a round of steroids. I was last seen on Monday 1/11/2021 by the AMG PCP & was given the magic mouthwash. The mouth lesions have since gone away but I continue to have intermittent SOB, wheezing, and a productive cough. At this time I will wait until I am completely better to take the second vaccine. I just want to remind you that I did register through the CDC VSAFE program & continue to answer their questions through text & made them aware of the problems I have had since taking the vaccine. As discussed please file this documentation in my employee health file. My office coordinators have been very helpful & understanding throughout this time. appreciate all you do. Thank you.
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| 49 | 2021-02-12 | anxiety |
Pt stated tingling on the back of her throat. Upon assessment lips appeared normal and no swelling w...
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Pt stated tingling on the back of her throat. Upon assessment lips appeared normal and no swelling was noticed. No respiratory distress and vitals signs were within normal range. Pt stated stated she was really anxious upon arrival to the clinic. She was alert and oriented and able to keep a normal conversation. Pt requested water and no issues noticed with swallowing . Benadryl 25mg was administered at 1550. Pt stated improvement and was discharged home at 1625 with all symptoms resolved and feeling comfortable going home. Observation total time was 55 minutes
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| 49 | 2021-02-14 | anxiety |
Pt had 2nd of Vaccination today and presented with dizziness, anxious and palpitations 10 minutes af...
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Pt had 2nd of Vaccination today and presented with dizziness, anxious and palpitations 10 minutes after the injection. She relates at history of HTN on HCTZ, no cardiac history or diabetes. She works as a Medical Staff and her nurse manager happened to be present and is staying with her. Her initial VS were very tachycardic and hypertensive. 1437 EKG was applied VS 163/114 HR 145 RR 24 sats 100% she does not know her baseline BP. She continues to be lightheaded and dizzy despite sitting in chair and resting with the RN manager. Called Doctor and he recommended to call the RN stat however a code campus was already in process. Second VS at 1449 191/97 HR 145 RR 20 and sats 100% very lightheaded. An IV was placed 22 G to right hand by RN. THe RN stat Team now also at bedside.1500 ER RN with wheelchair to take pt to the ER with RN manager accompaning pt. In ER BED 18 report given to RN same RN who transported pt last VS 174/93 HR 142 RR 18 sats 100%. Having a STAT 12 lead at 1507 in the ED. Doctor informed of pts admit to the ER and sent report and pts MRN to him.
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| 49 | 2021-02-14 | anxiety |
Pt stated feeling well more related to anxiety, refused having VS taken. Stated that it will make h...
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Pt stated feeling well more related to anxiety, refused having VS taken. Stated that it will make her feel worse. RR 20, HR 110. Supervisor notified. Pt walked few steps, had water, stated feeling better. Husband called and picked her up/ Spoke with husband and medical team made him aware if pt getting worse need to go to ER
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| 49 | 2021-02-14 | feeling abnormal |
At around noon 2/11/21 i began getting a headache and took prescription strength Tylenol, by 730pm I...
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At around noon 2/11/21 i began getting a headache and took prescription strength Tylenol, by 730pm I started having chills and couldn?t get warm, eventually just going to bed. Through out the night I was sweating and experienced awful body aches and twitching. I woke up on 2/12/21 at 6:00am with a 100.4 temperature and slept until about noon at which time I had 101 temperature and then continued to sleep until 5p, still having a fever of about 100. I then slept until around 830am 2/13/21, still experiencing twitching, body aches and sweating. When I woke on 2/13/21 I had no fever, but still achy and in a ?fog?.
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| 49 | 2021-02-15 | loss of personal independence in daily activities |
I was overly tired. Around 8:30 pm I started to feel very tired. I rested for the night and woke up ...
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I was overly tired. Around 8:30 pm I started to feel very tired. I rested for the night and woke up at my normal time 6:00am. I was still very tired when I woke. I ended back in bed at 9:30am till 2:30pm. Once I was up again I was still tired. I did complete daily activates as normal. Went to bed at my normal time 10:00pm Saturday night and woke 6 am Sunday. Felt great and well rested.
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| 49 | 2021-02-15 | nervousness |
Pt c/o shaky, dizziness, heart racing, @ 1204 BP 138/80, O2 99, HR 104. Brought in for observation....
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Pt c/o shaky, dizziness, heart racing, @ 1204 BP 138/80, O2 99, HR 104. Brought in for observation. Pt stated being nervous about the vaccine. @1210 HR 80 per Dr. @ 1251 BP 122/70, HR 72, Pt stating feeling better. Dr. walked her to her husband.
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| 49 | 2021-02-17 | sleep disorder |
Unable to fully lift arm, intense/sudden pain with no factors causing it, wakes during sleep, OTC in...
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Unable to fully lift arm, intense/sudden pain with no factors causing it, wakes during sleep, OTC interventions not working
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| 49 | 2021-02-18 | nervousness |
approximately 5 minutes after the injection my upper lip went numb along with my left side of my fac...
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approximately 5 minutes after the injection my upper lip went numb along with my left side of my face, primarily my upper cheek below my eye. Then it slowly moved to the top of my head and the top of my left hand. My heart was racing a bit, but that could be due to me being nervous about my face going numb. An attendant stayed with me until it started to subside, approximately 15 minutes later. Other side effects were mild the following day. A bit of a headache, fatigue and chills. Fatigue lasted a couple days but all minor.
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| 49 | 2021-02-18 | sleep disorder |
Developed 6 days after vaccine RUQ abd pain that woke her from sleep. Seen later that day by PCP in...
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Developed 6 days after vaccine RUQ abd pain that woke her from sleep. Seen later that day by PCP in another facility and had labs done: t..bili 1.6, GGT 472, alb 4.2, alkaline phos 257 (upper nl 150), AST 276 (upper normal 33), ALT 512 (upper normal 33) HepB surf ag - non-reactive, hep B core Igm - non-reactive, IgA non-reactive, hepC non-reactive CBC wbc-9.8 rbc 5.26 hgb 17.1 hct 49.7, MCV 94.6 MCH 32.5, MCHC 34.3, plt 229 mpv 10.3 RDW 14.2 Lipids - Tot-218, TRG-138, HDL - 65 LDL-125 non-HDL 153paLiver US (2.12.2021) - liver diffusely coarsened and increased in echogenicity that can be seen in fatty infiltration or other diffuse hepatocellular process. This limits the sensitivities for the detection of hepatic masses. Cholecystectomy. dilatation of th ecommon duct due to postcholecystectomy state.
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| 49 | 2021-02-19 | feeling abnormal |
High fever (up to 103 degrees) for three days, extreme muscle pain, joint pain, fatigue, brain fog, ...
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High fever (up to 103 degrees) for three days, extreme muscle pain, joint pain, fatigue, brain fog, nausea, joint pain, weakness
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| 49 | 2021-02-19 | impaired work ability |
I am not sure if this is related or not, but 15 days after my 2nd Pfizer dose I started having Vert...
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I am not sure if this is related or not, but 15 days after my 2nd Pfizer dose I started having Vertigo. I continue to have vertigo. I saw my doctor on January 27 and we tried steroids, lorazepam, and phenergan. I saw a physical therapist for vertigo and continue to do exercises to treat vertigo. I did have a previous incidence of vertigo a couple weeks after a flu vaccine about 3 years ago. I just wanted to report my symptoms as the Covid vaccine is new. I have currently not recovered from this episode of vertigo and cannot work at this time.
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| 49 | 2021-02-24 | panic attack, anxiety |
12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red...
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12/22 vaccination 4pm. 4:05 PM, my HR went way up. I broke out on neck, chest, face; fire engine red. Felt like burning from the inside, out. Lightheaded and dizzy. Got puffy. Was NOT anaphylactic. 2 Benadryl. I didn't feel good for a couple weeks. 14-20 days, same experience with redness/burning. I took pictures. That happened every day for 4-5 more days. I went to doctor after doctor; ER after ER. About 6-7 times I have been to the ER; SOB, dizzy all the time, panic attack/anxiety, Stomach is not emptying correctly (NOT diabetic), eye keeps twitching, hurting behind my eyes, all my muscles are shrunken now. Blood panel, stress test; gastroparesis; positive; ringing in my ears; SOB; *COVID; negative.
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| 49 | 2021-02-25 | insomnia |
No side effects with 1st dosage. within 8 hours of 2nd dose side effects included: rapid heart rate...
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No side effects with 1st dosage. within 8 hours of 2nd dose side effects included: rapid heart rate, insomnia, body pain, joint pain, lower back pain, severe chills, upset stomach, nausea, headache. Within 36 hours, most of the side effects were gone, except headache. 3 days later - still have headache, and flush feeling all over body with mild sore throat (as of 2/26/21 @ 11:27 a.m.)
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| 49 | 2021-02-26 | incoherent |
came to the vaccination appointment with no current illness or cough. Within less than 5 minutes af...
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came to the vaccination appointment with no current illness or cough. Within less than 5 minutes after the injection started with a cough that is similar to asthma attack onset. As talking with the nursing staff on site after waving them over I began to get worse very quickly. Within minutes I heard one of the staff say "she's crashing, move it". At that point I could not breathe, audible wheezing, shortness of breath, throat was closing, entire body felt like it was on fire, extreme itching on back (especially upper back), shaking/convulsing, incoherent. Paramedic staff was put into place and i was ambulanced to the hospital across the street from the vaccination site. Everything is a whirlwind at this point and treatment from what I can remember was albuterol svn, atrovent svn, use of cpap, epipen administration in the parking lot, benadryl via iv, solumedril, oxygen and pepcid. Once arrived at E.R. I was aggressively treated. Once stabalized began to wheen off the oxygen onto room air. I am a rare asthmatic and my oxygen sats usually do not drop, although I am in distress. At one point I heard oxygen sats were at 96, which is low for me. I was discharged from the hospital to my husband's care. In the next days now I am expriencing fever (100), itching, red rashy skin, severe headaches, joint pain, body ache, diarehha and extreme fatigue
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| 49 | 2021-03-03 | anxiety | Dizzy, anxious, tachycardia, nausea |
| 49 | 2021-03-03 | confusional state, agitation |
Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appet...
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Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appetite; stuffy nose; sneezing; drowsiness; confusion; agitation; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9269) via unspecified route on left arm single dose for COVID-19 immunization on 01Feb2021, 04:00 PM at 49-year-old. Medical history included: osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID-19, known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK923) left arm for COVID-19 immunization on14Jan2021, 01:30 PM at 49-year-old; had body aches, fever, sore arm and skin ach. No other vaccine received in four weeks. On 02Feb2021, 02:00 AM, the patient had intense pain, intense joint pain, intense eye pain, intense headache, loss of balance, loss of appetite, stuffy nose, sneezing, drowsiness, confusion, agitation. Outcome of the events was not resolved.
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| 49 | 2021-03-04 | anxiety |
1435 received vaccine. 1445 warmness to arm and dry mouth, anxiety. 124/80, hr-114, 02 sat 94%ra. Wa...
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1435 received vaccine. 1445 warmness to arm and dry mouth, anxiety. 124/80, hr-114, 02 sat 94%ra. Warmness to arm resolved 1500. anxiouness resolved 1505. throat cont to be dry able to drink water w/o difficulty. drank one full bottle of water. Report sensitive and has many allergies. Pt husband is in car and informed of pt condition. 1520 pt condition dryness in needs to take mask off.. went outside totake off and get fresh air. 1540 128/89-hr-122-02 sat 96%ra r-18. Pt instructed to f/u with MD has appointment on tuesday. upon discharge reports tired and dry throat.
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| 49 | 2021-03-04 | anxiety |
Pt. reports dizziness and anxiety. Given a snack and water; observed additional 15 minutes. Pt. fe...
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Pt. reports dizziness and anxiety. Given a snack and water; observed additional 15 minutes. Pt. felt much better, dismissed stable.
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| 49 | 2021-03-07 | feeling abnormal |
After 1st dose had 24 hours of headache, fatigue, aches and very sore arm. Lymph node under arm swol...
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After 1st dose had 24 hours of headache, fatigue, aches and very sore arm. Lymph node under arm swollen for weeks. After 2nd dose started with brain fog, woozy, aches and joint pain, then severe chills, fever, exhaustion and significant gas pain in chest for about 48 hours. Tylenol taken for 24 hours.
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| 49 | 2021-03-08 | feeling abnormal |
Within one minute of receiving injection, my heart started racing and I felt dizzy and light headed....
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Within one minute of receiving injection, my heart started racing and I felt dizzy and light headed. After waiting at the vaccination site for 30 minutes, my heart rate slowed and the dizziness lifted enough to drive myself home. It's now been almost 3 hours and I still feel a little off but mostly just have a headache.
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| 49 | 2021-03-08 | insomnia, mental impairment |
hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; he...
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hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-03-09 | feeling abnormal |
Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropp...
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Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropped to 99.6 for a day. I had chills, joint achiness, fatigue, foggy headed feeling, a runny nose, sinus pressure, headache, chest tightness and pain, arm pain, stomach pain, lymph nodes in my left armpit are sore (after 10 days), and I now seem to have a worsened allergy to dairy and a new allergy to nuts - I get very phlegmy, cough, and have chest pain and tightness. These symptoms lasted for 5- 6 days and the allergies with their symptoms and sinus pain and sore lymph nodes have continued.
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| 49 | 2021-03-10 | feeling abnormal |
I felt flushed but had taken double dose of Zyrtec. Second dose caused similar symptoms to first dos...
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I felt flushed but had taken double dose of Zyrtec. Second dose caused similar symptoms to first dose with more severe aches and pains. I had trouble getting up or moving. Tremors on the right side leg and arm were markedly worse than normal and I was unstable on my feet. Instability and fatigue lasted three weeks. Mood swings and brain fog were unusual and persisted for no reason for 2-3 weeks. For one day I had inflammation of glands on the right side of my throat. Phone contact with doctor to report that allergy did not occur.
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| 49 | 2021-03-11 | feeling abnormal, nervousness, disorientation |
About 2 minutes after receiving the injection - I went through 4 'waves' over the next 25 minutes - ...
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About 2 minutes after receiving the injection - I went through 4 'waves' over the next 25 minutes - each wave lasted about 2 minutes. During that time - I felt a wave/rush of lightheaded/disorientation feeling/ a cold sensation was rushing throughout my body internally/weak-shaky/ dry mouth/ and one of the waves I felt like I had to make myself swallow/like a rush of adrenaline. These subsided - and started again with a couple minutes between each wave. I took a Benadryl once I arrived home - only 2 very minor waves that morning. No other treatment but now afraid and need guidance if I should get the 2nd injection in case the 2nd reaction is worse.
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| 49 | 2021-03-12 | loss of personal independence in daily activities |
At around 1:30 I started feeling achy and tired. Overnight and the following day, I couldn't get out...
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At around 1:30 I started feeling achy and tired. Overnight and the following day, I couldn't get out of bed. I had an increase in hot flashes, which lasted through the 2nd day and I was back at work. On the 2nd day, the arm pain and swelling worsened. I had a 2 in x 2 in area of redness by the injection site. With the 1st one I had a lot of hot flashes, but nothing to where I was unable to work.
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| 49 | 2021-03-12 | sleep disorder |
02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the...
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02/12/2021- 12:36am woke up with chills that went on for about 1 hour. About 7am woke up went to the restroom and almost fainted (lightheaded, nausea, black vision, cold sweat). Blood pressure was 84 over 44. In the afternoon had muscular pain and a low grade fever of 100F for about 2 hours. A little sore at the injection site but all symptoms disappeared on day two 03/13/2021
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| 49 | 2021-03-13 | confusional state |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium
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| 49 | 2021-03-13 | feeling abnormal | chills nausea fatigue brain fog joint aches headache |
| 49 | 2021-03-15 | sleep disorder |
numbness and tingling in both hands, pain in muscle at injection site, worse at night, unable to sle...
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numbness and tingling in both hands, pain in muscle at injection site, worse at night, unable to sleep
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| 49 | 2021-03-16 | anxiety |
very bad dry mouth starting after first vaccine shot, worsening after second dose, gradually startin...
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very bad dry mouth starting after first vaccine shot, worsening after second dose, gradually starting to subside 1 week after 2nd vaccine . urination urgency. starting 1 week after the 1st vaccine shot. increasing for 1 week. continuing after second dose. gradually subsiding 1-2 weeks after second vaccine dose. eye pain, sensitivity to light only lasting 1-2 days 10 days after second dose. Pervasive anxiety either from circumstances or vaccine. i dont know. and a one time vaginal bleed a week after 2nd dose.
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| 49 | 2021-03-17 | sleep disorder, loss of personal independence in daily activities |
Patient states she received COVID-19 vaccine on 3/5/21 and "it seemed high up" and describes site as...
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Patient states she received COVID-19 vaccine on 3/5/21 and "it seemed high up" and describes site as "one finger width down from the top of the shoulder bone". Denies immediate pain with injection. Reports she went home and "kept trying to move it around" to minimize soreness at injection site. States she and her husband put together a treadmill, although she "just unwrapped the parts and did not do any heavy lifting". Reports pain worsened that night and rated it 7-8/10. Reports she used ibuprofen and ice without effectiveness. Reports she "did not sleep at all Friday night". Reports she couldn't get dressed or undressed and could not wash her hair.
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| 49 | 2021-03-18 | sleep disorder |
About 10 minutes after receiving vaccine, I experienced a gurgling sensation on the left side of the...
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About 10 minutes after receiving vaccine, I experienced a gurgling sensation on the left side of the chest while breathing. That lasted for about 5 minutes and then dissipated. Throughout the day, I had intermittent chest pain. Upon going to bed that night I found I could not sleep on my right side because it hurt to breathe (primarily to exhale). On my back, I was okay. I had minor chest pain, all on the left side, the next day (3/18) in the morning. By lunchtime it was gone. The evening of 3/18 (roughly 5:15-7:00), I experienced extreme chills. Finally put on my winter coat over my sweatshirt to get warm.
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| 49 | 2021-03-20 | loss of personal independence in daily activities, feeling abnormal |
Jan. 21-Jan. 24: In bed: fatigue, dizzy, nausea, body aches, headaches Jan. 24- present day: Fatig...
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Jan. 21-Jan. 24: In bed: fatigue, dizzy, nausea, body aches, headaches Jan. 24- present day: Fatigue, brain fog, headaches
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| 49 | 2021-03-21 | feeling abnormal |
About 1 minute after the patient's vaccine she said she felt badly. We took her back to the bed. She...
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About 1 minute after the patient's vaccine she said she felt badly. We took her back to the bed. She said she has a hx of anaphylaxis to allergy shots 3 times. She reports no history of hypertension. Her BP was 131/94, pulse 65, oxygen 99. Patient reported throat was getting tight. I gave 50mg of benadryl.
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| 49 | 2021-03-21 | insomnia |
I had soreness on my shoulder that progressively extended to all of my upper arm and became more pai...
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I had soreness on my shoulder that progressively extended to all of my upper arm and became more painful. I had difficulty raising my arm or moving it (it reminded me of the pain I felt when I had a case of bursitis on my other shoulder years prior). When lying down I could not sleep on that side and had difficulty sleeping on my right side as I could not find a comfortable position for my left arm that would not cause shooting pain. This lasted for 2-3 days. It subsided after 5 days. However, 10 days later, sometimes I get a softer pain on that arm when I move it. I did take extra strenght Tylenol, as recommended by the person that provided the shot. It did not help a lot, to be honest.
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| 49 | 2021-03-22 | feeling abnormal |
3/22 very severe tightening of neck muscles and neck ache 3/23 woke up w very tight neck and head p...
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3/22 very severe tightening of neck muscles and neck ache 3/23 woke up w very tight neck and head pain. As the day progressed, experienced pain/inflammation in leg muscles and body. Headache worse. Brain fog. Slow to focus eyes.
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| 49 | 2021-03-22 | feeling abnormal |
Approximately 8 minutes after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, the ...
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Approximately 8 minutes after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, the patient reported feeling ?funny?. She described symptoms including itching/tingling, sweating and increased heart rate. She was immediately ushered into the counseling room of the pharmacy and a blood pressure monitor was attached to her arm. At 2:09 p.m. her blood pressure was 166/78 and heart rate was 98 BPM. At this time 25mg of diphenhydramine was given to the patient orally. In addition to the subjective symptoms, the patient?s complexion had turned from neutral to red, and her face was covered in what appeared to be hives. EMS was called, and while on the phone with a dispatcher, a subsequent reading found the patient to have a BP of 140/122 and HR 121 BPM (2:15p.m.). As instructed by the EMS dispatcher, 0.3mg was administered to the patient via auto-injector into the left thigh. Paramedics arrived several minutes later and the patient was helped onto a stretched and subsequently escorted from the building for further observation and treatment.
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| 49 | 2021-03-24 | anxiety |
3/25/2021 Patient was observed post Covid-19 immunization for 10 minutes as she reused to stay due...
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3/25/2021 Patient was observed post Covid-19 immunization for 10 minutes as she reused to stay due to anxiety . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness. Assessment : Time of assessment 1148 Alert and oriented, anxiety Actions taken: VS taken at 1148 BP- 181/118, P- 73, O2- 97% Medications administered: No medication administered. Disposition: patient refused further care, concern voiced over elevated BP, and she voiced that it is " usually higher". She refused continued monitoring. She left facility with a friend. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/25/2021 11:38 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc
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| 49 | 2021-03-24 | feeling abnormal |
Pt had second COVID vaccine 11 days ago, and is still not feeling well. Pt is very tired, nausea, b...
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Pt had second COVID vaccine 11 days ago, and is still not feeling well. Pt is very tired, nausea, body aches, brain fog, cold then hot temp(~100), no appetite. Pt states she can hardly get out of bed.
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| 49 | 2021-03-25 | feeling abnormal | Brain fog, vertigo and naseaus |
| 49 | 2021-03-26 | nervousness |
I have felt extremely weak and fatigued since i got my First dose. It has not subsided at all and it...
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I have felt extremely weak and fatigued since i got my First dose. It has not subsided at all and it's been 8 days. I feel shaky and get hot flushing every time I exert myself. I feel like I have the flu.
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| 49 | 2021-03-29 | nervousness |
1204 pm given 1st dose of Pfizer vaccine. at 1220 pt began to complain of nausea, headache, feeli...
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1204 pm given 1st dose of Pfizer vaccine. at 1220 pt began to complain of nausea, headache, feeling hot, flushed, & some dizziness. Bp 150/84 , pulse 104, pulse ox 98% on RA; denies shortness of breath. Pt offered some water. At 1225 pm began having tingling lips & throat feeling funny; no lip swelling noted; pt offered EPI and declined; she was offered & took po Benadryl 25 mg. 1227 vitals bp 142/90 pulse ox 95% p 104. At 1229 pt began to state her throat beginning to tighten and EPI pen 0.3mg administered in L thigh by a different RN assisting writer. Stat call made at 1229 also. 1231 Oxygen given 2L per NC as pt stated difficulty breathing. 1232 pt stated she starting to feel better but more nervous now than anything. 1233 pt able to stand & and escorted to the ED with stat team staff.
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| 49 | 2021-03-30 | impaired work ability, delirium, disturbance in attention |
Pain in sacrum & hip flexors steadily increasing to entire pelvic girdle. Started at 10am and by 12p...
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Pain in sacrum & hip flexors steadily increasing to entire pelvic girdle. Started at 10am and by 12pm it was hard to sit to work. At 1pm I left work for the day (I work from home so simply let my supervisor know) because the pain was so intense I could not focus. The pain was constant & aching in the entire pelvic girdle with sharp random flashes - I would get one in my left hip flexor, then my sacrum, then down my right leg or in my right toes, then in my right TFL, then my left quad, etc. I could not find comfort standing, laying, sitting. I tried stretching, a heating pad, ice...nothing would help. It got steadily more painful to where I couldn't do anything but lay in bad trying to get comfortable from 3-6pm. My neck became tight as well as my rhomboids. When I would try to get up to walk, my sacrum hurt so much and everything was so stiff, it felt as if I had thrown out my back. I was on the border of being delirious from the ongoing & unrelenting pain. At 7pm I took 2 Advil and by 8:30pm it seemed like the edge was coming off a bit. By 10pm I was able to get comfortable enough to sleep. When I got up the next morning I thought I was better but after moving around a little the pain started to come back strongly in my lower back. I took 2 Advil again and that helped immensely. From then on I was SO much better with only occasional flashes of sharpness over the next two days (3/27 & 3/28). I am now totally fine. I have thrown out my back in the past, so I know what that is like and recognize the symptoms. This event was NOT due to anything like that. The pain set in slowly and steadily and the sharp flashes were not contained to a specific area as if I had an injury. They would happen in the most random spots and nothing was consistent about them (expect that they hurt a lot). Also, I would not have recovered so quickly if I had thrown out my back.
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| 49 | 2021-03-31 | loss of personal independence in daily activities |
I got the second shot at 3 pm and by 2 am I had a temp of 100 and body aches and felt like I had the...
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I got the second shot at 3 pm and by 2 am I had a temp of 100 and body aches and felt like I had the flu. It is now 8 pm- 29 hours after the injection and I still have a fever and a migraine. Haven?t gotten out of bed
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| 49 | 2021-04-02 | fear | Body aches, shaking chills, nausea, fever of 101 degrees |
| 49 | 2021-04-02 | impaired work ability |
I took my vaccine March 29 in pharmacy after that I can?t go to work for the side effect nauseas ,...
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I took my vaccine March 29 in pharmacy after that I can?t go to work for the side effect nauseas , dizzy and headache , those actually continue . The condition of the storage of the vaccine was not correct , the staff have more than 20 vaccine accumulated. in a plastic bag inside the drawer without fridge I don?t know for how long time , they continue with this practice , the patient take the shot in a small place and they prepare the syringe before that you seat down in the place to take the shot .Thanks
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| 49 | 2021-04-03 | sensation of foreign body |
Pain at injection site, redness, feels like there?s something stuck in there....like a piece of the ...
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Pain at injection site, redness, feels like there?s something stuck in there....like a piece of the needle broke off. This is 3 weeks after the injection!
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| 49 | 2021-04-05 | anxiety |
Pt is a 49 YO Female presented with severe anxiety upon initial contact with medical observation phy...
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Pt is a 49 YO Female presented with severe anxiety upon initial contact with medical observation physician. After some coaching and sitting with physician pt decided to get the vaccine and physician gave approval. Pt then proceeded to booth 9 and a paramedic gave pt her 1st does of the Pfizer vaccine. Pt was still very anxious but agreed to continue with the vaccine injection. After injection was given pt stayed in booth for an addition 10 minutes with the paramedic. Pt was coached to take slow deep breathes in order to get her breathing under control. After pt started to calm down, she was asked if she was ready to proceed to medical observation for her 30 preset time. Pt agreed and we walked to the observation tent. Pt was transferred to the observation unit team for the next 30 minutes. At approximately 1410, the paramedic was alerted that pt was having an adverse reaction and needed to be medically assessed. The paramedic immediately proceeded to patient with medical equipment given by facility. Upon assessment pt presented A&OX4, very anxious, skin flushed, complaining of dizzy, lightheaded, and a headache. Pt was speaking normally and vitals were assessed. Vitals are as follows: At 1418- BP 186/110, HR102, RR26, SPO2 99% Lung sounds clear in all fields, Skins: hot, flushed, moist; At 1427- BP 196/116, HR 99, RR 24, SPO2 98% Lung sounds clear in all fields, Skins hot, flushed, moist. PT was then assessed for possible stroke and was negative slurred speech, negative arm drift, pt had symmetrical smile, and equal grips bilaterally. The decision at that point was made by the paramedic to activate the EMS 911 system for further evaluation and possible ALS ambulance transport to the hospital for further evaluation by emergency physicians. After EMS arrived and assessed the patient, they agreed the patient should be transported to the ER and pt was transported to local hospital, Pt care was transferred to responding paramedics and pt contact ended at that point. Report was given to responding paramedics.
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| 49 | 2021-04-05 | disorientation |
Pt scheduled for 2nd COVID vaccination (pfizer). While in observation after vaccine administration,...
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Pt scheduled for 2nd COVID vaccination (pfizer). While in observation after vaccine administration, pt reported not feeling well. Clinic caregivers monitored vitals and eventually moved patient from chair to bed located behind curtain in observation room. Pt started to become increasingly disoriented and experiencing shortness of breath. Pt condition rapidly concerning as was visibly and audibly struggling to inhale and exhale with significant facial redness. Epinephrine 0.3mg auto injection given once. Med team called after dose of epi. Rescue breathing using bag was applied as patient appeared apneic. Upon med team arrival RN administered another 0.3mg epi and brought pt to ED for further treatment and monitoring. Pt was discharged from ED in stable condition.
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| 49 | 2021-04-05 | feeling abnormal |
Lips immediately started tingling. After about 25 lip tingling started to subside and then cheeks mo...
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Lips immediately started tingling. After about 25 lip tingling started to subside and then cheeks mouth and tongue feel funny. Top of mouth burns. I feel like when I have an allergic reaction to a cat
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| 49 | 2021-04-05 | sensation of foreign body |
Patient was being monitored for additional time as she has allergies. About 7-10 minutes patient n...
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Patient was being monitored for additional time as she has allergies. About 7-10 minutes patient noted she was feeling "itchy". She was found to be scratching her throat, and arms. Patient was brought to the exam room, she stated she was feeling warm, itchy and a lump in her throat along with dryness. BP at that time was 157/111. Patient reported increasing feeling of a lump in her throat, at that time Epinephrine 0.3 mg injection was administered. Nurse called 911. Patients BP was then noted to be 157/89. Patient stated she was feeling warm, and itchy, felt like she had to cough due to the lump in her throat. About 10 minutes after the first epi injection, patient was feeling nauseous, hot and her throat was still dry with the lump. The second dose of epinephrine 0.3 mg was given. About 2 minutes after the second dose of epinephrine EMS was on scene and patient was transported to Hospital. Nurse called Dr to Update on the patient incident.
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| 49 | 2021-04-06 | anxiety |
Pt developed dizziness, sob, and anxiety. Symptoms likely r/t anxiety. BP 160/78, HR 77, SpO2 98% RA...
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Pt developed dizziness, sob, and anxiety. Symptoms likely r/t anxiety. BP 160/78, HR 77, SpO2 98% RA. Repeat BP 119/70. Pt reported feeling better but still slightly dizzy from the inhaler, which is common for her.
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| 49 | 2021-04-07 | anxiety |
Pt was vaccinated at 2:12pm with Pzifer COVID vaccine. Pt went to observation room. at 2:15, pt aler...
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Pt was vaccinated at 2:12pm with Pzifer COVID vaccine. Pt went to observation room. at 2:15, pt alerted RN that she was feeling itchiness and that her "throat was closing". RN took vitals at 2:17, BP was 138/69 HR 66 spO2 97%. Additional RN present as a witness. Pt then became anxious and stated that she has hx of allergic reactions and that she needs to go to hospital now. RN told pt that she cannot leave without further eval and stabilization. RN opened the ER box to grab the Epipen and pt started to walk out. RN stopped pt and told her she needed to stay and given her reported sx, would need to have Epipen or Benadryl. Pt states she does not want Epipen or Benadryl, only wanting Morphine or Prednisone. BP reassessed and 169/71, spO2 98% at 2:20pm. RN alerted lead RN and Dr was brought with to assess. Dr assessed pt, still c/o of itchiness and throat closing. Pt denies: nausea, vomiting, inability to complete sentences, wheezing. Dr went over risks of not medicating and pt was agreeable to Benadryl 50mg IM one dose. BP taken again, 161/87 HR 68. Benadryl given. Dr told pt that she should take ambulance to nearest hospital. Dr thoroughly went over risks. RNs there as witnesses. Pt walked away and left AMA.
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| 49 | 2021-04-07 | anxiety |
About 20 minutes after vaccine given, patient reported symptoms of anxiety. Vital signs within norm...
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About 20 minutes after vaccine given, patient reported symptoms of anxiety. Vital signs within normal limits. Symptoms resolved on own.
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| 49 | 2021-04-07 | irritability |
First 24 hours, arm pain/ discomfort at injection site only At 24 hours, mild myalgias/ arthralgias ...
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First 24 hours, arm pain/ discomfort at injection site only At 24 hours, mild myalgias/ arthralgias and low grade fever At 30 hours, progressive worsening of myalgias/ arthralgias and fevers/ chills/ rigors; TMax 102.0 F At 36 hours, severe myalgias/ arthralgias, continued fever unresponsive to administration of antipyrectics, and onset of nausea PCP contacted, aware of reactions, recommended conservative management At 48 hours, continuation of above symptoms, all severe and unrelieved with supportive care Day #3: Fevers improved, myalgias/ arthralgias resolving, mild nausea and abdominal discomfort Day #4: Low grade fevers continue, no myalgias/ arthralgias, worsening nausea, abdominal discomfort, onset of diarrhea; irritable and fatigued Day #5: Low grade fevers continue, nausea, abdominal discomfort, diarrhea, inability to tolerate PO intake, worsening fatigue Day #6: Fevers resolved. Nausea, abdominal discomfort, diarrhea, inability to tolerate PO intake and fatigue persists Day #7: Diarrhea resolved. Nausea, abdominal discomfort improved, tolerating some PO, fatigue persists Day #8: Worsening of nausea, abdominal discomfort with PO intake, tolerating minimal PO, fatigue persists Week 2: Nausea improving, abdominal discomfort improving, PO intake improving, fatigue persists
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| 49 | 2021-04-08 | anxiety |
Received Pfizer dose on 4/3/21 first dose (lot# EN6201). On 4/5/21 patient brought in by ambulance w...
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Received Pfizer dose on 4/3/21 first dose (lot# EN6201). On 4/5/21 patient brought in by ambulance where the patient received an ECG which showed normal sinus rhythm and see ambulance run sheet prior to arrival. Patient who reports getting COVID-19 vaccination 2 days ago presenting with diffuse myalgias, fatigue, headache, perceived difficulty breathing, and tactile fever. She reports feeling these symptoms have also caused her some anxiety, which she has had cause some difficulty breathing before. She denies cough or wheezing. She denies abdominal complaints. She has not taken anything for her symptoms at home.
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| 49 | 2021-04-08 | feeling abnormal |
1:50pm Pt walked from parking lot to vaccine tent to report she felt strange. Complaining of a sens...
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1:50pm Pt walked from parking lot to vaccine tent to report she felt strange. Complaining of a sensation that started in her vaccination arm site and seem to spread over her upper body and described it as swimmy eyes and chest tightness. Patient placed in a chair, VS obtained: BP 150/90 in RUE, HR 60/normal, RR 20/normal. Otherwise the patient was calm in appearance in A&O x3. Patient states she hadn't eaten much that day. Provided a bottle of water and a Chewy snack bar. 2:05pm Patient reports symptoms are no worse or better; Nursing Supervisor notified. 2:07pm Medical Director, Doctor notified of patient and subjective/objective data. Order for Benadryl 50mg IM obtained. Along with instructions not to drive post administration of the Benadryl and to call EMS or report to the nearest ED if reported symptoms related to chest tightness did not improve. 2:08pm Benadryl 50mg IM given in right upper extremity. Patients husband has arrived and is standing next to her. Patient remains calm and in no apparent distress other than the symptoms previously reported. 2:18pm Patient states she feels woozy from the Benadryl, but no worse or better than previous. Offered to call EMS, patient and husband declined. 2:30pm Nursing Supervisor onsite. Patient re-evaluated by asking questions related to current symptoms. Patient states chest tightness had resolved. 2:40p Patient reports feeling better. Patient instructed not to drive due to the potential for drowsiness related to the Benadryl administration. 2:45p Patient and husband left the vaccination area together.
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| 49 | 2021-04-08 | excessive sleepiness |
About two hours after my first vaccine, my arm was a little bit sore and I felt tired. The next morn...
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About two hours after my first vaccine, my arm was a little bit sore and I felt tired. The next morning I was fine. On day 11 around 6 PM I noticed suddenly that my left arm started becoming extremely sore again. Especially where I received the vaccine. A few minutes after that I started not feeling well and extremely lethargic. I stayed in bed all day the next day but luckily today I woke up and I?m OK again. Just wanted to let you guys know.
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| 49 | 2021-04-09 | feeling abnormal, confusional state |
I got the 2nd dose about 2pm. I stayed for over the 15 min because I was talking with a friend and w...
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I got the 2nd dose about 2pm. I stayed for over the 15 min because I was talking with a friend and we were there closer to 20 min. I had a headache right after the shot was administered and my arm hurt. I was fine earlier that day. By about 2:25 I was heading home and wanted to get some McDonald?s because I had an hour drive. I noticed in the drive through that my eyes felt they were being sunken in. My right eye and side of nose started to tingle. It started spreading on my right side down to my lips and up to my scalp. Then down my arm to my fingers and down my right leg. I was dizzy and nauseous and confused. I managed to call my boss at triton who said to come back to the office. The nurse met me in the office where I had laid on the floor to try and help the pressure. By then I was numb on my whole face. Teeth and tongue but was able to swallow and talk. They called an ambulance to have me checked out. My blood pressure was high while there. They asked if I had been anxious or having a panic attack. I was neither. I just felt dizzy and numb.
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| 49 | 2021-04-09 | feeling abnormal |
8 Days after first injection almost fainted while driving. Heart raced and felt hot/clammy/dizzy/bl...
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8 Days after first injection almost fainted while driving. Heart raced and felt hot/clammy/dizzy/blurred vision. Lasted for 20 minutes. Continue to feel light headed, occasionally dizzy, and brain fog since then..
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| 49 | 2021-04-09 | sleep disorder |
after the initial vaccine like, woke me up at night; This is a spontaneous report from a contactable...
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after the initial vaccine like, woke me up at night; This is a spontaneous report from a contactable Nurse. A 49-year-old female patient received first dose of BNT162B2 (solution for injection; Batch/lot number: El1284) via intramuscular in left arm on 05Jan2021 at 11:30 as single dose for COVID-19 immunisation. The patient's medical history and concomitant were not reported. The patient was not pregnant at the time of vaccination, Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05Jan2021, the patient received the first vaccine, 16 hours after the initial vaccine, the patient reported that, she woke me up at night at 12:30 am. The outcome of the event was unknown.
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| 49 | 2021-04-11 | anxiety | ANXIETY, PT FELT OVERWHELMED WITH EVERYTHING, REFUSED TRANSPORT 140/82, 80 |
| 49 | 2021-04-12 | sleep disorder |
Fever, chills, severe headache and joint pain. Felt tired and fatigued. This occurred after both inj...
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Fever, chills, severe headache and joint pain. Felt tired and fatigued. This occurred after both injections but was considerably worse after the second. Headache has continued to be constant since the vaccine. I have also experienced heavy periods, and horrible cramps. Before the vaccine I almost had no period whatsoever. I didn?t have cramps at all. In my 20s I did have cramps and heavier periods. Since the vaccine the cramps have been so bad they wake me up at night. I also am experiencing a lot of bleeding for a longer duration. This is absolutely abnormal for me. I had an ablation three years ago so seldom had any period. If I did it would be very light brown spotting. Not enough to even wear a pad. So, this is highly unusual.
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| 49 | 2021-04-13 | depression | Headaches, low grade fever, exhaustion, chest palpitations, shortness of breath, depressive episode. |
| 49 | 2021-04-13 | feeling abnormal |
Anaphylactic Reation. everything swelled and rash appeared, couldn't swallow, throat constricting. ...
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Anaphylactic Reation. everything swelled and rash appeared, couldn't swallow, throat constricting. Epinephrine injection, Racepinephrine, diphenhydramine methlprednisolone, famotidine Day after feel like run over by a truck and nausea, feel sick, headache, joint pain not sure how long everything will last or if more will appear
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| 49 | 2021-04-14 | excessive sleepiness |
fever of 102.5, migraine, chills, body aches and exhaustion (slept for almost 2 days (Wednesday and ...
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fever of 102.5, migraine, chills, body aches and exhaustion (slept for almost 2 days (Wednesday and Thursday 4/6 & 4/8) I felt fine on Friday
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| 49 | 2021-04-15 | confusional state |
pt has history of MS arrived via wheelchair to OBS with c/o headache and nausea pt drowsy arousabl...
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pt has history of MS arrived via wheelchair to OBS with c/o headache and nausea pt drowsy arousable to verbal stimuli unable to follow simple commands cofusion noted VS stable called pt father father arrived to bedside pt and father agreeable to leave via EMS for further evaluation EMS arrived report given father left with patient wheelchair and personal belongings at 1240 VS 1205 bp 129/78 hr 95 rr 18 o2 99 1210 bp 126/78 hr 76 rr 16 o2 96 1215 bp131/76 hr 84 rr 18 o2 96
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| 49 | 2021-04-15 | crying |
On April 11th, woke up with a swollen left eye and upper cheek, with redness. On April 12th, woke up...
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On April 11th, woke up with a swollen left eye and upper cheek, with redness. On April 12th, woke up with left eye nearly swollen shut, and entire left side of face red and puffy. As the day progressed, blisters appeared and began weeping. Which does sound like it could be a poison weed, right? I had zero contact with any poison ivy, sumac, oak, etc. I had not changed my diet, changed any soaps/detergents, etc. Contacted primary care provider who diagnosed issue as poison ivy and prescribed 40 mg of prednisone for 3 days, 20 mg for 2 days. By Thursday April 14th, issue was not improving and my entire face was swollen, red, hot and itchy. Went to the urgent care clinic who conferred with my primary doctor and they decided to increase my prednisone treatment to 60 mg for 3 days, 20 for 3 days. As of today, April 16th, the prednisone treatment does not appear to be helping, as face is still red, swollen, hot and itchy. This has also spread to my neck area, but not any where else on my body.
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| 49 | 2021-04-15 | insomnia |
within a couple hours of receiving the vaccine i had a headache and felt tired. at 3am that evening...
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within a couple hours of receiving the vaccine i had a headache and felt tired. at 3am that evening i woke up with muscle, joint, bone aches that lasted through the night, uncomfortable enough that it prevented me from sleeping. I took tylenol the next morning and it felt better. by 2PM the next day I had a fever of 100. It increased to 101.5 by 6pm. i had chills, body aches, felt horrible (flu like). it started to go down around 9pm. I woke up the morning of the 16th feeling much better (vaccine was given morning of 14th), all symptoms gone, EXCEPT my armpit is hugely swollen and painful. it has grapefruit sized swelling and throbs. it is under my right arm, which is the same side I had the vaccination on.
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| 49 | 2021-04-15 | insomnia |
After taking the vaccine on March 25th, 2021 1. Starting 04/04/21, Tinnitus became severe in the ri...
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After taking the vaccine on March 25th, 2021 1. Starting 04/04/21, Tinnitus became severe in the right ear (7 on a scale of 10) . Also developed screeching metallic noise 24x7 (2 out of 10 severity). Masking with another sound also did not help. Hissing noise also started in the left year. Visited ENT doctor on 04/08/2021, got prescription for Medrol (Methyl prednisolone 4 mg) -- 6 day tapering dose. Medicine took starting 04/09/21, finished on 04/14/21. No change in symptoms. 2. Starting 04/10/2021 both knees started feeling very hot and painful. Also felt pressure in the back of the head. Unable to sleep. 3. On 04/12/2021 high blood pressure of 160/100 recorded by the primary care physician Dr.. 4. On 04/15/2021, pain and heat started in other joints (elbows and wrists). Pain in knees continues. Tylonol 1000 mg did not give any relief.
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| 49 | 2021-04-15 | restlessness, loss of personal independence in daily activities |
The expected fever, aches, and joint pain started around 11pm on 4/14 and led to a very restless ove...
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The expected fever, aches, and joint pain started around 11pm on 4/14 and led to a very restless overnight. I got up around 5am on 4/15 feeling very thirsty and went to the bathroom to get a drink of water. I remember feeling extremely dizzy, nauseous, and lightheaded standing at the bathroom sink with a cup to fill with water. The next thing I remember is sitting on the bathroom floor with the bathroom cup next to me but I didn't know right away where I was (I hadn't turned on the bathroom light so it was dark) and I still don't know how I got there. I must've passed out. It was so difficult getting back to the bed that I had to ask my husband to help me. The fever, aches, and chills continued all day on 4/15 but the lightheadedness improved.
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| 49 | 2021-04-16 | anxiety |
4/17/2021; Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination s...
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4/17/2021; Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: complained of scratchy throat. Assessment: Time of assessment 1752. Alert and oriented and Anxious. VAERS form obtained and completed by RN; 1752- BP- 129/84, P- 74, O2- 99%, recheck at 1804- BP- 122/90, P- 65, O2- 98%; Medications administered: Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1750. Administered by RN.; Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.; Immunizations Administered; COVID-19 Vaccine 4/17/2021 5:14 PM 0.3 mL 12/11/2020 Intramuscular; Lot: ER8729; NDC: 59267-1000-2
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| 49 | 2021-04-16 | feeling abnormal, impaired work ability |
The next day, I had a headache, 102 degree temp, vomiting, nausea, chills, body aches, dizziness , d...
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The next day, I had a headache, 102 degree temp, vomiting, nausea, chills, body aches, dizziness , dehydration and diarrhea. I had no appetite from this time and for days after. I hydrated with water, and took Tylenol, but it had no real effect. Day 5 I drank Pedialyte mixed with water and was able to eat soup and keep it down. The fever above 100 degrees lasted through Day 4, then was low grade (99.9) through Day 8. Day 8 I still had a headache, low grade temp and shakiness/dizziness. Brain fog is all I can use to describe the inability to focus my thoughts during even the most mundane conversations. My left arm felt like it had been punched for 3 days after the vaccine was given.
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| 49 | 2021-04-17 | disorientation |
My mouth on the right side droops slightly; feel a wired dizziness that got worse; Blood pressure wa...
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My mouth on the right side droops slightly; feel a wired dizziness that got worse; Blood pressure was high; I was disoriented and I could not move my arms or legs; they were not able to understand my speech; I could not move my arms or legs; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: ER2613) in right arm on 26Mar2021 08:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Graves Disease (in remission), papillary necrosis of kidney, Raynaud's, fibromyalgia, breast cancer survivor. Allergies to medications, food, or other products: Morphine, Sulfa, Aspirin, Ibuprofen, Bactrim, Escitalopram. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid, cobalt sulfate, copper sulfate, ergocalciferol, ferrous fumarate, magnesium sulfate, manganese sulfate, nicotinamide, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, vitamin b12 nos, zinc gluconate (MULTIVITAMIN (16)), gabapentin, tizanidine, paracetamol (TYLENOL). Patient experienced: Less than 10 minutes in the waiting area (reported as 26Mar2021 08:15 AM), began to feel a wired dizziness that got worse and she was able to signal a nurse who was attending to another lady having a reaction in the same seating area. Blood pressure was high, she was disoriented and she could not move her arms or legs. According to the doctor and nurse, they were not able to understand her speech. Her mouth on the right side droops slightly. Patient was admitted on 26Mar2021 and discharged from hospital on 28Mar2021. Events resulted in Emergency room/department or urgent care, Hospitalization. Treatment included testing, IV. Covid test post vaccination on 26Mar2021 (nasal swab) was negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 49 | 2021-04-17 | sleep disorder |
Side effects started with a headache and fatigue about 8 hours after shot. Did not sleep well, took ...
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Side effects started with a headache and fatigue about 8 hours after shot. Did not sleep well, took Tylenol in morning since headache did not go away. Headache came and went during the day after the shot. Not that severe. Also fatigue and slight muscle aches. Took about 3 dozes of Tylenol during that 24 hour day. Slept much better the 2nd night, awoke with left armpit hurting. There seems to be a lump in the left armpit and I assume it is a swollen lymph node. Continuing to hydrate a lot and rest as needed. Avoiding Tylenol unless pain gets severe. No signs of fever, some muscle aches in left arm. Injection site got more sore after 12 hours but is almost gone at 36 hours.
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| 49 | 2021-04-18 | crying |
6 days after shot I started to feel tingling in my face, the arm pain where injection was started to...
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6 days after shot I started to feel tingling in my face, the arm pain where injection was started to hurt, upper shoulder and neck pain, shooting pains to the head, light headed, throat tightness, chest pains in middle and difficulty breathing and speaking. Slight chills and happened for 2 days - shoulder and neck pain is still lingering to date. took tylonol, iced all areas and motrin - and a lot of tears and prayers.
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| 49 | 2021-04-18 | feeling abnormal |
Nausea, Dizziness, Lightheadedness, Brain Fog. When I am sitting everything around me seems to be m...
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Nausea, Dizziness, Lightheadedness, Brain Fog. When I am sitting everything around me seems to be moving further away, sound gets quieter, things seem strange. Sometimes feels like a floating feeling.
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| 49 | 2021-04-18 | loss of personal independence in daily activities, impaired work ability |
woozy feeling followed by 102+ fever, chills, muscle and bone aches, dizzy, headaches, chest pain/ti...
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woozy feeling followed by 102+ fever, chills, muscle and bone aches, dizzy, headaches, chest pain/tightness, stomach aches, low appetite, weight loss, fatigue, low energy, nausea, hives & itches. Not fit to operate machinery for 4 days post injection. Car sick as passenger. Could not even after 5 days complete a day of work (12hrs). Was banned from work until I documented I see a clinic. Phone appointment secured a lab referral, and the directive to eat 3x day, rest when tired, hydrate. I felt I have lost a week in a blurr of pain and discomfort, fatigue and sleep. Second week was so weak and tired, showering was a challenge.
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| 49 | 2021-04-19 | anxiety |
30 MINS POST VACCINE, PATIENT COMPLAINS OF MILD GENERAL ITCHING. BROUGHT TO OBS VIA WC. NO VISIBLE R...
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30 MINS POST VACCINE, PATIENT COMPLAINS OF MILD GENERAL ITCHING. BROUGHT TO OBS VIA WC. NO VISIBLE RASH NOTED. ADMITS TO SOME ANXIETY REEGARDING DEVELOPING A REACTION. BP ELEVATED BUT VSS BEFORE PATIENT DEPARTURE. PATIENT DENIES ANY CHANGES OR WORSENING OF S/S AND ESCORTED TO EXIT WITH NO ISSUES AT 1120. INSTRUCTED ON USE OF BENADRYL FOR S/S THAT WORSEN/BECOME INTOLERANT, AND SEEK FURTHER EVAL/TREATMENT IF NEEDED. 1105 INITIAL BP 176/93 HR 70 RR 18 SATS 100% RA 1110 BP 160/90 HR 99 RR 20 SATS 99% RA 1115 BP 158/89 HR 88 RR 18 SATS 99% RA
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| 49 | 2021-04-20 | anxiety | Patient felt dizzy, given water, food. Anxiety to needles. |
| 49 | 2021-04-20 | excessive sleepiness |
The morning after, I woke up with severe aches in my bones and pain in my joints, head, and left arm...
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The morning after, I woke up with severe aches in my bones and pain in my joints, head, and left arm. My nausea made it difficult to eat or drink. I was dizzy. I had a fever of 101 F, chills, and fatigue. I spent a lot of time sleeping and woke up with wet clothes and sheets. This lasted three days. Symptoms gradually lessened. This was the first shot in the series.
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| 49 | 2021-04-21 | feeling abnormal |
Headache, fever, muscle aches (especially my fingers) extreme exhaustion and brain fog. Tylenol is ...
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Headache, fever, muscle aches (especially my fingers) extreme exhaustion and brain fog. Tylenol is helping. Symptoms just started this morning
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| 49 | 2021-04-21 | loss of personal independence in daily activities, sleep disorder |
This was my second shot. On my 2nd day I could not lift my left arm. I could not lift it forward ...
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This was my second shot. On my 2nd day I could not lift my left arm. I could not lift it forward or to the side not even 1/2 an inch. Extremely painful to the touch. I had difficulties getting dressed, driving , working and horrible time sleeping due to the pain of the arm. This continued and saw my Dr. who gave me pain med naproxen 500mg. It helped slightly just taking edge off. After a horrible weekend I began using a heating pad and that seems to be helping. On Tuesday the 20th I had first sign of improvement. I was able to move my left arm to the side at a greater degree and the sensitivity to the skin is subsiding. I still cannot lift it forward and have an appointment scheduled with a specialist.
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| 49 | 2021-04-21 | nightmare, mental impairment, anxiety, crying |
Patient is a YO F who presents for OCD. Patient has been well managed on her medications for several...
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Patient is a YO F who presents for OCD. Patient has been well managed on her medications for several months. She says that she got her COVID shot on saturday and since then her psychiatric health has taken a dramatic decline. She is crying in the interview, reporting extreme anxiety, and mood swings. She denies any medical problems from the shot, but feels that it has destroyed her mental health. States that in one moment she will be happy and then later in the night she starts snapping at her husband. Sometimes she gets bursts of energy and starts doing a lot and cleaning a lot. Patient says her thoughts are driving her crazy. She says, "what's the point of feeling bad all the time." States she has had several really bad dreams in the last several nights that felt very real. Patient says she feels nauseas. Feels like her body wants to crawl out of her body. She feels like she movement makes it better. Patient says everything scares her. Patient has been stable for several months on this medication regimen. Despite significant life events in the last several months, including a miscarried grandchild, patient did well prior to her recent shot.
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| 49 | 2021-04-23 | loss of personal independence in daily activities, sleep disorder |
Nausea; Sweating; Shortness of breath; It's going from hot, cold goosebumps; Not been able to run; E...
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Nausea; Sweating; Shortness of breath; It's going from hot, cold goosebumps; Not been able to run; Elbow, back, knee, ankle pain; Sleeping during the day, take a nap or be in the bed was quite unusual; Normal cough-cold; Fatigue; Hot flashes; chills; Change in heart rate; Muscle soreness and tightness; Muscle soreness and tightness; Whole body joint pain; This is a spontaneous report from a contactable other hcp. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 intramuscular, administered in Arm Left on 25Jan2021 09:45 (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation. The patient had no allergies to medications, food, or other products. There were no concomitant medications. The patient told that she experienced extreme fatigue, hot flashes, change in heart rate anywhere from normal baseline to heart rate 160s and without exercising heart rate goes up to 120, hot flashes, not really chills. She never really had a fever after the second dose and never got a headache. But she got the vaccine on the Monday morning at 9:45 at midnight at that night woke up and had chills and was like okay. Took temperature and had no fever. Took Tylenol and Motrin and slept for the next 24 hours, woke up. Pretty much slept 24 hours. It was normal kind of normal cough-cold, extreme fatigue. Got up Wednesday was okay normal activities by 3 o clock in the afternoon again was out for the work and worked 12 hour shift the next day was off and then. Patient stated that she online looked for side effects for COVID-19 vaccine. She received both doses. So first vaccine was on 05Jan and the second vaccine was on 25Jan at 9:45 in the morning. At midnight, Monday night, after the vaccine about 16 hours, woke up with chills. So felt like she had fever but was not having fever, was extremely hot sweaty, but no fever, actual temperature. As expected, was like - okay, these are just normal side effects. She took Tylenol and Motrin at that time and got back to bed. She slept all night and then was just asleep, pretty much slept the whole next day. She slept and got up, with some nausea, typical normal side effects to be expected. She woke up Wednesday, felt okay. Again, by Wednesday evening, started having extreme fatigue, went back to bed. She slept from 3 in the afternoon to the next day and had to work at the hospital on Thursday, worked 12 hours shift. It was Friday again, extreme fatigue, heard these all are normal side effects for about the first week. So, did not pay much attention to it. Patient further stated: and when I say extreme fatigue, I am a person that does not nap or sleep during the day. So for me to take a nap or be in the bed was quite unusual. So anyways, I noticed hot flashes continued and chills. And when I say chills it is not, it kind of gets like chill cold. I think it's going from hot, cold goosebumps, never a fever but extreme hot flashes, sweating, full body sweat, and noticed kind of like increases in my heart rate when I got hot, I am sure that's just normal, and that continued, and has continued now since the vaccine. It's not, the hot flashes are continuing. It's random that's just not in the night or not just during the day, they are kind of all over the place. They happen from like every half an hour on a bad day, to I might be able to get thought at night, sleeping all night, to 3 times a day, extreme fatigue. I usually run 4 to 5 miles every day, I have not been able to run. I have shortness of breath, the heart rate kind of increases, I tracked it. Normally, I run 50-60 at resting heart rate and without exercise it will shoot up to the 120 and it is random throughout the day. I am going in today, just to get some standard blood work to see, you know, what's going on. And again, just extreme fatigue, muscle soreness, elbow, back, knee, ankle pain, joint pain, not really joint pain, but just you know, that kind of.' Consumer was informed about the role of Pfizer Drug Safety. Consumer stated, I called this morning and was disconnected, I was speaking to somebody and was disconnected.' (Not further clarified, hence, captured as Initial Report.) The patient stated, Yes, I had no symptoms prior to the second vaccine. I did not really have anything from the first vaccine, it started like I said, about 16 hours after the initial vaccine like, woke me up at night at 12:30 am and I have been experiencing this since the vaccine, the second vaccine.' The patient stated, I got the vaccine at 25Jan2021, since I got the vaccine so this is week number 3. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: no fever, heart rate: 160s, heart rate: 120. Therapeutic measures were taken as a result of chills (chills) , sweating (hyperhidrosis). The outcome of events fatigue, hot flashes, chills, change in heart rate, muscle soreness and tightness, whole body joint pain was recovering and for other events was unknown.
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| 49 | 2021-04-23 | loss of personal independence in daily activities |
At 09:50 BP 157/98,then 09:51 BP 161/101, At 08:58 am 167/80,At 10:13 BP 181/93, At 10:22, BP 165/98...
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At 09:50 BP 157/98,then 09:51 BP 161/101, At 08:58 am 167/80,At 10:13 BP 181/93, At 10:22, BP 165/98,At 10:24 BP 164/102, At 10:27 BP 167/99; Unable to work after the 2nd dose; I wasn't able to go back to work because of severe weakness; Dizzy; my BP went down to 90/60, 80/56; This is a follow-up spontaneous report from a contactable Nurse in response to HCP letter sent in cross referenced case. A 49-years-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in deltoid right on 14Jan2021 at 09:00 (at age of 49 years old) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration on 20Dec2020 as single dose for Covid-19 immunization. On 14Jan2021, the patient was placed on close monitoring after receiving the second dose for continuous pulse oximetry, O2 saturations ranged from 98%-100%. At 09:50 BP 157/98, HR 73, 99% O2 sat, then 09:51 BP 161/101, HR 100, SpO2 100%, at 08:58 am 167/80, HR 85, SpO2 94%. The PCP prescribed clonidine 0.1 mg as needed for SBP>160. The patient took 1 tab clonidine 0.1mg. At 10:13 BP 181/93, HR 63, SPO2 100%, at 10:22, BP 165/98, HR 59, 100% SPO2, at 10:24 BP 164/102, HR 77, 99% SPO2, at 10:27 BP 167/99 HR 74, 100% SPO2. Later the patient took 2nd dose of clonidine 0.1mg and at 10:36 BP 134/86, HR 65, SPO2 100%, at 10:47 BP 124/81, HR 65. The patient was released by employee health nurse. She was dizzy when she got home, her BP went down to 90/60, 80/56. The patient was unable to work after second dose because of severe weakness. The patient stayed in bed for 5 days. The patient went back to work on 19Jan2021. Treatment for the event blood pressure fluctuation was two dose of tab clonidine 0.1mg. The patient provided information regarding the reported adverse events with the use of the suspect product to the nurse and the nurse considered that the Pfizer product had a causal effect to the adverse event. The outcome of the events was unknown. Information on the batch number has been requested.
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| 49 | 2021-04-24 | feeling abnormal | Moderate diarrhea (8 hours) brain fog/fatigue (12 hours later until 36 hours later) |
| 49 | 2021-04-24 | insomnia |
Within 20 mins of injection, extreme tightness & pain level 5 at base of skull to top of shoulders. ...
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Within 20 mins of injection, extreme tightness & pain level 5 at base of skull to top of shoulders. ER following morning cldnt move head at all, pain level 8. Now 25th symptoms still there , meds help very little. Pain level 7 much trouble sleeping.
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| 49 | 2021-04-24 | nervousness |
immediately after getting shot patient reposted a hot chest, described as a hot flash. She remained ...
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immediately after getting shot patient reposted a hot chest, described as a hot flash. She remained seated and then described tingly, weak limbs, I did ask her if she was nervous, she does have anxiety and was nervous about getting the vaccine. patient left store after 20 mins feeling better.
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| 49 | 2021-04-25 | anxiety |
Pfizer-BioNTech COVID-19 Vaccine EUA: During post-observation period, vaccine recipient complained a...
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Pfizer-BioNTech COVID-19 Vaccine EUA: During post-observation period, vaccine recipient complained about anxiety. Their lip and tongue was cyanotic. They were monitored by EMS and the pulse ox was 98%. Symptoms resolved.
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| 49 | 2021-04-26 | anxiety |
Patient stated she felt like fainting, wanted oxygen, claims she was having an anxiety attack and "t...
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Patient stated she felt like fainting, wanted oxygen, claims she was having an anxiety attack and "throat closing". Given 0.3mg EpiPen, 911 called, patient taken to ED.
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| 49 | 2021-04-27 | insomnia |
The injection was higher on the shoulder instead of on the muscle it was closer to the acromion proc...
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The injection was higher on the shoulder instead of on the muscle it was closer to the acromion process, noted shoulder pain a few weeks after the first dose that didn't get any better. Certain motions trigger the pain, sharp pain that lasts several minutes. Hard to sleep as worse at night. Debilitating, lost strength and significant loss of motion. Doing physical therapy exercises but doesn't help. Worsening pain as the weeks rolled by. Hand an Xray today and shows "distal infraspinatus tendon calcium hydroxyapatite deposition, correlate for calcific tendinopathy" which on a previous Xray did not show (Chest Xray). Since I was the first few that received the Covid vaccine, I have a picture of where the injection was place and that is exactly where the now calcium hydroxyapatite deposition is.
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| 49 | 2021-04-28 | confusional state |
This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old fem...
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This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 49 years old at other facility type. The patient is not pregnant at time of vaccination. Medical history included allergies to Rosemary from an unknown date. No other vaccine in four weeks were noted. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); propranolol hydrochloride (INDERAL); lorazepam (ATIVAN); hctz; quetiapine fumarate (SEROQUEL); gabapentin taken for an unspecified indication, start and stop date were not reported. The patient previously took macrobid [nitrofurantoin] and experienced allergies. The patient previously received the first dose of BNT162B2 (Lot number: ER8727) on 17Mar2021 13:00 (left arm) for COVID-19 immunisation. On 10 Apr2021, the patient experienced Itchy palms (reported as within hours), tachycardia, tightness in chest, difficulty breathing, tingling tongue and fingers, vomiting, confusion, dizzy, fainting, abdominal pain, severe pain everywhere, too fatigued to move. Patient tried to call ambulance but could not get phone or unlock the door. She stated she tried from 1 AM to 07:30 AM. After 07:30 AM she had expected effects of fever as well as fatigue and pain. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not given. Outcome of the events was recovered on an unspecified date.
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| 49 | 2021-04-30 | insomnia |
her symptoms started as a couple of dots at the injection site; The rash started growing all over he...
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her symptoms started as a couple of dots at the injection site; The rash started growing all over her body; Rash growing all over body was worsened; It is still burning and itching; It is still burning and itching; Neither of them can sleep; This is a spontaneous report from a contactable consumer (Patient husband) via Medical Information Team. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# unknown), via an unspecified route of administration on 01Apr2021 (at the age of 49-years) as single dose for COVID-19 immunisation. It was reported that the patient received vaccine 22 days ago. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, patient experienced symptoms that started as a couple of dots at the injection site that got worsen and started growing all over her body, it is still burning and itching, neither of them can sleep. There is no relief for her rash even after ten days. Patient visited the emergency room four times and has been to her primary doctor and her pain management doctor where she received six different prescriptions, of which three are from a hospital which prescribed over-the-counter medicine and asked to come back after seven days. But nothing helped and the rash is still growing like poison ivy. Reporter described that patient back looks like the surface of Mars as seen on a television channel. Nothing else was different in her diet or medications outside of the vaccine. Later, patient visited another hospital where she was prescribed with another medication. Patient received treatment with an unspecified intravenous (IV) medication which helped her to sleep. Reporter stated that none of the medication helped except the IV medication, considered so because it helped her sleep. Reporter was upset and thought that Pfizer vaccine gave the patient that rash. The outcome of the event insomnia was recovered and the outcome of the event condition aggravated was unknown while for all the other events, it was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 49 | 2021-04-30 | insomnia |
Thyroid storm; Thyroid eye disease; Graves' disease; Trouble swallowing and eating; Trouble swallowi...
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Thyroid storm; Thyroid eye disease; Graves' disease; Trouble swallowing and eating; Trouble swallowing and eating; Throat is scratchy; mild symmetric ptosis; bilateral perinasal sinus disease/nasal problems like sneezing, running nose, and coughing; nasal problems like sneezing, running nose, and coughing; trouble sleeping; This is a spontaneous report from a contactable consumer reported for herself. This 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 49 years old on 06Apr2021 at around 16:50 in the top of her right arm (lot: ER8737) at single dose for COVID-19 immunisation (reported as to protect herself and others). Medical history included ruptured brain aneurysm, it was paraopthalmic from 12Sep2012, HELLP syndrome from 01Sep2012, allergies. Seasonal allergies. Mumps, chicken pox, tetanus, rubella, measles from 1989. She had a ruptured brain aneurysm on 12Sep2012. It was a direct result from pregnancy HELLP syndrome, like toxemia on steroids. On 27Aug2012 her daughter was born, then she was diagnosed with HELLP 5 days later. She was hospitalized for another week. She was released and on 12Sep2012 and had the ruptured brain aneurysm which they say in itself was hereditary, and her blood pressure went up so high that it burst. She was hospitalized for 40 days. She was paralyzed and everything. She went on physical therapy and got everything back, no deficits. Family history included hereditary in her family to have hyperthyroidism/thyroid problems on both sides (her father and mother). Concomitant medications included cetirizine hydrochloride for allergies, it was the generic antihistamine for Zyrtec. She had been taking them for about 20 years. The patient previously received first dose of BNT162B2 at age of 49 years old on 19Mar2021 in the top of her right arm (lot: ERU6208) for COVID-19 immunisation. The patient had an emergency reaction to the second dose of the Covid-19 vaccine. All events required a visit to Emergency Room and Physician Office, and received treatment. She walking into the ER with trouble breathing and swelling to her face after the second Covid shot. She had the second vaccine on 06Apr2021 at around 16:30, and everything went fine. She came home and felt fine. She went to bed that evening at around 23:00. She woke up on 07Apr2021 the morning at around 05:00 and was having excessively rapid heart rate, which is called tachycardia. Her left eye swelled open, and her right eye swelled shut. She took herself to the emergency room. She said that she had a hard time seeing now and had vision loss, and they gave her Iohexol intravenously. They also gave her ketorolac and methylprednisolone sodium succinate. The first one, Iohexol, they told her was iohexol (OMNIPAQUE) for a cerebral CT. They did an orbital CT with contrast. Her vitals were blood pressure 171/86, temperature 98.1, pulse 125, respirations 18, and oxygen saturation 97%. 9 years ago she had a ruptured brain aneurysm, it was paraopthalmic. She thought maybe the vaccine caused some type of brain bleed (Apr2021) because her eye was swelled out. That was the reason for the scan. After she left the ER, they sent her to an emergency ophthalmic appointment, and the ophthalmologist told her that she had to get glasses immediately. She had just had her eyes checked in February. Her vision in her left eye had deteriorated. She had to go and get glasses. Then they sent her to have thyroid lab work done. She had an appointment set up to be seen by her regular ophthalmologist that following Monday. Everything was on Wednesday, 07Apr2021. She was fine until Friday, drove to work and when she got to work at about 08:00 or 09:00 her body started shaking excessively. It was the tachycardia. She thought it was from the pain in her eye and took paracetamol (TYLENOL) but she still didn't feel well. On Monday she saw the regular ophthalmologist and he said that her neck was swollen with a goiter and she had thyroid eye disease and Grave's disease on 07Apr2021. He sent her to her primary care physician within an hour and he concluded the same thing. He immediately sent her to the pharmacy for a heart medication for tachycardia. It was propranolol (INDERAL) 20 mg, and she took it 3 times a day. He set her up with an emergency endocrinologist appointment and he spoke with the endocrinologist on Monday night and went over the charts with her. Everything that he diagnosed her with is at his office. He sent her to the endocrinologist for a final diagnosis. She went to the endocrinologist on Tuesday and she sent her for more lab work. They did a whole panel of labs. She definitely had Grave's disease with a goiter. They put her on methimazole 10 mg tablets, and she took them 2 times a day. That was only temporary until her labs come back. On Monday afternoon her primary doctor sent her to have an ultrasound of her neck. Her neck was swollen and she was having trouble swallowing and eating on 07Apr2021. The radiologist report said that it was strictly thyroid and she had no polyps or lesions. Her doctor suspected, they don't know exactly, but they suspect this happened because it was hereditary in her family to have hyperthyroidism/thyroid problems on both sides, and it was dormant and when she got the vaccine it triggered it to activate. She had thyroid storm (on 07Apr2021), and if she had not gone to the ER it could have been fatal. They were able to see everything during the thyroid storm so they could treat it. She was in thyroid crisis and had thyroid eye disease. Her left eye is permanently disfigured. She has an extremely protruding left eye and a right lazy eye. She had to see an ocular plastic surgeon to get it fixed at some point. She lost so much weight this past week (Apr2021). She had lost 8 pounds since Sunday, and she didn't know how many before that. It hit her hard. Her adrenaline was going so fast. Her throat was scratchy (on 07Apr2021), and she had a lot of nasal problems like sneezing, running nose, and coughing (Apr2021). It was reported that even with medicine, it only kept her heart rate down for a little while. She didn't take Tylenol until Friday morning for eye pain. It wasn't from the pain though, it was from tachycardia. She can close her left eye but she had damaged muscles behind her eye in Apr2021. It was still protruding, but the swelling went down about 80% 2 days after leaving the hospital. Within 24 hours after they injected her eye the swelling went down 80%, but it was still protruding. Her right eye was a lazy eye. It was swollen shut. She couldn't get it moving, so it may have been out of fear. She put cold compresses on her eyes before she went to the hospital. She was able to open her right eye. She can close her left eye but not all the way. She had to keep using eye drops because it got dry (in Apr2021). Her vision has gotten worse since February, especially her left eye. Her doctor sent her to get prescription glasses. The vision center had to adjust them and tilt them because the muscle in her eye won't let her eye move to see through the lens. It is her distance vision, mostly in her left eye. Her right eye droops and her left eye popped out. The shaking made her look like she had Tourette's. After she got medicine at the hospital it went away and her body calmed down. On Thursday it seemed okay. Her doctor said it was because she still had the IV medicine in her body. On Friday the medicine wore off and her heart was racing and it was making her body shake. Doctor said her heart was beating so quickly because her thyroid was causing her to make so much adrenaline and it caused her body to shake. 20 minutes after she took the propranolol it completely stopped. On 07Apr2021 they suspected she had Grave's disease and Thyroid eye disease. The thyroid testing came back as unreadable. It came back as 0.01 UIU/mL. It was thyroid stimulating hormone. It was not a full panel, but that was enough to try to find out if it was her thyroid. The endocrinologist ordered full testing. The goiter was pressing on her throat and she had a hard time swallowing when she was eating. It was scratching her throat. She has gone to soft foods until it was easier to swallow. She can swallow on her own, but it was hard to swallow foods, it got stuck in her throat. They told her she would get better with the thyroid medication. She lost weight so fast and would start to lose muscle. She was losing weight because her adrenaline was up. It had made her weak on 10Apr2021. They gave her a list of supplements and protein drinks. In October she started to exercise and lost a couple pounds between then and January. She was just taking long walks and thought it was going great. She had only lost a couple of pounds. After Wednesday her weight started rapidly changing, and every time she got weighed she had 3 more pounds gone. She started feeling really weak by the weekend. Her heart was making her feel weak, and she hadn't had any medicines yet and felt tired on 10Apr2021. After Wednesday, she started having 2 bowel movements a day which is very strange. Her doctor said it is a symptom of hyperthyroid. Normally it is like clockwork in the morning and that's it. She noticed it on Thursday 08Apr2021. She became hypersensitive after Wednesday and paid attention to everything. She already had seasonal allergies. She stopped any kind of decongestant. She knew with heart palpitations to stay away from that. She just took cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE). Her doctor said her body was used to that to keep her sinuses down, and with her body making so much adrenaline it could be excessive. Wearing a mask over her face was hard to breathe because the heart. She had trouble sleeping, which could be part of the fatigue because it was disturbing her sleep. They confirmed it was her thyroid on Monday and again Tuesday with more extensive labs for the correct level of methimazole. Investigations included: She had a CBC with differential on 07Apr2021. She had a CT orbit sella post fossa W contrast that showed facial swelling and periorbital edema of both eyes on 07Apr2021. The impression on the radiology digital imaging she can provide at a later time. She had mild symmetric ptosis on 07Apr2021 otherwise normal for appearance of orbital content. The impression for the CT scan on 07Apr2021 was bilateral perinasal sinus disease which was her allergies. The rest was stable coiling. She had vascular coiling directly behind her eye from the ruptured aneurysm. The outcome of events Thyroid storm, vaccine caused some type of brain bleed, hyperthyroid, pain in her eye, Lost so much weight, Dry eye, blood pressure 171/86, Hypersensitivity, trouble sleeping, facial swelling, mild symmetric ptosis, trouble breathing was unknown, outcome of events Eye swelling, Tired, Weak was recovering, outcome of event shaking was recovered on 07Apr2021, outcome of other events was not recovered.
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| 49 | 2021-05-04 | confusional state |
Pt (Patient) started feeling confused; She had numbness and tingling on R side; She had numbness and...
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Pt (Patient) started feeling confused; She had numbness and tingling on R side; She had numbness and tingling on R side; pain in R leg; headache; This is a spontaneous report from a contactable Physician. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration in left arm on 27Jan2021 at 10:45 AM as single dose for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was allergic to penicillin. The patient medical history included TIA, angina, and restless leg syndrome. Concomitant medication included Asprin 81mg daily. On 29Jan2021 at 09:00 PM, the patient started feeling confused, had numbness, and tingling on right side, pain in R leg and headache. AE resulted in emergency room/department or urgent care. Treatment was received for AE. The outcome of the events was unknown.
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| 49 | 2021-05-06 | impaired work ability |
12 hours after injection, I woke up with chills and a headache, followed by a fever and nausea. My ...
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12 hours after injection, I woke up with chills and a headache, followed by a fever and nausea. My temperature remained between 100-102 degrees for the following 2 days. My fever has dropped down to 99 and I still have the headache and fatigue causing me to miss work.
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| 49 | 2021-05-07 | insomnia |
Nose bleeds; Fainted; Insomnia; headache; Chills; This is a spontaneous report from a contactable co...
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Nose bleeds; Fainted; Insomnia; headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: ER8737), via an unspecified route of administration, administered in left arm on 05Apr2021 18:45 (at the age of 49-years) as single dose for COVID-19 immunization. Medical history included migraine and known allergies to sunflower oil, chamomile, mold, and dogs. The patient is not pregnant at the time of the vaccination. Concomitant medications included atenolol and rizatriptan benzoate (MAXALT). The patient has no other vaccine in four weeks. The patient previously had allergies to hydroxyethyl methacrylate, sodium pentothal, and erythromycin. The patient was not tested for covid post vaccination. The patient experienced insomnia and headache for three days, and chills on and off for over a week on 05Apr2021 at 21:00. The patient also experienced fainted on 06Apr2021 and nose bleeds lasting 15-45 minutes on 07Apr2021, 14Apr2021, 20Apr2021, and 23Apr2021 (patient never get nose bleeds previously). The patient received pain and antibiotics medications as treatments. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 49 | 2021-05-10 | anxiety, depression |
suicidal thoughts; Depressed; anxiety; This is a spontaneous report from a contactable consumer repo...
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suicidal thoughts; Depressed; anxiety; This is a spontaneous report from a contactable consumer reported for self. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 12:45 PM (Lot Number: ER8731) as 2nd dose, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. No known allergies. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included escitalopram received within 2 weeks of vaccination. Historical Vaccine included the first dose of BNT162B2 (lot number: EP7534) on 23Mar2021 02:30 PM in Right arm for COVID-19 Immunization. The patient experienced suicidal thoughts, depressed, anxiety on 16Apr2021, no treatment was received. Outcome of the events was not recovered. Follow-up attempts completed. No further information is expected.
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| 49 | 2021-05-10 | loss of personal independence in daily activities |
May 9 have not had a period since December 2020 and was always two days May 10 YES Headache Fatigu...
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May 9 have not had a period since December 2020 and was always two days May 10 YES Headache Fatigue or tiredness Nausea & feet cramp and no longer get periods since before 2021 and have had twice blood flow :(. Nausea and tiredness have kept me from being able to do my usual workout or other activities. NO Redness/Swelling Muscle pain/Pain Chills/ Fever
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| 49 | 2021-05-10 | mental impairment |
Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet;...
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Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; Slurred speech an difficulty swallowing; Slurred speech an difficulty swallowing; Feet felt super heavy and awkward; Significant urination; muscle aches; low-grade fever; very tired; Slight headache; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; blood sugar plummeted; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 15:45 (Batch/Lot Number: CR8735) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Type 1 diabetes, Some allergy medications like zyrtec, topamax, Nortriptyline, allergic asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included insulin lispro (HUMALOG); bisoprolol (BISOPROLOL); fexofenadine hydrochloride (ALLEGRA). Historical Vaccine included product=COVID 19, brand=Pfizer, lot number=EP7533, administration date: 04Apr2021, administration time =04:00 PM, dose number =1, vaccine location =Left arm for covid-19 Immunization. Reported Event: About 3 hrs after 2nd dose, lower back pain for 20 minutes followed by numbness in tongue, throat, lips, cheeks, hands, feet, slurred speech an difficulty swallowing. Extreme difficulty thinking. Feet felt super heavy and awkward, like they were bricks. She was a type 1 diabetic and her blood sugar plummeted. She had to stop her basal delivery for an hour, then she halved her basal rate for several hours. After laying down for a few hours, symptoms improved, but worsened when standing. Significant urination every 40 - 60 mins for several hours. In the morning, muscle aches throughout body, low-grade fever, very tired. Slight headache. Adverse event start date: 25Apr2021, Adverse event start time: 06: 30 PM, No treatment for AE. Lab data included blood sugar: plummeted on 25Apr2021. The event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
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| 49 | 2021-05-11 | feeling abnormal, restlessness |
was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really h...
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was feeling some chest pain; she wakes up freezing; eyes felt really hot and dry; eyes felt really hot and dry; slight fogginess; achiness; I tested positive for COVID; Restless body; Nausea; Weakness; Fast heartbeat; Headache; Chills; Muscle pain; Feeling unwell; high fever couldnt shake it at all; got congested/ Stuffy nose; facing joint ache; extremely tired/ Tiredness; Pain in arm/ whole hand just felt achy; Heart hurt when laying on side; Dizziness/ lightheadedness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 15:00 (Batch/Lot Number: EW0164) (at the age of 49 years old) at 1st dose, single for COVID-19 immunisation. Medical history included asthma and hypersensitivity (allergies). Concomitant medications included montelukast sodium (SINGULAIR) taken for hypersensitivity; formoterol fumarate, mometasone furoate (DULERA) taken for asthma; beclometasone dipropionate (QVAR); and levosalbutamol hydrochloride (XOPENEX). On unspecified date in Apr2021, she got pretty sick and swollen lymph nodes. On 23Apr2021, the patient experienced heart hurt when laying on side, high fever couldn't shake it at all, extremely tired/tiredness, headache, chills, muscle pain, feeling unwell, joint pain/ facing joint ache, dizziness/lightheadedness, fast heartbeat, pain in arm and got congested/ stuffy nose. On 24Apr2021, the patient experienced nausea and weakness. On 25Apr2021, the patient experienced restless body, her body also got extremely restless like she had restlessness lesions on whole body. On 26Apr2021, the patient tested positive for COVID-19. On unspecified date, the patient experienced chest pain, she wakes up freezing and her eyes felt really hot and dry and was exhausted, whole hand just felt super achy, slight fogginess and achiness. The patient had vaccination on Friday. On Friday night, she started not feeling well and then was like full blown all the Saturday all the Sunday (as reported). The patient got vaccination last Friday and had a severe reaction to the vaccination. She was extremely upset about it because now she tested positive for COVID. She was not really showing any symptoms and whatsoever before of any COVID like symptoms. Allergy was bothering her but no fever, no chills, no tiredness, no achiness and no nothing. She was nervous because she did realize that it wasn't FDA approved and now she was suffering positive, she started feeling a little better but still tested positive. It was reported that the event started at the time of report, 26Apr2021. The patient had a severe reaction. She had every symptom except that her arm didn't swell. She didn't have any rash in her body. She got pretty sick. She had a high fever couldn't shake it at all, got congested, facing joint ache and extremely tired. Her body also got extremely restless like she had restlessness lesions on whole body she couldn't lay down. The patient reported that it was hurting her so bad and she had to keep moving like she couldn't relax fall free. She had a severe reaction and doctor said she could have COVID knowing it and then got a shot and then came out full blown. The patient stated she was taking Tylenol (50mg, Not clarified), Tylenol Cold and sinus (325mg) for like a flu and Motrin (500mg). She had some time to shake the achiness and the fever was just coming back. She took Tylenol to help rid of fever and achiness, it didn't help and then she tried Tylenol cold and flu that help the little bit then she tried Motrin the Motrin help more with achiness but not hundred percent. The outcome of the events heart hurt when laying on side and fast heartbeat, both recovered on 26Apr2021; events high fever, tiredness, chills, muscle pain, feeling unwell, swollen lymph nodes and dizziness were recovering; events nausea, restless body and stuffy nose were not recovered; and unknown outcome for the other events. No follow-up attempts are needed. No further information is expected.
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| 49 | 2021-05-11 | sleep disorder |
First I got my 1st shot Sunday morning I sat in the observation, and for a brief period I got dizzy,...
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First I got my 1st shot Sunday morning I sat in the observation, and for a brief period I got dizzy, and nauseated. It was brief. Day two sore arm of course, and tired felt like flu symptoms Day 3 extremely tired, and couldn't keep my head up I was so lethargic. Felt like the Flu was coming on went to bed after work Thursday, Fri, and Sat my head was still feeling like I had a head cold. Fatigued still Sunday I was in dream state when I jolted from a spinning feeling in my sleep. I opened my eyes and I couldn't even function. I couldn't get out of bed nor move I was completely spinning. I tried to make it to the bathroom and threw up bile. Took a anti nausea pill Zofran, and didn't work. Nothing was working. I fell asleep and woke up just constantly dry heaving. The vertigo was so bad I felt faint It was then at the point I was passing out when we called 911. I couldn't move I was perspiring, and couldn't keep liquids down. I was shaking, clamy, and my body turned numb. Thought I was having a stroke. In the ambulance narapathy started up, and down my arms and hands,, and my fingers locked up. Chest was on fireI, and my whole body tingled with fighting off whatever it was.. The hospital IV me with Zofran several times. Antivert and Ativan. EkG fine CT head Brain CT head neck. Ears were fine. No infection in ears. Blood Glucose was high 182 CO2 was slightly low 22 Lymphocytes low 21.6 low Neutrophils Absolute 7.7 high Nothing else to do but send me home to follow up with ENT and Nuero to make appts to follow up. I scheduled my primary qs well to look me over.
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| 49 | 2021-05-14 | amnesia |
Got diagnosed with mild stroke after a high blood pressure crisis; Got diagnosed with mild stroke af...
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Got diagnosed with mild stroke after a high blood pressure crisis; Got diagnosed with mild stroke after a high blood pressure crisis; blurry vision on the left eye; Pins and needles feelings in left body side; headache; memory loss; This is a spontaneous report from a contactable consumer (reporting for herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Mar2021 at 10:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included high blood pressure, and asthma. The patient's concomitant medications were not reported. On 14Mar2021, the patient was diagnosed with mild stroke after a high blood pressure crisis and the symptoms showed days after the vaccine such as blurry vision on the left eye, pins and needles feeling in left body side, headache and memory loss. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of the events was unknown. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in emergency room/department or urgent care and was admitted in the hospital for 2 day. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 49 | 2021-05-21 | feeling abnormal |
had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on...
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had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 02Apr2021 (batch/lot number and expiration date were unknown) as the 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. Relevant medical history included Celiac disease and known allergies to Penicillin; both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had no COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had Celiac disease and had severe of domino pain for over two weeks, diarrhea, and "explain" rash on her left leg; complete fog brain; itching; all symptoms of Celiac contamination on 02Apr2021. The adverse events did result in a doctor or other healthcare professional office/clinic visit. Unspecified therapeutic measures were taken as a result of all the events. The outcome of the events was unknown. Information on the batch/lot number has been requested.
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| 49 | 2021-05-22 | sensation of foreign body |
Almost immediately after the shot was given I got a stabbing pain in my throat. I told the pharmaci...
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Almost immediately after the shot was given I got a stabbing pain in my throat. I told the pharmacist and he said that would have been too fast for a reaction. He told me to have a seat outside the door and get someone if I got worse. While sitting I began to feel like something was stuck in my throat, my voice got horse, I became dizzy and had a feeling of being disconnected with being there. I took a benadryl and I told the pharmacist he got me orange juice. I noticed the skin on my hands arms, legs, and feet got mottled. This had happened in a previous reaction. I took another Benadryl, The pharmacist took my blood pressure it was high and I was in tachycardia. He gave me a shot of epi and wanted to call the ambulance. I refused as my daughter was on her way. He asked me to wait 15 mins to see my reaction. The epi seemed to help, but my symptoms picked back up . I promised the phamacist if he gave me another epi shot I would head straight to the ER. So, I checked into ER and there they gave my IV fluids, IV Benadryl, Steroids, ad I think Pepcid. After watching me and symptoms subsided I was released. I had to take benadryl and steroids for the net 5 days to keep at no reaction.
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| 49 | 2021-05-23 | feeling abnormal, insomnia, sleep disorder |
The first night symptoms included insomnia, joint pain, stomach cramps, sweats and general malaise t...
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The first night symptoms included insomnia, joint pain, stomach cramps, sweats and general malaise that continued until the following evening. Over the next six days low energy, headaches and brain fog. Then random muscle twitches began. One week after the injection frequent muscle twitches up to 30 through the night that would wake me from sleeping. The next few days significant increase in heart rate upon standing or with any physical activity. Increased blood pressure up to 179/108 with headache. Heart Palpitations became almost constant with strong and painful skipped beats and bounding heart rate which caused chest pain, light headedness and shortness of breath. Within the following week I was experiencing gastric reflux, bloating and pale stools. Tingling and pain in feet and lower legs.
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| 49 | 2021-05-24 | feeling abnormal |
Lump in left neck - Ultrasound and MRI completed radiology reports shows inflammation, infection or ...
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Lump in left neck - Ultrasound and MRI completed radiology reports shows inflammation, infection or neoplastic Extreme fatigue Unexplained weight loss Achy spine Joint pain in elbows, knees, neck, shoulders Itchy Bruising Late period Brain fog Coordination/stability issues Sore Throat Headaches Night Sweats
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| 49 | 2021-05-24 | insomnia |
Patient came to the pharmacy 5/25/21 at 1:20pm to alert us that she had reactions that started 4-5 d...
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Patient came to the pharmacy 5/25/21 at 1:20pm to alert us that she had reactions that started 4-5 days after getting her first dose of Pfizer. She reports that her blood sugar increased >400 and >600 4-5 days after the dose. The patient spoke with her Dr and the Dr told her to increase her Lantus and Apidra. The patient also reports getting pain in her right leg that caused trouble walking, bruising on hip that both started 4-5 days after the dose. Patient reports headache, insomnia due to pain and increased blood sugar. Patient reports now sleeping a lot because of exhaustion and having to check her blood sugar every 2 hours and drink lots of water as directed by her Dr. Patient says she finally got her blood sugar down below 120 on Friday 5/21/21. Patient reports she lost some vision and had blurry vision in her left eye that started 5-6 days after the dose. Patient says her A1C was 5.6 before the Pfizer dose and after the dose her blood sugar was uncontrolled. Patient says her Dr told her to go to the ER if her symptoms continued. Patient also spoke with someone at the CDC and they told her they would follow up with her regarding her symptoms and they will let her know if she should get her second dose.
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| 49 | 2021-05-25 | feeling abnormal |
Urticaria; throat still has pain; odd feeling; low blood pressure, hypotension 70-90; General malais...
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Urticaria; throat still has pain; odd feeling; low blood pressure, hypotension 70-90; General malaise and ongoing; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received second dose of bnt162b2 (Formulation: Solution for injection, Batch/Lot Number: EN6205)) via an unspecified route of administration in left arm on 29Mar2021 at 14:45 as 2nd dose single for covid-19 immunisation. Medical history included asthma, hypothyroidism, insulin resistance. The patient's concomitant medications was not reported. Patient is not Pregnant at the time of vaccination, patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19 as Yes. Previously received BNT162B2 for COVID-19 im-munization (product COVID 19, lot number EL9269, administration date 08Mar2021, administra-tion time=02:45 PM, dose number 1, vaccine location Left arm). On 30Mar2021, the patient experienced Low blood pressure, hypotension 70-90, on unknown date in Apr2021, Throat "still has", pain, odd feeling and ongoing, on 02Apr2021 urticaria on several parts of the body, on 30Mar2021, General malaise and ongoing. ae resulted in emergency department. The patient underwent lab tests and procedures which included on 30Mar2021 hypotension 70-90 mmhg, on 29Mar2021, sars-cov-2 test: negative, on 30Mar2021 sars-cov-2 test: negative, on 07Apr2021, sars-cov-2 test: negative. No treatment received for the adverse events. The outcome of the events low blood pressure, hypotension 70-90 was resolved with sequel on Apr2021, throat still has pain, odd feeling, general malaise and ongoing was not recovered, urticaria was recovered on 03Apr2021. No follow-up attempts are needed. No further information is expected.
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| 49 | 2021-05-25 | nervousness |
49 y/o female with past medical history of Thyroid Dysfunction who presents with dizziness post vacc...
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49 y/o female with past medical history of Thyroid Dysfunction who presents with dizziness post vaccination. Patient states that this is her first vaccination in the two-dose series. Patient denies previous reaction to vaccinations in the past. Patient states that she received her vaccination to the left arm. NP and Paramedics at patient side. Patient vitals within normal limits (133/82 BP, 83 HR, 12 Resp and 99% RA). Patient placed in Trendelenburg position and provided a bottle of water. Patient within 10 mins of observation states that symptoms have resolved. Patient states that she was nervous and scared of the needle. Patient stated that she wanted to go home. Patient able to ambulate without difficulty. Patient discharged in stable condition.
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| 49 | 2021-05-28 | memory impairment, feeling abnormal |
lots of bodyaches, headaches, difficulty swallowing, loss of sensation on fingers difficulty walkin...
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lots of bodyaches, headaches, difficulty swallowing, loss of sensation on fingers difficulty walking, cognitive problems, memory problems, fatigue, brain fog, feel like I have the flu everyday.
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| 49 | 2021-05-28 | sleep disorder |
I was awaken at 12:18 am Thursday morning by being experiencing chills then a fever of 101.6. I had ...
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I was awaken at 12:18 am Thursday morning by being experiencing chills then a fever of 101.6. I had shortness of breath, feeling nauseous then I began throwing up. I tried to go back to sleep but once I fell asleep I was up every hour on the hour from 12:18am to 5:00am. I experienced congestion in my head along with headaches and a loss of balance as I tried to stand up. I also experienced tightness in my chest.
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| 49 | 2021-05-30 | feeling abnormal |
It felt weird from the get go. I felt it go into my arm. That night I could barely move my left arm....
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It felt weird from the get go. I felt it go into my arm. That night I could barely move my left arm. It got better, but in the days that followed I got a pain in my neck and shoulder. I thought maybe I slept wrong. I ended up going to a physical therapist, a massage therapist, and a chiropractor to get some relief. I had some numbness and tingling down the left side of my arm with my ring finger and my pinky. I got no relief from that. I went to my doctor and he found a knot under my arm. I thought the swelling from that might have hit a nerve. My PCP sent me to another doctor, who is a surgeon. He ordered an ultrasound. When that came back, it came back as a swollen lymph node. I went and had a biopsy done. When it came back everything looked good. Last week, I was taking off my dress and I was like "oh that hurts!". The lump under my arm was bigger and was hurting. I am having another ultrasound done Friday. It is still swollen and it has been like this since a few days after Jan 6 2021.
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| 49 | 2021-05-30 | insomnia, anxiety |
Felt mild nauseas and body/joint ache and fatigue within a few hours. By next day more increased. B...
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Felt mild nauseas and body/joint ache and fatigue within a few hours. By next day more increased. By evening moderate. During sleep my body became drenched in sweat. Saturated sheets above and below my body as well as my clothing. Strong body pain and joint pain, headache. Chills that shook me . Insomnia, heightened anxiety, pressure in my chest. This lasted through the night. By next morning the severity was gone. For the following week fatigue joint/body pain remained. The day of the vaccine I began to bleed but I had my menstrual cycle complete the week prior to vaccine. I had an intense experience with heavy blood clotting, heavy bleeding ( bleeding through super tampon inside 30 minutes ) this lasted for several hours, the intense bleeding. I continued to bleed for over a week, have deep fatigue and not feel like myself. Upon my second vaccine my symptoms began almost immediately with headache, body pain, joint pain and deep fatigue. I did not experience the severe symptoms during sleep however. I did begin to have my me atrial cycle again at the wrong time. And the bleeding still continues as well as an overall not feeling well. Fatigue, nervous system seems off. I am a cery healthy person. I do not drink alcohol, soda, or use drugs. I am gluten free, limited dairy, limited animal protein. I do have family history of inflammation and avoid foods that trigger this.
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| 49 | 2021-05-31 | anxiety |
sore arm; I am little concerned; Caller is concerned that the motrin affected the efficacy of her se...
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sore arm; I am little concerned; Caller is concerned that the motrin affected the efficacy of her second dose; This is a spontaneous report from a contactable consumer (patient, self-reported). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9810 and expiry date was not reported), via an unspecified route of administration, on 02Feb2021, as a single dose for COVID-19 immunization (to protect myself). The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: "EL3249" and expiry date was not reported), via an unspecified route of administration, on 14Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included that on Monday, she had slight procedure done on her leg and she was instructed by her physician to take Motrin. Concomitant medication included ibuprofen (MOTRIN). The patient reported that she had a procedure on Monday and took MOTRIN yesterday morning on 02Feb2021. She took her second shot late afternoon. The patient asked did she need to really worried that it was little you know the effectiveness of having the Motrin from the morning. She had her second dose of the Pfizer vaccine yesterday afternoon and she was concerned that the MOTRIN affected the efficacy of her second dose on 02Feb2021. The patient reported that this morning she didn't really feel that she had a side effect, and she was just having slight sore arm not much (no big deal) after the second dose of the Pfizer COVID 19 vaccine on 03Feb2021 and she was little concerned. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
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| 49 | 2021-06-03 | feeling abnormal |
I received my 1st vaccine on Friday May 14 and I felt worse than when I had Covid back in November...
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I received my 1st vaccine on Friday May 14 and I felt worse than when I had Covid back in November. My fever was spiking and holding between 100 and 101 since Saturday along with my whole body hurt and armpits swollen-lymph nodes. Monday my stomach started hurting and had diarrhea Fever was back to 99 but still felt icky tired weird until Tuesday. Wednesday May 19th I felt a lot better but still not 100% still feeling a bit weird head feels weird and my lymph nodes are still a little enlarged( armpit also) Had about a week of not feeling bad and then May 27th I got a sore throat headache stuffed up tired.. by Wednesday June 2nd my neck lymph nodes was swollen and sore went in for strep/Covid test both negative . They gave me a antibiotic it?s helping a little throat not as sore and lymph not as swollen But my head still feels weird (kinda dizzy and off) like after my shot so I don?t k is if it is another flare up from the vaccine or not and I was supposed to get my second dose today June 4 but I canceled and rescheduled it but I?m nervous to get it in case all of this is from the initial shot
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| 49 | 2021-06-05 | sleep disorder |
First dose was not much of an issue, I had the expected soreness in my arm where the shot was admini...
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First dose was not much of an issue, I had the expected soreness in my arm where the shot was administered. I would get an occasional twinge of pain ( as if I had the shot again). However, since I have had the second dose on 4/29/21 _ I am experiencing horrible pain in my deltoid, upper bicep and tricep. To the point that I cannot sleep due to the constant stabbing pain. I have rested the arm, iced it, heated it. I have seen the chiropractor, had massage therapy, and cannot find relief. The pain is AWFUL and stabbing and sharp. Yesterday I went to the orthpedic specialist and they say that it seems to be all muscular and likely inflammatory reaction from the vaccine. this is 6 weeks of a reaction.
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| 49 | 2021-06-06 | feeling abnormal, sleep disorder |
The shot was given very high up on the arm, into the left shoulder. The injection site was very tend...
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The shot was given very high up on the arm, into the left shoulder. The injection site was very tender and my shoulder hurt. It is still tender to the touch today. My shoulder still hurts. I have difficulty raising my arm up. I told the nurse when I went back for second dose. She was snotty, said it shouldn?t still be hurting from first dose, said I had been babying it. That was untrue; I used my arm as I normally would. She just blew me off. I have read about SIRVA, injury resulting from the injection being given too high in the arm or too deeply into the shoulder. Also, I have not felt well since getting both doses. I got bad headaches for a couple weeks after; I?m still getting headaches, just not as bad. I had bad body aches for a couple weeks; I?m still having body aches, just not as bad. The fatigue and sheer exhaustion have been present since the two doses; there has been no improvement. I?m not sleeping as well as I was. I am feeling kind of foggy.
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| 49 | 2021-06-07 | insomnia |
whole body has hives; Blisters; It hurts; I can't sleep; This is a spontaneous report from a contact...
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whole body has hives; Blisters; It hurts; I can't sleep; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Lot Number: LW0150 and expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 12Apr2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date,it was reported that her whole body has hives and blisters; it hurts and she can't sleep. Therapeutic measures were taken as a result of hives, blisters, it hurts, i can't sleep included went to Doctor, urgent care (16May2021) they gave me all the medication for reaction like Famotidine (20mg tablet), they gave me 10 mg Hydrocodone (not clarified) intramuscular. They gave me Sarna (not clarified) topical, they gave me Prednisolone (20 mg tablet), Hydroxyzine hcl 25 mg tablet, they gave me Zyrtec 10 mg. Consumer wanted to know what happed to her and she wanted to know.The outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.
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| 50 | 2021-01-04 | anxiety, emotional distress | Patient became anxious, nauseated and very fussy 20 minutes after injection. |
| 50 | 2021-01-04 | confusional state |
headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, som...
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headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, some chest pain, feel woosy, felt confussed right after vaccine,
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| 50 | 2021-01-04 | feeling abnormal |
diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bi...
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diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bit cruddy; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: paa156051), via an unspecified route of administration (arm left, dose number 1) on 17Dec2020 10:30 at single dose for COVID-19 immunisation. Medical history included Psoriatic arthritis from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL), propranolol, and curcuma longa (TURMERIC CURCUMIN). Patient is on unspecified birth control and unspecified vitamins. No other vaccines in four weeks were given. The patient previously took steroids and experienced allergies (similar reaction to steroid 1 year before), and FLONASE and experienced allergies. On 17Dec2020, It was reported that the patient was fine for the first 15 minutes, afterwards became very diaphoretic, woozy, heart rate went down to 43 and blood pressure down to 83/57. The patient recovered enough to leave about 20 minutes. After that, patient's heart rate was back into the 60's and BP stayed the same but the patient was feeling better. Patient's heart rate is usually in the 70's and his BP around 115/75 or so. The patient has no breathing problems. Other than headache and feeling a bit cruddy, the patient has been fine since. Patient mentioned she really wanted to take the second dose, but she does not know if she should. No treatment for the adverse events. No COVID prior vaccination and patient has not tested for COVID post vaccination. Event outcome was recovered on Dec2020. Events were considered non-serious.
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| 50 | 2021-01-04 | feeling abnormal |
allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her l...
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allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events "rash on her legs/ rash all over her" and "Fast heart rate" was not recovered, while other events were unknown.
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| 50 | 2021-01-04 | loss of personal independence in daily activities |
Chills; Muscle ache; Headache; Did not feel well in general; Right arm soreness in the same arm that...
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Chills; Muscle ache; Headache; Did not feel well in general; Right arm soreness in the same arm that the COVID vaccine was given; It was hard to lift her arm and woke her up when she was sleeping; It was hard to lift her arm and woke her up when she was sleeping; This is a spontaneous report from a contactable consumer (patient, occupation: Respiratory Therapist). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 22Dec2020 11:00 (reported as Approximately 11am in the morning) at single dose to help stop the spread of COVID. Location of the COVID Vaccine: Right arm. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no prior Vaccinations with 4 weeks. Medical history included she had tested positive for COVID on 02Oct2020. The patient did not have any illness at time of vaccination. Family Medical History Relevant to adverse event also reported as none. There were no concomitant medications. The patient previously had flu vaccine given at the hospital she works at and She had mild arm soreness after the Flu vaccine. The patient experienced Right arm soreness in the same arm that the COVID vaccine was given on 22Dec2020, Chills on 23Dec2020, Muscle ache on 23Dec2020, Headache on 23Dec2020, did not feel well in general on 23Dec2020. Caller reported that she experienced right arm soreness, in the arm she received the vaccine, that was unlike any other vaccine she had ever had. The arm soreness began the same evening as the day she received the COVID vaccine. It was hard to lift her arm and woke her up when she was sleeping in Dec2020. The remainder of the side effects began the following morning after she had received the COVID Vaccine. Other side effects included chills, which lasted until the 24th or 25Dec2020. Muscle aches, which lasted until the 24th or 25th Dec2020. Headaches, which she is still getting off and on, but it is hard to say if the headaches that she is still getting is still from the COVID vaccine. The headaches are coming less often. She has had to take something for the headaches. Caller stated that she did not feel well, in general. Asked caller what other vaccines she had received and had experienced arm soreness but not to the extent she had after the COVID Vaccine and caller stated that she had mild arm soreness after the Flu vaccine. Previous flu vaccines had been given to her at the hospital she works at; therefore, she did not have any lot number information for these flu vaccines. The reported adverse events did not require a visit to Emergency Room and Physician's office. The patient was not hospitalized. The outcome of event Right arm soreness in the same arm that the COVID vaccine was given was recovered on 26Dec2020, the outcome of the event Chills, Muscle ache was recovered in Dec2020, the outcome of the event did not feel well in general was recovered on 25Dec2020. The outcome of the event Headache was recovering. The outcome of the other events was unknown. The causality assessment for events Right arm soreness in the same arm that the COVID vaccine was given, Chills, Muscle ache, Headache, did not feel well in general with suspect COVID vaccine was assessed as related by Primary Source Reporter via Method of assessment Global Introspection. Information on the lot/batch number has been requested.
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| 50 | 2021-01-05 | impaired work ability, feeling abnormal |
Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115...
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Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115; she was not feeling right, so she took the day off from work today; Lightheadedness; wobbly; she felt weak; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, expiration date: Apr2021), via an unspecified route of administration at right deltoid on 29Dec2020 17:45 at a single dose for Covid-19 immunization. Medical history included asthma from 2003 and ongoing, tachycardia and major surgery. Concomitant medication included maintenance inhaler (unspecified) for asthma. Patient was officially diagnosed with asthma in 2003. She said her asthma was controlled, and she takes a maintenance inhaler every day. She said she has been taking the same maintenance inhaler since she was first diagnosed with the asthma. She said she rarely uses a rescue inhaler. Reported she was prescribed the Metoprolol Tartrate 25mg for her tachycardia that she had after her major surgery, but she did not take the full 25mg dose during that time. She said she hasn't had taken the Metoprolol Tartrate 25mg in almost a year, clarifying it was last Jan2020 that she used the Metoprolol Tartrate. The patient previously received a flu shot in Oct2020, and felt rundown for a day afterwards, but that she always does after she receives a flu shot. She said she had no heart issues after receiving the flu shot in Oct2020. The patient who is a registered nurse reported she received the COVID-19 vaccine last night at work, on 29Dec2020, at 5:45PM, and had experienced some tachycardia after receiving the vaccine. Reported the COVID-19 Vaccine was offered through her employer. She said the COVID-19 vaccine was optional and offered to all employees if they work at the hospital. She experienced the tachycardia at 11:00 PM last night, 29Dec2020. She said her normal resting heart rate is between the high 60s to low 70s. She said her heart rate at 11:00PM last night was at around 100, clarifying she was not running a fever at that time. She stated after she received the COVID-19 vaccine, she was not feeling right, so she took the day off from work today, and slept in. She said when she woke up this morning (in Dec2020), she still didn't feel right, saying she felt weak and wobbly, and when she checked her pulse it was 115. She said she does have a past history of tachycardia. She said a year ago she had major surgery, and she had tachycardia after the major surgery. She said the tachycardia eventually went away, but she did have to see a cardiologist and take a beta blocker. She said she took a tiny dose of the beta blocker this morning, and called the cardiologist to let him know what was going on. She said she has not heard back from the cardiologist yet. She said the tachycardia went away once she took the beta blocker this morning. She said she took the beta blocker because her heart rate was going higher, and higher. She said she didn't want to end up like last year after her major surgery with a heart rate in the 170s. She said the tachycardia she was experiencing after receiving the COVID-19 Vaccine was not normal for her. She said once she got over the major surgery last year, her heart rate was fine. Reported her employer was making employees wait around for 15 minutes after the employees received the COVID-19 Vaccine to make sure no one had a major reaction to the COVID-19 Vaccine. She said after she received the COVID-19 Vaccine, she waited around longer than the 15 minutes. She said she felt weird after she received the COVID-19 Vaccine and thought maybe she was experiencing anxiety. She said she was lightheaded on 29Dec2020 after she received the COVID-19 Vaccine and completed a report right then on the website. She said the website is for reporting adverse events, and she was sent a website link to complete the adverse event reporting. She said she signed into the website link while she was still at the hospital. She said one of the website's first questions asked was how she was feeling. She said the question made her wonder if her lightheadedness was due to her heart rate being up because she becomes lightheaded when that happens. She clarified she reported only the lightheadedness on the website, and not the tachycardia. She said her lightheadedness got better and she was fine, and then at 11:00PM the tachycardia hit her like a switch. Reported this morning she felt fine, and then all of sudden she wasn't fine. Tachycardia Treatment: Reported she took a 8.5mg dose, or one quarter of a 25mg tablet (as provided by the reporter) of the beta blocker Metoprolol Tartrate 25mg tablet this morning and called her cardiologist to let him know. She said she split the Metoprolol Tartrate 25mg tablet this morning, and only took a quarter of the 25mg tablet (reported as a 8.5mg dose by the reporter). Reported she believes 100% that her tachycardia was caused by the COVID-19 Vaccine, saying she has been fine up until receiving the COVID-19 Vaccine. She said she got the COVID-19 Vaccine because she was afraid of getting the COVID-19 Virus with her asthma. She said she has no other preexisting conditions besides the asthma. Reported she is not going to get the second COVID-19 Vaccine dose. She said it was scary when her heart rate shot up out of nowhere. She said the COVID-19 Vaccine is the only thing different she has done. She said before the COVID-19 Vaccine, she was completely fine. Patient asked if the Pfizer DSU agent had heard of anyone else who has experienced tachycardia after receiving the COVID-19 Vaccine. The outcome of the event tachycardia was recovered in Dec2020, event lightheadedness was recovering and unknown for the other events. The reporter assessed the event 'tachycardia' as Serious (Medically Significant).; Sender's Comments: Based on the close temporal relationship, the association between the event tachycardia with BNT162b2 can not be fully excluded. The medical history of tachycardia and asthma medication may be contributory as well. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-06 | disorientation |
Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive ...
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Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive impaired, dizzy, disoriented
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| 50 | 2021-01-07 | anxiety |
sudden skin flushing from head to toe with feeling of extreme heat, feeling of doom and uneasiness t...
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sudden skin flushing from head to toe with feeling of extreme heat, feeling of doom and uneasiness that occurred within 3 minutes of injection, no tachycardia, hypertension noted, no wheezing, lungs clear, no SOB, treated with Benadryl and Pepcid with close observation for 30 minutes
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| 50 | 2021-01-07 | confusional state |
Had altered mental status after vaccination. Potassium was low at 2.6; Lactate elevated at 5.7. He...
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Had altered mental status after vaccination. Potassium was low at 2.6; Lactate elevated at 5.7. Head CT was normal. PMHx: Diverticulitis and GERD. She has history of Airway constriction and Hives with lo dose aspirin
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| 50 | 2021-01-07 | insomnia, sleep disorder |
headache, sore throat, runny nose, arm pain that migrated to the axilla and down the side of the bod...
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headache, sore throat, runny nose, arm pain that migrated to the axilla and down the side of the body, joint pain ( hands, wrist, feet, hips, knees, spine, neck), insomnia, general malaise, fatigue, and lower grade fever. Most symptoms lasted about 7 -10 days. However, it is now day 20 after the initial vaccine and I still have joint pain that has not gone away. esp in hands, wrists, and feet. When I sleep I still wake up with all my joints hurting it gets better as I start moving but the wrist, hands, and feet pain has not gone away. This pain will wake me in the night when I change positions. I called my doctor today to inquire if it is a good idea if I should take the second dose because the first dose made me so dibiliated. Awaiting for a response. I am due to take the second vaccine on 2/9/21.
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| 50 | 2021-01-07 | insomnia | Insomnia for 3 nights following |
| 50 | 2021-01-07 | insomnia |
Day 1 Night: Sleeplessness Day 2: Muscle aches in left arm, left shoulder, neck. Fullness in ear,...
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Day 1 Night: Sleeplessness Day 2: Muscle aches in left arm, left shoulder, neck. Fullness in ear, dizziness.
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| 50 | 2021-01-07 | restlessness, feeling abnormal, insomnia |
Felt like her thyroid was off/could not function well; Felt exhausted; Feeling out of it, like she w...
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Felt like her thyroid was off/could not function well; Felt exhausted; Feeling out of it, like she was drugged/felt foggy; Feeling out of it, like she was drugged; Feeling restless at night; She hasn't been able to sleep at night; This is a spontaneous report from a consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Dec2020 on the left arm at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital (not a military facility). Medical history included ongoing Grave's disease from 2007. There were no concomitant medications. On 16Dec2020 (19:00), the patient was feeling out of it, like she was drugged, and felt foggy. On 17Dec2020, the patient had felt exhausted. In Dec2020, the patient was feeling restless at night; and has not been able to sleep at night. On an unspecified date, the patient had felt like her thyroid was off and could not function well. The outcome of the events was recovered in Dec2020 for 'feeling out of it, like she was drugged, and felt foggy'; was not recovered for 'feeling restless at night' and 'has not been able to sleep at night'; and was unknown for all the other events. The patient was leery about receiving the second COVID-19 vaccine dose.
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| 50 | 2021-01-08 | anxiety |
Patient was given the first COVID-19 vaccination at approximately 1254 today in her left deltoid. Sh...
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Patient was given the first COVID-19 vaccination at approximately 1254 today in her left deltoid. She approached writer at 1310 in no apparent distress. She voiced symptoms that were concerning to her. She indicated about 5 minutes after she received the injection, her tongue felt like it was burning and tingling. She also stated her chest was burning. Denies every having these symptoms ever before. She currently denied shortness of breath, chest pain, shoulder pain, nausea, or throat swelling. No changes in voice were observed by writer. Last time patient ate was between 0930 and 1000 this am. Patient shared that she was feeling anxious about having the vaccine and wonders if this is the reason why she is having the symptoms. Vitals taken, all within normal range. Patient encouraged to remain for 30 for observation. No further concerns were verbalized to writer during her stay. Patient was encouraged to call 911 if she develops shortness of breath, chest pain, throat swelling or other concerning symptoms after she leaves. Patient verbalized understanding and was agreeable with plan.
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| 50 | 2021-01-10 | impaired work ability | body ache, fever, nausea. called in sick to work. |
| 50 | 2021-01-10 | impaired work ability | nausea, headache, fever. called in sick to work. |
| 50 | 2021-01-10 | impaired work ability |
First night had fever (102.4), chills, body aches, fatigue and slight headache. My arm was sore but ...
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First night had fever (102.4), chills, body aches, fatigue and slight headache. My arm was sore but my armpit was so painful (felt like stabbing sensation). This lasted until around 2:00 pm Saturday. I felt ok except for being tired and armpit still hurting quite a bit. On Sunday, I was very tired and slept during the day and went to bed around 8:30 pm feeling like I had a slight sore throat, tired and mildly nauseous. My armpit still hurt quite a bit. I woke up Monday at 5:30 am and showered and was profusely sweating when I was getting ready for work - my temperature was 100.6 so I took 800 mg of Ibuprofen to help with the temp and the pain in my armpit. I did not go into work. I am still tired and my current temp is 100.1 (12:30pm) and sweaty. I do feel as though the severity of my armpit pain is lessening but it is still bothersome.
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| 50 | 2021-01-11 | feeling abnormal |
Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; Thi...
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Hypokalemia; Hypomagnesemia; Hypocalcemia; Hemoglobin dropped little bit; Tetany; Muscle cramps; This is a spontaneous report from a contactable healthcare professional, a physician assistant. A 50-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included tachycardia, tension headache, and glucose tolerance impaired. Concomitant medications included rosuvastatin calcium (CRESTOR), gabapentin (MANUFACTURER UNKNOWN), and metoprolol (MANUFACTURER UNKNOWN). On 18Dec2020, the patient experienced hypokalemia, hypomagnesemia, hypocalcemia, tetany, muscle cramps, and hemoglobin dropped little bit. The clinical course was as follows: The patient received the vaccine and about 30 minutes later she started to "feel bad". She went to the urgent care and about an hour after they took her to the emergency room (also reported as hospital). She had a complete blood count, complete metabolic panel, and magnesium level done on the 18th, 21th, 23rd, 26th, 28th, 30th of Dec2020 and then again on 04Jan2021. On 18Dec2020, her initial lab test showed potassium: 2.6, hemoglobin: 10.2, magnesium: 1.2, and calcium: 5.7. The physician assistant reported that a potassium of 2.6 was critically low and a hemoglobin was 10.2 was about normal for the patient. She received oral medications of potassium 20 mEq twice a day and calcium and magnesium supplements once a day. On 04Jan2021, lab data showed: potassium: 4.2, magnesium: 2.1, calcium: 9.5 and hemoglobin: 14.5. Per the reporting physician assistant, the above levels went back to normal but stated she had to be supplemented to get back to that point. The clinical outcomes of the hypokalemia, hypomagnesemia, hypocalcemia, and hemoglobin dropped little bit were recovered on 04Jan2021; while that of the tetany and muscle cramps, were unknown. The physician assistant assessed the events as related to the suspect vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-11 | impaired work ability |
GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DU...
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GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DUE TO SEVERE SORENESS AND PAIN. PAIN PROGRESSIVELY LESSENED BUT THE SORENESS STILL VERY APPARENT. ON 1/5, SPOKE TO PRIMARY MD, XRAY ON LEFT SHOULDER DONE ON 1/6. ON 1/7, STIFFNESS WITH SEVERE PAIN UPON MOVEMENT NOTED ESP IN THE MORNING. ULTRASOUND WAS DONE ON 1/8, NOTED BICEPS TENOSYNOVITIS. ORTHOPEDIC SURGEON SEEN ON 1/11, W DX OF ADHESIVE CAPSULITIS, SUGGESTED FOR PT FOR NOW, AND OFF WORK, AND TO BE FOLLOWED UP ON 2/1 BY SAME ORTHO SURGEON. WILL NOT OFFER CORTISONE SHOT FOR NOW AS IT MAY COMPROMISED OR WEAKEN IMMUNE RESPONSE, IN WHICH MY SECOND COVID SHOT DUE ON THE 15TH OF JANUARY. FIRST APPT FOR PT ON 1/15
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| 50 | 2021-01-11 | sleep disorder, impaired work ability |
Approximately 11 hours after the vaccination my arm became very sore, to the point that it was diffi...
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Approximately 11 hours after the vaccination my arm became very sore, to the point that it was difficult to lift it. I then developed body aches and chills. I did not develop a fever that I know of but the body aches and chills continues throughout the night. During the night a severe headache developed as well as generalized weakness. I was unable to sleep and had to miss work the next day. Because the weakness and body aches continue, I plan to miss a second day of work tomorrow. I treated the symptoms with Tylenol.
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| 50 | 2021-01-12 | impaired work ability |
30 hours post-injection I experienced intense body aches, fatigue, headache and fever (100.9F). Fol...
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30 hours post-injection I experienced intense body aches, fatigue, headache and fever (100.9F). Following the first injection in the series I experienced very mild body aches and minor fatigue, also noted at approx 30 hours post-injection. Symptoms following the second injection were much more intense, included a fever and headache, and lasted longer (12-13 hours). Symptoms experienced following the second injection caused a missed work day.
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| 50 | 2021-01-13 | confusional state |
Fever of 102; Body aches; Chills; Confusion; Headache; This is a spontaneous report from a contactab...
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Fever of 102; Body aches; Chills; Confusion; Headache; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EKS730 and expiration date not provided), via an unspecified route of administration in the right arm on 05Jan2021 09:30 at a single dose for COVID-19 immunization. The patient has no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 02:00, the patient experienced fever of 102, body aches, chills, confusion, and headache. Treatment was not provided in response to the events. The outcome of the events was recovering. The patient assessed the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
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| 50 | 2021-01-13 | impaired work ability |
Symptoms - ? EE reports at approximately 2:00 pm she began feeling tired and so fatigued she left wo...
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Symptoms - ? EE reports at approximately 2:00 pm she began feeling tired and so fatigued she left work. EE reports at time of call still fatigued, with muscle weakness and joint pain. EE denies fever. EE denies COVID-19 exposure without proper PPE and recent travel. Last day of work and shift - ? yesterday Home remedies? - rest Any improvement? - mild Recommendation? EE reports she called off of work today due to feeling unwell. EE encouraged to continue to monitor her symptoms and to contact the vaccine support line for further questions or concerns. EE educated to continue to manage per Illness in the Workplace Policy. EE verbalized back understanding and denied further questions at this time.
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| 50 | 2021-01-13 | sleep disorder |
1/7/2021 @1600 nausea lasted 2hr 1/8/2021 @ 0200 body aches & chills lasted off & on & continues pre...
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1/7/2021 @1600 nausea lasted 2hr 1/8/2021 @ 0200 body aches & chills lasted off & on & continues presently. Woke up 1/9/2021 @0400 with headache & severe body aches & chills lasted 2hr Currently: body aches, chills, exhaustion (these symptoms come & go since 2nd injection)
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| 50 | 2021-01-14 | feeling abnormal |
funky lightheadedness; weird feelings in head; tinnitus was noticeably oscillated up and down; This ...
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funky lightheadedness; weird feelings in head; tinnitus was noticeably oscillated up and down; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FK4176), intramuscularly on 07Jan2021 at 13:30 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 13:30 on the right arm for COVID-19 immunization and experienced funky lightheadedness, vertigo, normal tinnitus got louder and oscillating up and down, and sinus headache. Concomitant medication included colecalciferol (VITAMIN D). On 07Jan2021 at 13:30 (as reported), patient experienced funky lightheadedness, weird feelings in head, and tinnitus was noticeably oscillated up and down. The events were assessed as non-serious. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on 07Jan2021 at 15:30.
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| 50 | 2021-01-14 | impaired work ability |
1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tendernes...
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1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tenderness, body/muscle aches. 1/12/2021 @ 2300hrs - Body/muscle aches, chills. 1/13/2021 @ 0300hrs - Body/muscle aches, chills, fever 99.0, general malaise. 1/13/2021 @ 0600hrs - Body/muscle aches, chills, general malaise, no energy. Did not report to work. 1/13/2021 @ 1000hrs - Symptoms continued. Took Advil 600mg PO. Slept from 1030-1230hrs. 1/13/2021 @ 1230hrs - No energy, very tired, rested the entire day. Took Advil 600mg every 4 to 6 hours. 1/13 to 1/15/2021 - Left arm site tenderness with raised, hard area at injection site. Left armpit soft tissue swelling, possibly lymphadenopathy. 1/15/2021 - Reported symptoms to provider, awaiting appointment.
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| 50 | 2021-01-14 | poor quality sleep |
feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; wea...
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feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; weak; her middle finger and index finger feel tight; her left shoulder feel really tight but has full sensation; unable to lift her left arm more than 30 degrees; pain in her arm; unable to sleep very well last night; This is a spontaneous report from a contactable nurse (patient) reported that a 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 08Jan2021(yesterday morning, Deltoid Left) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Historical Vaccine was included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. Patient received her second dose and within an hour she started feeling extremely tired, had a severe headache. When she woke up she noticed a large palpable knot on her left upper lateral deltoid in Jan2021. She stated that the injection went well and noticed no problems when she received the shot. At this time she was still very weak, her headache was still severe and she has noticed that her middle finger and index finger feel tight and her left shoulder feel really tight but had full sensation. She stated that she was unable to lift her left arm more than 30 degrees. She does not have a primary care physician at this time as she just relocated to her current residence. She stated that she was so uncomfortable due to the pain in her arm she was unable to sleep very well last night. She was going to seek medical attention at a local urgent care to be safe. The outcome of events, fatigue, knot on her left upper lateral deltoid, finger feel tight, shoulder feel really tight, unable to lift her left arm more than 30 degrees, pain in her arm, unable to sleep very well was unknown. The outcome of events of severe headache, weak was not recovered. Information about lot/batch number has been requested.; Reporter's Comments: her symptoms online per the Fact Sheet instructions. Potential
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| 50 | 2021-01-14 | sensation of foreign body |
10:40 Employee complains of difficulties swallowing, sensation in throat. Denies troubles breathing....
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10:40 Employee complains of difficulties swallowing, sensation in throat. Denies troubles breathing. Is experiencing watering eyes and occasional coughing 10:49- received dose of 25mg diphenhydramine with slight improvement in symptoms, not resolved. 10:52- notes sensation of tingling tongue- Emergency Response Team called 11:02- 2nd dose of 25mg PO diphenhydramine administered Emergency Response Team Staff transports Employee to Emergency Room
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| 50 | 2021-01-14 | sensation of foreign body |
Employee received vaccine at 10:30 10:40- during post-vaccination observation period, Employee repor...
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Employee received vaccine at 10:30 10:40- during post-vaccination observation period, Employee reported sensation in throat while swallowing, eyes watering, occasional cough-Denies troubles breathing, denies swelling of lips tongue or throat. Drank water without difficulties 10:49- Provided 25mg of PO liquid diphenhydramine Observed- continued to have symptoms. Emergency Response Team called 10:55- Pt reports some improvement in symptoms- coughing resolved 11:02- Additional 25mh of PO Liquid diphenhydramine provided. Pt was transported to Emergency Room for Evaluation
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| 50 | 2021-01-15 | feeling abnormal, restlessness |
I had the first vaccine 12/22, no side effects at all. After this booster, I was fine until about 1...
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I had the first vaccine 12/22, no side effects at all. After this booster, I was fine until about 10 hours later-then had severe neck down my entire back pain, with restlessness, chills, and headache-this lasted about 24 hrs. The pain subsided and then I had liquid stooling for about 8 hrs with intermittent hot flashes. I am still having an "odd" feeling in my head, like foggy sensation, vertigo, and the sweating episodes as we speak.
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| 50 | 2021-01-15 | feeling abnormal |
Headache, Myalgia, Fever, fatigue, chills Narrative: Fever up to 101F, headache, chills, body ache...
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Headache, Myalgia, Fever, fatigue, chills Narrative: Fever up to 101F, headache, chills, body aches, almost felt delusional. Side effects are resolving, but still having head fogginess. Took OTC pain reliever and used ice for her head, was able to sleep afterwards.
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| 50 | 2021-01-18 | anxiety, feeling abnormal |
Got vaccine at 11:30am. At 1:30p not feeling right, sweating, anxiousL hand swollen and tight, inj...
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Got vaccine at 11:30am. At 1:30p not feeling right, sweating, anxiousL hand swollen and tight, injection site looked normal. Assessed and was given Benadryl 50mg PO and lay down for an hour. Went home at 2:30p. Returned to work the next day and at noon felt feverish (100.0F), SOB, overall muscles ached and sore, injection site sore. My blood pressure was taken x 2 at 200/100 by nursing. I was driven to local ER and worked up. They could not determine if symptoms r/t to vaccine or not. My BP returned to normal. I was given a diagnosis of hypertension and a script for Lisinopril 5mg PO qd. I continue to have fluctuating high BP readings. My left hand swelling resolved. I plan to see my PCP as I have now s
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| 50 | 2021-01-18 | impaired work ability, impaired work ability | rapid heart rate, fever, diarrhea. called in sick to work. |
| 50 | 2021-01-18 | insomnia |
There is a knot on my left arm. It is warm to the touch and red. Additionally, I am unable to lay on...
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There is a knot on my left arm. It is warm to the touch and red. Additionally, I am unable to lay on that side. I have also lost range of motion
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| 50 | 2021-01-18 | sleep disorder |
Severe arm pain after shot. Woke me out of sleep night after shot. Unable to lift arm horizontal t...
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Severe arm pain after shot. Woke me out of sleep night after shot. Unable to lift arm horizontal to shoulder, knot size of walnut. Diarrhea x 24 hrs, headache, low grade temp, wheezing day 4, shortness of breath noted upon exertion day 3-7. Expiratory wheezing. Much better (able to walk without shortness of breath day 7). Laryngitis day 2-6. Went to ER. Received IVF for low potassium and dehydration due to diarrhea. T max 99.9.
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| 50 | 2021-01-19 | anxiety | anxious, light headed |
| 50 | 2021-01-19 | feeling abnormal |
1/18 10pm started with chills then fever 1/19 not feeling right 8am chills 10am fever 101.1 severe n...
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1/18 10pm started with chills then fever 1/19 not feeling right 8am chills 10am fever 101.1 severe nausea near vomiting severe fatigue had fever all night 11/20 diarrhea put no fever
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| 50 | 2021-01-20 | feeling abnormal |
diarrhea; nausea; she was sick with a high fever; chills; felt deathly sick; couldn't get out of bed...
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diarrhea; nausea; she was sick with a high fever; chills; felt deathly sick; couldn't get out of bed all day; headache; a little bit of a sore throat; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, lot # and expiration not available) intramuscular in left arm at single dose on 11Jan2021 09:30 for Covid-19 immunisation, for precaution because she worked in hospital, administered ad hospital. There was no prescriber. Medical history included asthma diagnosed 30 years before when she was in her 20's around 1990, hypothyroidism. Family medical history was none. Concomitant medication included only levothyroxine sodium (SYNTHROID) taking for 30 years for hypothyroidism. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # and expiration not available) intramuscularly in left arm on 21Dec2020 09:30 (within 4 weeks prior to the 2nd dose of BNT162B2 suspect) Covid-19 immunisation and she was fine. No adverse events occurred following prior vaccinations. No additional vaccines administered on same date of BNT162B2 suspect. On 12Jan2021, she was felt deathly sick at 15:00. On 11Jan2021 she experienced headache at 17:00. On 12Jan2021, at 17:00 she experienced high fever and chills and couldn't get out of bed all day. On 13Jan2021, she was fine during the day. On 13Jan2021 night, she had a fever that went past 100 degree F, she experienced diarrhea and nausea 02:00. The fever came and went. In Jan2021 she had a little bit of a sore throat. The patient underwent lab tests and procedures which included body temperature: a fever on 12Jan2021; wsa fien on 13-JAN-2021, fever went past 100 degree F, on 13Jan2021at night. No other relevant test performed. She has been out of work since 12Jan2021. On 14Jan2021 she still has diarrhea and nausea with a little bit of a sore throat as well. No ER or physician's office was required. The outcome of felt deathly sick and chills was recovering, of headache, high fever, diarrhea and nausea was not recovered, of couldn't get out of bed all day and a little bit of a sore throat was unknown. She was not sure if her new symptoms meant she should get COVID testing and would like to find out. Information on lot number/batch number was requested.
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| 50 | 2021-01-20 | loss of personal independence in daily activities |
I had headache, dizziness, body aches, vomiting, joint pain. I have to take the day off of work af...
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I had headache, dizziness, body aches, vomiting, joint pain. I have to take the day off of work after my first and my second vaccine. I rotated ibuprofen and Tylenol. The first vaccine reaction lasted about 36 hours. The second is going on 48 hours.
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| 50 | 2021-01-20 | loss of personal independence in daily activities |
The following morning when she woke up had chills, temperature, very bad headache, and a head cold. ...
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The following morning when she woke up had chills, temperature, very bad headache, and a head cold. Went to HD, they sent her home and to report to us and monitor it. If she didn't get better to go to ER or Dr. 1/20/21, felt chills, woke up in pool of sweat, bad headache, and mucousy with runny nose and still having that symptom. 1/21/21 feeling like she may be getting a little better, but FU with her PCP tomorrow. No difficulty breathing, cold like symptoms. Feels like she doesn't have a temperature. Finally does not have a headache.
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| 50 | 2021-01-21 | impaired work ability |
Skin burning, severe joint pain, dizziness, headache, fatigue lasted for 5 days. Missed several shi...
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Skin burning, severe joint pain, dizziness, headache, fatigue lasted for 5 days. Missed several shifts.
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| 50 | 2021-01-21 | impaired work ability |
On day 2 post vaccine severe body aches, joint pain, skin felt like a very painful sunburn , dizzine...
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On day 2 post vaccine severe body aches, joint pain, skin felt like a very painful sunburn , dizziness, fatigue and headache, Difficult to get out of bed. Took Acetaminophen 500 mg 1-2 tabs a couple of doses. Missed several shift of work. Symptoms fully resolved by 1/17/21- back to work. Telehealth appt.
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| 50 | 2021-01-21 | impaired work ability | not feeling well. called in sick to work. |
| 50 | 2021-01-23 | disorientation | Chills (uncontrolled shaking), disorientation, fatigue |
| 50 | 2021-01-24 | sensation of foreign body |
Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Sh...
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Typical sore arm right away. Next day, I felt something in my throat - like it was a lodged bone. Short of breath and my heart was going faster than normal and short exertion. So I took an antihistamine - Allegra; tums; Tylenol; and took Prevacid. It didn't work. I was worried about my heart and that pressure on my throat. I went to my Dr. appt - she was able to get me in at short notice - and she examined me and did blood work and chest x-ray. Gave prednisone and albuterol . She said my lympyh nodes were swollen on my neck. Symptoms have resolved. And on second dose of vaccine I felt fine. But still have irregular heartbeat but I have a cardio appt coming up. I'm wearing heart monitor - Zeo - I mailed that on the 14 of January.
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| 50 | 2021-01-25 | impaired work ability, amnesia, disturbance in attention, feeling abnormal |
The day after receiving the second COVID-19 vaccine, I had a massive headache, to the point where I ...
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The day after receiving the second COVID-19 vaccine, I had a massive headache, to the point where I stayed in bed and slept all day. I also noticed that my brain was foggy. The next day I was able to move to the couch, but the headache was still severe with continued brain fog. I called by PCP to see if there was anything that I needed to be doing or taking and she told me that I should start feeling better the next week. The headache remains but is mild. I have memory loss and difficulty concentrating. I am a nurse and over my weekend at work, I had difficulty doing my job because I couldn't keep track of what I was supposed to be doing and had difficulty charting. My coworkers even commented that I seemed "really different", that my memory was poor, I had personality changes (according to one person) and that my standard of care was much less than usual. One person also commented that seemed to not be able to hear her and kept asking her to repeat herself. I find myself having to concentrate harder to see when I am reading or typing something. I missed work on January 14 and 15 because of the mental fogginess and headache. I thought I was doing better, but I realized that I wasn't when I returned to work on January 23 and 24. I have spoken to my PCP on the phone once and am awaiting calls from my PCP and neurologist regarding this event.
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| 50 | 2021-01-25 | insomnia |
chills; severe all over body aches especially left arm; headache; sleeplessness; This is a spontaneo...
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chills; severe all over body aches especially left arm; headache; sleeplessness; This is a spontaneous report from a contactable other HCP (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el0142) intramuscularly at left arm on 11Jan2021 16:15 at single dose for COVID-19 immunization. Medical history included herniated disk L5 S1. No known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), ergocalciferol (VITAMIN D), ascorbic acid (VITAMIN C), vitamin b complex (VITAMIN B), cefixime (FLEXERIL), calcium, magnesium, curcuma longa (TURMERIC). The patient previously received first dose of bnt162b2 (lot number: ek5730) intramuscularly at left arm on 21Dec2020 15:45 at single dose for COVID-19 immunization. The patient experienced chills, severe all over body aches especially left arm, headache, sleeplessness, on 11Jan2021 23:30. No treatment received. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovering.
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| 50 | 2021-01-26 | feeling abnormal |
involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscl...
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involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-26 | insomnia |
nausea, joint pain, muscle pain, headache, chills, insomnia, tiredness, injection pain, don't feel w...
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nausea, joint pain, muscle pain, headache, chills, insomnia, tiredness, injection pain, don't feel well
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| 50 | 2021-01-26 | sleep disorder |
After my first dose in the middle of the night I had an extreme arm pain from my left shoulder down ...
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After my first dose in the middle of the night I had an extreme arm pain from my left shoulder down to my finger tip that caused numbness of my fingers, I could not move my arm due to pain, I was not even able to roll over and sleep on it because the pain was so intense. The severe pain lasted about 2 days and my arm was sore for about a full week after.
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| 50 | 2021-01-27 | anxiety |
Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine o...
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Customer received FIRST COVID-19 vaccine at 1015 in medical center and transferred to post vaccine observation. At 1035 customer called out to provider. Customer reports feeling acute nausea and she states she feels as if she is going to throw up. She appears slightly pale and significantly anxious. Customer is moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. Reports feeling sweaty, with waves of nausea and intermittent ULQ pain that she describes as sharp and bandlike across the diaphragm. She episodically calls out in pain and clutches her left chest below her ribs stating that it feels better when she puts pressure at the site. Customer admits to having significant anxiety and a history of panic attacks. HR 102, 02 99%. Lungs CTA. Customer accepts Benadryl 50mg PO @ 1043. Customer monitored at site. Over the course of the next 15 minutes, she reports feeling better and more relaxed. Customer reports full resolution of symptoms @ 1100. BP 108/82, P 101, O2 100% RA, RR 16. Customer is agreeable to extended monitoring after receiving Benadryl. She has been driven to the vaccination site by a family member and states she will not be alone at home. She is instructed to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer agrees with plan and denies further questions/concerns. Customer released from site at 1115, ambulating independently with steady gait, no obvious s/sx of distress.
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| 50 | 2021-01-27 | fear, confusional state |
Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache t...
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Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old.
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| 50 | 2021-01-27 | feeling abnormal |
feeling tight in my lungs; feel tired; spacy; body aches; my limbs felt heavy; gastrointestinal issu...
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feeling tight in my lungs; feel tired; spacy; body aches; my limbs felt heavy; gastrointestinal issues; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (lot number: Ek4176), via an unspecified route of administration on 13Jan2021 08:00 in right arm at single dose for COVID-19 immunization. Medical history included asthma, thyroid cancer, thyroidectomy, attention deficit hyperactivity disorder (ADHD), and known allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), paracetamol (TYLENOL), salbutamol (ALBUTEROL HFA), budesonide/formoterol fumarate (SYMBICORT), and tiotropium bromide (SPIRIVA). The patient previously took azithromycin (ZPACK), and benzonatate and experienced drug allergy, and first dose of BNT162B2 (lot number: EJ1685) on 23Dec2020 08:00 in arm for COVID-19 immunization. The patient experienced feeling tight in lungs 45 min after on 13Jan2021 09:00, it lasted approximately 30 minutes. Around 3-4 hours after started to feel tired, spacy and body aches. Her limbs felt heavy, and gastrointestinal issues, nausea (ondansetron (ZOFRAN) took care of that issue) no vomiting on 13Jan2021, was brought home from work. And slept for 3 hours. Woke up and have continued body aches. The patient underwent lab tests and procedures which included nasal swab: negative on 04Jan2021. Therapeutic measures were taken as a result of nausea. Outcome of event body aches was not resolved and of other events was unknown.
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| 50 | 2021-01-28 | impaired work ability |
Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 ho...
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Starting one day after the vaccine, I developed a headache which turned into a migraine within 24 hours. The migraine became debilitating on Sunday, January 3, 2021. I had vomiting, nausea and dizziness as well. I was unable to work on Monday, January 4, 2021 because I still had the migraine. I take Ubrelvy (prn) and it did not work. I attempted to return to work Tuesday afternoon as the migraine subsided, but it returned shortly after I made it to work. Our treatment nurse took my blood pressure, it was high. My blood sugar was high. I was dehydrated and the migraine was back. My nurse practitioner treated me with an IV of saline solution, pain relieving injection for the migraine and Zofran for the nausea.
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| 50 | 2021-01-28 | insomnia |
This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on 13Jan2021 17:00 at a single dose (first dose) on left arm for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications reported as well. Patient has not received other vaccine in four weeks. Patient has no COVID prior vaccination. Patient stated:"I received the shot (13Jan2021) at 5 pm and I could not sleep that night. I felt fine, but was awake until 9 pm the next day". The outcome of the event recovered on unspecified date. The patient has not tested COVID positive since vaccination. Information on the Batch/Lot number has been requested.
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| 50 | 2021-01-28 | panic attack, anxiety |
pt states that within 10 minutes after vax that she experienced cool tingling sensation down both le...
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pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat. Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot. They checked her blood pressure and it was high at that time 153/? Pt was from out of town so transported to Urgent Care via ambulance. Her blood pressure was 170/? at this time. They did an EKG which was normal. Pt was given Benadryl. Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg. Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong. Pt is waiting for her PCP to do tele visit for a FU.
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| 50 | 2021-01-31 | feeling abnormal, anxiety |
NOT FEELING MY NORMAL SELF, HEARTBURN, HOT IN ABDOMINAL, TEMP99, ANIXETY, DIZZY SPELLS, AWKWARD FEEL...
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NOT FEELING MY NORMAL SELF, HEARTBURN, HOT IN ABDOMINAL, TEMP99, ANIXETY, DIZZY SPELLS, AWKWARD FEELING IN MY HEAD, EXTREAMLY WEAK, THE 1ST DAY NOT SO BAD BUT DAY2-6 MUCH WORSE DAYS 7 &8 GETTING BETTER DAY 9 BACK TO NORMAL SELF.
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| 50 | 2021-01-31 | feeling abnormal |
Fever, chills, large red circle with lump at injection site. Low grade fever for 2 1/2 days, felt b...
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Fever, chills, large red circle with lump at injection site. Low grade fever for 2 1/2 days, felt bad, still able to work from home though.
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| 50 | 2021-01-31 | impaired work ability |
My 2nd dose was given 1/18/2021. On 1/21/2021 at 2:00 am, my temp was 100.9 ( oral ). I started taki...
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My 2nd dose was given 1/18/2021. On 1/21/2021 at 2:00 am, my temp was 100.9 ( oral ). I started taking Tylenol and did not go to work. An hour before Tylenol is due, I start feeling the chills and then fever. If I skip Tylenol or Advil, my fever starts. I was cleared to go back to work today but yesterday 1/31/2021: took Tylenol close to 9 am and by 4:05 my temp is 102.6. Still not back to work.. My highest temp was 1/25/2021: 10:50 am: 104.3. I?ve been having fevers and at times chills for 11 days since the 2nd vaccine dose and still having fevers today.
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| 50 | 2021-02-01 | feeling abnormal |
Next day following vaccine - lymph nodes in neck above clavicle swollen and soft tissue swollen. Th...
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Next day following vaccine - lymph nodes in neck above clavicle swollen and soft tissue swollen. The area below the clavicle- chest wall above left breast was swollen and tender. This has lasted going on a week and is starting to dissipate, but still there. Day after #2 vaccine I also had fever 100.5 for 12 hours, chills and headache. Brain fog for 2-3 days post vaccine
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| 50 | 2021-02-02 | feeling abnormal, impaired work ability |
Body aches that evening, next day body aches, chills, swimming head feeling, sore throat and nausea....
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Body aches that evening, next day body aches, chills, swimming head feeling, sore throat and nausea. Today sore throat, spins and nausea. Left early from work yesterday and took today off.
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| 50 | 2021-02-03 | disorientation |
Client received vaccine at 1:25 pm. After approximately 15 minutes client reported feeling nausea....
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Client received vaccine at 1:25 pm. After approximately 15 minutes client reported feeling nausea. Instructed to stay for an additional 15 minutes for extended observation. Approximately 25 minutes after vaccination client feeling faint and described feeling of acid reflux, difficulty recognizing people and disoriented. Also pale, not clammy. assisted to supine position. EMTs onsite and doctor notified. Nausea continued. Vomited x 2. After approximately 60 minutes client was able to sit up. Spouse arrived and accompanied patient out of the building. Patient ambulated with limited assistance by her husband. Husband given recommendations on follow-up, if needed.
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| 50 | 2021-02-03 | impaired work ability |
Patient here for her 2nd Pfizer vaccine. Immediately after she got it, she began to have moderate/...
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Patient here for her 2nd Pfizer vaccine. Immediately after she got it, she began to have moderate/severe nausea. She is also having light headedness. Her vitals are 136/90, P-98, O2- 98 @ 1447. She denies history of vaccine allergic reactions. Her only reaction from 1st injection was a sore arm. Her baseline vitals are 121/?, P-60-70. @1452 vitals are 134/88, P-122, o2-99. No meds have been given. Patient given ice pack for neck and reclined in reclining chair. Dr. consulted. Vitals @ 1510 130/70, P-106, 24 resp. Dr. advised further monitoring for the mean time. TC to patient's manager, that patient is having reaction to vaccine and is being monitored and will be delayed in returning to dept. Manager verbalized understanding and appreciation. (Created on 2/04/2021 and 3:42pm) Vitals @ 1553 147/80, P-98. Patient reported that nausea is still the same but that her throat started feeling funny. 50mg Benadryl IM given in Right Deltoid by RN @1600. Dr. informed. Director and AD also informed of situation. Patient's manager called by RN to give update on patient and to request that someone in dept bring patient's handbag. (Created on 2/04/2021 and 4:21pm) Vitals @ 1620 139/86, P-86, O2-97, Resp- 28. Patient reports that strange feeling in throat is improving. Nausea & light headedness is the same. She said that she had been feeling hot earlier but not anymore. Updated Dr. on patient's status. Asked Dr. if she may be released to go home with her aunt who is picking her up at 5pm if patient is stable and her vitals are stable. Dr. stated that patient may be released with a Benadryl tablet to go. (Created on 2/04/2021 and 4:43pm) Vitals @ 1720 163/96, P-114, O2-100 Called IMT to PFW 4. Patient initially refused to be taken to ER. Noticed that patient was having labored breathing. Vitals @ 1739 162/91, P-124. After IMT team spoke with patient about vitals, patient decided to go to ER. Patient was taken in wheelchair by IMT team@ 1745.
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| 50 | 2021-02-04 | impaired work ability |
I had meningitis. Bad headaches went to the hospital was there for 5 days. I was out of work for tw...
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I had meningitis. Bad headaches went to the hospital was there for 5 days. I was out of work for two and a half weeks.
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| 50 | 2021-02-05 | anxiety | Body aches, chills, heart racing, anxiety, fidgety-took Aleve lasted 2 days |
| 50 | 2021-02-09 | feeling abnormal, amnesia, disturbance in attention, memory impairment |
massive headache; brain fog/really different; memory loss; difficulty concentrating; memory was poor...
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massive headache; brain fog/really different; memory loss; difficulty concentrating; memory was poor; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL 3246), via an unspecified route of administration in the left arm on 12Jan2021, at 18:30 as the second single dose for covid-19 immunization. Medical history included penicillin allergy , hypertension, peripheral neuropathy, asthma from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included clopidogrel bisulfate (PLAVIX), metoprolol (MANUFACTURER UNKNOWN), isosorbide (MANUFACTURER UNKNOWN), ranolazine (MANUFACTURER UNKNOWN). The patient previously received BNT162B2 (Lot number EL1284) as dose 1. On 13Jan2021, at 08:00, the patient experienced massive headache, brain fog/really different, memory loss, difficulty concentrating, memory was poor. Details were as follows: day after receiving the second COVID-19 vaccine, patient woke up with a massive headache and brain fog. She continued to have a mild headache and was experiencing memory loss and difficulty concentrating. As a nurse, she had difficulty doing her job because she couldn't keep track of what she was supposed to be doing and had difficulty charting. Her coworkers even commented that she seemed really different, that her memory was poor she was not conscientious like she usually was. She had spoken to her primary care physician and was awaiting a phone for the physician and neurologist regarding the event. No treatment was received for the events. The outcome of massive headache, brain fog/really different, memory loss, difficulty concentrating, memory was poor was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
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| 50 | 2021-02-10 | feeling abnormal, panic reaction |
tightening and swelling in her throat; tightening and swelling in her throat; slight swelling of the...
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tightening and swelling in her throat; tightening and swelling in her throat; slight swelling of the tongue; panicky, uncomfortable feeling; panicky, uncomfortable feeling; headache; Sore throat; Extreme tiredness; achy joints; sore muscles; generally feeling sick/unwell; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at right arm on 23Jan2021 13:30 at a single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism (has had for 15 years or so). The patient's concomitant medications were not reported. The patient previously took glycerin and had allergy (has been allergic to glycerin for at least ten years). The patient received the Covid-19 vaccine on Saturday. About 10-15 seconds after receiving it, she felt like it was moving up her arm. She also had a headache and sore throat on the same day. About 20 minutes later at 13:50, she had a tightening and swelling in her throat. It was a panicky, uncomfortable feeling. She reported a "narrowing of my airway" and slight swelling of the tongue/back-of throat. She was unsure if she should wait or go to the emergency room. She took some deep breaths and waited it out. It went away 40 minutes later. She also reported feeling extreme tiredness, achy joints, sore muscles, a headache, and generally feeling sick/unwell in Jan2021. The events did not require a visit to Emergency Room and Physician Office. No prior vaccinations (within 4 weeks). The outcome of the event headache and sore throat was recovering; event tightening and slight swelling of the tongue/swelling of throat was recovered/resolved with sequel on 23Jan2021; and unknown outcome for the other events. Information on the lot/ batch number has been requested.
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| 50 | 2021-02-10 | feeling abnormal |
felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100;...
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felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100; irregular HR with PVCs; HR 40; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283) on 25Jan2021 08:15 given intramuscular (left arm) single dose for COVID-19 immunization. Medical history included was reported as none. The patient was not pregnant at the time of vaccination. Concomitant medication included estradiol, testosterone, lorazepam (ATIVAN). The patient previously received ultram/ Zofran ad experienced drug allergies, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 04Jan2021 08:15 intramuscular single dose for COVID-19 immunization. The patient was not diagnosed with covid prior vaccination and the patient was not tested for covid post vaccination. On 25Jan2021 at 08:45 AM, 30 minutes after injection,-the patient felt horrible described as her heart was pounding hard and felt tachycardic. BP was 160/100 and HR 110 and felt near syncopal. Then PVCs started/ very short of breath, and HR went from 112, 69, 40, then 80. The patient went to ER. The patient was monitored and given was IVFs and O2, and labs checked. The patient was discharged 7 hours later and continued having irregular HR with PVCs. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on the available information, a possible contribution of the drug to the event syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-02-10 | impaired work ability | Not feeling good, stayed home from work on following day on 2/11/2021 |
| 50 | 2021-02-10 | loss of personal independence in daily activities |
patient states vaccine given 2/3/21 and 12 hours later onset fatigue, fever, body aches. Since then...
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patient states vaccine given 2/3/21 and 12 hours later onset fatigue, fever, body aches. Since then everything resolved except continued extreme fatigue more than 7 days after vaccine. Patient tired, sleepy, decrease AODL.
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| 50 | 2021-02-10 | nightmare, insomnia |
Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmare...
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Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine. The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The case will be reassessed if additional information becomes available.
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| 50 | 2021-02-10 | sensation of foreign body |
Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat ...
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Arm burned from the inside out from injection site to finger immediately , walk to seat for obs sat down immediately headache lump in throat then: tingling fingers , dizziness, swelling hands feet and face, flushed, turn bright & lump in throat bigger within 10 mins to the ER for treatment
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| 50 | 2021-02-14 | insomnia |
Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain...
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Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain in feet; Chronic neck and right shoulder pain/mid upper back; Chronic neck and right shoulder pain/mid upper back; Severe sweats from lung region up-censation of passing out; Severe nerve pain; Insomnia; This is a spontaneous report from a contactable nurse reported for herself. A 50-years-old female patient (non pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 13Jan2021 at single dose for COVID -19 immunization. Medical history included allergies to morphine,demerol, codiene, dilaudid, golytle, adhesive tape. Concomitant medication included flecainide (FLECAINIDE). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization on 23Dec2020 and experienced severe headache, lethargy, severe body aches, high fevers, COVID positive. The patient experienced severe headaches, heart palpatations, severe joint pain, tremors to hands, pain in feet, chronic neck and r shoulder pain/mid upper back, severe sweats from lung region up-censation of passing out, severe nerve pain, insomnia in Jan2021. It was reported as serious report, seriousness criteria was disabling/incapacitating. The adverse events result in doctor or other healthcare professional office/clinic visit. The events outcome was not recovered. Information on the lot/batch number has been requested.
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| 50 | 2021-02-15 | anxiety | anxiety after vaccine with no SOB no airway issues |
| 50 | 2021-02-15 | disturbance in attention |
From occupational health note: patient was asked by her supervisor to call. Received vaccine on 1/1...
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From occupational health note: patient was asked by her supervisor to call. Received vaccine on 1/14, had dizziness, seeing spots in her eyes, lethargy and was sent to to ED and discharged. Generalized itching the next day. All sxs have resolved since yesterday. Scheduled to work on Friday, 1/22. From ED note: 50 yo f c/o mild dizziness and light-headedness today, worse with standing up. No n/v/d/f/c. Describes sx as typical early flu like sx today but slightly worse that her usual feeling from flu vaccines. Received the covid vaccine yesterday and friend experienced same symptoms. Felt "difficulty concentrating at work", which was very busy. No weakness, pre-syncope, numbness, cp, sob. No unsteady gait, vision changes. occ vision spots assoc with standing up. H/o anemia, h/o gastric bypass 2005. Often gets routine labs q 6 months but has not had any yet since COVID.
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| 50 | 2021-02-17 | nervousness |
About 45 minutes after the vaccineI left I literally felt very shakey, heart racing. About 6:30 pm I...
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About 45 minutes after the vaccineI left I literally felt very shakey, heart racing. About 6:30 pm I got really nauseated and vomited for about 15 minutes straight ( it was horrible). About minutes after that I vomited again until I had dry heaves. Woke up at 5:08 a.m. to a horrible headache and a low grade fever. Finally started feeling better about 6:00 p.m. the next evening.
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| 50 | 2021-02-18 | anxiety, feeling abnormal |
Patient had high anxiety entering into vaccination chair. Talked at length about current data and al...
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Patient had high anxiety entering into vaccination chair. Talked at length about current data and allergy reactions. After about 10 min post dose resident reported feeling dizzy and that jaw "felt weird" . Took patients blood pressure at 11:15am - reading was 184 / mmHg and pulse was 106. Upon further discussion jaw felt "tight" - verified with patient that it did not feel like it was closing, and that roof of mouth was tingling. Benadryl offered, and patient declined. She stated she would like fresh air, and went outside and took a walk with a nurse. Blood pressure rechecked at 11:33am BP was 188 / 111 mmHg pulse 96. Resident states that her normal BP is around 145/90. Automatic BP checked again at 12:51pm was 188 / 112 mmHg and pulse 89. Had checked with pharmacy intern manually and reading was 166/104 mmHg. Patient stated she felt "better" jaw was ok and tingling in mouth was subsiding. Discussed importance of calling her PCP to discuss potential diagnosis of hypertension.
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| 50 | 2021-02-18 | anxiety |
Patient with past medical history significant for anaphylaxis 2 months ago to iron infusion, receive...
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Patient with past medical history significant for anaphylaxis 2 months ago to iron infusion, received PCP clearance to receive COVID-19 vaccine. Patient given Pfizer vaccine # 1 (lot # EN6201). Approximately 12 minutes into 30 minute wait she began to report that she had a "sore/scratchy" throat and took Benadryl 50 mg PO (patients own supply). Patient took medication on her own and was given permission to take by NP. Patient was assessed by NP with breath sounds CTAB, no wheezing or stridor. No visible swelling of the lips, tongue or face. No rash. VS: B/P 124/73, HR 110, SaO2 100% on RA. During assessment she began to clear her throat and therefore was taken to Facility for further evaluation and monitoring. At Facility, pt was monitored for about 30 minutes. Pt admitted to be anxious about the vaccine. Pt received no medications from Facility. Pt instructed to use diphenhydramine Q6-8 hrs PRN. Pt was discharged to home.
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| 50 | 2021-02-18 | feeling abnormal |
2/04/21, 1:00 PM, chilled "to the bone", temp of 101 degrees, very tired, nauseous - at 3PM took Adv...
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2/04/21, 1:00 PM, chilled "to the bone", temp of 101 degrees, very tired, nauseous - at 3PM took Advil and got a little relief - fever broke early morning of 2/05/21, remained nauseous for two days and exhausted for two weeks with brain fog Sore throat off and on, swollen glands off and on, occasional ear pain - this could be related to drainage, cause unknown 2/15/21 (about) sores began showing up - first two on the back of my left hand, then one on my left upper arm, today one on my right upper arm
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| 50 | 2021-02-18 | impaired work ability, excessive sleepiness, feeling abnormal |
On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling rig...
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On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling right. There was a pressure in my head, along with sinus and ear pain and a fuzzy feeling in my face. By Monday, Feb, 1, 2021, the pain was worse now with a fatigued feeling after sleeping 20 of the last 24 hours. I went to my Dr on 2/1/2021 and recognized a slide on the left side of my face. From my forehead not wrinkling up the same as right side, left eye wasn't closing as tight and the left cheek and side of mouth were sliding. He said it was Bells Palsy. He prescribed 10 days of prednisone and an antivirus medicine to be taken 3 times a day. That week I slept a lot and wasn't able to sit up much due to the head pain and the lightening bolt feeling in my face. By the 2nd week I was able to sit up more, but still very tired/fatigued. I was off work for 2 weeks, returning to work on 2/14/2021. There is still a slight slide on the left side in the eye and cheek.
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| 50 | 2021-02-21 | feeling abnormal |
Received the 2nd shot on 2/11/2021. I started feeling a little "off" later in the evening. I woke up...
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Received the 2nd shot on 2/11/2021. I started feeling a little "off" later in the evening. I woke up at 0300 with severe joint pain, headache and chills. Nausea started shortly afterwards. The joint pain was excruciating and it was very difficult to move. By 0330, I started vomiting. Vomiting continued until approximately 0745. I felt dehydrated but was not able to hold down any water. I contacted the Nurse Advice line and spoke to a nurse. She asked me a series of questions, all relating to signs indicative of an allergic reaction. I knew I was not experiencing a typical allergic reaction. But I was experiencing a bad reaction. Based on my responses to her questions, she did not recommend that I go an Urgent Care Clinic or see a Doctor. The severe joint pain continued through 02/14/2021. I started to feel better on 02/15/2021. Even though I did not experience an allergic reaction, given the severity of my joint pain and vomiting, I still feel it is important for what I did experience to be documented. Thank you.
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| 50 | 2021-02-21 | excessive sleepiness |
05:00 pm slept 15 hours over night. Slept through 2 alarm clocks. Arrived at work on time but cogn...
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05:00 pm slept 15 hours over night. Slept through 2 alarm clocks. Arrived at work on time but cognition was significantly slower all day. Brain got tired with mild headache after 7 hours on shift and went home early, due to could not mentally function to complete work shift.
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| 50 | 2021-02-23 | confusional state |
Side effects emerged approximately 12 hours after vaccinated. 1) temp that fluctuates from regula...
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Side effects emerged approximately 12 hours after vaccinated. 1) temp that fluctuates from regular to 101F. 20 hrs after vaccination, T100.7F, then persisted up and down for about a week. 2) Musculoskeletal pain to Left side of body: Mainly left upper body. -- 17 hrs after, woke up with severe pain to Lt shoulder and clavicle (thought it was broken somewhere.) The injected site was sore but mild. The Musculoskeletal pain still continues, and the pain comes in various sites, various forms, and in various level. It can be at Left shoulder, scapula, armpit, rib, lumber, hip, knee, and foot. Once in a while, Left ear pain. Mostly Lt shoulder, scapula, armpit, rib lately (today is 0224/2021.) Level changes depends on how it hurts; severe-moderate/shooting and needle pain, moderate/radiating pain, moderate-mild/dull pain, mild/annoying persistent uncomfortable pain. 3) neck and jaw joint stiffness only on left side. Current. 4) Extreme fatigue and brain fog--Extreme fatigue started on the next day and persisted for 3 days, then it became randomly daily. No warning signs given, suddenly feels extremely tired. This fatigue often comes with intermittent confusion. When severe, unable to move while laying. Today is 3rd week from vaccinated and unresolved completely.
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| 50 | 2021-02-24 | feeling abnormal |
I waited the recommended 15 minutes after my vaccine and felt okay. When I got to my car, my face f...
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I waited the recommended 15 minutes after my vaccine and felt okay. When I got to my car, my face felt very hot and was flushed and the right side of my tongue felt thick for a day or more. Yesterday was one week ago from my vaccine and my tongue intermittently still feels thick. My tongue feels like it does when novocaine starts to wears off from the dentist. My right arm also felt sore and puffy; however, there was no skin reaction. The next day or so the right side of my neck was sore. As to be expected, my arm was also sore.
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| 50 | 2021-02-25 | anxiety |
subjective 50 yo female presenting for 2nd covid vaccine with h/o anxiety a/w tingling in left hand ...
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subjective 50 yo female presenting for 2nd covid vaccine with h/o anxiety a/w tingling in left hand 15 min after first covid vaccination which resolved during a 30 min observations period . Again, approximately 15min after the 2nd covid vaccination c/o tingling without weakness in the palm of left hand a/w anxiousness Pt denies swelling in hand, no rash, no flushing, no swelling sensation in face or neck, no globus no sob no wheezing no chest pain no palpitation no gi sx no headache no altered mentation or brain fog Objective Pulse 63 bp=154/103 rr 12 temp afeb Heent wnl Neck wnl Chest clr p&a Cor rrr Neuro grossly intact Skin clr Assessment/plan Anxiety with psychosomatic features and elevated bp due to hyperadnergic state from anxiety. Pt reassured being observed by physician and pt reclined in a quiet room. Repeat vital signs were p 64 bp 150/89 and p 62 bp 120/85 repectively d . pt discharged home with resolution of left hand paresthesia and normalized vital signs
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| 50 | 2021-02-26 | impaired work ability |
Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle a...
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Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle and concussion. Transported to nearest hospital, I had to have emergency surgery on left ankle, by Dr. A plate and screws were placed in my ankle to stabilize the break. I am being treated and monitored by my general doctor for the concussion. I am currently non-weight bearing on my ankle, for a minimum of 2-4 weeks. I am unable to work due to the ankle break and concussion, for an undetermined amount of time. I am scheduled to meet with Dr. on the 4th of March, at which time he stated he will want to begin physical therapy, once the break has reached an adequate stage of healing. I will be re-evaluated by my general Dr. for the concussion in 2 weeks.
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| 50 | 2021-02-28 | anxiety |
her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high bloo...
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her legs kind of felt like they do when her legs go to sleep; anxiety; heart palpitations; high blood pressure; possible allergic reation; a cool, tingling sensation in her legs; a cool, tingling sensation in her legs; Heart rate increased; she numbness in her top lip; she had a tingling at the top of her head; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 and expiration date May2021, right arm on 25Jan2021 Administered between 16:00-16:15 PM as single dose (at the age of 50 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Retinitis pigmentosa from 2016, and breast cancer in Dec2015, she is in remission. Went through chemotherapy and reconstructive therapy. She has a family history of breast cancer. Additionally, patient has history of panic attack, supplementation therapy and eye disorder vitamin (she saw her eye doctor in Dec2020, and he recommended she start taking the eye vitamin. She said she started the eye vitamin in the end of Dec2020). The patient has historical vaccine information including flu vaccine Sep2020. Concomitant medication includes lysine;zinc (LYSINE;ZINC) as supplementation therapy from Dec2020 and ongoing, xantofyl, zeaxanthin, (LUTEIN-ZEAXANTHIN), as eye vitamin Dec2020, ascorbic acid (VIT C), acetylsalicylic acid (baby aspirin) and probiotics (PROBIOTICS). The patient experienced a cool, tingling sensation in her legs on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), heart rate increased on 25Jan2021 with outcome of recovered on 25Jan2021 (She said she thought maybe her rapid heart rate was from her nerves because she was getting her first COVID-19 Vaccine dose), she numbness in her top lip on 25Jan2021 with outcome of recovered on 25Jan2021 (treatment received), she had a tingling at the top of her head on 25Jan2021 with outcome of recovered, her legs kind of felt like they do when her legs go to sleep on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, heart palpitations on an unspecified date with outcome of unknown, high blood pressure on an unspecified date with outcome of recovered. She said the nurse suggested she talk to a medic located in the back are of where the COVID-19 Vaccines were being administered. She said she talked to medic. She said at that point it was probably about 25 minutes after she received the COVID-19 Vaccine. She said she never had allergies, and had no problem with the flu vaccine. She said she has had issues with anesthesia in the past, and if she is given the wrong type of anesthesia, she can get nauseous. She said the medic took her heart rate, and her heart rate was 154-ish. She said her heart rate was high, but sometimes for her, that is the case. She said the medic asked her how her breathing was. She said her breathing was OK, and could swallow fine. She said when the medic rechecked her heart rate, her heart rate was still the same. The medic said she has two things he can do: she can go to get Benadryl, or she can get checked out by a doctor. She said she wanted to see a doctor. She said she was brought to an Urgent Care to see a doctor. She said her heart rate was still elevated. She said the urgent care staff did a finger prick test (clarified as a blood sugar finger stick test), and she was told the finger prick test was fine. She said the doctor did an EKG, and her EKG was fine. She said the Urgent Care doctor eventually gave her Benadryl. She said after she took the Benadryl, her top lip was not numb, and her legs were fine. She said that was about 3 hours after receiving the COVID-19 Vaccine. She said the doctor felt she had a panic attack. She said she has had one panic attack in the past, and knows what a panic attack feels like. She said she maybe had some anxiety. She said her symptoms didn't seem like a panic attack because she wasn't having difficulty breathing and she wasn't short of breath, but she was somewhat nervous. She said she was not sure what to do, so she contacted her family doctor to see what she should do when she goes for her second COVID-19 Vaccine dose. She said the Urgent Care doctor gave her a prescription for Hydroxyzine Pamoate 25mg capsule, 1 capsule three times daily, as needed, for anxiety. She said her doctor told her the Hydroxyzine Pamoate is used for allergic reactions, as well. She clarified when she was at the urgent care her heart rate went down, and the nurse at the urgent care gave her 2 Benadryl pink capsules. Reported she took Benadryl when she got home because she was afraid she was having an allergic reaction to the COVID-19 Vaccine. Outcome of possible allergic reaction was unknown. She said she had a great night sleep, and the next morning took her first dose of the Hydroxyzine Pamoate 25mg. She said her primary care doctor suggested she take the Hydroxyzine Pamoate 25mg an hour before she gets the second COVID-19 Vaccine dose. The patient underwent lab tests and procedures which included blood sugar finger stick test: 117 on 25Jan2021, electrocardiogram: normal on 25Jan2021 said the doctor did an EKG, and her EKG was fine, heart rate: 154-ish on said her heart rate was high. She said her heart rate was still elevated. Therapeutic measures were taken as a result of a cool, tingling sensation in her legs, she numbness in her top lip, she had a tingling at the top of her head.
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| 50 | 2021-03-01 | insomnia |
dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purp...
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dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purple on the center of it; My legs were hurting like really heavy; I have not gone back to sleep and I feel like a bus hit me.; chills; the body ache; legs hurt really bad; fever; symptoms associated with the flu for a few days; feeling like really bad headache; nauseated; not feel so good; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: unknown), via an unspecified route of administration from 28Jan2021 to 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included verapamil for blood pressure. The patient received her first dose of BNT162B2 on 08Jan2021 and experienced arms a little sore. On 28Jan2021 at 18:00, the patient started feeling like really bad headache and then really nauseated. The patient took medicine and took Tylenol before went in to take her shot and started getting a headache again and not feel so good. On 29Jan2021 at 02:00, the patient stated that her legs were hurting like really heavy and had not been back to sleep since 2 o clock in the morning and she felt like a bus hit her. On 29Jan2021 at 11:00, the patient stated that her finger on the left side was numb and it has a little bit of purple on the center of it. On 29Jan2021, the patient experienced chills, body ache, her legs hurt really bad, fever, symptoms associated with the flu for a few days. On 30Jan2021, the patient experienced arm swollen. On 01Feb2021, the patient experienced dizziness and migraine. The patient already took Tylenol and ibuprofen. The outcome of the event chills, fever, flu symptoms, arm swollen was recovered on an unspecified date and the outcome of the other events was unknown.
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| 50 | 2021-03-02 | anxiety |
Patient was feeling anxious prior to vaccination. As soon as she received her shot she developed mil...
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Patient was feeling anxious prior to vaccination. As soon as she received her shot she developed mild chest pressure and palpitations. She was brought to the medical tent for evaluation. Her initial blood pressure and heart rate were both mildly elevated (BP 164/97, HR 101). She had an EKG which showed normal sinus rhythm with no ischemic changes. After 10 minutes of observation her symptoms had resolved and her vitals were improved (BP 137/98, HR 86). She was advised that typical chest pain evaluation includes blood tests that can only be done in ER to definitively rule out ACS, and offered transport to ER, but she felt better and declined, stated she would go to ER if symptoms return.
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| 50 | 2021-03-02 | impaired work ability |
Woke up the next morning (1/9/21) with severe vertigo. Was unable to walk without assistance. Got wo...
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Woke up the next morning (1/9/21) with severe vertigo. Was unable to walk without assistance. Got worse by the afternoon, unable to tolerate lying down, vomiting. Went to urgent care. Prescibed meclizine and zofran. Meclizine did not really help but able to lay down. By next morning was 70% better, able to walk on my own, slowly. The following Monday (1/11/21) saw ENT, unsure of cause, ears clear of infection. Sent me for hearing test which was done on 1/14/21, normal hearing. Had video visit with Dr. on 1/15/21. suggested exercise for benign positional vertigo. Follow up with ENT on 1/29/21. Symptoms much beter, able to go back to work, room spinning happens ocasionally when lying down.
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| 50 | 2021-03-02 | impaired work ability |
Woke up the next morning (1/9/21) with severe vertigo. Was unable to walk without assistance. Got wo...
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Woke up the next morning (1/9/21) with severe vertigo. Was unable to walk without assistance. Got worse by the afternoon, unable to tolerate lying down, vomiting. Went to urgent care. Prescibed meclizine and zofran. Meclizine did not really help but able to lay down. By next morning was 70% better, able to walk on my own, slowly. The following Monday (1/11/21) saw ENT, unsure of cause, ears clear of infection. Sent me for hearing test which was done on 1/14/21, normal hearing. Had video visit with doctor on 1/15/21. suggested exercise for benign positional vertigo. Follow up with ENT on 1/29/21. Symptoms much beter, able to go back to work, room spinning happens ocasionally when lying down.
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| 50 | 2021-03-02 | sleep disorder |
"The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since ...
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"The shot itself was very unpleasant, the vaccine stung. The nurse was concerned about this since it shouldn?t cause any discomfort at all. Other than immediate onset of a painful injection site no other symptoms occurred until later in the evening. I started feeling kind of yucky before I left work but nothing specific. By the early evening I was running a low grade fever and having muscle and joint pain. I didn?t sleep very well due to body aches and severe organ pain. At one point I woke up because my heart was beating so hard and fast I could feel it in my forehead. My lips and eyes were swollen and my neck was visibly swollen as well, I think due to the lymph nodes in my neck. My throat was some swollen but not enough to cause a breathing issue. The heartbeat issue didn?t last terribly long. I took a Benadryl to try and stop the reaction. I ran fever of a 102 give or take a few degrees either way for 2 ½ days. In addition, the injection site and whole shoulder area was swollen and hot with redness that wrapped around the front of my arm."
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| 50 | 2021-03-03 | confusional state | funny taste in mouth, felt buzzed, headache, confused, tunnel vision, pale, fainted, rash on torso |
| 50 | 2021-03-03 | feeling abnormal |
I experienced a stomach ache first, then feeling of nasuea, dizziness, severe sweating for approxima...
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I experienced a stomach ache first, then feeling of nasuea, dizziness, severe sweating for approximately 15 minutes on Feb 27th. The sx then went away except for the stomach aches for a few hours afterwards. Yesterday and today I have experienced feelings of lethargy, fogginess, stomach ache, sore throat, stomach ache and nasal congestion which have faded in an out throughout the day.
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| 50 | 2021-03-04 | anxiety |
Patient received shot and after 15 minutes started to have Headache and felt like throat itching/swe...
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Patient received shot and after 15 minutes started to have Headache and felt like throat itching/swelling. EMS came and took vital signs and assessed and determined no treatment was needed. Patient states just anxiety and improved with no intervention. No medical treatment given.
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| 50 | 2021-03-05 | disturbance in attention |
Left shoulder is noticeable swollen and has noticeable pain. I have never had this kind of reaction ...
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Left shoulder is noticeable swollen and has noticeable pain. I have never had this kind of reaction when receiving flu shots. Fatigue, difficulty concentrating.
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| 50 | 2021-03-08 | insomnia |
Minimal issues after 1st vaccine. After 2nd vaccine, about 8 hours later my arm hurt so bad I could ...
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Minimal issues after 1st vaccine. After 2nd vaccine, about 8 hours later my arm hurt so bad I could not sleep (2:30am) and taking Tylenol only cut the pain 50%. As time progressed that day about 12hours after injection I started to get the chills, achiness even after Tylenol which didn't do much. By 16 hours after injection I got hot/damp, shaky, nausea but once able to cool down nausea resolved. By 18 hours thru 28 hours I had difficulty walking due to achiness and extreme fatigue. Chills going on most of the time throughout and some looser stools. The next day 40h post injection I felt better-no chills. At 48h I was tired- no achiness, some looser stools. Day 3- I had some blood blowing my nose, resolved by day 4.
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| 50 | 2021-03-09 | feeling abnormal |
was fine at first then a little after 2 hours I started all of a sudden to get very light headed an...
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was fine at first then a little after 2 hours I started all of a sudden to get very light headed and dizzy....face felt very funny....swollen face and nausea along with slight fever and headache.
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| 50 | 2021-03-09 | incoherent |
Five minutes after received Pfizer Covid-19 vaccine at 5:51 p.m., patient was sweaty and unable to v...
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Five minutes after received Pfizer Covid-19 vaccine at 5:51 p.m., patient was sweaty and unable to verbalize thoughts. Blood pressure was 95/ 58, heart rate was 51. One dose of Epipen 0.3 mg was adminstered at 5:56 pm, EMS was called, patient was placed on the floor with feet elevated, blood pressure was checked at 6:00 p.m and was at 116 /79 and heart rate was 66. At this time patient became responsive and EMS arrived to check patient out. Patient declined to go with EMS. We monitored patient at the store for 30 minutes at which time she left with husband who was instructed to dial 911 if symptoms returned.
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| 50 | 2021-03-11 | anxiety |
Chest tightness and flashing with anxiety feeling immediately after the shot. Vital signs were stab...
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Chest tightness and flashing with anxiety feeling immediately after the shot. Vital signs were stable HR 86, Sat 98% RA, BP 107/75. Physical exam were unremarkable and she did not look in any acute distress she just felt anxious. Lungs clear to auscultation bilaterally. She was observed in the car for 30 minutes and was discharged home in stable condition. Denies any symptoms before discharge.
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| 50 | 2021-03-11 | feeling abnormal |
Fever, chills, body aches, joint pain, headache, extreme fatigue, brain fog, flare up of MS symptoms...
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Fever, chills, body aches, joint pain, headache, extreme fatigue, brain fog, flare up of MS symptoms, skin hurt to the touch.
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| 50 | 2021-03-13 | depressed mood, feeling abnormal |
Transcription of a text I sent to my colleagues: Hi all--I'm not sure who has received the second v...
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Transcription of a text I sent to my colleagues: Hi all--I'm not sure who has received the second vaccine, but I wanted to update as to my experience. I got sick with the first one from about 4ish hours after until the next mid morning maybe? Then I felt bad again that second night. I had my vaccine (second) yesterday at 4 PM, and I felt OK going to bed but had a pretty pitiful night. I woke up at 5 AM and I felt horrible. That felt like someone took a pair of metal cymbals and slammed them together on my head. The tinnitus was strong. I also had body aches and joint pain and felt like I had the flu. I felt a little better around 1 PM, but felt bad again around 330. Now I'm miserable again with terrible body aches and chills (this was at 7:38 PM). I'm sure I will feel better in the morning, just wanted to share my experience." Sadly, since then, I have had tinnitus with a metallic ringing in both ears along with hearing loss. I had some vertigo one day but unsure if this was related. The tinnitus makes me very sad. I am a hospitalist and am happy to have been vaccinated, still. It has been 2 months today, and it remains, unrelenting. It is worse in the morning and at night. The hearing loss is difficult.
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| 50 | 2021-03-15 | anxiety |
15 minutes after the injection I noticed that my heart was beating fast and I felt anxious. When I...
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15 minutes after the injection I noticed that my heart was beating fast and I felt anxious. When I got up an started walking I felt slightly unbalanced. 15minutes later I felt like my lips were swelling and my throat felt tight. On route to the emergency room my lips , tongue and mouth felt numb and tingling. I arrived at ER at 0930 and was given IV Benadryl and prednisone by mouth by ER Dr.
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| 50 | 2021-03-15 | insomnia |
101 fever for 2 days now down to 99 fever very bad muscular pain for 2 days and still happening inte...
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101 fever for 2 days now down to 99 fever very bad muscular pain for 2 days and still happening intense headache unable to sit due to back pain could not sleep due to pain left underarm is VERY swollen
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| 50 | 2021-03-17 | feeling abnormal |
I got the vaccine last Thursday, March 4, 2021 and I am experiencing strange side effects. I wanted ...
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I got the vaccine last Thursday, March 4, 2021 and I am experiencing strange side effects. I wanted to be sure to send this along to you as well as, to the adverse effect website. It?s almost as if I?ve had a stroke. Initially (after the shot), I was a little lightheaded but as the rest of the day wore on, (say around 6 hours later), I started to get foggy in my brain - like I had to remember to even breathe - and tightness in my chest like asthma. There was a high pitch scream in my ears and I was more or less, kind of out of it. My hands and feet were sweating profusely. My tongue kind of reacted, too and got a little burned, like when I eat pineapple. It was then that I noticed difficulty swallowing. My sister (a medical professional) suggested Benadryl for the mouth and tongue sensation and she kept an eye on me the rest of the night. She also warned that I should not get a second shot (I totally agree). Being a trooper, I thought all of the weird stuff would blow over in a day or two, so I decided to power on and not report my issues. Today is day 6 post vaccine and I can now see a pattern to the symptoms or episodes which are still present, on and off: 1. The ringing in my ears will intensify, and then I stare off into space, my words get garbled (I have to really concentrate on being present), my tongue gets very dry and then the swallowing issue returns (it?s like slow motion swallowing, so I bite my tongue to stay in the moment). 2. The tightness in my chest intensifies and my breathing gets shallow. I must focus and breath through it despite discomfort. Note, since the shot, I keep a Benydryl and my inhaler with me, although I haven?t used Benadryl since day 3. I used my inhaler yesterday, day 5 because of discomfort and that seemed to help, but using it triggered an ear ringing/screaming episode that came and went the rest of the day. 3. I also have nasal constriction throughout the day. The nasal passage just inflames and then relaxes. I also have phantom smells and my sense of taste got a little off on day 1, but recovered. ________________ March 18, 2021 Update Saturday, 3/13 went to the ER because the cognitive issues had advanced. I found myself staring off into space, losing my train of thought, and unable to speak. When I did speak I stammered or stuttered. They wanted to make sure I did not have a stroke or that I was not in the middle of one, so they did some tests. They also recommended that I go ahead and take the prednisone. After my ER visit the cognitive issues continued, but began to be not-so-frequent by Sunday afternoon. I felt like I was on the road to recovery and so delayed again, taking the prednisone. On Tuesday (3/16), I had what I would call an asthma attack. I was having very strong bronchial spasms that would not abate. I used my rescue inhaler to try to mitigate the symptoms, but that did not work. At the same time, the cognitive issues sort of returned and the big loud ringing and whooshing in my ears was really really noticeable. I am having a protracted allergic reaction to the vaccine. I am not normally allergic to things, but I have noticed new allergies since this all began. Certain food items seem to bother me now and push me into the lung seizing, raw tongue, neurological, ear ringing event.
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| 50 | 2021-03-18 | anxiety |
Fifteen mins after Pfizer dose #1, Pt. noted tingling of tongue. ARNP noted slight swelling of righ...
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Fifteen mins after Pfizer dose #1, Pt. noted tingling of tongue. ARNP noted slight swelling of right lower lip. Pt. received Benadryl 50 mg IM. Tingling resolved after 15 minutes. Pt. felt fully recovered at that time, and later did not have any systemic side effects from the Covid vaccine. She admits to feeling anxious with injections and venipuncture.
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| 50 | 2021-03-19 | disorientation, loss of personal independence in daily activities |
Doctor and EMT on site and provided care. Vasovegal syncope. Symptoms presented within 5 minutes of...
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Doctor and EMT on site and provided care. Vasovegal syncope. Symptoms presented within 5 minutes of vaccine given. Tingling started in Left arm tingling own to fingers and traveled to right arm and down through both legs. Rapid heart rate and disorientation prior to fainting. Sternum rub given to revive. Patient vomited. Able to drive home after 30-45 minutes. Continues to feel week and dizzy. Currently 24 hours after incident. Pain in arm preventing me from normal daily activities.
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| 50 | 2021-03-19 | hallucination, delirium |
Slight headache beginning evening of vaccination. Progressed to fever <100.2, body aches, extreme t...
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Slight headache beginning evening of vaccination. Progressed to fever <100.2, body aches, extreme trembling, chills and twitching, blistering of the skin on the forearm of the same injection arm, delirium and hallucinations, wet cough with blood in sputum. Patient called pharmacy on Saturday 3/20/21 03:45pm to advise of reaction, RPh advised patient to go to a physician ASAP for evaluation of symptoms.
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| 50 | 2021-03-19 | impaired work ability |
Pfizer vaccine. Flu like symptoms, sinus pressure, body ache, sore throat, fever and a headache. ...
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Pfizer vaccine. Flu like symptoms, sinus pressure, body ache, sore throat, fever and a headache. This lasted 3 days.
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| 50 | 2021-03-21 | anxiety |
anxiety before receiving vaccine, received vaccine, felt sick to her stomach, lightheaded, passed ou...
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anxiety before receiving vaccine, received vaccine, felt sick to her stomach, lightheaded, passed out and vomited while unconscious and very diaphoretic
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| 50 | 2021-03-21 | delirium |
Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and need...
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Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and needles sensation all over my body; Hearing noises in my ears like a throbbing when I stand up; Barely walk to the bathroom; Chills; Everything sore; Sore throat; Began violently shaking around midnight; Fever was 103/Ran fever of 100.5-103 until this morning/Fever is below 100 today; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation at a Public Health Clinic/Administration facility. Medical history included Hashimotos. The patient has no Covid prior to vaccination and not tested for Covid post vaccination. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), lisdexamfetamine mesilate (VYVANSE), venlafaxine, cyanocobalamin (B12 [CYANOCOBALAMIN]), and ergocalciferol (VIT D). The patient had no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9269) on 09Feb2021 17:30 in the left arm for Covid-19 immunization. On 03Mar2021, sore throat began around 17:30 and chills began at 21:30. Patient took Tylenol and went to sleep. Violently shaking began around midnight (Mar2021); the patient was unable to get warm, yet fever was 103 (Mar2021). It was reported that everything sore on 03Mar2021 17:50. The patient ran fever of 100.5-103 until this morning (04Mar2021). Temp now fluctuates from 95-100. Mostly all "ept" until this morning (06Mar2021) waking to drink water and take Tylenol every 4 hours. The patient was still sweating profusely and was feeling delirious and dizzy (06Mar2021). Left arm is numb and has a pins and needles sensation all over her body on 06Mar2021. It was very uncomfortable. The patient was also hearing noises in her ears like a throbbing when she stands up. Fever is below 100 today (unspecified date), after taking a shower this morning, it was 95. The patient can barely walk to the bathroom on 06Mar2021 and she hasn't left her room since this started Wednesday night. Her husband called her doctor and she say this should pass by 9:30 tonight. There were times she prayed to die; she hurts so bad. Fortunately, the pain is not this bad now. But she was suffering greatly from the 2nd shot. The events sore throat and chills were treated, while the other events were not. The outcome of the events was not recovered.
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| 50 | 2021-03-21 | feeling abnormal |
Patient had her vaccine at 1:45pm. By 2:12 patient noted lightheadedness and brain fog and fatigue. ...
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Patient had her vaccine at 1:45pm. By 2:12 patient noted lightheadedness and brain fog and fatigue. Patient requested to go to the bathroom. She was taken by a staff member. Patient reports hx of epilepsy, hx of covid with hospitalization, and kidney disease. 2:22 her bp was 104/63. Her HR was 80 and RR 20 and oxygen 95%. Still reported feeling lightheaded and sensation of head floating similiar to when she had seizures. We gave the patient orange juice and crackers. 2:32 bp was 110/72 with HR of 82 oxygen 99%. States feeling better but still slightly foggy in the head. 2:42 bp 118/76 hr 78 and oxygen 98% feels better and is more talkative. She asked to rest with her eyes closed for a few more minutes.
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| 50 | 2021-03-21 | sleep disorder |
My arm has been aching since the 1st one. I let the RN giving me the 2nd shot aware and he said that...
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My arm has been aching since the 1st one. I let the RN giving me the 2nd shot aware and he said that?s weird. I just happened to have the same person injecting both times. Never reported or had me speak with anyone at that time. He said I could get it in the left, but I denied due to I didn?t want the pain in both arms. When he gave me the 2nd shot I felt it so much more than the first shot that I blurted out that hurts and a felt a twinge in my arm, as if it hit something other than the muscle. My arm 2 mos later is not let up the pain. I can only raise it so high. I cannot sleep on either side w/o pain. Same days are worse than others. The pain is right at the injection site. This is the only thing I have had done to my arm so I know it has something to do with the vaccine. I alternate ice and heat along with ibuprofen and it does not touch the pain/aches. It is a constant ache in my arm. I did contact my employee health at work and she advised me to fill out report on this website and in the Hospital safety report.
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| 50 | 2021-03-22 | impaired work ability, loss of personal independence in daily activities |
On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morn...
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On the 16th, I had the right ear and head pain. That lasted Sat, Sun and Mon. I woke up Tuesday morning (18th), I had a small Shingles lesion along with those symptoms. . I went to the doctor's office and saw the NP, who diagnosed me with an ear infection--right Otis externa. On Wed (19th) my right eye was swollen and my scalp, right forehead and eye were covered in shingles. On the 20th, I was diagnosed with having Ocular Shingles. I was put on steroids and sent to an emergent appointment with ophthalmologist because they were concerned that I would lose my sight. He put me on Acyclovir 800mg, 5 times a day and increased my steroids to: 40mg a day for 2 days, 30mg for 3 days and 20mg for 3 days and 10mg for 4 days. Fortunately the branch that goes into my cornea was not affected. I was in bed the entire time. I still had lesions when I went back to see him, which is why he kept me off work until Feb 1st. I continued to have neuralgia (nerve pain) and then I started itching. I went back to quick care and put on Atarax. I took that every 4 hours for about a week. Then I tapered it down to about twice a day. It eventually got better, but I do itch sometimes. Looking back, I did have a little right ear pain after the 1st dose of the vaccine.
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| 50 | 2021-03-22 | nervousness |
Client c/o feeling shaky and denies any other symptoms. Client seen by EMT and all vitals are withi...
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Client c/o feeling shaky and denies any other symptoms. Client seen by EMT and all vitals are within normal limits. Client then verbalized that she had been nervous about receiving vaccine. Client cleared by EMT to go home.
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| 50 | 2021-03-23 | feeling abnormal |
Vaccine given IM about 9:30am to right deltoid muscle. Patient monitored for 15 minutes, felt okay ...
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Vaccine given IM about 9:30am to right deltoid muscle. Patient monitored for 15 minutes, felt okay and left monitoring area. Patient returned after about 20 minutes from vaccine (a little after 9:50am) complaining of itching of throat, shortness of breathe, and feeling very hot and "off" Due to SOB and itching in throat administered 1 dose of Epinephrine autoinjector 0.3mg shortly upon her return, called EMS. EMS arrived and evaluated patient, patient refused transport to hospital since she was feeling better except for jitters/shaking from epinephrine. We monitored patient for additional 20-30 minutes. Patient walked around store, felt fine and drove home. Called patient, verified still feeling mostly better with some slight itchy throat. Patient will continue to monitor.
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| 50 | 2021-03-23 | panic reaction |
3-23-21 3:47PM PT STATES SHE 'FEELS PANICKY'. A/O, PINK, W/D, RESP REG WITH EASE. NO ACUTE DISTRESS ...
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3-23-21 3:47PM PT STATES SHE 'FEELS PANICKY'. A/O, PINK, W/D, RESP REG WITH EASE. NO ACUTE DISTRESS NOTED. NO SOB/DYSPNEA, NO PAIN, NO DIFFICULTY SWALLOWING. COMFORT AND REASSURANCE GIVEN. 3:52PM STATES 'FEELS BETTER NOW'. AMBULATORY TO EXIT WITH HUSBAND; GAIT BRISK AND STEADY. NO ACUTE DISTRESS NOTED. 3-24-21 9AM TC: HUSBAND STATES PT 'FEELS BETTER.'
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| 50 | 2021-03-24 | sleep disorder, loss of personal independence in daily activities |
Chills, fever, dizziness, weakness, jittery, can?t sleep, fatigue, swollen, thirsty. Received shot ...
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Chills, fever, dizziness, weakness, jittery, can?t sleep, fatigue, swollen, thirsty. Received shot at 8:48am, symptoms began at 12:30pm while on a bike ride. I finished the ride but was too weak to do anything the rest of the day. That night I couldn?t stop shaking and lay in bed wide awake until about 2am. I felt dizzy like I was spinning when I closed my eyes. I slept off and on until 6:30am. Today I?m feeling slightly better but still can?t sleep. I am drinking an excessive amount of water and herbal tea.
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| 50 | 2021-03-24 | sleep disorder |
Starting either the night of the vaccine or the next I had a horrible time sleeping. Up and down, ba...
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Starting either the night of the vaccine or the next I had a horrible time sleeping. Up and down, back and forth. Then I developed terrible pain in my neck all over. I tried OTC meds that did not alleviate the pain in addition to heating pad, stretching, neck constriction with neck brace. This lasted about a week with the pain mostly in the two front muscles in the neck. I had a day or two of respite but the pain came back as what feels like muscle spasms in my upper left and right shoulder/neck area. Difficulty turning head. Headache.
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| 50 | 2021-03-25 | anxiety |
Patient received her 1st Pfizer vaccine on 3/21/21 around 2:30. She states she started to feel numbn...
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Patient received her 1st Pfizer vaccine on 3/21/21 around 2:30. She states she started to feel numbness over her face and some slight difficulty swallowing within minutes after receiving her vaccine. She sat in the observation area for 15 minutes but never reported her symptoms to the staff. She also states that she started to feel anxious as well and wasn't sure if it contributed to her symptoms. She said she felt like she just needed to get some fresh air. When she got home she took Zyrtec 10mg and had relief of her throat symptoms and some improvement of the numbness over her face. She did not have complete numbness until 3/25/21. She notified her physician of this event and he advised her to return to the clinic and report it.
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| 50 | 2021-03-25 | anxiety |
Patient received the Pfizer COVID vaccine (lot ER8732, exp 7/2021) at 0935. At 0946, she told EMT th...
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Patient received the Pfizer COVID vaccine (lot ER8732, exp 7/2021) at 0935. At 0946, she told EMT that she felt dizzy. PHN and EMT assessed patient who reported feeling dizzy, sweaty, and anxious due to the peer pressure of getting the vaccine when she was not interested. At 0946 vital signs: blood pressure 122/84, pulse 101, O2 99%, respirations 18. Allergies include penicillin and seasonal allergies. Medical conditions include asthma. Medications include albuterol inhaler. Patient stated she did not eat breakfast. PHN offered patient Benadryl, patient declined reporting that she had driven herself and would take some when she returned home. At 1000 vital signs: blood pressure 120/78, pulse 97, O2 99%, respirations 18. Patient stated symptoms of dizziness and feeling sweaty were improving. Patient noted less anxiety. At 1010 patient decided she would leave, PHN encouraged patient to notify provider and symptoms when to call 911. At 1011 patient walked out with steady gait.
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| 50 | 2021-03-25 | confusional state |
Confusion, dizziness, loss of coordination, excruciating body pain, nauseous,diarrhea, headache, vo...
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Confusion, dizziness, loss of coordination, excruciating body pain, nauseous,diarrhea, headache, vomiting Within 48 hours of both vaccines menstrual cycle began with severe cramping , heavy bleeding and 2 weeks early
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| 50 | 2021-03-25 | insomnia |
I began with some throat closing and pain in arm. It progressed to body aches, feeling winded and fa...
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I began with some throat closing and pain in arm. It progressed to body aches, feeling winded and fatigue, weak, sneezing, congestion, dripping nose, hot flashes and joint pain. I went to bed and had insomnia the whole night. Had rapid heartbeat and trouble breathing. I called doc next day and they recommended o go to hospital.
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| 50 | 2021-03-25 | sensation of foreign body |
Patient received COVID vaccine at 1048 a.m. Initially reported "throat numbness to medical assistant...
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Patient received COVID vaccine at 1048 a.m. Initially reported "throat numbness to medical assistant after 15 minutes of observation. At 1126 patient reports "hot flashes and knot to throat. Epinephrine 0.3 mg administered to left thigh. EMS called and patient transferred to hospital ER per patient request.
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| 50 | 2021-03-26 | memory impairment |
Diarrhea, vomiting, chills, shivering, headache, dizziness aches, foggy memory, strange taste in mou...
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Diarrhea, vomiting, chills, shivering, headache, dizziness aches, foggy memory, strange taste in mouth
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| 50 | 2021-03-27 | anxiety |
SOB, anxiety, pain in neck that radiated to head, intermittent numbness in lips; vomited at 0925. BP...
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SOB, anxiety, pain in neck that radiated to head, intermittent numbness in lips; vomited at 0925. BP 130/84, HR 64; breath sounds clear. Medics on site at 0932. Signed out AMA.
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| 50 | 2021-03-28 | sleep disorder |
Pain in area surrounding right knee started in afternoon of 03/24/21 and it caused me to limp. By t...
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Pain in area surrounding right knee started in afternoon of 03/24/21 and it caused me to limp. By that evening, the pain increased so that it was excruciating and I could not walk or put any pressure on it; even using crutches was difficult. Area around knee also was swollen. It was very painful to extend and bend my knee; very difficult for me to walk and go up & down stairs. I did not fall or slam my knee/leg recently nor did I take any different medications; the only thing different I had done was get the Pfizer vaccine the day before. Pain continued through the night; I was able to sleep but woke up several times. The next morning pain had subsided a little to where I could walk slowly with a limp.
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| 50 | 2021-03-29 | disorientation |
Headache, chest pain as pins and needles, shortness of breath, swollen throat, tounge, limpthotic no...
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Headache, chest pain as pins and needles, shortness of breath, swollen throat, tounge, limpthotic nodes, difficulty to breath and to swallow, weakness, disoriented, pain in body, difficulty to urinate, dizziness, blurry vision, nausea, tachardia, pulse rate increase, blood pressure increase, fatigue, body and muscle pain.
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| 50 | 2021-03-29 | hallucination |
It started with chills then my body got completely stiff and sore I had to get help to the bed when ...
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It started with chills then my body got completely stiff and sore I had to get help to the bed when I got in the bed I was there for four days during that. I had extreme body pain from the feet to the top of the head my eyes hurt I started sweating about three days in to the point where I mean my mattress was soaking wet my sweat smelled horrible I started having Hallucinations about two times seeing things that were not there my vision was very very cloudy and blurry I can hardly speak I have cramps in my feet on the fifth day I woke up yeah my body didn?t hurts I was no longer sweating but I had a headache. I also did not eat anything and could not eat anything for all those days it wasn?t until six days later that I was able to move around And feel somewhat back to normal my vision is still cloudy
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| 50 | 2021-03-29 | sleep disorder, insomnia |
Pt reported to the health unit today that she received the vaccine on 3/25/2021 at 12 PM. She repor...
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Pt reported to the health unit today that she received the vaccine on 3/25/2021 at 12 PM. She reports that ~5 minutes later her palms became diaphoretic and she started to feel "on edge." She waited for 30 minutes before checking out with the nurse. She reports that since the vaccination she has constantly been on the verge of a panic attack and is having difficulty sleeping because she is being "jolted" awake. However, she admits she has not actually had a panic attack since vaccination, but she believes the vaccination is responsible for her current symptoms since they have not completely resolved. Pt does report an intermittent history of panic attacks dating back to 1997. She reports her panic attacks started after she started taking mefloquine. She has had panic attacks as recently as 2017, 2018 and 2020, usually secondary to external stressors.
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| 50 | 2021-03-30 | anxiety |
1726-Vaccinated 1734-C/o dizziness, flushing, lightheadedness, sweating, palpitation, anxious/jitte...
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1726-Vaccinated 1734-C/o dizziness, flushing, lightheadedness, sweating, palpitation, anxious/jittery, sleepy, tingling-tongue. 1820 c/o chest tightening. Patient refused Epi. Benadryl 50 mg/IM given, Patient was transferred to ER.
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| 50 | 2021-03-30 | feeling abnormal | Brain fog, rapid heart beat, dull headache |
| 50 | 2021-03-30 | feeling abnormal | Vomiting, nausea, fever, chills, severe headache, muscle/joint pain, dizzy, confusion, brain fog, |
| 50 | 2021-03-30 | insomnia |
I did not follow-up with the doctor as I slept for two days with difficulty. Severe allergic reacti...
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I did not follow-up with the doctor as I slept for two days with difficulty. Severe allergic reaction. My right side lymph node became severely swollen disrupting my ability to breath and very itchy. This lymph node on the front side of the neck was protruding making it difficult to swallow. Used breathing inhalers. Immediately leaving the vaccination site my temperature went high and I had to take off my shirt while I began to sweat profusely. When I arrive home I checked my temperature it would fluctuate between 98.6 and 101. My vision became extremely blurred for two days. I could barely see so I had to lay down and close my eyes and rest as I thought I was losing my vision. These symptoms were adverse while standing. General feeling of be unwell.
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| 50 | 2021-03-30 | loss of personal independence in daily activities | Severe pain on left side of torso and neck. Inability to turn neck to the left or lift left arm. |
| 50 | 2021-03-30 | nervousness |
Received vaccine at 3 pm. Feeling fine until 1520, noted some chest tightness and shortness of breat...
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Received vaccine at 3 pm. Feeling fine until 1520, noted some chest tightness and shortness of breath. Denied trouble swallowing; sipping apple juice. Notes of late being tested for low blood sugar issues; no diabetes. HR 105, BP 118/74, p ox 98%. Additionally feeling hot. Transferred to wheelchair; feels weak, shaky. With chest tightness, called Rapid Response; patient agreeable to ED evaluation. Notes having to breathe a bit more deeply to help breathe. Transported to ED by Rapid Response team.
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| 50 | 2021-03-30 | sleep disorder |
Almost passed out driving on the way to work the next morning. Started sweating profusely, terrible...
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Almost passed out driving on the way to work the next morning. Started sweating profusely, terrible body aches, headache, and then nausea for 1/2 hour. I hurt so bad I couldn?t go to sleep. Ended up taking Tylenol PM and sleeping for a couple hours. Symptoms lasted all day until 9:00PM. I continued to take ibuprofen and Tylenol to ease pain.
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| 50 | 2021-03-31 | disorientation |
after scheduling her second dose appointment patient reported feeling lightheaded, was sitting on th...
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after scheduling her second dose appointment patient reported feeling lightheaded, was sitting on the floor. Moved patient to an exam room for privacy and elevated her feet. She asked to lie down because she was getting ready to pass out and then did. Patient was out for approximately 1 minute, was snoring. Applied a sternal rub and eventually patient came to. Patient was very disoriented afterward and discovered patient had urinated. Patients husband was with her, but in the parking lot, brought him in. She reports a history of fainting. BP 134/87, pulse 77. Patient also reported nausea, but states she had not eaten this morning because she doesn't normally eat breakfast. Gave patient a coke to sip on. Patient was recovered when she left.
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| 50 | 2021-03-31 | feeling abnormal |
Immediate ear ringing and feeling fuzzy. Later chills body ache muscle aches. Next morning woke with...
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Immediate ear ringing and feeling fuzzy. Later chills body ache muscle aches. Next morning woke with red rash from chin to chest.still have dry bumps from rash today 4-1-2021
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| 50 | 2021-03-31 | insomnia |
AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being f...
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AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/30/2020.pfizer Lot#EL0142 2nd dose:01/20/21.pfizerLot#EL3247 Diagnosed covid positive: 03/22/21 Exposure: Home Exposure Symptoms:Fatigue,insomia,cold sore, headache, chills, runny nose, loss of taste/smell
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| 50 | 2021-03-31 | insomnia | Headache, muscle pain, nausea, insomnia, chills, fever |
| 50 | 2021-04-01 | anxiety |
Patient felt anxious and initially had palpitations. Then began itching and sensation of difficulty ...
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Patient felt anxious and initially had palpitations. Then began itching and sensation of difficulty swallowing. Her blood pressure increased from 155 to 177 systolic. She was given epinephrine due to worsening throat tightness sensation. She was transported via EMS to a local hospital. Upon arrival there she still had sensation of difficulty swallowing but it was improving. Itchiness continued. She was given Benadryl and solumedrol within a few hours these initial symptoms resolved. She had progressive dizziness. Unclear if dizziness part of vaccine reaction or consequence of treatments for vaccine reaction
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| 50 | 2021-04-01 | mental impairment, feeling abnormal |
Immediately after getting shot, I experienced the following: extreme drowsiness, dizziness, redness ...
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Immediately after getting shot, I experienced the following: extreme drowsiness, dizziness, redness all over, and feelings of being intoxicated?slow to speak hard to gather my thoughts. Was taken to ER and given Benadryl shot and another IV medication. While in ER both my hands swelled.
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| 50 | 2021-04-02 | anxiety |
right side of nose feels like it went numb congested, but no congestion/Whole right side of nose and...
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right side of nose feels like it went numb congested, but no congestion/Whole right side of nose and nostril went numb/could not feel/It was like it was numb on inside but not on outside; right side of nose feels like it went numb congested, but no congestion/It is congested in a weird way/ cannot blow nose; Headache; Pain at injection site; Weird tingling and ringing in right ear; Weird tingling and ringing in right ear; Nausea; Anxiety /Anxiety worsened/spiked when she could not feel her nose; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular in the left arm, on 09Feb2021 13:00, as single dose, for prevention/COVID-19 immunization. Medical history included severe allergies to environmental, sensitivities to some foods, anemia and severe asthma diagnosed in 1973. The patient reported that her dad has COPD, emphysema, high blood pressure, asthma and allergies. Concomitant medications included azelastine hydrochloride (AZELASTINE) taken for allergies from Dec2020; fluticasone propionate (FLONASE) taken for allergies; and an unspecified steroid for asthma. Historical vaccine included live flu vaccine received 20-30 years ago and she was severely ill and sicker than she has ever been as on the brink of going to the ER, but she did not go. On 09Feb2021 at 13:20, 20 minutes after the vaccination, the patient experienced nausea which lasted for 2 hours; and anxiety. The patient never vomited. On 09Feb2021 at 16:00, 3 hours after the vaccination, the patient experienced pain at injection site and weird tingling and ringing in right ear. On 09Feb2021 at 17:00, 4 hours after the vaccination, the patient experienced headache. On 10Feb2021 at 11:00, the patient's right side of nose felt like it went numb congested, but no congestion, could not feel. The whole right side of nose and nostril went numb. It was congested in a weird way and could not blow her nose. The congestion felt like it was plugged but it was different from congestion. It was like it was numb on inside but not on outside. She wanted to know if this was normal. It was reported that her anxiety worsened/spiked when she could not feel her nose. The patient wanted to get shingles vaccine and asked if she should wait, if she should get the second dose of the COVID-19 vaccine and does she have increased risk because of her first dose experience. The patient had negative COVID test in Jan2021. The patient recovered from the event nausea on 09Feb2021 at 15:20; was recovering from pain at injection site, "weird tingling and ringing in right ear", headache, "right side of nose feels like it went numb congested, but no congestion/whole right side of nose and nostril went numb/could not feel/it was like it was numb on inside but not on outside" and "right side of nose feels like it went numb congested, but no congestion/it is congested in a weird way/ cannot blow nose". The outcome of the event "anxiety /anxiety worsened/spiked when she could not feel her nose" was not recovered. Information on the lot/batch number has been requested.
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| 50 | 2021-04-02 | insomnia |
Chills, headache, dizziness, vomiting, sharp pains in temple, right hip and arm, body aches, insomni...
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Chills, headache, dizziness, vomiting, sharp pains in temple, right hip and arm, body aches, insomnia
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| 50 | 2021-04-04 | anxiety |
Along with headache, injection site pain, body aches and joint pain, I experienced crippling anxiety...
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Along with headache, injection site pain, body aches and joint pain, I experienced crippling anxiety, increased heart rate and paranoia with suicidal thoughts. I thought the tv was sending me messages and could hear the voice of my dead father in my head trying to communicate with me. There was also another voice that was telling me to kill myself. This lasted for 10 days. I have never experienced anything like this before I had the shot.
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| 50 | 2021-04-04 | feeling abnormal |
Within a few seconds of getting shot I had immediate strong metallic taste in my mouth. My left arm ...
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Within a few seconds of getting shot I had immediate strong metallic taste in my mouth. My left arm ( arm that received vaccine) turned red and splotchy , chest and face then turned red and splotchy. I felt lightheaded and my tongue and throat felt thick and like ?fuzzy? feeling. EMT put me on stretcher, gave me O2 and took BP...BP was higher than normal but not so high that was concerning. O2 was ok. I was monitored for 30 min then released. I felt weak the remainder of the day. The next day I was very ill, fatigued , body/joint aches, chills, sweats, bad headache, nausea, diarrhea- no fever. This lasted three days.
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| 50 | 2021-04-04 | impaired work ability, feeling abnormal |
20 minutes after shot, I experienced a warm sensation move across my chest. I began having a headach...
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20 minutes after shot, I experienced a warm sensation move across my chest. I began having a headache in the right temple. These two effects lasted 30-40 minutes. I began to feel a little better so I returned to work. On Friday 3-26-2021 I began feeling extremely weak and muscle aches. My heart rate was also elevated. I continued to feel bad and wasn?t able to return to work. I went to the Dr on 4-01-2021. Heart rate and blood pressure were both elevated. I had bloodwork and ekg done. Heart was in Tachycardia. All bloodwork was normal. I haven?t returned to work because of these symptoms
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| 50 | 2021-04-05 | anxiety |
Patient reported metallic taste in mouth after and feeling light headed when driving away from vacci...
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Patient reported metallic taste in mouth after and feeling light headed when driving away from vaccine tent. Patient reports history of Bipolar Disorder and she was anxious prior to receiving vaccine fearing it would trigger an episode BP 138/88, Pulse 76
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| 50 | 2021-04-05 | disturbance in attention |
Immediately experienced intense erratic nerve pulsations along left cheek. Left side of cheek and ja...
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Immediately experienced intense erratic nerve pulsations along left cheek. Left side of cheek and jaw felt numb and tingly. Jaw felt sore. I could feel the nerve pulsations with my fingertips very strong. The Pulsations continued on and off and subsided but the numbness tightness soreness and tingling feeling on the left side of my face lasted for about 36 hours until it completely resolved. 72 hours later the left side of my cheek still feels mildly sore or like a little tense at the jar hinge and under the skin. I also experienced dizziness and that lasted for most of the day I had trouble for instance focusing on things up close like washing dishes. I had to look further away. I also experienced an intense headache on the left side of my skull like a hammer pounding ten times at about 9 PM. Then it went away then the pounding came back again so Itook 500 mg Tylenol which seem to help but I still had a little bit of an ache in my jaw a few hours later so I took another 500 mg and that seem to resolve the headache and jaw pain. The next morning my face was still a little numb tingly and tight all day. It wasn?t until Sunday that it felt like it had finally resolved itself.
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| 50 | 2021-04-05 | feeling abnormal |
Swollen lymph nodes left armpit, pain along arm, some pain in jaw Extreme tiredness, lots of naps, b...
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Swollen lymph nodes left armpit, pain along arm, some pain in jaw Extreme tiredness, lots of naps, bit of brain fog
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| 50 | 2021-04-05 | impaired work ability |
I could not work but my knees hurt so bad. I had an arthritis pain in my joints, wrist knee and my f...
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I could not work but my knees hurt so bad. I had an arthritis pain in my joints, wrist knee and my fingers. I was in a lot of pain and limping at the end of the day. I went to the ER and they did tests. A few days later I developed a rash on my thighs and when it started to spread to the other thigh. It looks like hives and it is was very itchy. The rash then appeared on my buttock and then to the other side. It proceeded to spread in patches in different areas of my body and then spread to the contralateral side of the same body area. I had swelling in my right hand on two fingers. A month after vaccination I also got a fever. All tests were negative except my CRP was elevated each time. I was prescribed Prednisone, but the rash still appears periodically, and my joints still hurt after 12 weeks. The rash is not as itchy when it appears. I have had another course of Prednisone after seeing the immunologist.
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| 50 | 2021-04-05 | nervousness |
Pt. received the Covid-19 vaccine. She reports symptoms of "feeling her throat weird" pt stated she ...
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Pt. received the Covid-19 vaccine. She reports symptoms of "feeling her throat weird" pt stated she has a hx of anxiety and was very nervous. RN had Epi on hand pt sat with RN, pt drank water and pt's HR was 88 when she stated she did not feel well at 3:52pm, 15 min after her vaccine was given. Treatment/intervention: Pt was given water and sat and additional 30 mins after initially feeling unwell. Pt stated she feel fine at 4:08pm. Pt denies any throat or tongue swelling. Pt states she feels fine. At 4:15pm: HR: 76 O2: 99% BP: 120/80 At 4:30pm: HR: 73 O2 100% BP: 118/78 Pt stated she felt well, she did not have any swelling in face or tongue or difficulty breathing.
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| 50 | 2021-04-05 | sensation of foreign body |
A sudden on set of dizziness or feeling of vertigo, loud buzz in my head, nausea, pain at back base...
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A sudden on set of dizziness or feeling of vertigo, loud buzz in my head, nausea, pain at back base of neck, numbness and tingling in face and hands, strange feeling in throat almost like a lump, extreme fatigue . It was not debilitating but I did not feel well enough to drive my car. Symptoms started March 22 and all have dissipated except feeling dizziness and buzz noise in my head.
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| 50 | 2021-04-06 | anxiety |
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: SHE...
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Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: SHE FELT ANXIOUS, FELT DIZZY AND SWEATING, WE TOOK HER BLD PRESSURE 104/75 HR 68. AFTER SHE RELAXED AND LIE PAT DOWN AND ELEVATE FEET,. SHE FELT BETTER HER BLD PRESSURE WENT UP TO 113/82 HR 80. O2 ST 98%. FOLLOW UP WITH HER ON 4/7/2021. SHE FELT COMPLETLETY FINE.
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| 50 | 2021-04-06 | feeling abnormal |
On Monday, the same day as the shot... Towards the evening left arm hurting: like someone punched me...
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On Monday, the same day as the shot... Towards the evening left arm hurting: like someone punched me really hard in the arm (like it did after the first shot) Around 8 PM or so, I started to feel achy and sore, like I had been working outside all day moving heavy items. My whole body was sore. Woke up the next morning and felt off. Took my temp. and it read 101. I took Tylenol. Pretty much stayed in bed the whole day. I was tired and achy. Fever went up to 103 at around 4 PM. Took Tylenol. By the evening I was feeling better. Next morning I woke up. Not achy but not 100percent. Fever at 99, but now I'm dizzy. (This is written on 4-7-21 2:40 pm)
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| 50 | 2021-04-06 | sensation of foreign body |
Swelling of left arm, down to the wrist Swelling of the front and upper back, I couldn?t see my cla...
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Swelling of left arm, down to the wrist Swelling of the front and upper back, I couldn?t see my clavicle bones Stiff neck, left side only Skin felt tight, 10 minutes after receiving the immunization, like a bad sunburn Felt like there was something in my throat Body ache Headache Tiredness Nauseous
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| 50 | 2021-04-07 | feeling abnormal |
4/5/21 Started feeling tired and run down 4/6/21 Feelings of exhaustion, body aches, headache, fever...
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4/5/21 Started feeling tired and run down 4/6/21 Feelings of exhaustion, body aches, headache, fever of 102.7 degrees, chills, slight nausea 4/7/21 Still feeling run down, headache, fever of 100.1 degrees
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| 50 | 2021-04-07 | feeling abnormal |
Injection site pain Tiredness Severe headache Brain fog Muscle pain Joint pain Chills Hot sweats Fev...
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Injection site pain Tiredness Severe headache Brain fog Muscle pain Joint pain Chills Hot sweats Fever (101) more than 24 hrs Nausea Sore throat
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| 50 | 2021-04-08 | excessive sleepiness, restlessness, feeling abnormal |
4 am: 2 hours of chills and violent trembling. My teeth were clenched so tight for so long, my jaw a...
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4 am: 2 hours of chills and violent trembling. My teeth were clenched so tight for so long, my jaw ached. 6 am: I couldn?t lift a glass of water. Someone brought my cup and straw, which I nestled between my face and pillow. I sipped what I could. 6:30: Sleep 8:am: Woke up thinking it was 6pm. I couldn?t roll over. Dizzy and weak, I collapsed back into bed from trying to stand. Someone walked me to the bathroom. Once there, I wheezed and gasped for air. Then I got scared and cried, which made it even harder to breathe. It felt like my body wasn?t absorbing the oxygen it took in. 8:05: Sleep 9 am: Woke up hoping the day was almost over and I slept through it. The cruelest part is sleeping what felt like the deepest sleep only to wake up an hour later ? over and over again. My spine and neck ached, which made my head hurt ? or my head hurt all on its own. 12 pm: Sharp abdominal pains with any movement. If I did move, I had fits of gasping for air. Had to ask Someone for the phone sitting just a foot away. I couldn?t look at the screen. My eyeballs were too sore, head too achy, and brain too fogged. The phone was only to ask for help while someone worked in the other room. 12:30: Abdomen sore to touch. Hard to talk. My bowels became so shut down it hurt(s) to move straight water through them. The rest is kind of a blur. Lots of sleep. In the afternoon, someone walked me to the bathroom. Back in bed, I had another breathing fit. My abdominal pain felt inescapable. Through was happy for his company, I think I fell asleep during our conversation. At some point, someone brought me broth but I didn?t get much down. By evening, I could walk to the bathroom alone, albeit hunched like a 120 year old in need of a walker. My guts just hurt too much to stand upright. Day 2: I still suffer from abdominal pain, a headache and muscle aches, but I CAN roll over, lift a glass of water, and focus on a screen for short stints. (I documented this in stages.) I can walk slowly but still painfully to the bathroom without help, but I get winded beyond that. I?m afraid to eat with my digestive tract so inflamed, but I have far more energy today, 32 hours after my last meal, than I did yesterday. I?ve also lost 6 pounds. Day. 3: 10 pounds down, still with diarrhea, but eating again. Restless sleep. Significantlt winded and dizzy after mild activity, like walking from one side of the house to the other.
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| 50 | 2021-04-09 | feeling abnormal |
Patient experienced flushing/sweating, dizziness, spacing out. Had two puffs of albuterol inhaler at...
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Patient experienced flushing/sweating, dizziness, spacing out. Had two puffs of albuterol inhaler at 11:08. VS at 11:15 - BP 149/90, HR76, RR18. VS at 11:33 - BP 146/84, HR75, RR18. Patient given water and crackers. Patient stable and released from vaccination site
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| 50 | 2021-04-09 | impaired work ability, excessive sleepiness, sleep disorder |
Approximately 2:30pm, on 4/3/21, I started developing very bad lower back pain, which made it very u...
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Approximately 2:30pm, on 4/3/21, I started developing very bad lower back pain, which made it very uncomfortable to stand or sit. By 8pm, I was asleep for the night, not awakening until 8am on 4/4/21. I woke up with very little energy and had body aches. My temperature was 99.5 and I slept on and off for the whole day. During the overnight hours of 4/4/21 to the morning of 4/5/21, I maintained a temperature of 100 and went from chills to feeling feverish. I woke up on 4/5/21 and had severe head and chest congestion and no energy, which caused me to call out of work on 4/5/21. A cough developed the afternoon of 4/5/21 and my temperature on 4/6/21 was 100.5, so I missed a second day of work. By 4/7/21, I no longer had body aches and no more fever. I did have a productive cough until 4/8/21. On 4/9/21, my cough became dry. As of today, 4/10/21, all adverse events are just about gone. My treatment was Vicks daytime liquid medicine and tylenol through 4/8/21.
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| 50 | 2021-04-09 | impaired work ability, loss of personal independence in daily activities |
Woke with elevated fever at 3:00 AM. At highest, fever was 2.3 degrees above my normal. Loss of appe...
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Woke with elevated fever at 3:00 AM. At highest, fever was 2.3 degrees above my normal. Loss of appetite. Fever sweats. General discomfort. Slight pain in arm. Extreme fatigue. Treated with two Tylenol and sleep. Most symptoms disappeared within 24 hrs of the shot except for the following: one-degree temperature on the second day (took more Tylenol); and extreme fatigue for nearly five days before it started to taper off. I was unable to perform normal daily activities during that time ,due to the fatigue, including my job. Treatment: sleep, rest and time.
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| 50 | 2021-04-09 | sleep disorder |
Rash on upper back and hives present constantly for 4 days starting 4 days after injection then int...
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Rash on upper back and hives present constantly for 4 days starting 4 days after injection then intermittent over first two weeks especially in evening. Had to get steroids After 1 week also noted swollen lymph nodes on entire right side of face sling jaw line up to temple extremely tender Unable to sleep for two weeks Finally got steroids again finishing now Nodes are still slightly tender and palpable entire body aching as well
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| 50 | 2021-04-10 | anxiety | Headache, nausea, anxiety |
| 50 | 2021-04-10 | feeling abnormal |
Very swollen and painful lymph nodes and tissue under arm. Very uncomfortable and I am now at day 8...
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Very swollen and painful lymph nodes and tissue under arm. Very uncomfortable and I am now at day 8 and it is not fully recovered.
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| 50 | 2021-04-10 | insomnia |
Diarrhea for 6 hours continuously and next day sporadic, headache with intense stabbing pain in base...
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Diarrhea for 6 hours continuously and next day sporadic, headache with intense stabbing pain in base of skull, nausea, abdominal cramping for 6 hours, hot and cold feeling, and insomnia. Sleep and Tylenol
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| 50 | 2021-04-11 | feeling abnormal |
I felt like I was having a heart attack I had a very sick stomach too. I had to go to the emergency ...
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I felt like I was having a heart attack I had a very sick stomach too. I had to go to the emergency room and get fentanyl and Benadryl in an IV.
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| 50 | 2021-04-11 | excessive sleepiness, sleep disorder |
About 6-7 hours after shot, I started feeling achy and feverish. About 10 hours after the shot, I h...
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About 6-7 hours after shot, I started feeling achy and feverish. About 10 hours after the shot, I had uncontrollable shaking for about 2 hours. I was so cold, I could warm up all night. I had to clench my teeth to keep from biting my tongue. I also felt nauseous all that night and the next day. I couldn't lay flat that night or I felt like I would vomit. Once the shaking subsided (after 3 Tylenol), I still couldn't sleep because of the nausea and the aching. I got about 2 hours of sleep and woke in the morning with a massive headache. I took more Tylenol and it helped with the headache but had chills and nausea all day. I slept much of the afternoon and all that next night. The following day, I still felt a bit nauseous, achy and fatigued but much better than prior. By the following day, I was back to normal.
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| 50 | 2021-04-11 | sensation of foreign body |
near immediate lump in throat that increased to a sensation that I might not be able to swallow with...
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near immediate lump in throat that increased to a sensation that I might not be able to swallow within approximately 20 minutes. I maintained the ability to swallow. Shortly after the throat swelling, my eyes began to itch. This was followed by general face itching. I also experienced a metallic taste in my mouth within 15 minutes of the dose. I took a Benadryl at around 8 PM after my throat and the itching had not resolved. The benadryl resolved the itching and ease the swollen throat. My throat remained tight feeling the next day, but was normal feeling by 4/11/21.
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| 50 | 2021-04-12 | disturbance in attention |
On 4/5/21, two days after my second injection, I was sitting at my desk working (at home) when I not...
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On 4/5/21, two days after my second injection, I was sitting at my desk working (at home) when I noticed my vision wasn't clear even with my glasses on. I had been feeling nauseous for a few hours and then my eyes started bouncing back and forth uncontrollably. I was unable to see correctly or move from my chair. Once my eyes stopped moving my vision became tunnel vision and everything around it became foggy. I felt weak and dizzy. I started getting a headache. I didn't think I could even call out for help as I was unsure my voice would work. Once it all calmed down I figured it must be part of a migraine, even though nothing this extreme had ever happened before. I moved to my bed as I was suddenly completely exhausted, and immediately fell asleep for almost 3 hours. Once I got up I was still very groggy and had to force myself my. I stayed up for about 3 hours and went back to bed for the night. The next morning I woke and was feeling better so I figured it must have been a migraine. However a few hours later the same problems started back up again. I was having a hard time seeing my computer screen, I had a foggy head and was finding it hard to concentrate and do work. My headache started again and my vision started as foggy and became tunnel vision again. This time my eyes did not bounce, but my lips started tingling. This lasted for about 1 minute. This time with everything I was making sure to take a mental note of everything going on because I was scared I was going to have to call 911. Because I was home alone I opened my phone to dial if it got any worse. The event backed off enough that I took myself to the ER. By the time I was in the waiting room my head felt like a balloon and my whole body just felt "off." I can't explain how it felt, it just didn't feel normal. My headache never got overly severe like it does with a migraine, but I was worried about a stroke. The ER did a CT scan and did rule out a stroke, but was unsure of what it exactly what it was, but guessed it was an abnormal migraine attack and told me to follow up with my PCM in a couple of days and to keep my appointment with my neurologist on April 15th. The symptoms lasted a full week off and on every day, with a tampering down of severity of symptoms.
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| 50 | 2021-04-12 | feeling drunk | lightheaded "felt drunk", dry throat. Evaluated by EMS-Refusal to transport. |
| 50 | 2021-04-12 | excessive sleepiness, anxiety, emotional distress |
Within the first 5 minutes after the vaccination, I felt faint, lightheaded, dizzy, disillusioned, l...
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Within the first 5 minutes after the vaccination, I felt faint, lightheaded, dizzy, disillusioned, like I had vertigo also. I experienced these symptoms w/in the first 5 minutes once I left the designated vaccination area. My entire body felt hot, my face was red, I felt sweaty. I went to find a nurse nearby who walked me to an area to sit/rest so that she could monitor me. I did inform her that I had my EpiPen with me, however, she recommended that if I had Benadryl to take it immediately. She provided me w/water and I took one 25mg pill. She continuously took my pulse as I felt my heartbeat was fast, I had anxiety about the way I was feeling because I felt short of breath. While my throat/chest did not feel tight, I did feel a heaviness in my chest and my breathing was somewhat labored. My face became flushed and then pale/drained and I began to feel extremely nauseous w/in 10 minutes. The nurse continued to monitor/take my pulse/heart rate at this time. I did experience stomach cramps and had to go to the bathroom. I experienced diarrhea and continued to feel nauseous while in the bathroom. I continued to feel dizzy and just out of sorts so I was asked to remain at the hospital. I was asked if I'd like to be taken to the ER, however, I chose not to go to the emergency room because I did not want to incur any additional hospital charges if they were not going to utilize my EpiPen. I remained at Hospital vaccination clinic at the hospital for what I believe was approximately 2.5 hours. I did ultimately eat a small bag of pretzels and drank a small bottle of water. Thankfully, the Benadryl did help fairly quickly and tremendously to get me over the hump of symptoms and anxiety that I was feeling. Once I returned home, I literally just collapsed in bed and remained there basically sleeping for over the course of the next 48 hours. I followed a diet as my stomach was still upset. I did have a slight fever, but it did not get any higher than 99-100. I felt clammy the first day/evening, with subsequent chills, but ultimately, by Friday night and into Saturday, I felt well enough to get out of bed and move around the house. I felt back to some normalcy on Sunday. My left arm was swollen from Wednesday (day of vaccination) to Saturday. I could not lift my arm, or sleep on my left side due to the pain and I also couldn't lift my arm for approximately 48 hours.
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| 50 | 2021-04-12 | sleep disorder |
Constant tinnitus began on March 4th. It has continued and worsened over the last month. It never st...
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Constant tinnitus began on March 4th. It has continued and worsened over the last month. It never stops and interrupts concentration and sleep. EL9267
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| 50 | 2021-04-13 | agitation |
Walked a few minutes after received vaccine, walked with son toward observation. Pt reports feeling ...
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Walked a few minutes after received vaccine, walked with son toward observation. Pt reports feeling hot, agitated, dizziness, nausea, placed on w/c to medical bay. Placed in gurney - had oatmeal for breakfast - states feeling HA/nausea. HA 8/10 dizzy 10/10, +room spinning. PERRL, slight diff to arouse. Unable to walk d/t dizziness/drowsiness. Alert to name, place, vaccination area. 0 difficulty breathing, able to answer questions, slower to respond. Similar s/x >1 year ago d/t stress related son went to ER, dc'ed from ED). Son reports feeling fatigue for past 2 months. Son reports heavy menstrual period stopped 2 months ago p son. BP 131/84; HR 70 RR 16; Sat 98% on RA.
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| 50 | 2021-04-13 | anxiety |
PATIENT STATES HAS HEART PALPITATIONS. PATIENT HAS NO SHORTNESS OF BREATHE, SWELLING OR RASH. PATIEN...
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PATIENT STATES HAS HEART PALPITATIONS. PATIENT HAS NO SHORTNESS OF BREATHE, SWELLING OR RASH. PATIENT IS SLIGHTLY DIAPHRETIC. PATIENT STATES I JUST ANXIOUS AND REFUSED AND INTERVENTIONS. PATIENT STATES FEELS BETTER AND WENT HOME WITH FAMILY.
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| 50 | 2021-04-13 | feeling abnormal |
When I was released from waiting in the drive line for the 15 minutes I pulled away and for the stra...
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When I was released from waiting in the drive line for the 15 minutes I pulled away and for the strangest unknown to me reason, I began yawning... Like non stop yawning for the next 40 minutes and then it stopped. Just as fast as it started, it stopped. I was telling a friend about my weird experience and she said I should report it even if it sounded insignificant.
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| 50 | 2021-04-14 | disorientation |
Vertigo has lessened since the weekend of the injection but still present everyday. disorienting and...
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Vertigo has lessened since the weekend of the injection but still present everyday. disorienting and concerning. Fatigue comes in waves but often hard to push through has not improved since injection. Concerned about amplification with the 2nd vaccine scheduled for tomorrow.
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| 50 | 2021-04-14 | insomnia |
Body rash and itching; loratadine; body rash subsided the following day Extreme pain in arm of inje...
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Body rash and itching; loratadine; body rash subsided the following day Extreme pain in arm of injection site; unable to utilize; could not sleep on that side; pain dissipated after two days
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| 50 | 2021-04-15 | mental status changes | Altered Mental status |
| 50 | 2021-04-15 | nightmare |
First dose- barely had chills ( I am usually cold so this may not be a side effect except for the go...
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First dose- barely had chills ( I am usually cold so this may not be a side effect except for the goosebumps that came and went once or twice) and goosebumps for an hour in the evening and arm soreness for 24 hours. Second dose - barely had chills with goosebumps again for an hour or two in the evening in the evening and arm soreness for 24 hours. I typically have a body temperature of 97.4 and this evening it went to 98.1 for the hour or two. Had I not been monitoring due to the vaccine I would have chalked it up to tiredness or just cold as usual. The unexpected side effect which is why I am filling this form out was very bad dreams on both nights 4/9 and 4/10 and more than one bad dream on 4/9.
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| 50 | 2021-04-15 | panic attack, anxiety, depression |
Day 1: 3PM Sore throat, 11PM facial swelling, 4AM panic attack Day 2: 2PM, lasting for 3+ hours: N...
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Day 1: 3PM Sore throat, 11PM facial swelling, 4AM panic attack Day 2: 2PM, lasting for 3+ hours: Nausea, dizzy/faint/weakness, rapid heart rate (120-150 BPM), elevated blood pressure, chest pain and pressure, bronchoconstriction, pharyngeal constriction, sore throat, burning tongue, tinnitus ; 5PM chills, temp up to 101.5, intense lower back pain, headache, anxiety Day 3: intense headache, lower back pain Day 4: Mild headache, depression and fever blister later in the day Day 5: Deep depression, feeling of impending doom Days 6-16: Elevated anxiety, chest pain and pressure, bronchoconstriction, pharyngeal constriction, sore throat, burning tongue, tinnitus, GERD, esophageal spasms
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| 50 | 2021-04-15 | sleep disorder |
24hrs after the second vaccine I had the usual reactions: fatigue, nausea, body aches. On the 2nd da...
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24hrs after the second vaccine I had the usual reactions: fatigue, nausea, body aches. On the 2nd day I woke up without any discomfort and was fine for 6-7 days. SEVEN DAYS AFTER THE 2ND VACCINE: Jabbing, throbbing pain, itching and "running ants" located in: hands, (knuckles, wrists, palms, both sides), forearms, armpits and under breasts, upper back between shoulder blades, upper ribs, thighs, behind knees, and bottoms of the feet. Ongoing, all over, both sides of the body going on now for 48hrs. I do not have any history of fibromyalgia. Constant urination. Difficult to sleep. Fatigue.
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| 50 | 2021-04-15 | sleep disorder |
Left arm sore at injection site within five hours. I woke up with chills at 2am on 4/16/21 and kept...
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Left arm sore at injection site within five hours. I woke up with chills at 2am on 4/16/21 and kept waking up because I was so cold even though I had three blankets on me and the house thermostat was set to 75. I continued waking up from being so cold and started to have muscle aches in my buttocks, hamstring, and quads in the middle of the night. Got up at 8am on 4/16/21 and still have goosebumps/chills and aches in the above mentioned areas.
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| 50 | 2021-04-16 | feeling abnormal, amnesia |
Syncope, collapse, seizure, amnesia, brain fog, migraine, nausea, vomiting, double vision; all ongoi...
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Syncope, collapse, seizure, amnesia, brain fog, migraine, nausea, vomiting, double vision; all ongoing since time of second dose administration
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| 50 | 2021-04-16 | feeling abnormal |
After receiving vaccine within two hours became very tired and tightness in throat. Went home laid d...
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After receiving vaccine within two hours became very tired and tightness in throat. Went home laid down. By evening nausea started. Went to bed woke up an vomited a few time through night. Nausea and vomiting continued for about 3-4 days along with lethargy. Was in bed for about 5 days. Completely out of it for about two weeks. Noticed a bruise at injection site within a few days. White ara abpout the size of a softball around that and pinkish-red rash around outside of that. Numbness developed at site of injection. Pain in joints developed within about a week and loss of mobility of L arm as well. Intermittant diahrrea and vomiting and constant nausea for a few weeks then intermittant nausea after. Continued pain
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| 50 | 2021-04-18 | feeling abnormal |
24 hours after second Pfizer vaccination, began to experience eye pain and swelling in the right eye...
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24 hours after second Pfizer vaccination, began to experience eye pain and swelling in the right eye / conjunctivitis; which escalated dramatically on 4/14/2021. on 4/15/2021 eye pain continued to escalate and began experiencing severe light sensitivity. Saw opthalmologist on 04/15/2021 and began taking steroid drops to reduce eye inflammation. Pain reduced, but experiencing fuzzy vision on 04/17/2021 and 04/18/21. Unsure yet of resolution. 24 hours after second Pfizer vaccination experienced fever of 101.2 before reducing with tylenol (lasted from about 5pm to 9pm on 04/13/2021). Extremely tired with brain fog throughout the week (and still experiencing as of 04/19/2021)
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| 50 | 2021-04-18 | insomnia |
I began to have body aches at 11 am the next day. Throughout the day I was achy and nauseous. By 7 p...
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I began to have body aches at 11 am the next day. Throughout the day I was achy and nauseous. By 7 pm I had chills and a fever of 102.4. I was also short of breath and felt like I had to cough every time I talked. I also have mitral valve and left bundle branch block, and I've experienced this feeling before. So I took 2 baby aspirin and drank a Gatorade and the shortness of breath/cough sensation improved within 30 minutes. Felt better the next day. Then, had insomnia and bought of energy 3 days after the shot (Sunday, 4/11/21). All worth it to avoid COVID, but reporting it in case the information is useful to you. THANK YOU!!!!
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| 50 | 2021-04-19 | anxiety |
"Ache" in throat. No further signs of allergic reaction. Patient reports anxiety surrounding getting...
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"Ache" in throat. No further signs of allergic reaction. Patient reports anxiety surrounding getting vaccinated.
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| 50 | 2021-04-19 | feeling abnormal | Began feeling dizzy almost 15 minutes after the injection. Gradually also felt nauseous and foggy. |
| 50 | 2021-04-19 | impaired work ability |
Pain in the arm location where the shot was given with some pain radiating into my shoulder and neck...
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Pain in the arm location where the shot was given with some pain radiating into my shoulder and neck at times. Gets better and then pain returns and since the 2nd shot in the other arm where there was no reaction my right arm hurts again at the injection site and does not stop even taking pain reliever. I?ve also been sick with sinus aches, congestion, fever, chills, and cough that aches and sore throat on and off since the 2nd vaccination on March 31st. I feel this is lasting for a while and I?m so exhausted all the time. I don?t know if this has any relation to getting the vaccine but I?m never hardly ever sick and now I can?t go a day without pain or worse flu like symptoms.
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| 50 | 2021-04-19 | impaired work ability |
I received my 1st vaccine shot on 04.09.21 at 4:05pm CST. Around 5:15pm CST, my lower extremities an...
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I received my 1st vaccine shot on 04.09.21 at 4:05pm CST. Around 5:15pm CST, my lower extremities and entire left side went numb. All feeling in my lower extremities returned by 11:00 pm CST. The facial and left arm/hand numbness remained with varying degrees of transient numbness. The numbness has ranged from 10% to 95% of feeling. I started doing research and determined my reaction was temporary and inflammatory and Bell Palsy like in nature. I missed work on 04.13.21 and notified my primary care physician, Dr by phone about the numbness. I was informed to go to the ER, especially if the numbness worsened. After taking Benadryl, by morning, the numbness remained transient, but subsided a bit. On 04.17.21, I started to feel a pull on my left eye muscle and a glare when I looked down. I notified my eye doctor, Dr I underwent an exam. My eye nerve was fine, however, my prescription in the left eye increased. As of today, 04.20.21, I am MUCH better, but the injection site remains little sore. The numbness remains transient in my left arm/hand, facial cheeks, and forehead with about 95% of feeling. My skin on my face (T-zones), also feels like sandpaper. I am making this report because I am apprehensive about receiving the 2nd shot.
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| 50 | 2021-04-19 | sleep disorder |
1) I've had a throbbing pain in my left, frozen shoulder as of early morning the day after receiving...
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1) I've had a throbbing pain in my left, frozen shoulder as of early morning the day after receiving the 2nd COVID shot. All progress I had made since an x-ray guided cortisone injection on February 16th followed by weekly PT since is gone. I was awoken during the night with extreme pain in my shoulder several nights in a row after receiving the 2nd COVID shot. The throbbing pain has started to decrease, but it still comes multiple times each day. I saw Dr. for a scheduled follow-up visit for my cortisone injection today and he confirmed that my shoulder is back to where we started 3 months ago. I have had some joint pain in my right shoulder as well, but not nearly to the extreme pain in my left shoulder. I attribute this to the COVID vaccine as I was making steady progress until I received the 2nd shot. I still wake several times each night due to the pain in my shoulder, but I have not had a throbbing pain wake me in a few days. 2) I also had a large (golf ball-sized), red, hot lump at the injection site beginning the day after the shot. The redness spread Fri-Sat and Sat-Sun before starting to lessen in redness and heat. The heat and redness were mostly gone by Wednesday (6 days post-injection). I had the nurse at the school where I work look at my arm on the Monday after I received the shot. She agreed that it appeared to be getting less red and less hot.
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| 50 | 2021-04-20 | disorientation |
Headache, fever, chills, lethargy, disorientation, loss of appetite, muscle soreness, pain at inject...
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Headache, fever, chills, lethargy, disorientation, loss of appetite, muscle soreness, pain at injection site.
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| 50 | 2021-04-20 | feeling abnormal, excessive sleepiness, confusional state |
Extremely sore neck and horrible headache and spine pain. My brain felt inflamed and I was not able...
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Extremely sore neck and horrible headache and spine pain. My brain felt inflamed and I was not able to function cognitively. I should have called 911 or gone to hospital but I was so confused I didn?t understand what I needed to do and the only other people in my house were my dependents. I fell asleep frequently and my child could not rouse me. My daughter was afraid I was dying or completely suddenly senile. Extremely dizzy and unable to figure out how to complete daily tasks. It felt like I was under water. Symptoms began to improve 4/6/21. I did not see a doctor because I was unable to figure out how to do that at the time. I had a hard time communicating with my children and would become extremely confused. I attempted to drive to grocery store and ended up at a tool store and didn?t know why I was there. It took a very long time for complete cognitive function to return so that I could create lectures and teach as a lecturer at IU. My dependents would have had to call on my behalf but they did not. I was not even able to communicate with my courses to let them know there was a problem as I normally would.
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| 50 | 2021-04-20 | feeling abnormal |
After approximately 8 hours, initially very lethargic and expected left arm pain at injection site. ...
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After approximately 8 hours, initially very lethargic and expected left arm pain at injection site. A few hours later developed Severe headache, light headedness nearly fainting, motion sickness, mild cough, general fogginess, tingling of head (possibly nerves & related to severe headache ). Left arm pain & lethargy are not active.
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| 50 | 2021-04-20 | loss of personal independence in daily activities, impaired work ability |
Fever as high as 102, stabbing joint pain, fatigue, muscle aches, loss of appetite. Inability to wor...
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Fever as high as 102, stabbing joint pain, fatigue, muscle aches, loss of appetite. Inability to work or do activities of daily living. Fever started 4 hours after vaccine and continues 44 hours later.
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| 50 | 2021-04-20 | loss of personal independence in daily activities |
she had the prickly feeling like when her nerves were regenerating; feeling draining from my right a...
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she had the prickly feeling like when her nerves were regenerating; feeling draining from my right arm from the site of the shot downward to my finger tips/ I lost more and more feeling; numbness in my peripheral nerves/have not fully regained the feeling in my palm and fingers; trouble working due to the issues with typing and issues playing piano. Basic things like holding a cup and driving were an issue; could not get my arm to move and steer the car properly; weakness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number : ER2613) via an unspecified route of administration, administered on the right arm on 21Mar2021 10:30 at a single dose for COVID-19 immunization. Medical history included GBS (when I was 20 years old), Type 2 diabetes mellitus and high blood pressure related to type 2. Concomitant medications included rosuvastatin and metoprolol succinate. The patient previously took paracetamol (TYLENOL) and experienced allergies (anything with Tylenol). In less than 5 hours after the vaccine (21Mar2021 03:30 PM), patient started to feel the feeling draining from her right arm from the site of the shot downward to her finger tips. As each hour passed, she lost more and more feeling. She had complete numbness in her peripheral nerves for over 48 hours and have not fully regained the feeling in her palm and fingers. She had trouble working due to the issues with typing and issues playing piano. Basic things like holding a cup and driving were an issue and nearly caused an accident yesterday b/c she could not get her arm to move and steer the car properly. It has considerable weakness as well. The feeling between her right and left arm were distinctly different and it's really frightening. She was scared she won't get the feeling back in her right arm fully. From my elbow down was still a significant issue. Last 01Apr2021 she did have one incident where she had the prickly feeling like when her nerves were regenerating. The events resulted to a doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Outcome of the events was not recovered.
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| 50 | 2021-04-20 | sensation of foreign body |
On the night of the vaccine, my Lymph nodes below left, right ears and neck area swelled with a ras...
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On the night of the vaccine, my Lymph nodes below left, right ears and neck area swelled with a rash. My throat was burning as if I swallowed fire. This sensation still lingers. On 4/6/21 I woke up with pain on the left side of my neck to discover a small lump the size of the top and eraser. Today, 4/21/21 the lump is wider and I now have 2. My throat is still sensitive.
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| 50 | 2021-04-21 | feeling abnormal |
Severe runny eyes. Severely of runny noses I've ever had. Fatigue. Head pressure. Severe night sweat...
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Severe runny eyes. Severely of runny noses I've ever had. Fatigue. Head pressure. Severe night sweats that disappear and reappear quickly. Taste and hearing has decreased by 50%. Miserable.
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| 50 | 2021-04-21 | feeling abnormal |
blurred vision & itchy eyes - this actually started yesterday afternoon and is continuing today sev...
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blurred vision & itchy eyes - this actually started yesterday afternoon and is continuing today severe joint and muscle pain - took aleve - did not help - so far all morning shortness of breath and chest pains - so far all morning - don't know of anything to do lethargy and brain fog - so far all morning - don't know of anything to do severe pain at injection site
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| 50 | 2021-04-22 | impaired work ability |
Fever, chills, green diarrhea, loss of taste, excessive coughing for loss of voice, throat swollen...
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Fever, chills, green diarrhea, loss of taste, excessive coughing for loss of voice, throat swollen, loss of appetite, sugar lows, coughing fits, wheezing. Out of work Self quarantined
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| 50 | 2021-04-22 | loss of personal independence in daily activities |
Vaccine was given at 11am 4/10/2021. That day I had a slight headache, occasional dizziness, and a ...
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Vaccine was given at 11am 4/10/2021. That day I had a slight headache, occasional dizziness, and a sore arm. Then on Wednesday 4/21/2021 I woke up at 6am and couldn't function. I felt so extremely tired that I could barely move, had a pretty sever headache and chills. Thursday 4/22/2021 was the same: chills (couldn't get warm), severe headache, and extreme fatigue. Today, Friday the 23, I still have a slight headache, but the extreme fatigue and chills have gone away.
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| 50 | 2021-04-23 | depression |
Sore throat next day and for weeks afterwards (it has not gone away in 2 weeks). Depression since va...
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Sore throat next day and for weeks afterwards (it has not gone away in 2 weeks). Depression since vaccine and continuing.
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| 50 | 2021-04-23 | nervousness |
Patient received 1st dose of Pfizer COVID 19 vaccine. Patient started to feel dizzy and nauseous aft...
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Patient received 1st dose of Pfizer COVID 19 vaccine. Patient started to feel dizzy and nauseous after the vaccine was administered. Patient did not vomit. Patient stated that she started to feel this way after the shot, however the patient stated that she was very nervous prior to getting the shot and thinks that here feeling nauseous was due to being nervous. After initial dizziness patient improved and had resolution of symptoms with no other issues. Patient provided call back number however it is based in (country). Patient stated that she felt fine and did not need follow up.
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| 50 | 2021-04-24 | feeling abnormal |
Severe muscle cramps like extensor muscles locking up in back , arms & legs , severe nausea, blurred...
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Severe muscle cramps like extensor muscles locking up in back , arms & legs , severe nausea, blurred vision , light headness . With the 2nd shot the same again but add rash , increased BP ( high! ) . The pain in my muscles lasted 4 months ( 24/7) in my arms , legs & back, proprioception issues with my R leg , then it for the most part stopped and remained in my ankles & feet, and I feel like some cognitive issues . I still get waves of pain all over lasts for a couple of hours verses 24/7, I have a strange sensation constantly if my arms , legs & back .
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| 50 | 2021-04-24 | feeling abnormal |
caller did not have a lot of energy; it is weird because she never sweats profusely; cough; could no...
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caller did not have a lot of energy; it is weird because she never sweats profusely; cough; could not catch her breath; splitting headache/headache that she could not even touch her head or hair; sick; fatigued/felt drained; sick to her stomach; arm started hurting; felt super heavy; could not move her body hardly to get up; This is a spontaneous report from a contactable consumer (patient). A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Left Arm on 31Mar2021 around 11:30 (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation. Medical history included sleep disorder from an unknown date and unknown if ongoing. The patient received first dose of BNT162B2 administered in left arm on 10Mar2021 at 12:45 (Lot number: EN6198) for COVID-19 immunization and Caller adds that she had no side effects after the first dose, nothing. Concomitant medication included zolpidem tartrate (AMBIEN) taken for sleep disorder, start and stop date were not reported. Patient take Ambien (NDC: 13668000810) at night time, she had been on it for years. The dose is 10 mg, she normally breaks it in half so she guesses 5 mg at night. It is just to sleep, since she does not sleep really well. Caller adds she also takes allergy shots but she did not get that until this week and she only does that once a month. No additional details of allergy shots. The patient experienced arm started hurting on 01Apr2021 02:00 with outcome of unknown, felt super heavy on 01Apr2021 02:00 with outcome of unknown, could not move her body hardly to get up on 01Apr2021 02:00 with outcome of unknown, sick to her stomach on 03Apr2021 with outcome of unknown, caller did not have a lot of energy on an unspecified date with outcome of unknown, splitting headache/headache that she could not even touch her head or hair on 05Apr2021 04:30 with outcome of unknown , sick on 05Apr2021 with outcome of unknown , it is weird because she never sweats profusely on 07Apr2021 with outcome of unknown , cough on 07Apr2021 with outcome of unknown , fatigued/felt drained on 05Apr2021 with outcome of unknown , could not catch her breath on 07Apr2021 with outcome of unknown. Therapeutic measures were taken as a result of headache and sick to her stomach. Clinical source: Caller was calling because she called her primary care physician and they said to call Pfizer. Caller took her second shot on the 31st and ever since she has taken that, every other day she has had some weird symptoms going on like this. She took her shot on Wednesday. Thursday at 2, all of a sudden her arm started hurting, she felt heavy, and could not move her body hardly to get up and go to the bathroom or whatever. Friday, she felt fine. Saturday she did not feel up to par. She was sick Saturday night. Sunday she was okay. Monday, she woke up with a headache that she could not even touch her head or hair. She then had to take some medicine because her head hurt so bad that it was making her sick. Today (07Apr2021), she got up and went and worked out and thought she could do workout class. Caller adds that it was weird because she never sweats profusely. She was drenched. Sweat was pouring off of her head and all over her body. She was fatigued again. She could not catch her breath, and she works out all the time. Caller's arm started hurting. Wednesday the 31st was her second shot at 11:30. Caller adds that her arm started hurting at 2 o'clock on 01APR2021. This went away. Along with this, caller felt super heavy if that makes sense at all and she could hardly move. Felt super heavy and could hardly move: caller adds that this was also at 2 o'clock on 01APR2021. This went away the next morning when she woke up. Friday she was okay. Friday caller was fine, and she felt good. Then Saturday night is when she was just sick to her stomach. Saturday night was when caller was just sick to her stomach. Whatever she ate that night, she got sick but she thinks it had something to do with the shot. The next morning, probably mid morning, caller started feeling better again. And then Sunday she was fine. She did not have a lot of energy but she was fine. Monday morning, she woke up probably around 4:30 am with a splitting headache. Caller adds that, like she said, she could not touch her hair. She took 800 mg Ibuprofen but it did not make her feel better. At 9 am, she took the Zofran because she was feeling sick to her stomach. Caller adds that she slept until 11. The headache subsided but the whole day she felt drained and could hardly move. Caller clarifies this was this past Monday, 05Apr2021. Tuesday, 06APR2021, caller was okay. Caller adds that she was pretty normal, and then today she woke up at 4:30am and thought since she had a good day yesterday that she was going to go back and workout and do her crossfit. She has been working out for three months. After her run, she was pouring sweat, which is not normal for her. Caller states that the sweating went away and just every once in a while she can not catch her breath and has kind of a little cough. Caller can not catch her breath and has a cough: caller adds it could be the pollen, she does not know. Caller then adds that she feels like she does not have energy today, normally when she does her workout she feels good the rest of the day if that makes sense. Caller adds that she wants to make sure this is normal. Caller states, like she said, she has been working from home since they sent her home back in March so she has not really been around a whole bunch of people and she has been really healthy. All of a sudden, she took the second shot and she is just not feeling the same. Caller states she wishes she would have known this, because she would have not taken the second shot if she knew this would linger this long. Caller adds that was everything. She just feels like she just does not have a lot of energy today (07Apr2021). Treatment included Ibuprofen, it was prescription Ibuprofen 800 mg. She just took it for her headache, she has not taken anything today (07Apr2021). She didn't take anything yesterday. None other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Family Medical History Relevant to AEs reported as none. No relevant tests. All events did not require a visit to Physician office or Emergency Room. No Follow-up attempts are needed. No further information expected.
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| 50 | 2021-04-25 | anxiety, nervousness |
Patient is a 50 year old female in the observation area presenting with "funny feeling on her throat...
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Patient is a 50 year old female in the observation area presenting with "funny feeling on her throat" post vaccination. Denies SOB, CP, swelling of tongue or lips. Physical exam unremarkable. Initial BP with HTN, but endorsed that she haven't taken her BP med today. Otherwise, pt is nervous and anxious because of the possible allergic reaction she might have. Given Cetirizine and felt better. Symptoms resolved. Referred to Allergy clinic given unverified if allergic reaction. Sent home stable and in no distress.
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| 50 | 2021-04-25 | disturbance in attention |
Out of body feeling Small pupils with dizziness Severe body aches Mild nausea Feeling of being hi...
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Out of body feeling Small pupils with dizziness Severe body aches Mild nausea Feeling of being high Can?t focus
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| 50 | 2021-04-26 | sleep disorder |
Lymphadenopathy and lymphatic cording limiting use of the arm and severe pain all the way to the wri...
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Lymphadenopathy and lymphatic cording limiting use of the arm and severe pain all the way to the wrist. Pain is constant, limiting sleep, and more severe with raising the arm above the head. Continuous pain three weeks after 1st shot.
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| 50 | 2021-04-27 | crying |
Was menstruating at time of second shot, but near end of bleeding stage Within 4 hours of second sh...
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Was menstruating at time of second shot, but near end of bleeding stage Within 4 hours of second shot: pain in vaccine arm (right arm), veins at wrist of vaccine arm (right arm) also began hurting/throbbing; off and on pins and needles feeling in thighs; began feeling strange -- just feeling that things were happening inside my body; headache when playing with child Within 16 hours of second shot: feeling of malaise, sadness, lethargy, lack of appetite, extreme thirst. Redness at vaccination entry site (had this after first shot as well) Within 20 hours of second shot: feeling of malaise, sadness/crying, lethargy, really tired, lack of appetite, extreme thirst, very very cold extremities (especially fingers), chills, body aches, weakness, nausea, low grade fever, pain in vaccine arm, several hours of alternating shaking chills and sweats Fever broke and chills, sweats, nausea subsided by 26 hour mark since second shot. Lack of appetite, weakness, tiredness continued. 40 hours post second shot: all major symptoms subsided, except feeling of apathy, lack of energy By 48 hours post second shot feeling mostly better. 5 days post second shot: STILL BLEEDING FROM PERIOD!!! Unheard of. Never had something like this happen. Also had blinding, excruciating, utterly debilitating pain in vaccine arm upon waking from overnight sleep. The most horrible pain; was sobbing with the pain. Could not lift arm, intense muscle pain in upper arm on vaccine arm (right arm). Mostly subsided after about an hour of massaging, but still have dull pain and do not have full range of motion 2+ hours later.
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| 50 | 2021-04-27 | feeling abnormal, disturbance in attention |
I received my second shot on April 17th, 2021. I injured my foot on April 21, 2021. I went to my G...
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I received my second shot on April 17th, 2021. I injured my foot on April 21, 2021. I went to my General Physician the following day and received a tetanus shot. Up until that time, my side effects were very light; slight headache, arm muscle pain. Two days after receiving my tetanus shot I could barely get out of bed. I woke up feeling as if someone had drugged me; my mind was very fuzzy and it was hard to focus. Every muscle in my body was in extreme pain and it hurt to breathe. I had bouts of terrible stomach cramps. I felt nauseous to the point that I was unable to eat solid food other than chicken soup and crackers for three days. I do fully believe my side effects happened because of the tetanus shot as I had very little side effects before the shot. I felt like I was dying. Luckily I had some medicine at home that helped with the symptoms; gabapentin for my shoulder injury, zofran from a past hospital visit, and I took tylenol. I am a Medical Assistant and didn't feel the hospital or the Dr. office could have offered me any relief from my symptoms.
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| 50 | 2021-04-27 | feeling abnormal |
cellulitis; kind of tired and achy; kind of tired and achy; She had a headache; felt kind of off; sl...
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cellulitis; kind of tired and achy; kind of tired and achy; She had a headache; felt kind of off; slight fever; This is a spontaneous report from a contactable consumer, the patient. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 04Apr2021 at 12:30 (Batch/Lot Number: EP7533) as a single dose (at the age of 50 years-old) for COVID-19 immunisation. Medical history included allergies (unspecified) from an unknown date. There were no concomitant medications. The patient experienced vaccination site cellulitis on 11Apr2021, tired and achy and headache on 05Apr2021, and "felt off" and fever on an unknown date in Apr2021. The clinical course is as follows: the patient received bnt162b2 on 04Apr2021. She felt kind of tired and achy and had a headache the next day (05Apr2021) and for a few days. She "felt kind of off". On 11Apr2021, she developed a spot on her arm where she received the first dose of the COVID vaccine. Her arm was itchy where she got the vaccine, and she developed a big red hot lump. The patient noticed an itch on her arm, and when she scratched it, she noticed a big red lump and it was hot to the touch. She also had a slight fever. She called her doctor, and the doctor thinks it is cellulitis, so they gave her antibiotics. The patient reported her headache is somewhere in between ongoing and recovered completely, her headache is off and on. Her arm was itchy where she got the vaccine, and she developed a big red hot lump: It is not as red anymore. It is still hot. Everything else is still the same. The patient stated she has allergies, she is not sure if that comes into play. The patient was inquiring if taking the antibiotic will interfere with the COVID vaccine and if was okay to take antibiotics with the vaccine as everything that she has read online about the COVID vaccine, says that she should not take an antibiotic for this. She was concerned that she should not be taking the antibiotic, because she does not want the antibiotic to interfere with the COVID vaccine. Therapeutic measures were taken as a result of vaccination site cellulitis and included unspecified antibiotics. The clinical outcome of the event vaccination site cellulitis (arm was itchy where she got the vaccine, and she developed a big red hot lump), achy, feeling off, fever and headache was unknown. The clinical outcome of the patient tired was recovering.
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| 50 | 2021-04-28 | impaired work ability |
This is the second shot. My first Phizer shot was 3/27/21 Lot ER8732. The first shot I was just en...
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This is the second shot. My first Phizer shot was 3/27/21 Lot ER8732. The first shot I was just ending my period. Right after the first shot I started getting heavy cramps and experienced flooding, clotting, and cramping for the next 3 weeks. After this second shot I was not having my period (having ended about 1 week before the second shot). 3 days later I again got heavy cramps and heavy bleeding. I have not experienced the clotting as much this time - but I am bleeding MUCH heavier and experiencing uncomfortable cramps to the point I had to take some time off from work yesterday.
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| 50 | 2021-04-29 | anxiety |
Of note, after 15 minutes of observation, patient felt sensation of carotid pulse racing. I was call...
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Of note, after 15 minutes of observation, patient felt sensation of carotid pulse racing. I was called by support staff to evaluate patient. Patient was directed to chair and I interviewed patient. She reports history of low blood pressure at baseline, and not eating food today. She reports a coffee on her way to the vaccine site. Nursing staff available and assisted with collection of vitals. Vitals were SpO2 98%, HR 70-78, Blood Pressure 98/70, RR ~16. Patient reports this is her blood pressure baseline. I auscultated heart and lungs, with a RRR, no murmurs, and CTAB. I checked patient's right carotid pulse, at the location she felt it was quick, and it matched pulse oximetry heart rate of ~70. Patient self-checked behind me and agreed that it felt back to normal. Patient denied presyncopal sensation, and denies any other symptoms and agrees she feels back to normal. At this point patient seems medically stable, and differential diagnosis of symptoms includes mild vagal response, dehydration/caffeine intake-induced tachycardia (transient), or anxiety component. Discussed these possibilities with patient, who agrees. Patient was discharged from the vaccination site.
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| 50 | 2021-04-29 | feeling abnormal |
Wednesday 4/28/2021 I was foggy and tired. Thursday 4/29/2021 I woke up feeling like I had the flu...
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Wednesday 4/28/2021 I was foggy and tired. Thursday 4/29/2021 I woke up feeling like I had the flu. At approximately 1pm on Thursday 4/29/2021 I was in the bathroom and started seating and seeing white spots. I went to my bedroom to lay down in front of the cold air and passed out. I woke up about an hour later. I slept the rest of the day and woke up Friday 4/30/2021 feeling fine
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| 50 | 2021-04-29 | nervousness |
Patient began with symptoms of feeling flushed within l minutes of receiving the vaccine. she compl...
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Patient began with symptoms of feeling flushed within l minutes of receiving the vaccine. she complained of feeling shaky and was evaluated by EMS. She was monitored for more than 30 minutes including BP which ranged from Systolic 183-202 and diastolic 109-121. Her HR ranged from 110-130. her symptoms did not resolve and seemed to intensify. she was transferred to the hospital for further evaluation.
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| 50 | 2021-05-09 | disturbance in attention |
Woke up fine the next morning but then got two hives on my face, sneezing and iching. Body weakness...
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Woke up fine the next morning but then got two hives on my face, sneezing and iching. Body weakness later in the day. Thoughtout the next week experienced chills, up and down temp around 99.7 at the highest. Difficulty concentrating at 72 hours past vaccine. Periodic sore throat post 4 days of vaccine. Very concerned with getting the second dose.
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| 50 | 2021-05-10 | feeling abnormal |
Shakes that feel like a seizure; Shakes that feel like a seizure; Choking; Side effects are minimal ...
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Shakes that feel like a seizure; Shakes that feel like a seizure; Choking; Side effects are minimal unless she got sun on her; sunlight made her sick; Nauseous; Light headed; Weak; Sweaty but chills; Sweaty but chills; Brain fog got really bad; This is a spontaneous report from a contactable consumer(patient). The 50-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 22Apr2021 16:00 (Lot Number: ER8736) as first dose, single for covid-19 immunization. Medical history included Polycystic ovarian syndrome(PCOS), Neuropathy, disabled, asthma, allergies, beat kidney cancer, autoimmune deficiency, anemic, gastric bypass. Concomitant medications included hydrocodone 10-325, escitalopram oxalate (LEXAPRO) 20mg, omeprazole 20mg. The patient had known allergies: tramadol, melamine, gabapentin. The patient stated sunlight made her sick. Side effects are minimal unless she got sun on her. Even through window. She got nauseous, shakes that feel like a seizure, light headed, weak, choking, sweaty but chills. Brain fog got really bad. She had brain fog from it but to the point she forgot she was headed to the bathroom after sunlight touched her. She had been able to handle indirect sunlight until today. Now she can't have any sunlight touch her without a reaction. Direct or Indirect. Nothing helped. Just sundown. Once the sun went down, the side effects calmed down. Events occurred on 26Apr2021 14:30 with outcome of recovering. There was no treatment received. Since the vaccination, the patient had not been tested for COVID-19.Case was assessed as non-serious by reporter.
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| 50 | 2021-05-18 | feeling abnormal |
pt states she was nauseated and then started getting the severe flu like symptoms. She was achy, he...
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pt states she was nauseated and then started getting the severe flu like symptoms. She was achy, her tongue was tingling and numb. She had a sore throat, was light headed, and had a 101 temp. She was having heart palpitations and fast heart rate and felt out of it. On 5/19/21 she is feeling better with a slight head ache. Pt will contact PCP if symptoms do not improve.
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| 50 | 2021-05-21 | disorientation |
sharp passing pain near my heart; Almost fainted; woozyiness; disorientation; weakness in arm; Pain ...
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sharp passing pain near my heart; Almost fainted; woozyiness; disorientation; weakness in arm; Pain going across shoulders and across upper back; Pain going across shoulders and across upper back, lasted through part of the night; Fever started after I came home. I usually get fevers when I have an allergic response.; This is a spontaneous report from a contactable consumer (patient). This 50-years-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 04May2021 15:00 (Lot Number: EW0172) as single dose for covid-19 immunisation. Medical history included penicillin and latex (allergy). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8729) administered in left arm on 13Apr2021 02:45 pm (at 50-year-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04May2021 at 15:15, patient experienced almost fainted, woozyiness, disorientation and weakness in arm, could feel the loss of control of arm, pain going across shoulders and across upper back, lasted through part of the night. Fever started after patient came home, she usually get fevers when had an allergic response. Patient experienced discomfort as drug initially moved through the body, she had a sharp passing pain near heart, this subsided after a few minutes on 04May2021. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the events. Outcome of the event sharp passing pain near heart was recovered on 04May2021, other events was recovered in May2021. No follow-up attempts are needed. No further information is expected.
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| 50 | 2021-05-24 | feeling abnormal |
A MCAS flare that was manageable for the first 5 days and then unbareable for the next 10 days. Ear...
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A MCAS flare that was manageable for the first 5 days and then unbareable for the next 10 days. Ear ache. Low grade fever. Exhaustion. Nasal drip. Sore throat. Respiratory steaming. Elevated heart rate. Diaphragm pain. Brain fog.
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| 50 | 2021-05-24 | impaired work ability, feeling abnormal |
That first few minutes after nausea and headache. Got home and I started having warm, flushing feeli...
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That first few minutes after nausea and headache. Got home and I started having warm, flushing feeling. Like you feel hot inside. I took my temperature. It was 99 and then 100. I started feeling like somebody beat me up. My body was over fatigued and feeling weak - sore everywhere. I went to bed as I was dizzy, too. I didn't want to eat anyways because I was nauseated. It was up to 102. I had fever, nausea, and that night my temperature was even higher and I couldn't get out of bed. I had headaches. I took 2 500 mg (1000 mg) of Tylenol. I took Pepcid. I tried to eat something. That headache was so severe and I took Benadryl. That continued on for the next week. I didn't want to keep taking Tylenol all the time. I took 1000 mg and then maybe Ibuprofen or 500 mg of Tylenol later that day and Benadryl that night. Going to the next week, I still had fever, headache, I had gurgling stomach. It felt like someone was working on something inside of my tummy. It wasn't gas. It felt like someone was touching different organs and it was making feel nauseated. I had dizziness if I didn't take Benadryl. Once I woke up, I'd have the headache, dizziness would be better and I'd try to eat but the nausea would still be there - I vomited once or two times. Body sore, really really tired. Chills lasted for more than a week - especially at night. Face was flushed from the first day of injection and it was flushed for about a week because I had a fever. I was so weak - couldn't do anything - like I had the flu but more severe symptoms. Would walk down our stairs and I would already be exhausted. Severe for first two weeks and then the nausea symptoms lessened but it's still on and off when I went back to work. The headache was just there and not going away - my head feels so heavy. Like something is puncturing me - sharp pain. I do have a very high tolerance of pain and so if I say it's hurting, it's really bad. I can tolerate more than other people. Severity of headache has been better since end of April - I was working and it was so hard. I'm a nurse and that's why I can't take off that long from work. The moment I didn't have the fever anymore, I went back to work even though I was suffering from the other symptoms still. . I missed two weeks of work. Because I'm part-time, it wasn't covered to have the time off. The Tylenol or alternating with Motrin would help lessen the pain a little but it was not getting rid of the pain so I just stopped taking it because I didn't want to damage my Kidneys. Headache, nausea and dizziness is at this time is about 80% gone. It's not as severe as those first month now by the first week of May.
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| 50 | 2021-05-25 | feeling abnormal |
Fever, chills, headache, fatigue, malaise, body ache felt like beaten up and could not get out of be...
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Fever, chills, headache, fatigue, malaise, body ache felt like beaten up and could not get out of bead or walk, brain fog, unable to eat. This lasted for about 2.5 - 3days.
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| 50 | 2021-05-25 | feeling abnormal |
muscle ache; decrease smell; Arm immediately became heavy; headache; brain fog; complete exhaustion;...
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muscle ache; decrease smell; Arm immediately became heavy; headache; brain fog; complete exhaustion; This is a spontaneous report from a contactable other HCP. A 50-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right on 22Jan2021 14:00 (Lot Number: EL3302) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid tested post vaccination. The patient experienced arm immediately became heavy (and lasted for apprx 24 hours) on 22Jan2021 14:30. Within 20-30 min of injection patient developed headache (circular around head -temple level), brain fog, complete exhaustion all on 22Jan2021. All symptoms lasted for 6 days. The events recovered on 28Jan2021. Other brief 2-3 hour symptoms were muscle ache between neck and shoulders, decrease smell. These last events recovered on an unknown date No follow-up attempts are possible. No further information is expected
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| 50 | 2021-05-28 | depression |
Experienced loss of appetite/ lost appetite; Getting depressed, it isn't right in head/ feeling depr...
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Experienced loss of appetite/ lost appetite; Getting depressed, it isn't right in head/ feeling depressed; Something isn't right mentally/ couldn't connect the thought to switch the action/ delayed response to do the actual action; When getting ready to make any type of motion or walk, equilibrium is off; Pressure in the back of head; Weakness/ weak; Fatigue; This is a spontaneous report from a contactable consumer. A 50-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, distribution number and expiry date was not reported) via an unspecified route of administration on 21Jan2021 (at the age of 50-year-old) in left arm as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not received any other product and investigation assessment was not reported. As per the description, the caller stated, she received the first dose of the Pfizer covid vaccine last Thursday i.e. on 21Jan2021. Since she got the covid vaccine she experienced fatigue, weakness, felt like she was getting depressed, something wasn't right mentally, it wasn't right in her head, she felt like she can't. On Monday i.e. 25Jan2021 she was driving, 30mph and her brain was telling her to press the pedal. There was a delayed response to do the actual action, while driving down the road doing 30 in a 45, she wanted to speed up, but she couldn't connect the thought to switch the action, and it was the same thing when she got home, she wanted to pick up the remote, but it was putting the thought to the actions she couldn't do, she was just not herself. She had experienced loss of appetite, pressure in the back of her head, like when she was getting ready to make any type of motion or walk, her equilibrium was off. Her equilibrium being off depends on how much pressure was in the head, how much she felt it, to determine if her equilibrium is off, and was been varying. It is not the same all the time. She took off work on Tuesday i.e 26Jan2021 hoping she needed more rest. She went to the doctor on Wednesday i.e 27Jan2021, and the doctor thought maybe she had some tension from receiving the shot. It wasn't getting any better. She was due to get her next shot (second dose) and she asked if anyone else had these symptoms and if so how long did they last. She was trying to not take herself the second shot, she likes to travel and is trying to be brave for her children, and she works around soldiers everyday, the reason she got it is to protect her family, but she doesn't want to feel like this after the second shot. She had been 22 years in the army and had gotten many vaccine. she went into work on monday i.e. 01Feb2021, and haven't been back, covid test was negative. Hoping by monday i.e. 01Feb2021, she would be better. The patient underwent lab tests and procedures which included sars-cov-2 test as negative on an unknown date. The outcome of the events fatigue, asthenia and decreased appetite was not recovered/not resolved and for all other events it was unknown. Information on Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
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| 50 | 2021-05-29 | disturbance in attention, amnesia |
Moderate memory loss, hard to focus, dizziness, lightheadedness - daily since vaccine (32 days so fa...
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Moderate memory loss, hard to focus, dizziness, lightheadedness - daily since vaccine (32 days so far).
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| 50 | 2021-05-29 | insomnia, panic attack |
Right inner ear whooshing coinciding with heartbeat began 6d post 1st Covid shot (had on April 15, 2...
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Right inner ear whooshing coinciding with heartbeat began 6d post 1st Covid shot (had on April 15, 2021). Persistent and constant. Coupled with extremely high blood pressure; atypical for patient. Ear whooshing went away 2 weeks after 2nd Covid shot. Intermittently returning 3+ weeks after 2nd Covid shot. Three days post 2nd shot (May 9th), awoken at night with repeated intense 'adrenaline' rushes/panic attack like feelings, which prevented sleep. The events seemed to occur at the moment the patient was about to fall asleep, then would jolt patient up. These INTENSE events continued for 4.5 hours. Patient tried deep breathing exercises to no avail. Patient eventually rose from bed and did multiple 'full body shakes' to try and relax. Finally was able to sleep. Patient experienced 2nd menstrual cycle in one month. Atypical for this person, who had never had any anomalous or difficult cycles in her life. May 29. This night again experienced same adrenaline rush/panic symptoms overnight, again wholly preventing sleep. Patient took ibuprofen to relax muscles, to no effect. Patient again tried full body shakeout 2x. After 2nd time, was able to sleep after 4-5h of insomnia--complete inability to fall asleep.
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| 50 | 2021-05-31 | impaired work ability |
multible events shoulder injury tremors throughout her body body aches blood circulation problems sh...
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multible events shoulder injury tremors throughout her body body aches blood circulation problems she has seen multible doctors neurologist cardiologist gastro were as the doctors feel the vaccination has triggered these series of events that is dibilitating her body.she has not been able to work since inception of covid vaccination.
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| 50 | 2021-05-31 | sleep disorder |
This is my second shot and I have a very bad rash on my breast, under my breast, and my groin. I hav...
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This is my second shot and I have a very bad rash on my breast, under my breast, and my groin. I have had it since last month of May and it keeps me up at night along with a fever at times now. I need to know what I should do?
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| 50 | 2021-06-01 | disturbance in attention |
1st shot in right arm. After 24 hrs sore arm then intense headache on right side. Took 200mg Advil...
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1st shot in right arm. After 24 hrs sore arm then intense headache on right side. Took 200mg Advil. Very tired with intense lack of focus. Mental cramps on 5th & 6th days. Most symptoms lasted 2 weeks. 2nd shot 05/06/2021 in AM in left arm. 2nd day started having pain in chest on left side, lungs heavy, like couldn't catch breath, very weak in the knees and very tired. I am a non-smoker, healthy, only take vitamins and only have an occasional drink with alcohol 1x or 2x per week.
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| 50 | 2021-06-01 | impaired work ability |
I had a very heavy tight chest feeling on that Friday. I left work and when I got home was tired and...
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I had a very heavy tight chest feeling on that Friday. I left work and when I got home was tired and all over achy. One trip to Medical Center -went to ED on 23rd - for shortness of breath. Albuterol inhaler was prescribed (had already been prescribed by my doctor.) I felt ready to go back to work in about two weeks and I felt back to normal in three weeks or so. My Dr. just left practice recently.
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| 50 | 2021-06-02 | anxiety | Pt. experiencing anxiety, light headedness and dizziness. B/P 89/54, B/P 101/65 |
| 50 | 2021-06-02 | feeling abnormal |
heart rate elevated; muscle pain; blood cell counts abnormal; equilibrium off; Blurred vision; Diarr...
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heart rate elevated; muscle pain; blood cell counts abnormal; equilibrium off; Blurred vision; Diarrhea; felt sick all day; sinuses feel off; pressure from headaches; Feeling hot and cold; Chill; fever 101.7 up to 103/ fever 103°F; foggy; Nauseous; tired; Light-headed; pain in arm; couldn't sleep; pain in arm; couldn't sleep; left arm sore and inflammed; swelling; headaches; This is a spontaneous report from contactable consumer (patient) or other non HCP. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch number/Lot number: EW0162, Expiration date: unknown), via unspecified route of administration in arm left on 09Apr2021, at 1ST DOSE, SINGLE for COVID-19 immunization. Patient medical history included ongoing prediabetic , Chronic sinusitis on unspecified date in 2014 and patient had undergone sinus surgery on unspecified date in 2014, COVID-19, acid reflux, patient had family history of father had a heart attack and mother had a heart attack and they are both diabetic. Concomitant medication included pantoprazole (PANTOPRAZOLE) on unspecified date at 2021 to ongoing for acid reflex which was diagnosed years ago, but has been actively taking for 3 months until now, multivitamin on unspecified date. Patient did not received any other vaccines Prior to that Vaccinations within 4 weeks. Patient had no know illness at the time of vaccination. 09Apr2021 patient experienced headaches, Light-headed, pain in arm; couldn't sleep, left arm sore and inflammed; swelling, on 10Apr2021 patient experienced chills, fever 101.7 up to 103/ fever 103°F, foggy, Nauseous, tired, Diarrhea, felt sick all day, sinuses feel off; pressure from headaches, Feeling hot and cold. on 12Apr2021 patient experienced equilibrium off, Blurred vision. on an unspecified date patient experienced heart rate elevated, muscle pain, blood cell counts abnormal. Patient reported that she had her Pfizer BioNTech vaccine on Friday 09Apr2021 and has had some serious side effects. patient wants to understand why she had such bad side effects compared to other people. Husband and other people she knows didn't have any side effects and she did. She states her next shot on 30Apr2021 and when she got the Pfizer COVID-19 vaccine, she felt fine as stayed the wait time at the facility but got lightheaded when she got to her car. She reported that on 09Apr2021 she had the lightheadedness comes and goes and she also experienced a headache and her arm soreness inflammed; swelling on 09Apr2021 in Friday. She reported that her arm pain was so bad that she couldn't not sleep. She could not lay on it. she states it is a little better now, it still hurts, but she is able to roll off of it and get some sleep. Patient experienced chills and a fever from 101.7 up to 103 degrees and Feeling hot and cold on Saturday 10Apr2021. she stated that she was taking Ibuprofen for pain and fever, and was told she shouldn't take Ibuprofen, she should take Tylenol to break the fever and she took some Tylenol and her fever broke after taking Tylenol. Patient stated that on 10Apr2021 she had also felt foggy, nauseous and tired. She reported that she had COVID in Jun2020 and felt like COVID all over again. she had the same symptoms; really tired, could sleep for days. patient thinks she had a bit of an allergic reaction on her arm. It has improved, but now she has a red swollen splotch on her arm, and it is not even where they put the needle it is down a little bit lower. Patient reported that her heart rate was elevated as well. Patient reported that 12Apr2021 she felt like equilibrium is off, and had blurred vision, feels fine right now, but all she has done was slept since she got home from work yesterday and hasn't exerted herself today yet and right now she is not tired, she slept for 12 hours. Patient reported that she felt sick all-day and had diarrhea on 10 Apr2021 in Saturday, nausea started on Saturday, all she could eat was chicken noodle soup and she experienced it yesterday. she states yesterday she took some Tylenol, and got a chicken sandwich, since she had taken some medication, and then wanted to throw it up when she got home and she is not foggy now, but it comes and goes, the symptoms are intermittent, she doesn't know if she will be ok. she can still feel on 10 Apr2021 her had sinuses feel off and she had chronic sinusitis and whenever she gets sick her sinuses get attacked. she states she didn't think she would get side effects because she already had COVID, but apparently it is the opposite. Patient reported that she was being told so many different things and now she was scared to get the second shot and is freaking out. she reported that she had to cancel all the appointments at work yesterday day because of the events and she thought she would have the weekend to recover from any side effects but couldn't do her job yesterday. Patient was not their in-Emergency Room nor visited physician office. It was reported that blood cell counts abnormal, so her doctor has her going to see a hematology doctor on Thursday. It could be nothing but sending there to check. The patient underwent lab test and procedure which include blood cell counts abnormal on 10 Apr2021 Outcome of events headache, chills, fever, foggy, nausea, tired, equilibrium off, Blurred vision, felt sick all day, sinuses feel off; pressure from headaches, heart rate elevated, muscle pain were unknown, light-headed, Diarrhea, Feeling hot and cold were not resolved, pain in arm; couldn't sleep, left arm sore and inflammed; swelling, were resolving, Follow up (13Apr2021): This is a follow-up spontaneous report from contactable consumer. A 50-year-old female patient reported new information received which included event detail, relevant medical history, concomitant medication. No Follow-up attempts are needed. No further information is expected
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| 50 | 2021-06-03 | insomnia |
could not sleep (toss and turn all night); Headache; Flu like symptoms; Chills; This is a spontaneou...
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could not sleep (toss and turn all night); Headache; Flu like symptoms; Chills; This is a spontaneous report received from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: lot number: EL3247) via an unspecified route of administration in the left arm on 23Feb2021 at 11:15 (at the age of 50-year-old) and her second dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: EL3247,) via an unspecified route of administration in the left arm on 16Mar2021 at 10:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 10:30 PM, the patient could not sleep (toss and turn all night), experienced headache, flu like symptoms and chills. The patient did not receive any treatment for the events. The clinical outcome of the events could not sleep, headache, flu like symptoms and chills were recovering. No follow-up attempts are needed. No further information is expected.
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| 50 | 2021-06-05 | loss of personal independence in daily activities |
Patient felt pain right on the injection site when the vaccine was administered. The pain persisted ...
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Patient felt pain right on the injection site when the vaccine was administered. The pain persisted and extended to the whole arm in the next few days. There was no redness or swollen tissue. Now, after 1 month since the shot, the pain is not going away. After tried some OTC pain medications, Patient still feels pain all the time, and it affects her daily movements also, i.e. reaching out or driving, and this is the reason patient came back now to report the issue.
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| 50 | 2021-06-06 | amnesia |
Multiple seizures, went to ER, lost complete memory for 18 hours, 3 day hospital stay, loss of drivi...
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Multiple seizures, went to ER, lost complete memory for 18 hours, 3 day hospital stay, loss of driving privileges for 90 days, on Keppra for seizures and on Eliqios for blood clot near the lung.
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| 50 | 2021-06-07 | feeling abnormal |
I started itching on my elbows, legs, rear./break out in hives; driving me crazy; This is a spontane...
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I started itching on my elbows, legs, rear./break out in hives; driving me crazy; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3249 expiry date was not reported), first dose , single via an unspecified route in the right arm on an 21Jan2021 at 06:30 AM as a single dose and dose 2 via an unspecified route of administration, at Arm Right on 12Feb2021 06:00 (Lot Number: EL9269, expiry date was not reported) as a SINGLE DOSE for covid-19 immunisation. The patient's concomitant medications were not reported. The patient had Known allergies Sulfa. The patient did not have covid prior vaccination. The patient did not covid tested post vaccination. On 20Feb2021 08:15 the patient experienced itching on patient elbows, legs, rear, break out in hives, (driving me crazy (feeling abnormal) the outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 50 | 2021-06-07 | loss of personal independence in daily activities |
previously injured biceps tendon flared up with extreme pain; doctor believed it could have been an ...
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previously injured biceps tendon flared up with extreme pain; doctor believed it could have been an immune response leading to frozen shoulder; doctor believed it could have been an immune response leading to frozen shoulder; extensive calcification of the biceps tendon; range of motion was extremely limited; unable to work, drive, get dressed by herself, or care for her children; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 29Apr2021 at 09:45 AM at the age of 50 years old (Batch/Lot number and Expiration date were unknown) as the 2nd dose, single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient previously received the 1st dose of BNT162B2 on 01Apr2021 at 09:30 AM (Batch/Lot number and Expiration date were unknown) in the left arm for COVID-19 immunization. Relevant medical history included injured biceps tendon, biceps tendonitis, and known allergy to Penicillin, all from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Following the vaccination on 30Apr2021 at 07:00, a previously injured biceps tendon flared up with extreme pain. The patient's doctor believed it could have been an immune response leading to frozen shoulder. Urgent care took x-rays, which revealed extensive calcification of the biceps tendon. The patient's range of motion was extremely limited and pain was difficult to manage with over the counter medication. The patient was unable to work, drive, get dressed by herself, or care for her children. Prednisone was prescribed and brought the pain level way down. The patient later had an ultrasound (US) guided needling and barbitage procedure as well as a cortisone shot in her shoulder to manage the pain. The adverse events started date on 30Apr2021 at 07:00 AM. The adverse events did result in both doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures, which included ultrasound guided needling and barbitage procedure with unknown result on an unspecified date. Therapeutic measures were taken as a result of all the events, which included prednisone, Us guided needling & barbitage, and a cortisone shot, hydrocortisone sodium succinate (CORTIS). The patient was recovering from all the events. Information on the batch/lot number has been requested.
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| 50 | 2021-06-08 | impaired work ability, feeling abnormal |
Ok I was in bed and I feel terribly like warm inside my body but outside my body, I was shaking and ...
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Ok I was in bed and I feel terribly like warm inside my body but outside my body, I was shaking and froze. My brain was telling me to move but I could not move. I called my husband for help and I could not move my body. I had him go get some Advil that I took then I checked my temperature and it was over 100, I don't remember exactly. And it took like 1 hour I tried to get up but I could not, I felt so dizzy and like I going to vomit. So I went back to bed and I got up two hours later and when I get up, I felt so totally blocked and dizzy, kind of seasick feeling. I sat down because I could not walk, I was so shaking. I kept trying to get up and after 3 attempts I was able to go to the bathroom and when I did I had diarrhea and vomiting but that was mainly saliva not food. I drank a lot of water to hydrate and wash it out. When I drank some water it also came back out. My body was like it did not want to take anything in. My fever was going down in another day, but I had to call into work. I was in bed for another day. I was still very warm inside but shivering and cold. My muscles also felt tingling and tight and uncomfortable. The next day I called into work again. On the 3rd day I had no more fever and had some muscle pain but did not feel warmness inside but am still shaking a little bit.
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| 50 | 2021-06-08 | insomnia |
Wednesday, May 19, 2021 1st COVID-19 vaccination shot Summary: Wednesday, May 19, 2021 received my ...
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Wednesday, May 19, 2021 1st COVID-19 vaccination shot Summary: Wednesday, May 19, 2021 received my 1st COVID-19 vaccination shot. My body tried to reject it. I threw up 5 times. Ensued many unwanted side effects. I don?t think it would be good to get the 2nd vaccine dose. Given I am not fully vaccinated, I need an alternative solution to prevent being infected with the virus. Help!!!! Please Help!!! Bad Side Effects: Stuffy Nose Congested Nose Headaches Vomiting Nauseous Upset Stomach Unsettled Stomach Unusual Perspiration Pain in Left Arm Abnormal Period Menstrual Blood Clots Shoulder Pain/Tension Upper Back Pain/Tension Chest Pain/Tension Shooting Pain in Chest Heart Palpitations? Numbness Runny Nose Sneezing Profusely Allergies? Hoarse Voice Winded Dry Mouth Existing Worsened: Cold Sores Stomach Noises Snoring? Foot Numbness Ear Ringing Eye Floaters Joints Popping Sound Other Observations: Stomach Bloated Increased Flatulence Pseudo Conclusion: Given my body?s adverse reaction I don?t think it is wise to get the 2nd shot. It is obvious my body does not like it. I am disappointed because I really did not plan to get vaccinated; however, I felt I had no other option when the government made the announcement. When the government announced No masks for those vaccinated, I know there would be some NOT vaccinated & NOT wearing a mask thus putting me at risk. I am okay with wearing a mask for another year or even for the next 5 years. The doctors have said me wearing a mask is protecting others not necessarily myself. I concluded even if I continue to wear a mask there would be others (NO mask & NOT vaccinated) not following the rules potentially exposing me to the virus. Hence the only way to protect myself is to get vaccinated. The vaccine appears to have affected so many areas of my body. I regret getting the 1st shot, I want to remove every trace of it from my anatomy. Please let me know if it is possible to rid the vaccine along with all the bad side effects from my body. I do not want to subject my body to anymore of this vaccine; however, I still need a reliable solution to avoid being infected with the virus. I don?t know what to do. Details: Wednesday, May 19, 2021, I received my 1st COVID-19 vaccination shot around 3:30pm. The medical staff had all those being vaccinated to sit for at least 15 minutes for observation to be monitored. I stayed for monitoring for close to an hour (wearing my masks). I felt fine, I noticed my right nostril felt stuffy, congested with a slight burn sensation. I noticed a slight headache when I left. I had about 3 errands to do. 2 hours later I wasn?t feeling well. In addition to a stronger headache my stomach felt queasy. Around 6:30pm I had to pullover to vomit; I threw off my mask and threw up once and then a 2nd time. I sat in my car taking deep breaths until I felt I could make it home. I make it home around 7pm in time to throw up 3 more times, for a total of 5 times. The vomit tasted acidic, sour, citrusy, and metallic at times, and salty. I was only throwing up the vaccine it was mostly clear with white alka seltzer looking deposits. I last ate some crackers around 12 noon. Vomiting is NOT normal for me. I can?t remember the last time I threw up, many many many years ago. l had a headache, queazy stomach, and was exhausted; about 7:30pm tried to sleep. I got up around 10:30pm ate a few saltines and drank a little water but I still didn?t feel good so I didn?t eat anything else. Rough night trying to sleep, tossing and turning. Next day (Thursday day 2) I felt slightly better, not comfortable enough for real food so I drank plenty of water in small amounts and ate saltines; headache subsided. I also had more than usual underarm perspiration with a strong unfamiliar odor. Wednesday, May 19, 2021 1st COVID-19 vaccination shot It appears the vaccine affected my menstrual cycle. My period usually lasts for 3-5 days max, usually light blood flow on days 4 and 5. It was a normal light day 5 when I received the vaccine. After the vaccine, I began having heavy blood flow. The heavy blood flow is accompanied by blood clots. In the past I?ve had a blood clot here and there but not like this. Menstrual blood clots for 9 days after being vaccinated. This is NOT normal for my body. My period was 14 days. Prior to being vaccinated, I NEVER had a period last this long. To my surprise the vaccine affected my female organs. I am right handed, so the nurse recommended using my left arm for vaccination. Left arm where vaccine injected was very sore. Arm pain subsided after 3 days. Pain soreness tension primarily on my left side, shoulder, upper back, chest area. There is a shooting pain on left shoulder, down back to breast, chest heart area; pain comes and goes. Heart palpitations? Experienced this for over a week about 10 days. Numbness in left hand when I sleep on my left side, wake with my left hand numb. Numbness in both hands when I try to sleep on my back. Numbness in my feet after standing for about 15 minutes. Numbness in my leg and buttocks, primarily left side after sitting for an extended period of time. Before being vaccinated I only experienced numbness in my right foot after being on my feet for an extended period of over 4 hours. Last year my right foot/heel would began to hurt after being on my feet for an extended period of time (> 4 hours). Then there would be pins and needles sensation. The solution would be to rest and elevate my feet. I also replaced my shoes (proper support). Post vaccination even before the time my feet would hurt now my right foot goes numb within 30 minutes of standing even while wearing supportive shoes. My left butt cheek goes numb when I am sitting with my legs elevated; this was my most comfortable position pre-vaccination. Since the vaccine my stomach feels upset or unsettled especially in the morning. I am also noticing bloating and more gas than usual. My stomach is also excessively more noisy. Before the vaccine my stomach would make noises when I was hungry or hadn?t eaten, but now there are so many stomach noises almost nonstop all day and night long all the time My nose is feeling congested with a slight burn sensation since getting the vaccination. Immediately after getting the shot my right nostril felt stuffy, congested with a slight burn sensation. This congested feeling comes and goes, especially noticeable when wearing a mask. Prior to being vaccinated I had not experience this issue even as I have worn multiple masks for over a year with NO stuffy nose. Saturday, May 29, 2021 (day 10 post vaccination) I get cold symptoms; runny nose and sneezing. I haven?t had a cold in years; I don?t really get colds; if so the symptoms are mild and quickly dissipate. Now my nose has been running pretty much non-stop causing me to blow my nose just as often. I am also sneezing a lot. This is NOT normal for me. I drank plenty of liquids; however, running nose and sneezing continued leading to hoarse voice. These symptoms prevented me from sleeping. I don?t know if these are cold or allergy symptoms. I had NO allergies before the vaccine. These symptoms finally subsided after 3 or 4 days. My neighbors are waking up in the middle of the night (2am, 3am, 4am, 5am). I began to wonder if I am waking my neighbors possibly with snoring. I don?t really know, no evidence. Throat feels winded and dry when talking especially when I try to whisper. I have to drink a lot of water. Ringing in my ear started In 2019. I thought this phantom sound went away; however, post vaccination I?m hearing the ringing sound again. It seems worse than before. 2018 diagnosed with eye floaters. I am noticing floaters more since getting the vaccine. I usually see the eye floaters when going to light from dark. Post vaccination I am noticing the floaters even in dim light; not normal. I started getting Cold sores in 2006. I thought I had them somewhat under control. Since the vaccine l keep getting cold sores, this may be due to my menstruation. Recently within the past year, my shoulder and elbow joints sometimes make this popping sound when I exercise/move my arm. Post vaccination my shoulders and elbows are making the popping sound every time I move my arm. Now sometimes my knees and ankles are also making a popping .
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| 50 | 2021-06-08 | sleep disorder, insomnia |
Developed common side effects fatigue, aches and headache day 2. Day 6 developed severe temporal hea...
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Developed common side effects fatigue, aches and headache day 2. Day 6 developed severe temporal headache with palpable temporal scalp tenderness and neck ache with severe sleep disturbance lasting 3 days. After injection 2 developed similar but more symptoms day 5. Subsequent development of occipital neuralgia on left increasing frequency and duration with associated severe insomnia and chronic muscle spasms of neck, shoulders and chest. Also developed intermittent muscle cramps in legs, biceps and triceps as well as short lived muscle fasciculation. Treated with tizanidine, Medrol dose pack, Celebrex and massage with no relief. Occipital nerve block on 5/28 relieved occipital neuralgia but developed severe spasm of neck, shoulders, upper back and chest being treated with PT with reported mild improvement.
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| 50 | 2021-06-09 | feeling abnormal, insomnia, anxiety |
feel like in a fog; severe headache/all over the top of my head and throbbing; chills; anxious; coul...
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feel like in a fog; severe headache/all over the top of my head and throbbing; chills; anxious; could not relax or sleep; Soreness at the injection site; Diarrhea for 3 hours; exhausting/fatigue; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 24May2021 (Batch/Lot Number: ER8735) (at the age of 50-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history included COVID-19 prior to vaccination. Concomitant medications included fluoxetine; mirabegron (MYRBETRIQ); propranolol and lithium; all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8735) on 03May2021 (at the age of 50-years-old) in the right arm for COVID-19 immunisation. Patient had vaccine number 2 in the afternoon. On 24May2021 at 23:00, patient began to experience a severe headache. It was all over the top of her head and throbbing. Patient had the chills, anxious and could not relax or sleep. Patient was unsteady on her feet. Patient had soreness at the injection site and diarrhea for 3 hours. It was exhausting. This morning (date unspecified), she still have not had any sleep. She had a slight headache and fatigued. She felt like she was in a fog. No treatment was given to the patient. Since the vaccination, patient has not been tested for COVID-19. Outcome of headache was recovering, diarrhea was recovered on 25May2021, while remaining events was not recovered. Information on the lot/batch number has been requested.
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| 51 | 2020-12-31 | feeling abnormal |
About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and fe...
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About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and feeling tingling and maybe swollen, also, all of my regular pains in my body, ie. various mouth pains and said pains, certain things that act up in my body, were intensified and more bothersome, and I had a headache that wouldn't go away. I felt "off" that night and the next day. Probably like I was mildly sick and fatigued with body feeling sore all over and headachey. About 36 hours after getting the initial dose, I was feeling regular again.
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| 51 | 2021-01-03 | feeling abnormal |
20 minutes after receiving the vaccination the resident started to not feel well. She said she felt ...
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20 minutes after receiving the vaccination the resident started to not feel well. She said she felt very far away and just kept repeating I don't feel well. She was diaphoretic and her chest was very red and she kept scratching and rubbing it at it. I asked if she wanted IM Benadryl or epipen and she at first denied. She also said she felt like she needed to focus on her breathing. At this time we decided it was best to administer Epipen x 1 dose. Immediately after she felt better. She was observed for another 30 minutes and then went home. at 7:17pm I called and spoke with her. She said her arm was sore and that her oxygen levels were about 88-89% which is low for her but she said she felt fine and is currently working right now.
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| 51 | 2021-01-04 | sensation of foreign body |
swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), to...
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swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ek5730, via an unspecified route of administration on 30Dec2020 at 12:00 (at the age of 51 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included lupus from an unknown date, and allergy to Celebrex (itching). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine, vitamin D3, and zinc, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 30Dec2020 at 14:30, the patient experienced swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands. The patient received treatment for the events which included Pepcid, Benadryl and prednisone. The clinical outcome of swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-04 | thinking abnormal, feeling abnormal |
waves of nausea for 2 days after; Dizziness; headache; difficulty with higher thought processes - fe...
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waves of nausea for 2 days after; Dizziness; headache; difficulty with higher thought processes - feeling "zoned out"; difficulty with higher thought processes - feeling "zoned out"; This is a spontaneous report from a contactable other healthcare professional (patient). A 51-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number unknown due to not available/provided to reporter at the time of report completion), intramuscular at left arm on 23Dec2020 09:00 at single dose for COVID-19 immunization at a "Nursing Home/Senior Living Facility". The patient's medical history included Gluten and FODMAP food allergy. Concomitant medications received within 2 weeks of vaccination: dietary supplements. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 post the vaccination. COVID-19 test post vaccination on 23Dec2020 result was negative. It was reported that on 23Dec2020 09:30, the patient experienced dizziness, headache, difficulty with higher thought processes - feeling "zoned out", and "waves of nausea for 2 days after". No treatment was taken for the above events. The outcome of the events was recovered in Dec2020. Information on the lot/batch number has been requested.
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| 51 | 2021-01-05 | sensation of foreign body |
felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling ...
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felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there. Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown. Information on the Lot/batch number has been requested.
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| 51 | 2021-01-06 | impaired work ability |
Patient started experiencing extreme fatigue and headache on 1/6/2021. She arrived at work on 1/7/20...
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Patient started experiencing extreme fatigue and headache on 1/6/2021. She arrived at work on 1/7/2021 and was experiencing extreme fatigue, severe headache, welts, naussea, and feeling of walking on broken bones. Patient was advised to go home from work.
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| 51 | 2021-01-06 | sleep disorder |
36 hours after receiving the vaccine I was awakened at 4:00 AM 12/20/20 by muscle fasciculations- mo...
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36 hours after receiving the vaccine I was awakened at 4:00 AM 12/20/20 by muscle fasciculations- mostly in my legs. It was very bothersome and caused difficulty sleeping for a few days. The second week after the vaccine it seemed to get better. I?m due for my second dose tomorrow and the fasciculations are back as of a few days ago, around 1/4/21. I?m wondering if I should get the second dose.
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| 51 | 2021-01-07 | anxiety |
Patient received vaccine at 13:30. She started feeling anxious after receiving vaccine but went back...
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Patient received vaccine at 13:30. She started feeling anxious after receiving vaccine but went back to work. Patient received 50 mg of diphenhydramine at 14:30, she then started experiencing hives and shortness of breath. She was administer 0.3 mg of epinephrine into the thigh and EMS was called.
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| 51 | 2021-01-07 | nervousness |
feeling very shaky and dizzy when I stand up.; feeling very shaky and dizzy when I stand up.; This i...
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feeling very shaky and dizzy when I stand up.; feeling very shaky and dizzy when I stand up.; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19, lot number and expiry date not reported), intramuscular on 03Jan2021 13:15 at a single dose on right arm for COVID-19 immunisation. Medical history included none. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient reported, "I'm feeling very shaky and dizzy when I stand up on 03Jan2021 14:30. No treatment was given for the events. The outcome of the events was unknown. The events were considered as non-serious. Facility where the most recent COVID-19 vaccine was administered was in Nursing Home/Senior Living Facility. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications received within 2 weeks of vaccination. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19. Information about lot/batch number has been requested.
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| 51 | 2021-01-07 | panic attack |
I started few hours later started feeling thought it was stress. The next morning around 9am high mo...
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I started few hours later started feeling thought it was stress. The next morning around 9am high moderate pain left leg jaw, chest hurt, sudden panic attack and I had to calm down for minutes. I informed my coworker I was having a reaction and then it stopped. Then I scheduled an appt with my PCP had lab work, EKG results was normal. On 12/24 still exp high mild left jaw pain, heart racing and chest pain .I was scheduled stress test on 12/30 was normal.
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| 51 | 2021-01-08 | feeling abnormal |
Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "differ...
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Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "different" and spotty non-confluent erythema and pruritis over affected arm, upper chest, posterior neck. She reported feeling faint and began to have mild hyperventilation. Vital signs remained stable and WNL, lungs were clear with good air movement and there was no mucosal involvement. Pt was treated with PO bendryl. Over the course of 45 minutes her rash faded and her sense of pruritis also lessened. She was able to return to work with no further symptoms
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| 51 | 2021-01-09 | impaired work ability |
1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever ...
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1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever and chills temp at that time 100 degrees , : fever 100 to 101 degrees on day 1 , 2 , 3 , 100 degrees on day 4 , day 5 , myalgia , body aches and headaches daily week 1 and fatigue week 2 was bed bound for 2 days and then could not work for 3 days after that 2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6
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| 51 | 2021-01-09 | sleep disorder |
1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 13...
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1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 1330 still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 1415 reported to the vaccination clinic and told them of symptoms, SOB with movement, and general pressure in the chest. 2 Tylenol taken. I was required to check into the ER for Observation. oxygen saturation checked for 2 hours. no change in symptoms, no worsening. I then left work in the ER and went home. At approx. 1800 ate dinner, no real taste, but needed to eat. At 1830 showered, 2000 to bed, just feeling malaise. continued pressure in the chest and general soreness. 2 Tylenol Through the night I slept very poorly, tossed and turned, woke frequently. Body and joints with extreme pain everywhere it touched the mattress. I have a screw in my left foot, it felt like it was on fire at some point during the night. My left leg ached up into my hip. On the morning of January 8, woke approx 0800 with a temperature of 99.9, pain in all my joints, back and up into neck, headache, and nausea. Took 2 Tylenol, 3 ibuprofen, and 4 mg Zofran. 1200 symptoms began to lessen and felt like I had the flu, still sore, but less severe. 1300 - 2 Tylenol Slept better, just sore January 8 night. January 9 - 2 Tylenol in the morning, sore everywhere, right arm site sore, headache, eye pain, intermittent nausea. 2 more tylenol around 1800 January 10, 2 tylenol 0900, remain sore but lessening, headache and eye pain continues, intermittent nausea
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| 51 | 2021-01-10 | feeling abnormal |
On dec 29 I began fever, chills and bad headache. Tested negative for covid and flu. Also fatigue. ...
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On dec 29 I began fever, chills and bad headache. Tested negative for covid and flu. Also fatigue. Then dizzy and just didn?t feel good. Tested negative again on January 4. But still dizzy and fatigue.
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| 51 | 2021-01-10 | sleep disorder |
Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sle...
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Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sleep the whole night. fever went up to 101F. Also feeling extreme fatigue, not able to get up from the bed, took another dose 1000mg tylenol, completely lost appetite, body ache. Low grade ever lasted up to 1/8/21. Even now still feeling fatigue and frequent headache. The injection site felt fine two days following injection. But started feeling inlamed and painful on 1/8/21. On 1/9/21, the pain of the site expanded towards the armpit and left upper shoulder and back.
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| 51 | 2021-01-11 | disorientation |
achiness; Headache; Dizziness; Disorientation; Nausea; This is a spontaneous report from a contactab...
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achiness; Headache; Dizziness; Disorientation; Nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, expiration date: Mar2021), via an unspecified route of administration at the left arm on 05Jan2021 12:10 at a single dose for COVID-19 immunization in the hospital. The patient has not had any vaccines in four weeks. The patient has no medical history. There were no concomitant medications. The patient received the COVID vaccine on 05Jan2021 and confirmed that it was the first dose she received of the COVID vaccine. She clarified that she started to have dizziness, disorientation, nausea, achiness and headache. The dizziness, disorientation and nausea started about 8 hours after she received the vaccine, 05Jan2021 20:10. She stated that she was just trying to push through with the side effects. She woke up in the morning, 06Jan2021, feeling both achy and with a headache. She stated that she had the achiness that was regular and knew would normally come along with it. However, she also had a headache. The outcome of the events was not recovered.
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| 51 | 2021-01-11 | feeling abnormal |
COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/...
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COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; arm pain; she felt like crap the night; chills; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899, expiration date Mar2021), intramuscular on left arm, on 18Dec2020 at 0.3 mL, a single dose for vaccination. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and she tested positive with Covid. She received the Pfizer Covid vaccine on 18Dec2020. She was exposed to the virus through close personal contact right around this same time-frame and did develop the virus herself. She wanted to know if there were any recommendations regarding her needing to get the second dose in series. She stated that her husband, who was not vaccinated, had the virus and developed more serious symptoms than she did. She is concerned about worsening side effects with the second dose and stated that she felt like crap the night after her first dose with chills and arm pain. The patient tested positive for COVID-19 on 26Dec2020. Specific test name was unknown, but she knows it was not a rapid test. She is scheduled to get the second dose of the Pfizer COVID-19 Vaccine on 08Jan2021. She called to ask if she should or should not get the second dose relative to the COVID-19 diagnosis. She has not been able to find the information she is asking about. The outcome of the event of Covid-19 was recovering while other events was unknown. The Covid-19 was assessed as unrelated to the suspect drug.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment. COVID-19 antigen test positive.
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| 51 | 2021-01-12 | anxiety |
Jitters and increased anxiety and feeling of being overwhelmed. Prescribed Prozac 10 mg daily at th...
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Jitters and increased anxiety and feeling of being overwhelmed. Prescribed Prozac 10 mg daily at this office visit.
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| 51 | 2021-01-12 | feeling abnormal |
I received the vaccine on Monday at 4:30, around 5:30 I noticed my tongue feeling weird, no difficul...
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I received the vaccine on Monday at 4:30, around 5:30 I noticed my tongue feeling weird, no difficulty swallowing, no resp issue and no rash. I took 25 of Benadryl and went about my evening. Tuesday around 12:00 I had that same sensation but a little stronger, I would call it a tongue swelling but no resp issues or swallowing problems. I called my PCP and he recommended me to take Zyrtec (which I take 1 daily) BID and Benadryl prn. I took 3 doses of Benadryl Tuesday and a Zyrtec Tuesday night and one Wednesday and around 8:15 had the same sensation, tongue swelling but milder. I immediately took 50 mg of Benadryl and called my Dr again and he recommended a steroid pack and Benadryl prn and to not take the 2nd dose.
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| 51 | 2021-01-12 | impaired work ability |
The day after receiving the vaccine I woke up with slight soreness of the arm. At work at 10:00am I ...
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The day after receiving the vaccine I woke up with slight soreness of the arm. At work at 10:00am I began to get fatigued chills overall body aches but was afebrile. I also had nasal congestion and sneezing for 4 hrs. that resolved. At 12 noon I felt progressively worse and had to leave work. I got home and my temp was 100.2 and took more Ibuprofen at 1 PM. At 2PM the body aches and chills were pretty severe- my temp rose to 103.2. I took more Ibuprofen and alternated with TYLENOL and it returned to normal at 10 PM. I notified my Drs office and had a telemedicine visit with Dr at 4PM who thought it was a normal immune response but suggested getting a COVID Test in the meantime before returning to work. I woke up this morning afebrile with no issues notified employee health got a referral and had my COVID test completed at 09:30am. The urgent care MD strongly urged me to report to VAERS, not just CDC as I had yesterday. My COVID tests are still pending.
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| 51 | 2021-01-13 | feeling abnormal, impaired work ability, loss of personal independence in daily activities |
Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30a...
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Day 7 post vaccine, woke with vertigo, nausea and double vision prior to my alarm going off at 5:30am, told my husband that I did not feel right and it felt like something was wrong with me. I asked him to send a message to work that I was not feeling well and would not be in. I was not able to see my phone clearly as I had double vision. I went back to sleep to try to get relief, woke up and called out to husband for help and he said I was just making groaning noises but I know in my head I was saying please help me as I could not move my right side and I was not sleeping or having a dream. At approximately 9:30am my husband kept telling me someone was trying to text me and needed a response. I tried to get up and still could not move my right side. He helped me sit up and I could not use my right arm and hand. He helped me get some clothes on and took me to the ED. When we arrived I still could not use my right hand and my arm still felt weak. The weakness resolved within a couple of hours and I got the strength back in my hand. I did have some concern that my TIA type symptoms could possibly be related to vaccine but it was just a thought until I received my second dose. 3 hours post vaccine my face became numb and tingly. It remained that way until I went to sleep. This is why I am reporting this incident.
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| 51 | 2021-01-13 | excessive sleepiness |
Please note: I had documented symptomatic COVID19 infection March 2020. Recovered fully without lo...
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Please note: I had documented symptomatic COVID19 infection March 2020. Recovered fully without long term symptoms. SARS-COV2 Ab testing was positive on 12/6/20 Dose #1 Vaccine was received 12/22/20 at 3:30pm - on 12/23 I woke up at 5:30am with fever, body aches and fatigue - fever went up to 103F and I spent the day in bed - symptoms resolved approximately 12hr later (around 5:30pm) I then felt fine until 1/2/21 (10 days later) when I awakened with fever, generalized body aches and fatigue - this time fever was lower to 100.4. I again spent much of the day in bed and symptoms resolved after 8 hrs
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| 51 | 2021-01-14 | feeling abnormal |
24 hours waves of nausea and sweats started, then a short time later a bad headache and about 40 min...
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24 hours waves of nausea and sweats started, then a short time later a bad headache and about 40 minutes later diarrhea and chills. Also very fatigued and just feeling off.
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| 51 | 2021-01-14 | sensation of foreign body |
Patient felt a sense of fullness and tingling in throat shortly after vaccination (10 minutes), and ...
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Patient felt a sense of fullness and tingling in throat shortly after vaccination (10 minutes), and was transferred to urgent care for closer monitoring. She did not experience any dyspnea, and vital signs remained stable until she was cleared to discharge. No other complications noted during the 2 hours patient was observed in urgent care.
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| 51 | 2021-01-14 | sleep disorder |
soreness at the injection site; I slept off and on from 8:00pm to 12:00am - I did not really feel li...
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soreness at the injection site; I slept off and on from 8:00pm to 12:00am - I did not really feel like moving from the couch, but got up to go to bed; my entire left arm felt "odd" - not painful, just different than my right arm; very tired; joints/muscles on my left side (neck, leg, arm) started to ache; joints/muscles on my left side (neck, leg, arm) started to ache; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm), on 08Jan2021 at 12:00, at a single dose for COVID-19 immunization. The patient's medical history included stomach flu (about 2 years ago), pneumonia (14 years ago), and oral surgery (recently). Concomitant medications included lisdexamfetamine mesilate (VYVANSE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), calcium, ergocalciferol (VIT D) and red yeast rice. The patient previously received influenza vaccine. The patient has no known allergies. Patient's body mass index (BMI) was 32.5. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the pharmacy or drug store. About 30 min after vaccination on 08Jan2020, the patient's entire left arm felt "odd" not painful, just different than my right arm. About 6 hours after the shot, the patient started getting very tired, and my joints/muscles on my left side (neck, leg, arm) started to ache. She slept off and on from 20:00 to 12:00 and she did not really feel like moving from the couch, but got up to go to bed. She checked for fever around 19:30 and 12:00 but had none. She took one of my left over 600 mg ibuprofen (from a recent oral surgery) as treatment, then went to bed and woke up feeling much better. Today, she only has soreness at the injection site (as she normally did with a flu vaccine). She decided to be proactive and took another 600 ibuprofen around 15:00 and felt consistent all day. Patient stated that how she felt the evening of the vaccine was not painful; just "different" than she experienced before. Outcome of the events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
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| 51 | 2021-01-16 | emotional distress, anxiety, nervousness |
01/17/2021 @11:41 am Covid Vax in Left Deltoid @12:03 pm stated tongue was ?tingly? and had a headac...
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01/17/2021 @11:41 am Covid Vax in Left Deltoid @12:03 pm stated tongue was ?tingly? and had a headache 5/10. She took 1000mg Tylenol. Given history of allergies, I gave her 50mg oral diphenhydramine ? liquid. She also took an Ativan 1mg. She was nervous and upset, but no further reaction except ?tingly tongue?. No rash, examined arms, torso, face, lips. 12:15pm BP 152/82, admitted to some anxiety 12:30 ?feels good?, still some tongue tingling 12:36 BP 140/80 tongue/mouth nothing remarkable I advised her not to drive and sister came to pick her up at 1:30. No further incidents I advised her to talk to her dr about 2nd vaccine and consider an allergist due to prior allergies.
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| 51 | 2021-01-17 | impaired work ability |
Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fati...
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Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fatigue, bilateral orbital pain. No visual problems. Took Tylenol every 4 hrs and fever (101. 5)returns in 1-2 hrs. Pulse ox remained normal, 98%, but pulse was 99/min. Usually my resting pulse ox is 55/minutes. Was unable to go to work and see patients. Had these symptoms for 48 hrs even though stayed in bed, took Tylenol around the clock and drank plenty of fluids (2-3 liters of water in addition to natural orange and apple juices). Never lost appetite either, do eating my vegetables and fish diet. Ice cream help between Tylenol?s. Completely resolved after 72 hrs. Now still have LEFT injection site tender deltoid and left axillary tender nodes, improving as well. All along breathing fine, no cough or congestion or sore throat. No anosmia or dysgeusia. This was after my second Pfizer dose. After the First dose only had tenderness on the RIGHT deltoid muscle injection site and tender axillary node, resolved by now.
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| 51 | 2021-01-18 | feeling abnormal |
9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 we...
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9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.
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| 51 | 2021-01-18 | impaired work ability |
Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sne...
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Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sneezing; Body aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 14:50 at single dose at right arm for covid-19 immunization. No additional vaccines administered on the same date. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing migraine. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) for migraine, patient had been alternating this with paracetamol (TYLENOL) while she has been recovering. She clarified the symptoms she experienced as the same day she got the vaccine that evening she had a headache on 29Dec2020. It eventually became a migraine and she left work early. On 30Dec2020 she had body aches, little nausea, and chills. On 31Dec2020, she had more chills, a runny nose, she felt like she was coming down with a cold. She was sneezing, had more chills, more body aches. On 01Jan2021 she felt like she noticed she had phlegm in her throat, but she did not have any pain. The phlegm was causing her to cough more. She had a runny nose the next morning as well. She did the rapid test for COVID on 02Jan2021 evening, and it was positive. She had a headache almost every day. The body aches had pretty much worn off. Runny nose and sneezing resolved in Jan2021. Phlegm in throat confirmed with no pain. This also resolved, as well as coughing. Outcome of event tested positive for COVID was unknown, outcome of event headache was not recovered. outcome of event nausea was recovered on 07Jan2021, event chills was recovered on 08Jan2021, outcome of other events was recovered on unspecified date in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Information of lot/batch number has been requested.
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| 51 | 2021-01-18 | panic attack | vasovagal syncope followed by panic attack |
| 51 | 2021-01-19 | feeling abnormal |
immediate massive headache, bad taste/metal-pepper about 15 mins after shot, fatigue Saturday mornin...
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immediate massive headache, bad taste/metal-pepper about 15 mins after shot, fatigue Saturday morning 1.9.21; foggy mind body aches Symptoms subsided Tuesday morning 1.12.21
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| 51 | 2021-01-19 | feeling abnormal |
Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , D...
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Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , Disiness, feels like electrical currents in head and ears. These symptoms have been all 7 days.
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| 51 | 2021-01-21 | anxiety |
Received the Pfizer COVID-19 vaccine this morning and, while walking back to work, experienced hyper...
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Received the Pfizer COVID-19 vaccine this morning and, while walking back to work, experienced hypertension, tachycardia, diaphoresis, shortness of breath, anxiety and chest discomfort. Code Blue was called; she received supplemental oxygen and was given Aspirin 81 mg. Emergency Medical Services (911) were contacted and arrived at 11:45 AM. She was assessed and an intravenous line was inserted. She was transported to an emergency room and left this facility at 12:20 PM. Update: The employee was assessed and treated at Hospital. She was not admitted; she was directed to follow up with her primary care provider and to seek a referral to a cardiologist.
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| 51 | 2021-01-21 | anxiety |
received the Pfizer COVID-19 vaccine this morning and while walking back to work, experienced hypert...
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received the Pfizer COVID-19 vaccine this morning and while walking back to work, experienced hypertension, tachycardia, diaphoresis, shortness of breath, anxiety and chest discomfort. Code Blue was called; she received supplemental oxygen and was given Aspirin 81 mg. Emergency Medical Services were contacted and arrived at 11:45 AM. She was assessed and an intravenous line was inserted. She was transported to an emergency room and left this facility at 12:20 PM. Update: was assessed and treated at Hospital. She was not admitted; she was directed to follow up with her primary care provider and to seek a referral to a cardiologist.
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| 51 | 2021-01-21 | confusional state |
0805 Felt confused , heart pounding, lightheadness. BP 180/102 0809 911 called 0810 160-90 0816 Para...
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0805 Felt confused , heart pounding, lightheadness. BP 180/102 0809 911 called 0810 160-90 0816 Paramedics arrived, Hx of panic attacks that precipitate ED visit, not on any meds.
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| 51 | 2021-01-21 | feeling abnormal |
An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tyl...
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An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tylenol as soon as I got home due to symptoms getting worse. That night I went to bed at 10pm and didn?t wake up till 7:45am (I was dead tired, I didn?t even hear my alarm). Jan/19/21. Soon as I got up, I experienced headache, vertigo, and this time with mild body aches/heavy feeling and mental fog (Tylenol helped relieved symptoms). Towards the afternoon, I also felt mild burning sensation in my eyes and somehow I felt hot flashes around my face only. Been taking my temperature with normal results. Jan/20/21 Still experiencing off/on headaches and light headedness, otherwise feels okay. All symptoms gone by end of the day.
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| 51 | 2021-01-21 | insomnia |
Feeling of warmth on head and face at 9:00pm on 1/19/21 Woke with fever (99.6F), shaking chills, he...
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Feeling of warmth on head and face at 9:00pm on 1/19/21 Woke with fever (99.6F), shaking chills, headache at 4:00am on 1/20/21 Fever (100.6) joint pain, muscle pain at 9:00am Fever 101.0 at 1:00pm with intense headache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise. Fever 101.0 at4:00pm. Accompanied by symptoms listed above.Took 1,000mg Tylenol. Fever 101.0 at10pm. Accompanied by symptoms listed above. Took 1,000mg Tylenol. Insomnia. 1/21/21: Fever 99.0 degrees 4am. 1,000mg Tylenol. Intense headache and neck ache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise 1/21/21: Fever resolved at 6pm. Intense headache and neck ache, muscle and joint pain accompanied by dizziness, nauseous, fatigue, malaise 1/22/21: Body aches, headache, fatigue, malaise, fatigue, dizziness, nausea
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| 51 | 2021-01-21 | insomnia |
1/21/2021 - 9pm, slight aches in neck muscles 1/22/2021- 3am, fever 102.8 F (forehead) and 102.1 F (...
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1/21/2021 - 9pm, slight aches in neck muscles 1/22/2021- 3am, fever 102.8 F (forehead) and 102.1 F (ear), chills, body aches, joints achy, headache, slight sore throat, couldn't sleep. Took 2 butalbital and drank Pedialyte; forehead temp was 100.1 F by 5 am, and 99.7 F by 6 am 7:30 am (1/22/2021) fever returned and was 102.2 F (forehead) and 101.4 in ear. All other symptoms remain the same. Took 2 butalbital and drank more Pedialyte Called doctor and left voicemail with nurse to put these notes in my chart It should be noted that I had Covid-19 from onset of symptoms on 11/13/2020 and had symptoms through 11/29/2020. I had two visits to urgent care for fluids and medication (11/20/2020 & 11/29/2020). Exposure came from my husband who presented with symptoms on 11/12/2020 and contact tracing revealed his exposure was on 11/09/2020
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| 51 | 2021-01-26 | feeling abnormal, nervousness |
About 5-10 min after injection, I started to feel a little bit shaky and I felt my heart rate had i...
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About 5-10 min after injection, I started to feel a little bit shaky and I felt my heart rate had increased a lot. I just did not feel myself, out of sorts. Paramedics checked my heart rate, pulse ox and BP. O2 was normal - I did not have any respiratory symptoms. My heart rate was quite elevated and blood pressure as well. They had me come to the ambulance to monitor me for a bit longer. Around the injection site I had a large ring of hives, it was red and quite warm. I was red and warm also on my neck and somewhat on the top of my back. They hooked me up to EKG, took my blood pressure, pulse ox and heart rate again, BP and heart rate were still high, O2 sats were normal, but I was feeling better. We waited 15 minutes approximately and they checked my vitals again and my blood pressure has down, as well as my heart rate. So they felt it was OK to discharge me with instructions to take an antihistamine when I got home, and to call emergency services if I needed further help. My symptoms all subsided completely and I was fine at home.
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| 51 | 2021-01-31 | feeling abnormal |
She got the vaccine and now she has Covid, she is tested positive; She got the vaccine and now she h...
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She got the vaccine and now she has Covid, she is tested positive; She got the vaccine and now she has Covid, she is tested positive; This is a spontaneous report from a contactable nurse (patient's husband). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142, expiry date not reported) on 07Jan2021 intramuscularly in left deltoid muscle at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID), amlodipine besilate/ atorvastatin calcium (CADUET). The patient received the vaccine and then had COVID. On 07Jan2021 Thursday, the patient received the vaccine, and on Tuesday (12Jan2021) she said she was not feeling good. On Thursday (14Jan2021) she went to work and because she was not feeling good, she was tested and she was tested positive. The patient worked in a nursing home where she had been tested almost everyday. She was tested negative before she got the vaccine. She was at home, not receiving treatment for COVID. The reporter didn't understand why the patient (reporter's wife) got the vaccine and then had COVID. The outcome of the event was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive based on the known safety profile. However the short duration of 7 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
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| 51 | 2021-01-31 | impaired work ability | Chills, body aches, little bit of sore throat Treated with APAP, missed work |
| 51 | 2021-01-31 | thinking abnormal |
malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; ...
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malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
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| 51 | 2021-02-03 | feeling abnormal | Body aches, extreme fatigue (still present almost 3 weeks later), brain fog |
| 51 | 2021-02-03 | insomnia, feeling abnormal, loss of personal independence in daily activities, impaired work ability |
chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm...
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chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.
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| 51 | 2021-02-04 | confusional state, nervousness, anxiety |
10:16 Pt came up to me and said she worked downstairs. She had her vaccine earlier and was feeling v...
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10:16 Pt came up to me and said she worked downstairs. She had her vaccine earlier and was feeling very itchy, like hives all over. She stated she was shaky and felt anxious. I walked her over to the AMR team. 10:17 epinephrine given by AMR in Right Arm 10:20 VS:140/81, 137, 100% 1025 EKG leads applied 1025 IV L arm with flush 1028 Benadryl 50 mg IV given by AMR 1029 BS 156 Patient had a blank expression and when asked to respond she stated it felt like she couldn't take a breath. We asked if she wanted some water and she said yes. We gave her water but she didn't drink any. AMR transferred her to stretcher and transported to ED at 1035. 1034 VS HR128, 100% She stated that she had a hx of anaphylaxis of unknown cause Pfizer vaccine dose #1 given 1/6/21 in right arm- only side effects were fever and chills
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| 51 | 2021-02-04 | sleep disorder |
"Patient reports 8 days ago had first COVID vaccine. 4 days ago she had 2 episodes of diarrhea, 3 da...
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"Patient reports 8 days ago had first COVID vaccine. 4 days ago she had 2 episodes of diarrhea, 3 days ago HA. Better on Saturday. Yesterday and today every time she eats she had diarrhea. no fever/chills/body aches Tired today but up a lot of the past 2 nights due to her symptoms"
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| 51 | 2021-02-05 | impaired work ability, sleep disorder |
I got my first round of the Pfizer vaccine on 1/14/21. On 1/27/21 I woke up feverish, with chills, b...
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I got my first round of the Pfizer vaccine on 1/14/21. On 1/27/21 I woke up feverish, with chills, body aches, diaherra and intense nausea. I went to Urgent Care on 1/28/21 and was tested for Covid, Influenza (A and B) and strep, all 4 tests came back negative/ not detected. I was told I had a viral infection and to be off work for 7 per symptoms. All of my symptoms worsened extremely over the next week. I went to Hospital on 2/2/21 after 3 days of no sleep, intense pain aches, headaches, and severe vomiting. They also gave me another Covid test that came back negative. The ER physician informed me that he thought my symptoms were too late to be considered an adverse reaction to the Pfizer vaccine.
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| 51 | 2021-02-07 | anxiety |
Patient experienced tingling in throat/neck area, and had elevated HR (patient attributes to anxiety...
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Patient experienced tingling in throat/neck area, and had elevated HR (patient attributes to anxiety). Monitored for 60 minutes and drank some water. Started to feel better. Patient said she experienced this after her first dose, but not until after she left the clinic. She said that time it resolved within 12 hours. Patient said she felt well enough to leave and said she'll seek medical help if symptoms don't resolve or worsen.
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| 51 | 2021-02-07 | confusional state |
Headache; Bodyaches; Confusion; Nausea; No Appetite; Fatigue; Malaise; Loose stools; Joint pain; Mus...
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Headache; Bodyaches; Confusion; Nausea; No Appetite; Fatigue; Malaise; Loose stools; Joint pain; Muscle Pain; Kidney Pain; Watery eyes; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) intramuscularly in left arm on 29Dec2020 16:15 at single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis, Hypothyroidism, known allergies to pineapple. Concomitant medication included thyroid (ARMOUR THYROID), naltrexone. The patient previously took levofloxacin and experienced allergies, amoxicillin and experienced allergies, levonorgestrel and ethinyl estradiol (reported as LEVONORGESTREL-ETHINYL) and experienced allergies. The patient experienced headache, bodyaches, confusion, nausea, no appetite, fatigue, malaise, loose stools, joint pain, muscle pain, kidney pain, watery eyes, all on 05Jan2021 13:00. No treatment received. No other vaccine in four weeks. No covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab with result of negative on 10Jan2021. The outcome of the events was recovered in Jan2021.
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| 51 | 2021-02-07 | insomnia |
Fever; Chills; Headache; Severe neck Pain; Muscle ache; Joint pain; Malaise; Fatigue; Nausea; Dizzin...
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Fever; Chills; Headache; Severe neck Pain; Muscle ache; Joint pain; Malaise; Fatigue; Nausea; Dizziness; Insomnia; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3302/expiration date: not provided), via intramscular route of administration, on 19Jan2021 04:15 PM (at the age of 51 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included Hashimoto's Thyroiditis and hypothyroidism. The patient had known allergies to levofloxacin, amoxicillin, levonorgestrel and ethinyl estradiol and pineapple. The patient previously received the first dose of BNT162B2 (lot number EJ1685) via intramuscular route of administration on 29Dec2020 at 04:15 AM (at the age of 51 years old), as a single dose in the left arm for COVID-19 IMMUNIZATION. On 05Jan2021, at 01:00 PM, the patient experienced headache, bodyaches, confusion, nausea, no appetite, fatigue, malaise, loose stools, joint pain, muscle pain, kidney pain, and watery eyes. The patient did not receive treatment for these events and has recovered from the events. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included thyroid (ARMOUR THYROID) and naltrexone. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines (besides the first dose of BNT162B2) within 4 weeks prior to the COVID vaccine. On 20Jan2021 at 04:00 AM the patient experienced fever, chills, headache, severe neck pain, muscle ache, joint pain, malaise, fatigue, nausea, dizziness, and insomnia. The patient did not receive any treatment for these events. The outcome of the events fever, chills, headache, severe neck pain, muscle ache, joint pain, malaise, fatigue, nausea, dizziness, and insomnia was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-02-08 | feeling abnormal |
yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 10...
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yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 105.00 with Tylenol; increased dizziness/light-headed; body aches; severe headache; nausea; chills; sweating/sweats; Fatigue; feeling crappy; blood pressure tends to be low but was 95/81 at the time she got the shot; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 25Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration on 19Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. Medical history included ongoing severe Crohn's disease, pneumonia, allergy to eggs/anaphylactic reactions to eggs, anaphylactic with bee stings on 2020 (this has happen twice in 2020), collapsed her lung (reaction to anesthesia that collapsed her lung), high fever, anaphylactic reactions. Concomitant medication included sertraline (SERTRALINE), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took Hep B and experienced fever, flu like symptoms, achy, and lethargic (no issue with the first 2 doses but with the 3rd dose she had a high fever); MMR and had an adverse reaction. It was reported that the shot was given on 19Jan2021. She experienced the following severe dizziness which started that day (17:45) and lasted 3 days. It has resolved. Nausea which started that day (17:45) and stayed constant for 3 days. Now it has only been happing in the late afternoons or evenings. Light headed which started that day and last 3 days. Headache (17:45), the initial headache felt like her whole head was going to explode into a 1000 piece. Now it just starts about 4-5pm in the evening. It was better and not as severe but like a migraine with nausea (17:45), feeling crappy (17:45), and body aches. Body aches which started on the day of the shot (17:45) and lasted 3 days. Fatigue which started on the day she got the shot (17:45) and was ongoing in the evening now chills and sweats which started on the day she got the shot and was ongoing. Her husband asked about if this was being related to the change of life but she doesn't think so. Fever which happened on the day she got the shot (17:45) but not at the site, later that night and was 105.00 with Tylenol. It has resolved. She noted that her blood pressure tends to be low but was 95/81 at the time she got the shot (17:45). The patient has not taken her blood pressure and does know if this has resolved. It was relayed that she took Tylenol and Benadryl before the shot due to her history and was still taking it as treatment for the symptoms. She has a lot of drug and other allergies, the only that was anaphylaxis was bees and egg. This was why she brought 2 EpiPens when she had the shot. She didn't have to use her EpiPen and was really proud of that but did have some reactions. The patient reported she did not go to the doctor. At this point she was somewhat expected that she had a not great reaction so the fact that she could still breath after getting it was a good thing. She also noted she could not have driven home due to dizziness. The patient was not brought to the emergency room and did not went to a physician's office. The patient has an ongoing medical history of Crohn's disease and reported that yesterday (as reported) started a flare up but she was not sure if this was related to the vaccine use. The patient recovered from fever on 23Jan2021; was recovering from dizziness, body aches, severe headache, nausea, chills, sweating, and fatigue; while outcome of blood pressure tends to be low, feeling crappy and Crohn's flare up was unknown.
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| 51 | 2021-02-09 | feeling abnormal, amnesia |
Had the first COVID vaccine on 1/8 and did a hike on 1/9 that was about 2-3 miles and did fine and t...
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Had the first COVID vaccine on 1/8 and did a hike on 1/9 that was about 2-3 miles and did fine and then developed severe exhaustion on 1/10 while hiking 2-3 miles and had trouble getting back due to exhaustion. She then had to stay in bed due to exhaustion for about 2 weeks. Also developed 2 days after the vaccine, symptoms of nausea, shakiness and sweating. Brain fog, decreased short term memory loss/trouble with word finding with tachycardia started about 10 days after the vaccine. Baseline, has a mild stutter which she does not think worsened with her symptoms, but was not sure. Difficulty with word finding and memory most unusual for patient that she is a scientist and a poet. She developed symptoms of dysuria and incomplete bladder emptying on January 13. I saw her for a telephone visit on January 20, ordered urine tests and empirically treated for UTI with Augmentin.
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| 51 | 2021-02-10 | anxiety | Facial pressure, anxiety/adrenaline surge |
| 51 | 2021-02-14 | anxiety, confusional state |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Other- Anxiety/Panic-Medium
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| 51 | 2021-02-15 | impaired work ability, feeling abnormal |
09:00 PM - every joint in my body hurt that evening. I had to leave work; I couldn't finish my eigh...
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09:00 PM - every joint in my body hurt that evening. I had to leave work; I couldn't finish my eight hours. All my joints hurt - even my toe joints. I called my doctor. I had a fever. That went away in 2-3 days. Two weeks later or so- on February 5, I started feeling pretty bad. I started having chest pains. It progressed. No coughing. By the 10th, I ended up in ER. I thought I was having a heart attack - chest pain I was hospitalized. I am still dealing with that issue. I received morphine I'm diagnosed with Pleurisy -like virus - the lining of chest wall can become inflamed and when I breathe in and out it causes severe pain. Tachycardia - fast heart rate. I'm on anti-inflammatory - Naproxen - 500 mg twice a day and I'm already improving. I saw a cardiac dr today - he says my heart seems fine. I still have a fast heart rate. Pleural Rubbing - he could hear it on my chest wall. I had a positive antibody test - COVID -on January 20th. I'm recovering but I am not recovered.
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| 51 | 2021-02-15 | impaired work ability |
At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three ti...
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At arm pain at 11:00 pm. The following day, my left arm swelled up from wrist to shoulder - three times it's size. I couldn't move my arm for 24 hours. Arm pain was gone after 24 hours. Two days after - I was freezing cold, on the couch. Following day, I called my doctor. He told me to rest. I had a high fever and I had body aches. I was really cold. I felt like I had the flu for about a week - missed a couple days of work.
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| 51 | 2021-02-18 | confusional state, disorientation |
Dizzy after 30 minutes. By noon felt disoriented and had a headache. Fatigued about 1300. Left work ...
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Dizzy after 30 minutes. By noon felt disoriented and had a headache. Fatigued about 1300. Left work to go home, to bed at 1800. On next day had a fever 101.9, chills and sweats, headache, sore throat, confusion, nausea, and intense pain at injection site, neck and back pain, extreme fatigue. All prior symptoms continued until the evening of January 31. Slept almost continuously until February 1. On this day still had chills, confusion, fatigue and a headache. Did go to work on February 1. Most symptoms were improved by February 4. Mildly confused until February 9.
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| 51 | 2021-02-18 | feeling abnormal |
After first injection, did not feel good starting about 12 hours after the injection for about 24 ho...
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After first injection, did not feel good starting about 12 hours after the injection for about 24 hours of minor chills, aches, pains and headache. After second injection, did not feel good starting about 12 hours after injection for about 24 hours with full flu like symptoms, nausea, diarrhea, heavy chills, persistent headache, strong body aches, night sweats. After 24 hours, persistent neck, shoulder and arm aches and pain on the right side (same side as injection).
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| 51 | 2021-02-21 | anxiety |
Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO wi...
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Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO with water, monitored closely for 1 hr. Instructed per Dr. not to have the second dose administered and to discuss with her physician. Symptoms subsided and pt sent home.
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| 51 | 2021-02-21 | memory impairment, feeling abnormal |
Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. Th...
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Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. They asked me what are my allergies and medical history. I couldn't remember - so had brain fog at that time. My left ear, face, and neck (left side of head) is numb at that time. The symptoms were the same for two hours. Memory remained fogged. An hour or so after the incident - I called the advice nurse from medical clinic and I did remember the doctor's name. Pain on head and numbness remained for days. My auto-immune system was stimulated my doctor said. Everything kept cascading down - now I'm on post surgery 9 days and I'm on disability. I went to ER on January 18, I was complaining of left sided numbness, vomiting, headaches. Facial numbness (left), mild headaches. Left sided headache progressed to (similar to prior migraine headaches) migraine like. January 29, I emailed my physicians (in between the 17th and 29th). On the 29th, I went to see the doctor - joints - really swollen and painful and I cannot walk. I was given steroid shots. February 2, - appt with neurologist. February - with Dr. - for painful swollen feet; Feb 10 - appt with Rheumotologist - Feb 10 with Dr - a Specialist - , as well. Right foot is swollen as well as the left foot at this time. Dr. - axperatated the right ankle -he said it was infected. February 11, Dr said I have infected joints and need surgery. They did surgery on February 13th. Dr. the surgeon . Had surgery at medical facility for infected ankle. February 15 - discharged home. Appt with surgeon on the 16th. Appt with Primary on the 19th. Appt with my Rheumotologist today. Discharged - with Home Health care; Physical and Occupational therapist and nursing. I have been on bedrest since discharge. I need maximum care. Tomorrow I have a appt with surgeon to hopefully remove cast and sutures on surgical site.
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| 51 | 2021-02-24 | feeling abnormal |
1 hour past 2nd shot, I felt fatigue, dizziness, brain fog and mild nausea. Possibly 12 hours past ...
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1 hour past 2nd shot, I felt fatigue, dizziness, brain fog and mild nausea. Possibly 12 hours past the shot, I awoke with a massive headache, achy joints & muscles from head to toe, chills, sweating, congestion, sore throat, increased dizziness and weakness. This was similar, but not as severe, as the onset of Covid-19 symptoms I experienced on January 5, 2021. 30 hours past the 2nd shot, I am still experiencing aches, pains, dizziness, fatigue, and a headache I cannot alleviate with Ibuprofen.
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| 51 | 2021-02-24 | feeling abnormal |
day 1-little light headed, tired day 2-arm hurt, light headed, day 3-feel week light headed, day 4...
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day 1-little light headed, tired day 2-arm hurt, light headed, day 3-feel week light headed, day 4-week foggy, day 5- little week foggy
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| 51 | 2021-02-24 | impaired work ability |
First Fever, body aches, joint pain. Second Fever, head ache, body aches, joint pain, hot flashes an...
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First Fever, body aches, joint pain. Second Fever, head ache, body aches, joint pain, hot flashes and has missed work for 3 weeks.
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| 51 | 2021-02-26 | amnesia | Global amnesia |
| 51 | 2021-02-28 | depressed mood |
Within 15 minutes of shot, itching and muscle pain. Within 45 minutes of shot muscle cramping in ex...
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Within 15 minutes of shot, itching and muscle pain. Within 45 minutes of shot muscle cramping in extremities. Had taken 2 benadryl to ward off allergic reaction. That evening these symptoms continued and fatigue as well as low mood occurred. Next morning, right flank over the kidney pain-all day. Muscle pain- all day. Fatigued. Sunday, severe vertigo that lasted for several hours. Remitted for 5 hours and then returned. Dr. and Neurologist contacted.
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| 51 | 2021-02-28 | feeling abnormal |
~approximately 30 min after vaccination received a funny feeling in my head not quite like a headach...
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~approximately 30 min after vaccination received a funny feeling in my head not quite like a headache and pain around my nose and between my eyes which lasted about 5 minutes followed by ear popping which ceased after about 5 minutes followed by ear pain for about 15 minutes
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| 51 | 2021-03-02 | sleep disorder |
The lymph nodes on the left side of my neck are extremely sore. It feels tight and painful to move ...
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The lymph nodes on the left side of my neck are extremely sore. It feels tight and painful to move or sleep.
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| 51 | 2021-03-03 | feeling abnormal | Fever, chills, headache, foggy thinking, body aches....lasted over 72 hours |
| 51 | 2021-03-04 | mental impairment |
Patient received vaccine, reports that she had "chills, shakey, trembling, difficulty thinking, brea...
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Patient received vaccine, reports that she had "chills, shakey, trembling, difficulty thinking, breathing fast"
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| 51 | 2021-03-07 | feeling abnormal |
Patient has a history of anxiety and anaphylaxis to latex. She started feeling weird in head, nausea...
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Patient has a history of anxiety and anaphylaxis to latex. She started feeling weird in head, nauseated, and dizzy a few minutes after her vaccine. BP 153/96 with pulse of 101 5 minutes post vaccine. We continued to monitor her. 20 minutes post vaccination bp 136/89 with pulse 97. 30 minutes post vaccine we tried to sit her up. She was very nauseated. bp 144/99 pulse 85. 35 minutes post vaccination bp 140/108 and pulse 83. She felt sick with her IBS, and we got her into the bathroom via wheelchair. 50 minutes post vaccination, bp was 129/93 with pulse of 83. We called her husband to pick her up because she was exhausted after all of this.
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| 51 | 2021-03-07 | impaired work ability |
Right arm swollen. Pain in joints and muscle tissue. Headache and nausea. Inability to work or be pr...
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Right arm swollen. Pain in joints and muscle tissue. Headache and nausea. Inability to work or be productive for 5 days.
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| 51 | 2021-03-08 | abnormal dreams |
first night had strange vivid dreams, extremely fatigued/sleepy, muscle aces all over, joint pains a...
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first night had strange vivid dreams, extremely fatigued/sleepy, muscle aces all over, joint pains all over (arthritis is only in a few joints), runny nose, sore throat. 2nd day felt better but still very sleepy, fatigued, muscle cramping. 3rd day still extremely sleepy, muscle soreness, joint pain. 4th day fatigue, weakness, nausea.
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| 51 | 2021-03-09 | feeling abnormal |
1st day just sore arm. 2nd day just felt off, 3rd day mild headache chills, 4th day sever headache, ...
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1st day just sore arm. 2nd day just felt off, 3rd day mild headache chills, 4th day sever headache, vomitting, nausea, stiff neck and shoulders.
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| 51 | 2021-03-09 | excessive sleepiness |
Approx. 11 hours post-injection I began to feel slight body aches, followed by chills. Within an hou...
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Approx. 11 hours post-injection I began to feel slight body aches, followed by chills. Within an hour after onset, I was shivering uncontrollably so added layers and hat under my down comforter. I awoke 4-5 hours later drenched in sweat with a slight fever. I drank some water and went back to sleep. Over the next ~60 hours I slept, only waking for about an hour at a time for a total of 6 hours, with slight nausea. My fever spiked at 101.4F before subsiding around hour 50. Took 2 acetaminophen around hour 36 and again around hour 48. Headache began around 36 hours. On 3rd day I was able to stay awake but was light-headed most of day. Finally on 4th I began to feel like myself again.
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| 51 | 2021-03-09 | impaired work ability |
I exp low grade fever 100.5 on Saturday, diarrhea and severe joint pain.On Wed/Thurs I had to miss w...
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I exp low grade fever 100.5 on Saturday, diarrhea and severe joint pain.On Wed/Thurs I had to miss work due symptoms.
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| 51 | 2021-03-09 | poor quality sleep, excessive sleepiness |
Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with...
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Saturday, day of shot, symptoms began with being tired about 4 hours after the shot and started with being tired then led to extreme exhaustion and lethargy and loss of taste (salty and sweet), but had an appetite and drank a LOT of water, taking Tylenol around 6 pm; slept restless and in pain with fever and feeling both burning up and freezing cold with clammy chills. Couldn't settle. Approximately 3:30 am, had diarrhea until I had nothing in my system and developed uncontrollable shaking. Finally got some sleep after a hot bath. The next day, no appetite, drank little water and kombucha to settle my stomach, exhausted, feverish, napped off and on all day, right arm began hurting tremendously and right side including jaw and tongue felt swollen, took Tylenol in the morning and BC Powder pm before bed. Slept moderately well. Monday, napped off and on but started feeling better with only moderate exhaustion around 6 pm, but right arm was in pain. Tuesday, moderate exhaustion, had to nap for 2 hours mid-day, right side of body including tongue was swollen, arm in pain and entire upper arm muscle felt knotted. Went for a massage and worked out knot quite painfully. Today, moderate to mild exhaustion, upper right arm a bit sore, semi- decent appetite.
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| 51 | 2021-03-09 | sleep disorder |
One hour and 15 min after the shot extreme fatigue began. Also my Left Arm was hurting. Then when I ...
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One hour and 15 min after the shot extreme fatigue began. Also my Left Arm was hurting. Then when I got in bed at 10pm, all of my muscles began hurting really badly, and I was awake most of the night, feeling sick with nausea, dry mouth, and pain all over. The next day I felt really wrecked, way worse than my usual Fibromyalgia/Anxiety symptoms. My body really hurt all over and I was really fatigued. I felt general malaise all day long and my left arm hurt a lot. That second night I slept better and the next day I was better except my left arm was still sore that day also.
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| 51 | 2021-03-10 | amnesia |
Around two days later, I started noticing I was having sinus headaches and memory issues. I have ext...
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Around two days later, I started noticing I was having sinus headaches and memory issues. I have extremely increased body aches; muscles aches. I don't know if it is just me or in relation to the vaccine or not. Mood seems altered but I am in pain. Taking Tylenol to try to help with symptoms.
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| 51 | 2021-03-10 | feeling abnormal |
At time if waking up around 7:30 to 8 am on 3/9, started sneezing, running nose, foggy brain, red fa...
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At time if waking up around 7:30 to 8 am on 3/9, started sneezing, running nose, foggy brain, red face, some minor headache but no fever. It lasted that day (3/9) but brain doggies lasted till 3/10 early afternoon
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| 51 | 2021-03-10 | feeling abnormal | tongue numb/tingling, "medicine head", HA. Evaluated by EMS-Cleared |
| 51 | 2021-03-13 | irritability, feeling abnormal, memory impairment |
Im not sure if this is an adverse effect - But here are the sxs I felt - after my shot - when i was ...
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Im not sure if this is an adverse effect - But here are the sxs I felt - after my shot - when i was sitting in the waiting area for the mandatory waiting period of 15 or so minutes - I felt a slight pain in my left arm, a slight pain in my left chest area, and a slight pain in my left back area. I came home and felt a brain fog. I was forgetful, and very slow, I could feel a part of me being acutely aware that I was struggling to process information that I processed before normally. I was very irritable more so than I have experienced before, and that lasted approximately days till March 17th. The brain fog dissipated slowly over 24 hrs, Blood Pressure on March 11th ( fourth day) was 143/80 - 69 beats per minute at 6:15 pm and 155/88 - 75 BPM at 8:14 pm. Blood pressure reading on March 12th 155/105 - 71 bpm at 5:31 pm. and 142/98 - 80 BPM at noon . The pain in the chest and arm area existed, for a few more days and is intermittent in the last few days. Today 3/13/21 i felt it when i was bending to push and pushing potted plants around. But that was the only time. Today's BP reading was 139/85 - 88 BPM at 6:15 pm. I am concerned if I should take the second dose or not. If this is normal and Im ok to take the second dose please email me either way. I just want to ensure that this is not an adverse cardiological side effect and wanted to check in . Thankyou
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| 51 | 2021-03-14 | feeling abnormal |
Extreme Headache, Rash on lower portion of both arms, felt like my skin was on fire from the inside ...
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Extreme Headache, Rash on lower portion of both arms, felt like my skin was on fire from the inside out on my face, neck and arms, extreme fatigue, chills. Lasted for a week. Longer Effects, extreme fatigue and brain fogginess ( it's now March 15th, I am still having these effects)
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| 51 | 2021-03-15 | impaired work ability |
Low grade fever, headache, fatigue causing me to miss work and lasting one day (very similar to Covi...
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Low grade fever, headache, fatigue causing me to miss work and lasting one day (very similar to Covid symptoms experienced)
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| 51 | 2021-03-16 | feeling abnormal |
Lethargy, feeling foggy Narrative: Patient reports receiving her 2nd Covid vaccine 2 days prior and...
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Lethargy, feeling foggy Narrative: Patient reports receiving her 2nd Covid vaccine 2 days prior and then office/clinic visit stated she feels "wires are crossed", Patient reports feeling foggy and having loose stools 4-5 times per day. Patient denies any reaction to previous Covid vaccine. Patient denies any fever/temp/chills, abd pain, chest pain wheezing or sob.
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| 51 | 2021-03-16 | feeling abnormal |
Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6...
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Vaccine in left arm at 1:45pm and shortly after started feeling stiffness in left side of neck, at 6:30pm I began to feel extremely wired and like my body would jump through my skin. I tried to relax and started feeling sick at the stomach. I went to bed early. 3/12/21 at 6:15am I was awakened with heart racing extremely fast and migraine starting at base of back of head. I could not get my heart to slow down. My husband called 911. Paramedics came and my blood pressure was 163/116 and heart rate 85. 10 minutes later it was 157/84 and heart rate 64. (The day before vaccination my cardiologist recorded my blood pressure at 110/52 and it has always run low. ) I had no energy nor appetite and slept most of the day 3/12/21 through 3/12/14. Still feeling extremely fatigue and ears ringing and can hear heart beating in ears.
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| 51 | 2021-03-16 | impaired work ability, disturbance in attention, loss of personal independence in daily activities |
The following is the timeline of progression: First 48 hours: Immediately following the vaccine I fe...
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The following is the timeline of progression: First 48 hours: Immediately following the vaccine I felt I would vomit. That lasted 2 hours. The remainder of the 48 hours I had a growing headache that turned into a migraine level. Cognitively my husband would say I was out of it, not able to focus. The area around my eyes my eyelids and below eyelids bright red like I had put a bright red blush on them. Three to four days later: Saturday night my symptoms started to progress over a span of a few hours very drastically. I had symptoms of Diarrhea crazy impact in my gut. Sunday I still had migraine level pain in a headache. I felt increased symptoms of nausea and diarrhea increased. Sunday I still had migraine level pain in a headache. I felt increased symptoms of nausea and diarrhea increased. By Sunday afternoon I had full blown symptoms of stomach flu. I had chills, extreme nausea that became debilitating. We do not have a thermometer that works, as a result I do not know if I had a fever. By Sunday night I was vomiting and symptoms progressed to tightness of chest, shortness of breath, vomiting, diarrhea, chills. My gut was literally moving in sharp pain, sounds, and cramping. It was severe diarrhea. I was achy and tired, but could not fall asleep due to nausea and vomiting. I was unable to stand up without the fear of passing out. I tried to manage the nausea with medicine that I have at home. It assisted but did not ultimate make an impact. By 4:30 a.m. I was scared by the lack of breath and asked my husband to call 911. The paramedic stated that I had an increased heart rate, but good blood pressure. I went to the hospital and received fluids, two different additional doses of nausea medicine, oxygen and a gut muscle relaxer. After 30 to 40 minutes I showed improvement and was able to go home. Still had pink color tone in skin around my eyes. On that Monday (2/8/2021), I was unable to go to work and called in for Covid PTO. I slept most of the day. Five days later: Still have a headache that can be managed with Tylenol. I still have diarrhea. I no longer have nausea, the pink color around my eyes seems to be gone.The nurse team and ambulance team all stated that the second shot was awful. Three folks stated they were in fetal position for two days. I was not able to ask what that meant due to my extreme nausea and trying to not dry heave. Note: I did not have any symptoms from the first vaccine just a dull headache.
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| 51 | 2021-03-16 | impaired work ability |
It was 20 minutes after vaccination my throat was closing. I went to the ER and they gave me Benadry...
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It was 20 minutes after vaccination my throat was closing. I went to the ER and they gave me Benadryl. I had headaches on the crown of my head for four days After the headaches subsided, I was really short of breath after five days and was unable to work. I am normally in good shape. I went back to the Emergency Room and they did more tests which was a week after the vaccine.
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| 51 | 2021-03-17 | anxiety |
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: , MD at 3/18/2021 7:58...
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Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: , MD at 3/18/2021 7:58 AM Expand AllCollapse All COVID VACCINE CLINIC 66612 3/17/2021 Patient: Date: 3/17/2021 Subjective is a 51 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience dizziness and nausea and tingling down left arm where she got her shot. . She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency . Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of frequent throat clearing, vomiting (nausea), muscle aches (left arm), dizziness and headaches CONT negative Eyes negative Respiratory negative Skin negative Previous Reactions: Nausea with first Covid shot Objective Vitals Vitals: 03/17/21 0140 03/17/21 1332 03/17/21 1407 BP: 134/82 (!) 144/87 135/74 Pulse: 93 89 SpO2: 97% Physical Exam Constitutional: Appearance: Normal appearance. She is well-developed. HENT: Head: Normocephalic. Jaw: There is normal jaw occlusion. Right Ear: Hearing normal. Left Ear: Hearing normal. Nose: Nose normal. Mouth/Throat: Lips: Pink. Mouth: Mucous membranes are moist. No angioedema. Pharynx: Oropharynx is clear. Eyes: General: Gaze aligned appropriately. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: Cervical back: Full passive range of motion without pain. Neurological: Mental Status: She is alert. Psychiatric: Behavior: Behavior is cooperative. Assessment/Plan Treatment included: water and pepcid, zofran and Ibuprofen Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Released to go home with sister. No driving tonight. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) 2:30 pm Electronically Signed 3/17/2021 2:30 PM
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| 51 | 2021-03-17 | confusional state |
headache @1:30pm pain left arm @ 8pm body aches9:20pm nausea10pm an urgency to move bowels 10:30pm...
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headache @1:30pm pain left arm @ 8pm body aches9:20pm nausea10pm an urgency to move bowels 10:30pm ( relieved after bowel movement @7am) chills10:30pm sweating10:30p loss of strength/ lack of energy/ weak 11pm muscle aches 11pm slight confusion 1:30am joint (wrists and ankle) 7am all previous symptoms exists into next day 3/18 except the confusion motion appears to relieve the body aches
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| 51 | 2021-03-18 | nervousness, anxiety, panic attack |
2 weeks after my second vaccine I had a bad panic attack. I have never had one before. I have had m...
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2 weeks after my second vaccine I had a bad panic attack. I have never had one before. I have had mild anxiety in the past but nothing like this. I continue to have major anxiety with a rapid heartbeat at times. I feel my body is experiencing something it has never before. Due to my multiple medical issues I am very aware of changes in my body and this ongoing severe nervousness and anxiety is definitely new. My husband and my family see a change in me as well.
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| 51 | 2021-03-19 | feeling abnormal, sleep disorder |
Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since ...
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Headache since day 1; pain at injection site since day 1; bitter, "disgusting" taste in mouth since day 1; brain fog since day 3; PMS like symptoms (cramps, achy feet) only on day 3; itchiness around injection site since day 1; redness and inflammation around injection site (moderate redness, size of adult woman's thumb from day 1 to day 3; increased about 25% in size on day 4 and had returned to previous size with a less red color). Has taken Tylenol when pain was present, removed headache pain on days 1-3 but not on day 4. Used cold compress on day 3 to reduce swelling but did not affect redness/swelling. Has not slept on injection site arm.
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| 51 | 2021-03-20 | disorientation |
Sudden ringing ears with intense headache and dizziness. Sudden strange taste in mouth with difficul...
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Sudden ringing ears with intense headache and dizziness. Sudden strange taste in mouth with difficulty swallowing. Disorientation. Close to passing out. About 3 hours after vaccine I was intensely nauseous.
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| 51 | 2021-03-20 | loss of personal independence in daily activities, feeling abnormal |
The day after the vaccine, pt experienced typical side effects of fatigue and fever that was control...
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The day after the vaccine, pt experienced typical side effects of fatigue and fever that was controlled by Tylenol. The fatigue was extreme and has continued to present day. Also, she has inability to focus and concentrate. She is nauseated daily intermittently. The main complication was in post vaccination day 5, she felt worse than before. Vertigo, nausea, extreme fatigue and inability to perform ADLs and spent most of the day in bed. Approximately 1 am the next morning she woke me, cold, clammy and pale collapsing on the side of the bed with a feeling of impending doom after having diarrhea saying ?something is really wrong.? She went back to the toilet, but had a syncopal episode from standing where she fell straight and flat on her back with no attempt to break her fall. She hit her head on the marble floor and shoe molding. She was unresponsive for 10-20 seconds with no palpable pulse or visible respiratory effort before becoming arousable. She was groggy, but oriented to person and place. She was amnestic for the event. She had an approximately 6 inch full thickness laceration to her posterior scalp that required staples. I took her BP- 85/56, pulse 50, respirations were normal. Ambulance called. Mild hypotension that responded to fluid bolus. CT of head was negative and other than non-specific leukocytosis, labs were normal (CBC, CMP, TFTs, Mg and PO4).
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| 51 | 2021-03-21 | depression, anxiety |
Overwhelming anxiety and severe depression? started shortly after receiving the vaccine and has prog...
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Overwhelming anxiety and severe depression? started shortly after receiving the vaccine and has progressively worsened (prior experience with both was over 10 years ago)
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| 51 | 2021-03-23 | feeling abnormal | Paresthesia of left arm and leg, foggy brain, muscle weakness, headache, |
| 51 | 2021-03-24 | feeling abnormal, impaired work ability |
low grade fever 101, for 3 days. Felt like I had been hit by a truck. Muscle aches and pains. Headac...
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low grade fever 101, for 3 days. Felt like I had been hit by a truck. Muscle aches and pains. Headache, sleepy, no energy. Out of work for 3 days was miserable. I'm on day 10 after the first shot of the vaccine and still feel foggy headed, low energy and tired.
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| 51 | 2021-03-24 | nervousness | Numbness right upper extremity at vaccination site. VS WNL, patient is nervous |
| 51 | 2021-03-25 | loss of personal independence in daily activities |
I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back ...
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I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back of my throat felt numb and had a significant headache. I could not sit up straight due to dizziness. By 11:30 it was hard to talk, my throat felt thick, tight, and like it was getting small. It was difficult to swallow. I was too dizzy to stand up. I would tip over when I stood up. The hospital was called and advised my family to closely observe my symptoms. At 11:20 the pharmacist gave me liquid Benadryl. At 11:30 I took hydroxyzine, prescribed after an adverse reaction to my first covid vaccine and Tylenol. At 12:30 my throat felt less enflamed but sore and scratchy. At this time my whole head was itchy and the headache was not reduced. I had a difficult time walking due to the dizziness.
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| 51 | 2021-03-28 | loss of personal independence in daily activities |
Continuous weakness/fatigue and discomfort/pain in upper left arm. Having difficulty doing normal t...
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Continuous weakness/fatigue and discomfort/pain in upper left arm. Having difficulty doing normal tasks like lifting pan out of oven, carrying a grocery bag, typing on computer at work, painting/creating art, holding dogs leash, etc. Feeling of fatigue/discomfort is present even when I am sitting still.
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| 51 | 2021-03-29 | sensation of foreign body |
Patient experiencing tingling lips, lump in throat, and left arm numbness. Reports worsening over w...
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Patient experiencing tingling lips, lump in throat, and left arm numbness. Reports worsening over wait period. Provider notified. Escorted to ER.
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| 51 | 2021-03-30 | anxiety |
Patient had generalized anxiety disorder. Onsite EMS was called vitals BP 129/76 BG 99% O2 HR 80. P...
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Patient had generalized anxiety disorder. Onsite EMS was called vitals BP 129/76 BG 99% O2 HR 80. Patient refunded evaluation or care and released against medical advise.
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| 51 | 2021-03-30 | confusional state |
2 hours after the shot i thought I had got bitten by a mosquito because I had an itchy raised bump o...
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2 hours after the shot i thought I had got bitten by a mosquito because I had an itchy raised bump on my jaw I looked in the mirror and my left side of my neck was flame red then it spread to the front of my neck then it spread to the right side. It started moving down to my chest. The rash started getting raised hives that looked like they were turning into blisters.. It was horribly itchy but the worst part is it felt like I had been scorched. Luckily I had antihistamines here on hand that eventually thank God turned it around. The next day on Monday I was in almost a comatose sleep like anesthesia I didn't know what day it was. Then on Tuesday my right side of my face went numb and felt like it was drawing down. My speech was slurry I was drooling out of my right side and I was having glitches with my memory. Today I'm still having speech difficulties gait problems and I'm hearing roaring in my ears. This is so terrifying.
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| 51 | 2021-03-31 | feeling abnormal |
hard of hearing; Bell's palsy; Left eye felt weird/weird feeling like when went to the dentist and g...
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hard of hearing; Bell's palsy; Left eye felt weird/weird feeling like when went to the dentist and get the Novocain shot; Left side of mouth muscle not holding water while brushing teeth; Cannot close left eye/eye wasn't moving; Left eye burning during shower; sick; cannot move that part of your mouth; Sore Arm over Weekend; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 12Mar2021 08:15 (Lot Number: EN6204) at single dose for covid-19 immunization. Medical history was none. Concomitant medication included diphenhydramine hydrochloride (BENADRYL Tablet). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200) on 19Feb2021 and experienced felt really tired, and received flu shot. The patient experienced bell's palsy on 18Mar2021, sore arm over weekend on an unspecified date in 2021, Left eye felt weird/weird feeling like when went to the dentist and get the Novocain shot on 18Mar2021, left side of mouth muscle not holding water while brushing teeth on 18Mar2021, cannot close left eye/eye wasn't moving on 18Mar2021, left eye burning during shower on 18Mar2021, sick in 2021, cannot move that part of your mouth in 2021, hard of hearing on an unspecified date. She felt great over the weekend other than a sore arm. Morning on 18Mar2021 when she woke up her left eye felt weird. When brushing her teeth she noticed the left side of her mouth muscle was not holding water to spit out. Looked in the mirror and noticed when she smiled her left eye wasn't moving. Went to the emergency room and the doctor told her she has Bell's Palsy. Explained that was why she cannot close her left eye. Was given two medications to take; one a steroid and one a antiviral. Left eye has been feeling weird, like when you look away from your cell phone and one eye hasn't dilated or adjusted to the darkness yet. Stated she took a sick day from work today. Mentioned again her left eye burning in the shower and that she has to sleep with an eye patch. She was hard of hearing. Stated she had hearing aids and can currently hear call handler fine. Had a CAT scan and everything at the emergency room this morning. Her grandmother and aunt died from a stroke and she was concerned that she had one. She cannot close her left eye completely. Stated was a weird feeling like when went to the dentist and get the Novocain shot and cannot move that part of your mouth. The doctor told her he thought it will last for 2 weeks. Stated that it could've started overnight but she was uncertain as she was sleeping and didn't notice it until this morning. Mentioned her husband was at the hospital all day yesterday for procedures. After receiving her second dose of the vaccine she thought she didn't feel to bad at all, not tired like with the first one; until she woke up with this today. Stated no for medications but mentions that on 11Mar2021 she had bad allergies and was like a water faucet. She took Children's Benadryl 12.5mg 2 tablets and some eye drops. Stated that it helped. Thought she was allergic to something in the building. Stated was given Prednisone, as she was reading the label she notices she was supposed to take two a day and had only taken 1 this morning. Prednisone is prescribed as 20mg 2 tablets by mouth every day for 7 days. Spelt out name of antiviral medication as IC Valacyclov. Prescribed as 500mg 2 tablets by mouth three times a day. Also has eye drops to keep eye moist. Has eye patch for bedtime. Was instructed to manually close left eye and cover with eye patch at night. Mentioned that she had a flu shot in October no issues voiced. Nephew with Covid, Niece that had Covid. Stated she was not around them. There was no physician office visit reported. The patient underwent lab tests and procedures which included blood sugar: normal, blood pressure: normal, CAT scan: normal on 18Mar2021. There was treatment and emergency room visit except event hard of hearing. The outcome of the events was unknown.
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| 51 | 2021-03-31 | impaired work ability |
1st Dose - effects surfaced apprx 5 days later - painful swollen lymph nodes 2nd Dose - effects surf...
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1st Dose - effects surfaced apprx 5 days later - painful swollen lymph nodes 2nd Dose - effects surfaced within hrs. Massive headache - affected peripheral vision, nausea, body aches, hot, and chills, mild dry heaves, vomitted once, weak & slightly faint, dizzy , sharp painful lymph nodes (left collar bone, Left underarm area, side of left breast, slight burning sensation, Thursday woke up with pain in back of knees, back, neck and head, in bed Wed evening through Friday, touch of diarrhea, bowel movement seemed to slightly alleviate headache, touch of stomach gas, back to work Monday, Tuesday woke up with massive headache again unable to lift head from bed, nausea, & chills unable to go to work. Wednesday back to work - got home felt fatigued slept from 5pm to 6:45 am.
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| 51 | 2021-03-31 | loss of personal independence in daily activities |
Headache, achy joints and shortness of breath which has been constant and possibly getting worse. ...
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Headache, achy joints and shortness of breath which has been constant and possibly getting worse. Am unable to run as normal.
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| 51 | 2021-03-31 | restlessness |
Slight headache overnight after 1st dose on 3/8. Adverse reaction after 2nd dose on 3/29 at 3:30 ...
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Slight headache overnight after 1st dose on 3/8. Adverse reaction after 2nd dose on 3/29 at 3:30 that afternoon. I started seeing ?floaters? in my right eye only. Floating dark strings, dots, squiggles in my peripheral vision. Took my blood pressure and it was elevated at 168/93. I immediately took an additional 25 mg of losartin and called my eye doctor and was told to come in the next morning for an eye exam. My blood pressure lowered to normal over the next few hours. I felt tired and restless overnight. The next evening 3/30 after my eye dr appt, I developed a very severe headache, first in the front area of my head, then finally on the left side of my head. Overnight the pain in the left side of my head increases and I experienced nausea, body aches and fatigue. The floaters in my right eye remained the same. No floaters or problems with my right eye.
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| 51 | 2021-04-01 | feeling abnormal |
Patient started to feel "spacey, cloudy" in her head about five minutes after receiving the vaccina...
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Patient started to feel "spacey, cloudy" in her head about five minutes after receiving the vaccination. She stated she s unable to describe the feeling. Patient taken to the observation area for eval. BP 113/67 HR 88 oxygen sat 98% room air. Once in the observation area she complained of a headache "4/10". She was given cold water. 1315 patient states that her symptoms have resolved, headache is still there but she is wanting to take tylenol when she gets home. 1323 patient released from observation and escorted to the exit via wheelchair and staff member
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| 51 | 2021-04-01 | feeling abnormal |
Immediate whole body sensation. Dissasociative feeling at leaving injection booth. Tachycardia start...
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Immediate whole body sensation. Dissasociative feeling at leaving injection booth. Tachycardia started immediately when sitting in observation room. Observer noted rash and flushing on chest and face. Medics called. Blood pressure 182/108, heart rate 152, o2 sat 100. Taken to triage area. Had a hard time responding to questions because tongue felt thick. Airway was clear despite edema. I was taken by ambulance to to Medical Center. The paramedics wanted to administer Epi but I was hesitant since I was still able to breathe and I didn?t want to further increase blood pressure. I have a narrative to paste but the Continuation Page is not letting me input text. Please email me.
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| 51 | 2021-04-01 | irritability |
very puffy and swollen face around eyes. Left eye mostly affected. Red and dry skin around eyes. V...
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very puffy and swollen face around eyes. Left eye mostly affected. Red and dry skin around eyes. Very irritated and painful. Healing, but still evident today.
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| 51 | 2021-04-02 | feeling abnormal |
1. Mild allergic response: lip and eyelid swelling, itchy throat, scratchy/itchy feeling 2. 1.5 inch...
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1. Mild allergic response: lip and eyelid swelling, itchy throat, scratchy/itchy feeling 2. 1.5 inch diameter bruise at injection site 3. Mild arm pain 4. Intermittent fever?99.1, 99.6, 100.1, 102.1, 99.3 5 Two days after horrible headache with halos and occasional double vision 6. Brain fog and tiredness
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| 51 | 2021-04-02 | hallucination |
High fever for 18 hours 103 degrees, severe headache, earache, backache, legs felt strange, had hall...
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High fever for 18 hours 103 degrees, severe headache, earache, backache, legs felt strange, had hallucinations, nausea, still have pain in injection site and surrounding area after 48 hours.
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| 51 | 2021-04-03 | feeling abnormal, confusional state, amnesia |
Memory loss, memory issues; Blurred vision; Severe headache down to her neck; still little bit stumb...
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Memory loss, memory issues; Blurred vision; Severe headache down to her neck; still little bit stumbling/stumbling like couldnot keep her balance like tripping; Hard to get her words out; very lost and confused; very lost and confused; cognitive issues; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 20Jan2021 (at the age of 51-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, "she guess this was the number her doctor told her she needed to call to report side effects from vaccine. She got it on 20Jan2021, first Pfizer vaccine and then two weeks later, she started experiencing memory loss, memory issues, blurred vision and severe headache down to her neck, hard to get her words out, very lost and confused, stumbling like couldnot keep her balance like tripping/ still little bit stumbling, that was after her first vaccine and they sent her to the emergency room, she got an MRI and 'CAT' (not clarified) scan to see as she was having symptoms."Consumer further stated, " she have more information, two weeks after the first dose was when the cognitive issues started and then, a week to the day later, she started feeling herself again maybe 90 percent. Then this afternoon, she got the second vaccine dose and next day she was feeling okay and day and a half later, it all started all over again, headache, back of the head pain, memory loss, blurred vision, all started again. She got an MRI this time and the other day, since then she have severe headache all day, every day, pain down my neck and still little bit stumbling. She went to her neurologist and he said all of her symptoms were symptoms that someone would have with the concussion but she never felt like, she don't have a concussion (hence, concussion not captured as event as consumer was not sure). So, she wanted her to call this number as she said that she believed that memory cognitive issues were all from the vaccine and she guess it was needed to be reported."Outcome of the events were unknow.
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| 51 | 2021-04-03 | feeling abnormal |
March 6-30 -- > headache every day, primarily tension type; variety of meds used to treat March 16-...
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March 6-30 -- > headache every day, primarily tension type; variety of meds used to treat March 16- April 4-- > Vertigo, Brain Fog; 50 mg of meclizine daily
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| 51 | 2021-04-03 | restlessness |
Arm pain began within a few hours of injection. Mild fever, restlessness began 9 or 10 hours after i...
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Arm pain began within a few hours of injection. Mild fever, restlessness began 9 or 10 hours after injection ? treated fever with acetominophen 325 mg. Headache began about 14 or 15 hours after injection ? treated with acetominophen 325 mg. Mild stomach upset (without vomiting) about 23 hours after injection (maybe caused by acetominophen on an empty stomach)
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| 51 | 2021-04-04 | insomnia |
I had severe pain/aches in the administered arm. Aches were so sever that I was up all night in tea...
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I had severe pain/aches in the administered arm. Aches were so sever that I was up all night in tears and unable to sleep. I also had an awful ache at the base of my neck and was extremely tired the day after receiving the second shot.
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| 51 | 2021-04-05 | insomnia, loss of personal independence in daily activities |
Some pain at injection site in the 3 days following shot. Pain mostly gone after that until two day...
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Some pain at injection site in the 3 days following shot. Pain mostly gone after that until two days ago. Now quite painful, making it difficult to sleep or function normally. I can't think of anything I did that would have caused the pain otherwise.
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| 51 | 2021-04-06 | depression |
I had normal side effects as mentioned in my paperwork, such as; injection site pain, neck pain on t...
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I had normal side effects as mentioned in my paperwork, such as; injection site pain, neck pain on the left side, fatigue, joint pain, weakness, difficulty being mobile. There was also depression, the extreme joint pain and weakness made the depression feel worse. I didn't have any treatment but the pain lasted 3 or more days and the depression and joint pain for more than 7 days.
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| 51 | 2021-04-06 | hallucination |
Hot flashes, began within 10min of injection?resolved after 2hours Dizziness, began within 40min of ...
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Hot flashes, began within 10min of injection?resolved after 2hours Dizziness, began within 40min of injection?resolved after 3hours Hallucinations, began approx 45min post injection?resolved after 3hours Wild mood swings, laughing then crying, began approx 45min post injection?resolved after 2hours Vision improved, began approximately 12hours post injection?continues, previously -4.25 now approx -2
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| 51 | 2021-04-06 | sensation of foreign body, disorientation |
Within a few minutes I became extremely dizzy and disoriented a bit, immediately following I had ext...
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Within a few minutes I became extremely dizzy and disoriented a bit, immediately following I had extreme difficulty swallowing as if I had a ball in my throat. Nurses recognized and immediately gave me Benadryl. Today I feel a lot of pressure in my head, fatigue, tingling in lips and right hand.
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| 51 | 2021-04-06 | sleep disorder |
1. Within 3 minutes of getting the vaccine I had the closing of the throat, sneezing, feeling of a c...
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1. Within 3 minutes of getting the vaccine I had the closing of the throat, sneezing, feeling of a closed throat, rapid heart rate, high blood pressure- 145/74. My normal rate is 104/69. I began to have very numb toes on the next day and burning in the toes in the evening. I also had itchy toes and on the 3rd day had several sores on my right foot making it difficult to walk. On the 5th day the pain was so intense that I could not sleep. It felt like fire was in my toes. A call to Dermatology suggested that I had "Covid-Toes" brought on from the vaccine and they suggested that I see a medical Dr for a check up. Dr saw me on that Friday and I had also acquired a rash on my belly.
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| 51 | 2021-04-07 | anxiety |
This is the second day of flu like symptoms and a low grade fever. The date listed in the beginning ...
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This is the second day of flu like symptoms and a low grade fever. The date listed in the beginning was the date of my second shot. After the first shot on 3/13 I only had mild symptoms like two days of soreness in arm and moments of unexplained anxious feelings after a couple of weeks.
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| 51 | 2021-04-07 | anxiety |
3PM 'FEELS A LITTLE ANXIOUS'. A/O, PINK, W/D, RESP WITH EASE. BP 130/70, HR 53, R 20, 02 SAT 94%. 3:...
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3PM 'FEELS A LITTLE ANXIOUS'. A/O, PINK, W/D, RESP WITH EASE. BP 130/70, HR 53, R 20, 02 SAT 94%. 3:05PM PT STATES 'DOING OK NOW AND OK TO GO HOME.' NO ACUTE OR OBVIOUS DISTRESS. 4-8-21 12N TC: PT STATES 'FEELS FINE TODAY.'
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| 51 | 2021-04-08 | anxiety, nervousness |
AFTER RECEIVING THE VACCINE SHE FELT NERVOUS AND ANXIOUS. ON SITE EMS RESPONDED AND VITALS ARE BELOW...
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AFTER RECEIVING THE VACCINE SHE FELT NERVOUS AND ANXIOUS. ON SITE EMS RESPONDED AND VITALS ARE BELOW. SHE WAS GIVEN GRAHAM CRAKERS SINCE SHE HADN'T EATEN YET TODAY. SHE FELT BETTER AND WAS RELEASE TO HOME
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| 51 | 2021-04-08 | feeling abnormal |
Pt reports that she started feeling fussy in the head and her left arm started tingling. Pt also re...
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Pt reports that she started feeling fussy in the head and her left arm started tingling. Pt also reported an odd taste in her mouth. Pt reports that she has had a busy morning seeing her chiropractor and having a massage and has not drank any water for hours. Pt was given water to drink and symptoms resolved.
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| 51 | 2021-04-08 | feeling abnormal |
Systemic: warm and sweaty face--hot face-Mild, Systemic: Flushed / Sweating-Mild, Additional Details...
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Systemic: warm and sweaty face--hot face-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt waited a half hour--vitals were monitored by nursepractioner---122/78 hr in 80s---pt was walked out to car with husband waiting by employee---total dose benadryl 50mg--chewable and then liquid--pt immediately felt better after laying down--Np feels it was vasovagal
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| 51 | 2021-04-08 | nervousness |
Got shot in right arm. Sat in waiting area and within 5 - 7 min felt sick and faint. Dropped to the ...
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Got shot in right arm. Sat in waiting area and within 5 - 7 min felt sick and faint. Dropped to the floor and I could not move. I heard people wanting to sit me up to get me in a chair but I could not move on my own. They lifted me and then I went out completely. I remember dreaming and then within seconds, that is what I was told, I could hear them. I then was taken to an area that they checked my pulse, BP, and sugar. Blood pressure, I believe was around 92. I usually run around 120 but can run lower. They called an ambulance because I was unresponsive for a bit while on the floor. I was given IV fluids because of concern with BP. I was aware the rest of the time. I felt nauseous, shaky, cold, thirsty, and very weak. I went to the hospital and they did a CBC and differential as well as a chest xray. All were very good. They also did an EKG which was ok. I started to feel better and the doctor said I could drink and since I felt hungry and had a small protein bar. I was discharged around 12:15p. I continued to feel very weak, some nausea, some diarrhea and a slight headache. I woke in the morning very dizzy and off balance with a sore arm, a little nausea and weak. On 4/8/21 I woke up feeling very weak in my limbs. Headache, sore arm and nausea were gone. By the end of the day the weakness was a bit improved. By 4/9/21 the weakness in my limbs was much better. Still get a little dizzy if I bend over.
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| 51 | 2021-04-08 | sleep disorder |
first symptom began about and hour after injection . I felt hyper and it last until about 8pm when...
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first symptom began about and hour after injection . I felt hyper and it last until about 8pm when I began to experience a very bad headache and body pains. I was unable to sleep that night, experiencing hot and cold flashes and joint, and muscle pain intensified. By the next morning I was running a fever of 100.9. I continued to have extreme body pain, headache, and fever between 100.5 and 100.9 until Friday, March 26, 2021
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| 51 | 2021-04-10 | disturbance in attention | Severe headache, vision changes, unable to concentrate or think clearly. |
| 51 | 2021-04-10 | excessive sleepiness | Tired right after. Fever for a day. Slept a lot. Swelling at injection sight. |
| 51 | 2021-04-10 | insomnia |
Had tinnitus before but it much louder after dose #2. Difficulty falling asleep and unable to distra...
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Had tinnitus before but it much louder after dose #2. Difficulty falling asleep and unable to distract myself from the sound as I had been able to previously.
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| 51 | 2021-04-10 | sleep disorder |
Developed chest pain and pressure which woke patient up from sleep. Clinical history suggestive of p...
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Developed chest pain and pressure which woke patient up from sleep. Clinical history suggestive of pericarditis. Patient had previously had COVID-19 in 8/2020. Treated with prednisone and colchicine, pain improving on time of discharge.
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| 51 | 2021-04-11 | feeling abnormal, confusional state |
Began having the sensation of being poked with needles all over my body. Continuously. Like a se...
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Began having the sensation of being poked with needles all over my body. Continuously. Like a severe tingling. Head to toe, including face and extremities. ( With the 1st dose, I had the same sensations on a very slight level, and only on arms and legs and not all the time). Sensations started day 2. Severe at day 4, when I had to drive 4 hours to another State. Accompanied by random dizziness, and feeling mentally "out of it" a little. I'd read it was Ok to exercise after getting the shots, so Day 2 and 3 I attempted crossfit. I got thru the classes, barely. Afterward I thought I was going to pass out and I felt bizarre, mostly my head. Very unwell. I would also get random hot flashes with dizziness. I am perimenopause, but dont have hot flashes very much any longer and they dont make me dizzy. With the day 4 severity of the needles sensation, I honestly started to worry. I decided Id see a doctor upon my return to home, which would be day 7. Today is day 7 after dose 2. Huge improvement, but still having some of the sensations, so I dont plan to reach out to my doctor unless my next workout feels like the ones last week. I expected the common side effect of tiredness and fever chills, but got this crazy stuff that felt like my nervous system was misfiring/freaking out. I am afraid to get a booster shot for Covid if that's the path in a few months!
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| 51 | 2021-04-11 | feeling abnormal |
4/5/2021; 02:20pm: Onset of symptoms. Burning, tingling, numbness in injection site left arm, moved...
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4/5/2021; 02:20pm: Onset of symptoms. Burning, tingling, numbness in injection site left arm, moved to back of shoulder blades, neck, hand/fingers and to right arm and facial and head. Extreme dizziness. Brain fog, difficulty swallowing but no swelling, rash or hives. Evening of 4/5 and all day 4/6 had arm soreness and mild headache that subsided after 2 days. 4/6-4/11: dizziness/lightheaded, blood pressure fluctuation - systolic and diastolic high, difficulty swallowing on 4/9 and 4/10 - felt like something stuck in middle of throat, voice hoarseness, slight sore on right side of throat. 4/11: Cold sweat while sleeping 4/12: Lightheaded (mild), blood pressure fluctuation (not as high as previous readings), voice hoarseness, slightly sore on right side of throat. Mild/light tingling at right shoulder blade and back of neck.
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| 51 | 2021-04-11 | sensation of foreign body |
patient reports lump in throat, and needing to clear throat. Denies difficulty swallowing or breath...
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patient reports lump in throat, and needing to clear throat. Denies difficulty swallowing or breathing. Benadryl given at 1:16pm. Patient reports improvement in symptoms at 1:24pm
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| 51 | 2021-04-12 | disturbance in attention |
Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general ...
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Day 1 (within 30 minutes of vaccine): Tingling and prickling on left fingers and left toes; general malaise; fatigue; difficulty concentrating; Day 2: General malaise, fatigue; difficulty concentrating; headache; lower back pain Day 3: Fatigue; runny nose, sneezing, cough, aches all over the body; headache; a red, itchy blotch on the right index finger; lower and upper back pain Day 4: Same as above, but vision problems right before bedtime; Day 5: Severe headache, lightheadedness, difficulty talking, numb left side of thCT e face, left hand, left arm, left food. Went to ER and still in the hospital in observation (Day 6)
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| 51 | 2021-04-12 | feeling abnormal |
I was brought to the hospital by the ambulance because my throat swelled up.; eyes are tired; My bod...
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I was brought to the hospital by the ambulance because my throat swelled up.; eyes are tired; My body is itchy and feel like crap; My body is itchy and feel like crap; she's allergic to the Covid 19 vaccine; I was wheezing within 10 minutes after receiving the first dose of the vaccine.; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8732 and expiry date: 31Jul2021) via an unspecified route of administration in left arm on 29Mar2021 at single dose for covid-19 immunisation. Medical history included Multiple sclerosis (from 1996 to ongoing), 2006-2007, it was because of an MS drug (Interferon (receiving 3 times a week)), it gave her mild cardiomyopathy. She just stopped taking another treatment for multiple sclerosis called Mavenclad. Mavenclad is a chemotherapy drug. She received her first dose in Oct2020, she took Mavenclad for 5 days. Then in Nov2020 she started taking the Mavenclad again for 5 days. She doesn't restart the Mavenclad again until Oct2021. She reports the Mavenclad takes the B and T cells out of her bone marrow. When she has the next dose of Mavenclad, the B and T cells will be depleted again and when the B and T cells come back they are "tricked" so they won't attack her body. Her hair fell out in clumps with the Mavenclad and her throat swelled too. She would really like a haircut to fix her hair. She premedicated prior to receiving the Mavenclad. She reports she was premedicated for 3 days prior and the day she received the Mavenclad, with Benadryl. Within 15 to 20 minutes of taking the Mavenclad she had a reaction. Concomitant medications included vitamin b12 (about a year) for vitamin b12 deficiency and vitamin d (10-15 years) with calcium for Vitamin D deficiency. On 29Mar2021 within 10 minutes after receiving first dose her throat swelled up. The next thing she knows is people are all around her, she's on a gurney and she's going to the hospital in an ambulance. She would say she's allergic to the Covid 19 vaccine. In the emergency department she had to have an IV with all kinds of medications. Yesterday in the emergency department the doctor wanted to give her an epi pen. She told the doctor she didn't want to have the epi pen. In her IV in the emergency department she received Solu-Medrol, Benadryl (as needed), and Famotidine (20mg twice a day 10 days). She was prescribed Prednisone 20mg tablets, take 3 tablets orally every day for 5 days. She also reports she is allergic to egg whites, not deathly allergic. She can eat a hardboiled egg but she has to take Benadryl because her throat will start to close up. She can eat scrambled eggs just fine because the eggs are cooked different. The emergency room was watching her because if she didn't improve, they were going to give her the epinephrine. She started to improve, and she was thankful. She was afraid something else could have happened to her and her husband was in the parking lot and wouldn't have known. She's not sure how many hours she spent in the emergency room. She was not admitted to the hospital; she was discharged from the emergency room. Now she's taking medication for the next 5-10 days. She's not shocked, with her history and her reactions to medications. She didn't really think an allergic reaction was going to happen because the Covid 19 vaccine is not a live vaccine or anything like that. She's not going to look online for allergic reaction information because her eyes are tired. She's been up since 1:30 AM because of all the steroids she's on. On 30Mar2021, her whole body is itchy. She's taking Benadryl and the Benadryl has helped. The itchy feeling is moving on to different parts of her body. She had the swine flu when it came out and it was hellacious. She feels like Covid is much worse and she she believes in science. She knows Covid 19 isn't made up. She's all for the Covid 19 vaccine. Give her the Covid 19 vaccine so she can move on. She reports everyone in her family got the vaccine, and they were all fine besides aches and pains. When probing for specific information regarding the caller's family members, she reports her daughter, who is in nursing school had the Covid 19 vaccine. After her daughter's first Covid 19 vaccine, she had a sore arm that night and she was really tired. The next day her daughter felt a little lightheaded and she felt like she had flu symptoms. She had some body aches. Then under her daughter's armpit where her lymph nodes are were swollen. By the third day her daughter felt better. She was totally fine. She thinks her daughter may have reported her experience online. The outcome of event eyes are tired and I was wheezing within 10 minutes after receiving the first dose of the vaccine was unknown, the outcome of event My body is itchy and feel like crap, My body is itchy and feel like crap and she's allergic to the Covid 19 vaccine was not recovered where the patient recovering from the event I was brought to the hospital by the ambulance because my throat swelled up.
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| 51 | 2021-04-12 | feeling abnormal |
At 12:28 p.m. on Saturday, April 10, my blood oxygen went down to 87%. I felt cold, had chills, and ...
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At 12:28 p.m. on Saturday, April 10, my blood oxygen went down to 87%. I felt cold, had chills, and was shivering. I felt weak and felt malaise when i stood up. I was monitoring my blood oxygen and temperature. Blood oxygen improved but I still felt malaise, weakness. I took one 600 mg ibuprofen at 2:40 p.m. At around 3:43 p.m. my blood oxygen was 98% and i felt better finally. Subsequently, I took 2 (200 MG) Advils at 9:50 p.m. before going to sleep. At 2:00 p.m. on Sunday, April 11, I got up to get my salad out of the fridge and I started feeling malaise. My heart rate went up, I was breathing shallow. I drank 2 Advils (400 MG). I took 1 more ibuprofen at 3:30 p.m. I felt bad until before going to sleep. Before going to sleep, I drank chamomile tea to help me breathe better and took 3 Advils. At around 8:00 p.m. on Monday, April 12, I started to experience shallow breathing. I made myself chamomile tea and drank two cups but it didn't seem to help shallow breathing. I then made myself a tea with ginger, turmeric, cayenne pepper, black pepper, lemon peel, lemon juice, coconut oil and honey. I drank it around 11:25 p.m. I was up until after 12 a.m. until finally I felt I could breathe better and went to sleep.
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| 51 | 2021-04-13 | feeling abnormal, sleep disorder |
I submitted a report after my first dose of the vaccine , and now this is the report after my 2nd do...
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I submitted a report after my first dose of the vaccine , and now this is the report after my 2nd dose of the Pfizer vaccine: I got the 2nd dose at 4:10pm. I did not feel the shot at all this time, but my arm was a bit achy soon after. One hour after the shot my leg muscles hurt and I felt fatigued. Two hours after the shot I felt really tired and really silly, kind of loopy. Three hours after the shot my L arm was hurting more and it hurt to take the band aid off. Then my stomach started feeling upset. I went to bed at 10:30pm and had a very rough sick night. I was awake most of the night, only dozing a few times. I had a fever (101) and chills; nausea and belching; dry mouth; aching and strange pains coming and going; a slight headache; and my L arm was hurting. By 7am I started crying, and I had more physical pain. I got up at 8am feeling so sick with extreme fatigue, headache, and in a lot of pain in body. My Mom had to make my breakfast for me and I took small bites of that oatmeal throughout the day. I couldn't eat very much because my stomach was so upset. I felt hot and cold and got chills often during the day. By 6:45pm the fever returned (100.3) and I felt sicker again with head and tummy hurting; body aching; and nausea. Finally at 8pm I took 2 Tylenol which helped a lot, but then I worried what if that reduced the effectiveness of the vaccine. I went to bed at 9:15pm and fell asleep right away, but woke up many times soaking wet with sweat. The next day I still had trouble with temperature regulation and I felt very tired and headachy and my L arm still hurt. A few days later I got my menstrual cycle about one week early, and it was the strangest period I've ever had. It was a very light flow, I had lots of clots, and along with the small amount of blood, there was lots of clear stretchy mucous like I get at ovulation. After my first vaccine dose I got my period a few days later also, but that time I only had brown spotting for 4 days and no regular blood flow at all, so this time it was slightly more of a period, but it was really not my usual kind of period. Overall, I felt completely whacked and wrecked by the 2nd dose. It was a terrible experience.
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| 51 | 2021-04-13 | feeling abnormal |
sudden feeling of dizzyness. started by feeling wobbly, just something that felt "off". within an ho...
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sudden feeling of dizzyness. started by feeling wobbly, just something that felt "off". within an hour i felt like my balance was off. standing and sitting didn't feel quite enough, started to feel that hotness and start of naseau, but laying down to left side and then sitting up seemed like a head rush. then within maybe another 20 min, definite dizzyness. when looking up to the ceiling, visibly looked like world spinning. but not as visible looking down. no change in vision though. felt okay to lie down and sleep. pretty intense for a couple of hours. but better by morning. worked from home as usual. felt mildly wobbly when moving around fast or animated. all gone by 6pm/supper. ate fine all day. drank fine.
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| 51 | 2021-04-13 | feeling abnormal |
First, I had a tight throat and I blamed it on the pollen, next at home potato chips got stuck in my...
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First, I had a tight throat and I blamed it on the pollen, next at home potato chips got stuck in my throat, and I was just like 'I am eating too quickly', then at boy scout meeting that evening I couldn't breath and blamed it on my mask (we have to wear masks outside), came home took an expired Benadryl and thought, I will call allergist in the morning for an appointment. Next day woke up, felt fine then around 1pm I was on the toilet and I felt a drop like hitting the bottom on the elevator and I thought I won't be able to get off the toilet, I felt super dizzy and nauseous and I thought I would fall. I seriously don't think I have ever felt worse. Yelled to husband got on sofa and started calling 'ask a nurse' which was stupid, called 911 and they told me to take epi-pen which I should have known to give myself the whole time! EMT came and I went to ER. Felt better almost immediately with epic-pen and drip with steroids and Benadryl. Next day went to allergist and felt like I was having another reaction, she gave me some additional meds. I started on Zyrtec and I didn't like how drowsy I was feeling so on 4/5 I didn't take Zyrtec that night and Tuesday I woke up fine and then around 1pm I thought I was going to die, I called the allergist, they said you should continue taking Zyrtec every night and take one then. I felt like I was having another allergy attack. I felt so dizzy I couldn't move, I felt like I was going to fall, I threw up. I was still too dizzy to move, called ER, went to ER and started feeling better due to the Zyrtec now in my system.
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| 51 | 2021-04-14 | feeling abnormal |
Irregular and fast heart rate started 10 hours after inoculation, followed by chills, headache, body...
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Irregular and fast heart rate started 10 hours after inoculation, followed by chills, headache, body ache, fatigue, no appetite. All symptoms lasted 36 hours or so but irregular and fast heart rate lasted for days. Today is day 12 after the shot, still feel a bit irregular.
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| 51 | 2021-04-15 | anxiety |
Clammy, tingling in bilat hands, anxiety. Pt stated she fainted before - feels cold, clammy beforeha...
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Clammy, tingling in bilat hands, anxiety. Pt stated she fainted before - feels cold, clammy beforehand. She felt this way w/ bilat tingling & called for nurse. A&O x4. Vitals stable. Gave water - hasn't drank since 10 AM. After drinking water, pt stated she is feeling better. Offered w/c for exit, declined. Vitals still stable. Pt left Yahoo in stable condition. BP 123/63; HR 72; RR 18, SpO2 97%
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| 51 | 2021-04-15 | feeling abnormal |
she had a low grade fever of 99.5 degrees; body ache; felt feverish, but had no fever; Back pain; sh...
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she had a low grade fever of 99.5 degrees; body ache; felt feverish, but had no fever; Back pain; she said she had pain in her arm, and the pain went away after the first day; This is a spontaneous report from a contactable other health Care Professional. A 51-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EL1284) via an unspecified route of administration in right deltoid on 26Jan2021 at 10:30 as single dose for covid-19 immunisation. Medical history included anxiety. Concomitant medications included on 27Jan2021 at a dose of 50 mg once a day for anxiety.On26Jan2021,the patient experienced on pain in her arm, and the pain went away after the first day, body aches, particularly severe back pain and feeling feverish on 29Jan2021, she had a low grade fever of 99.5 degrees on 31Jan2021, treatment received for this events with she took Tylenol and Motrin and this morning she felt better. The patient underwent lab test included body temperature Body temperature 99.5 Fahrenheit. The outcome of the events pyrexia was unknown and for pain in extremity was resolved, body ache, feeling abnormal, back pain was not recovered.
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| 51 | 2021-04-16 | sensation of foreign body |
After an hour of injection felt a lump in my throat like I do with bee sting, whole body turned red ...
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After an hour of injection felt a lump in my throat like I do with bee sting, whole body turned red and got nauseous
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| 51 | 2021-04-17 | disorientation |
Rcvd injection at 10 am, 10:05 am rapid heartbeat, dizziness, weak. Sat down. 10:20 am heartbeat st...
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Rcvd injection at 10 am, 10:05 am rapid heartbeat, dizziness, weak. Sat down. 10:20 am heartbeat steadied, still a little disoriented but able to leave facility. 10:25am, left side of face swelled up. 10:30 am, in bed, slept for 3 hours, profuse sweating. Upon waking up, tired, swollen left side of face, headache, sore throat, injection site and other muscle pain. Back to bed 8pm, same symptoms. Sunday morning the 18th 8 am drenched with sweat, injection site pain, swollen left side of face. By noon, after taking daily medications and shower, cold compress on left side of face, swelling down, still feeling tired, but overall feeling better.
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| 51 | 2021-04-17 | feeling abnormal |
Immediately felt strange and somewhat dizzy. By evening, I felt fatigue and dizzy. The next morning,...
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Immediately felt strange and somewhat dizzy. By evening, I felt fatigue and dizzy. The next morning, I had slight stomach pains and diarrhea. As the following day went on, I had the chills and aches. By that following evening, it was back to fatigue only and all other symptoms were gone. The second day following the shot, all symptoms were gone.
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| 51 | 2021-04-18 | excessive sleepiness |
Left arm at injection site is red and swollen and very sore. Had fever of 102.5 all day yesterday (...
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Left arm at injection site is red and swollen and very sore. Had fever of 102.5 all day yesterday (16 hours), couldn't break it with advil, but was able to reduce it to 100.2 for about 2 hours, before climbing right back up. Very fatigued, slept all day. Today, slight fever of 99.5 and still fatigued but feeling much better than yesterday.
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| 51 | 2021-04-19 | nervousness, anxiety | Anxiety, Dizziness, shaky and pale. Sugar level check 64. |
| 51 | 2021-04-21 | feeling abnormal |
I started feeling dizzy, and then later on i had the worst headache for 2 days and it felt like i wa...
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I started feeling dizzy, and then later on i had the worst headache for 2 days and it felt like i was catching a cold, i got really hot, and was and still very sluggish after the second day. My chest also felt very tight and body aches, i feel terrible.I couldn?t even get out of the bed to use the bathroom and a little runny nose.
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| 51 | 2021-04-22 | confusional state | Patient went to a state of confusion and syncope. |
| 51 | 2021-04-23 | feeling abnormal |
April 10 very fatigued, headache, ?brain fog?. Woke up around 3 am April 11 with horrible high pitch...
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April 10 very fatigued, headache, ?brain fog?. Woke up around 3 am April 11 with horrible high pitched ringing in my ears. It does not stop.
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| 51 | 2021-04-23 | impaired work ability, insomnia |
Was unable to work two days, 04/19-20 as was very bad. Duration 2 days: Fever 102.5, worst headach...
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Was unable to work two days, 04/19-20 as was very bad. Duration 2 days: Fever 102.5, worst headache ever, worst chills ever, pain all over, extreme difficulty standing up from a laying down position, nausea, vomit one time, dizzy off balance, unable to sleep more than 30 minutes at a time, could not cope with any sound or lights, and diarrhea. 24 hours after second shot had to take Motrin since so bad. Duration 4 days: fatigue and arm pain. Diarrhea is back today, 6 days after second shot. The poop is skinner than normal, with diarrhea and the color is lighter than normal today. I have not seen a doctor, I just want to report since it was so bad, and I am very anxious about these being annual shots and not sure when to worry about the diarrhea.
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| 51 | 2021-04-23 | sleep disorder, loss of personal independence in daily activities |
Excruciating shoulder pain, stiffness, weakness, very limited range of motion . Difficult doing most...
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Excruciating shoulder pain, stiffness, weakness, very limited range of motion . Difficult doing most anything that requires me to to bring my arms up or to move them side to side. Loud sounds of popping and crackling, crunchy sounds upon the slightest movement. Extremely painful when I?m trying to get to sleep. I wake up several times in such pain that it causes me to scream out loud. to I can hardly turn my steering wheel to drive, I have a difficult time carrying most anything. Started in my left arm after first vaccine and my right arm after the second one. I?ve never had any problems or issues with my shoulders prior to this.
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| 51 | 2021-04-24 | feeling abnormal |
Bell's Palsy; something felt weird; asthma; facial numbness and tingling; facial numbness and tingli...
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Bell's Palsy; something felt weird; asthma; facial numbness and tingling; facial numbness and tingling; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration administered in arm left on 05Apr2021 (Batch/Lot Number: ER8727) at age of 51 years old as single dose for covid-19 immunisation. There was no medical history. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No events following prior vaccinations. There were no concomitant medications. The patient had her 1st dose of Pfizer Covid-19 vaccine on Monday morning (05Apr2021). The patient experienced facial numbness and tingling on 05Apr2021. After the injection she sat and waited for 15 minutes. When she got in the car, she felt her face tingling. It had been a couple days of having the sensation in her face. She called her physician and it was labeled as Bell's Palsy. Her physician suggested she phone and report her experience. She had her appointment at 11:30. She was back in her car around 13:00. She noticed as she was driving, that something felt weird. She didn't know if it was numbness or tingling. She added it was not painful and she was not distorted. She thought it's numb. Her physician advised she take Motrin. Her physician shared an article about a trial that some people may experience this after, it included 4-5 people. Her symptoms shifted. First in her cheeks, then over the course of yesterday and today, she feels it's on the side of her face. The forehead had gone away, but it's on the right side of her face. She added the symptoms were improving and clarified they were persisting. She had asthma and wanted to minimize the severity of Covid if she would ever get it. She had loved ones around and added that you never know. She wanted to protect herself. She wanted to get out and see her family and friends. Some of them have already been fully vaccinated. She was concerned when it started. It wasn't affecting her breathing, but she called her physician and asked if she needed to come in. Her physician suggested to just monitor it. The events did not require visit to emergency room or physician office. The outcome of events facial numbness and tingling was not recovered. The outcome of other events was unknown.
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| 51 | 2021-04-24 | insomnia |
Excruciating pain on my arm (vaccine arm) can?t move, raise the arm, can?t sleep due to pain. Will c...
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Excruciating pain on my arm (vaccine arm) can?t move, raise the arm, can?t sleep due to pain. Will contact family doctor on Monday if it does not get better
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| 51 | 2021-04-24 | insomnia |
My ears are ringing constantly; My eyesight changed and I can't see out of my glasses./vision is so ...
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My ears are ringing constantly; My eyesight changed and I can't see out of my glasses./vision is so bad I cannot drive; Eyes are blurry; Nausea; Couldn't keep food down; Dizzy; can't get balance; Couldn't sleep for five days; Sore throat; runny nose; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 (Lot Number: SJCFR EN 6199) on 24Mar2021 09:00 as single dose, and dose 2 (Lot Number: En6199) on 24Mar2021 (to be confirmed) as single dose, both via an unspecified route of administration, administered in left arm for covid-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID prior vaccination. She has not been tested for COVID after vaccination. On 31Mar2021, the patient reported that her ears were ringing constantly, her eyesight changed, and she couldn't see out of her glasses. Her eyes were blurry, and vision was so bad she cannot drive. She had nausea for a week straight. She also couldn't keep food down. She was dizzy and couldn't get balance. She also couldn't sleep for five days. She also had sore throat, and runny nose for a week. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and has caused disability or permanent damages. Treatment for the events included prednisone and anti-nausea medicine. The outcome of the events was not recovered.
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| 51 | 2021-04-24 | sleep disorder |
Reactions: 1. Jabbing pain in upper left chest area within first two hours. It was a specific pinp...
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Reactions: 1. Jabbing pain in upper left chest area within first two hours. It was a specific pinpoint area of chest where I had experienced pain early in the pandemic in Spring 2020. (Also had a reaction 3 days after first shot in the same exact area, but only numbness and warmth in upper left chest area that went away within a day). The jabbing pain was off and on and went away within the first 12 hours. 2. Immediate fatigue within hours of getting shot 3. Body aches, slight chills and sweating that started during the night, woke me up at 3:12am and continued until morning of April 24
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| 51 | 2021-04-25 | sleep disorder |
Entire left shoulder area is extremely painful after second shot. Arm cannot dangle; it must always ...
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Entire left shoulder area is extremely painful after second shot. Arm cannot dangle; it must always be in propped position. Pain reliever, whether oral or topical, does not work. Hot nor cold compresses do not work. There is marked weakness and range of motion present. Unable to lie on back or side at night while attempting to sleep. Extreme tiredness began on second day after first vaccine with lower fever.
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| 51 | 2021-04-26 | feeling abnormal |
I had 103 fever; flu-like symptoms: aches, chills, fatigue, headache. I was wiped out and felt overa...
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I had 103 fever; flu-like symptoms: aches, chills, fatigue, headache. I was wiped out and felt overall malaise. The fever ran that high for a day. For a whole day, I felt really bad. And then it was low grade for 2 days and then I felt still like I had a flu but fever was 100. I took Tylenol and took plenty of fluids and rested. It was three days before it was better - each day was getting progressively better. By fourth day, I was fine. I had almost no arm soreness at injection site with this vaccine. The first full day, it was a bit sore but then it went away. (The first Pfizer dose of vaccine, I had arm soreness - intense- for two weeks.)
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| 51 | 2021-04-28 | feeling abnormal |
Reaction was immediate Dizzy Blurred vision Nausea Body felt very warm and overheated Heavy feelin...
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Reaction was immediate Dizzy Blurred vision Nausea Body felt very warm and overheated Heavy feeling and pressure in chest when breathing Overall uneasy feeling
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| 51 | 2021-04-28 | loss of personal independence in daily activities, feeling abnormal | dizziness, weakness, heart rate elevated, incapacitated, shortness of breath, lethargic, brain fog |
| 51 | 2021-04-29 | anxiety, feeling abnormal |
initially while driving home, eye spasms and eye dryness, various sharp pains in leg and right foot,...
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initially while driving home, eye spasms and eye dryness, various sharp pains in leg and right foot, a feeling of heightened anxiousness. Following day the typical fatigue, unusual headache, full tunnel feeling in head and ears, off balance feeling, some muscle aches as well as previously mentioned symptoms. this lasted for about 3 days. some mild relief in fatigue and headache but all of a sudden non stop ear ringing (Tinnitus) high pitched EEEEE with occasional low tone whistle sound. fast forward currently no relief in ear ringing and off and on mild pressure headaches, off balance,(some days worse than others) mild fatigue, some isolated off and on muscle aches. slight fainting feeling (occasional), don't feel grounded..... among other things
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| 51 | 2021-05-09 | nightmare, anxiety |
2 months ago feeling anxiety and having nightmares - night mares about falling my fear!!- not height...
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2 months ago feeling anxiety and having nightmares - night mares about falling my fear!!- not heights but falling -wakes me up every night and recently started having ice pick pains in my left side of my head and smelling odd odors while trying to sleep
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| 51 | 2021-05-12 | disturbance in attention |
Tinnitus started approximately 4 hours after receiving my first dose of the Pfizer COVID 19 vaccine....
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Tinnitus started approximately 4 hours after receiving my first dose of the Pfizer COVID 19 vaccine. Other symptoms include dizziness, fatigue, difficulty concentrating at times. The tinnitus has been constant. I saw my PCP, an ENT specialist, and an Audiologist. There is no treatment for the tinnitus and it may be permanent.
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| 51 | 2021-05-13 | anxiety |
About 30 minutes after getting the first shot of Pfizer vaccines, the left side of my body started t...
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About 30 minutes after getting the first shot of Pfizer vaccines, the left side of my body started to feel like getting swollen. Left half of my face started feeling swollen and tingling - like when your dental anesthesia was wearing off, and my left arm feeling swollen. I checked my left hand and my face on the mirror to see if they were really swollen, but they looked normal. I think it was more of the neurological effect. I can't remember if my left leg was also impacted. I think about 30 minutes or so, it started get better so I didn't go to see a doctor. About an hour after the shot, I think it was pretty much gone. Now, I may be too self conscious, but I feel like something wrong /weird with the left side of my body/face, but that may be my anxiety tricking me.
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| 51 | 2021-05-14 | feeling abnormal |
Immunocompromised; patient is skinny/underweight; having a multiple sclerosis relapse/Multiple Scler...
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Immunocompromised; patient is skinny/underweight; having a multiple sclerosis relapse/Multiple Sclerosis flared up after she got the vaccine; double vision that is intermittent and unilateral; had a funny feeling around the lips, tongue, and on the left side of her face; This is a spontaneous combined report from a contactable consumer (patient) via Pfizer. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199) (51 year at the time of vaccination) via an unspecified route of administration in arm left on 15Apr2021 at 10:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Medical history included multiple sclerosis from 2000 and ongoing. The patient's concomitant medications were not reported. On 15Apr2021, after the first dose the patient started experiencing double vision and had funny feeling in her lip, tongue and left side of the face (started prior taking the vaccine). The patient said she might be relapsing from multiple sclerosis. The patient was confused whether she should take the second dose of the vaccine. The patient also received IV methylprednisolone (3gm) (to be administered over 2 hours for three days) and taking prednisone for her double vision which comes and goes. Patient stated she had been immunosuppressed due to being on prednisone for 7days. The patient went to the health care professional and the health care professional gave her a steroid and patient stated the steroid was not responding to the double vision. The patient reported that she does not remember having any issues with her eyes subsequent to taking the vaccine which could be coincidental or nothing to do with the vaccine, but she then developed double vision which was getting worse. The patient also reported that she was skinny and underweight. The patient took 3 grams of Solumedrol IV and it did not help her. Therapeutic measures were taken in response to the events and the patient also had to visit emergency room. The outcome of the event's multiple sclerosis relapse, double vision, immunocompromised and skinny/underweight was unknown while for the event funny feeling around the lips, tongue, and on the left side of her face it was reported as not recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 51 | 2021-05-14 | hallucination |
Dizziness; Hallucinations; This is a spontaneous report from a contactable consumer (patient). A 51-...
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Dizziness; Hallucinations; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 11:45 as unknown, single for COVID-19 immunization. Medical history included other medical history: asthma, known allergie: shell fish, thyroid, COVID prior vaccination: Yes, known allergie: bee stings, and known allergie: codine. Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D), and fluticasone propionate (FLONASE). Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hallucinations on 30Apr2021, and dizziness on 30Apr2021 15:30. No treatment was received for the events. The outcome of the event hallucinations was recovered on 30Apr2021 and for dizziness was recovered on 01May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 51 | 2021-05-17 | nervousness |
Numb left ear and parts of left side of face; Heart Pressure; Irregular heart palpitations; very sca...
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Numb left ear and parts of left side of face; Heart Pressure; Irregular heart palpitations; very scary; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received first dose of BNT162B2 (Lot Number: ER8731) via an unspecified route of administration, administered in left arm on 07Apr2021 at 14:00 at age of 51-year-old as single dose, and received second dose of BNT162B2 (Lot Number: EWO167) via an unspecified route of administration, administered in left arm on 28Apr2021 at 14:00 at age of 51-year-old as single dose for covid-19 immunisation. Medical history was not reported. Facility where the most recent COVID-19 vaccine was administered reported as Public Health Clinic facility. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 28Apr2021 at 16: 00, patient experienced heart pressure, irregular heart palpitations - almost went to emergency room a few times. Patient was very scary, had numb left ear and parts of left side of face. No Hospitalization Prolonged. No treatments were received for events heart pressure, very scary and numb left ear and parts of left side of face. The outcome of events was recovered with sequelae. Information on Lot/Batch number was available. Additional information has been requested.
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| 51 | 2021-05-17 | nervousness |
flu like symptoms; headache; Shaky; pass out; feel faint; felt a bit achy; sweat; very weak; This is...
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flu like symptoms; headache; Shaky; pass out; feel faint; felt a bit achy; sweat; very weak; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 29Apr2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. at the age of 51 years old. The patient medical history was not reported. The patient was not pregnant. Concomitant medication(s) included loratadine, pseudoephedrine (CLARIDIN-D) (medications the patient received within 2 weeks of vaccination). The patient previously took bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:30 AM (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced pass out, feel faint, felt a bit achy, sweat, very weak,shaky all on 30Apr2021 07:30, flu like symptoms and headache on an unspecified date. Reported as: I received my shot on Thursday afternoon. Friday morning, I woke up and felt a bit achy, but otherwise OK. I drove my daughter to school and in the car on the way, I began to feel faint. I pulled over, broke into a sweat, and proceeded to pass out in the drivers seat. My daughter called my friend who picked us up. I was shaky, and very weak. I went home, had fluids and slept for the remainder of the day with flu like symptoms and a headache. By Sunday, I was back to normal. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered. Information about lot/batch number cannot be obtained. No further information expected.
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| 51 | 2021-05-20 | impaired work ability |
patient started with back pain the next day and it progressed to nodules in the muscles of the back,...
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patient started with back pain the next day and it progressed to nodules in the muscles of the back, starting with left lower back, left upper back, then appearing in the right lower and upper back. Patient had to take time off work and file for short term disability
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| 51 | 2021-05-21 | feeling abnormal |
nearly passed out; the shoulder where she got her injection started hurting really bad; getting hot;...
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nearly passed out; the shoulder where she got her injection started hurting really bad; getting hot; sweating; thirsty; Her blood pressure dropped; couldn't breathe; arm hurting really bad; got very weak; turned gray, like an elephant; felt floaty; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at left shoulder (Arm Left) on 19Apr2021 10:00 AM at age of 51 years old (Batch/Lot number was not reported) as 1ST, SINGLE for covid-19 immunisation. The patient's medical history was reported as just told her blood pressure dropped on an unknown date, hooked patient up to a bunch of wires and stomach, monitoring her on a machine. The last couple of time patient had blood drawn, the one last time, she went into shock and passed out. This wasn't quite the same thing with this time. This was maybe 2 years before unspecified date. One time it was pretty bad and patient fell down, get the doctor and hook patient up to all that stuff. Didn't' quite feel the same way as this time. She didn't get hot and sweaty. Patient was not taking any pills. The concomitant medications were not reported. After first dose of the Pfizer covid vaccine. After the injection on 19Apr2021, patient sat for 15 minutes (wait for 15 minutes) and the shoulder where she got her injection started hurting really bad. Arm hurting really bad, walked across the hall and sat in the chair, maybe 2 minutes later. Then started tearing her mask off because she couldn't breathe. Patient started getting hot, sweaty and thirsty. Patient was sweating, started getting hot and thristy and then got really sweaty and super hot. Got really thirsty and was given water. She was trying to grab a bottle of water and she didn't have the strength. She got very weak, turned gray, like an elephant and her blood pressure dropped, and nearly passed out. It lasted maybe 10 or 15 minutes. They called the ambulance. By the time they got there, she was feeling more back within herself and It was pretty much done and was totally better, maybe 90 percent. She just wanted to go home and did not go in the ambulance. She felt floaty but did not pass out. With the first one, she had a reaction and is wondering if she should even take the second one. Therapeutic measures were taken as a result of thirsty included water. Treatment for other event was reported as none, and she was not taking any medication. The event outcome of recovered on 19Apr2021. Information about lot and batch number was requested.
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| 51 | 2021-05-24 | anxiety | Patient reports on and off palpitations and smoking more due to anxiety |
| 51 | 2021-05-24 | sleep disorder |
On and off numbness and tingling in my left arm and hand (primarily) and also in my right hand (a f...
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On and off numbness and tingling in my left arm and hand (primarily) and also in my right hand (a few times) during the day for about 3 weeks. Involuntary movements in my fingers in both hands. My arms and hands still fall asleep at night and this did not happen to me before except on some rare occasion that I slept on my hand or arm. I have been awoken by a limb that is asleep about 4 times since my vaccine. Intermittent headaches for about two week after the vaccine and a very unusual, heavy and somewhat painful period with several large clots the size of a half dollar and lasting much longer than a normal period. I felt dizzy and lightheaded for about a day. I have never had these kinds of periods before.
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| 51 | 2021-05-24 | sleep disorder |
After the 2nd shot, second day after; I had left arm pain that woke me up in the middle of the night...
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After the 2nd shot, second day after; I had left arm pain that woke me up in the middle of the night. I also, suffered a terrible headache with chest tightening, shortness of breath, hard time swallowing and a pulsating pain on the back of my head. This lasted four days before it eased. Also, I have been feeling run down and headaches since.
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| 51 | 2021-05-25 | excessive sleepiness |
I had the "normal" aches and tiredness starting many hours after 2nd shot (1st shot only had the ver...
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I had the "normal" aches and tiredness starting many hours after 2nd shot (1st shot only had the very sore arm/unable to lift left arm straight up on the second and third day). Went to bed around 10pm. Slept hard and woke up at 12:05am the next morning with EXTREME convulsing chills and clearly had a very high fever. I didn't have a thermometer to check, but had the old fashioned second person feel my forehead and cheeks. Teeth were chattering, literally. Every joint in my body and muscles ached and i felt extremely arthritic. Woke up in a pool of sweat maybe 24 hrs after 2nd shot. Slept on-and-off all day. Second morning after still had the chills/sweating. Still had arthritic-feeling joints on day 2. What is scaring me is that it has been 16/17 days later and I still have a constant dull ache in my left shoulder with a dull ache/weekness in my left hand.
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| 51 | 2021-05-25 | sleep disorder |
Right arm swelled up within 5 minutes after shot, hard to move fingers with the swelling. Tingling,...
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Right arm swelled up within 5 minutes after shot, hard to move fingers with the swelling. Tingling, numbness. Next day intense pain at injection site, but swelling had gone down. Trouble sleeping first 3 nights after vaccine. Pain at injection site lasted until 4 days later when right shoulder joint began to hurt causing limited mobility. 7 days after vaccine lymph nodes very swollen and tender in left armpit and large swollen nodule next to right ear on scalp appeared. 9 days after vaccine still having pain and mobility issues with right shoulder. Have been generally fatigued, harder to exercise in the days after the vaccine.
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| 51 | 2021-05-25 | sleep disorder |
My menstrual cycle started immediately when I was given the shot. It was one week early. The period ...
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My menstrual cycle started immediately when I was given the shot. It was one week early. The period was extremely extremely heavy. I had severe cramping while bleeding that kept me awake into the night. I do not usually have cramping with my periods.
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| 51 | 2021-05-26 | feeling abnormal |
Feeling terrible; Chills; Achiness; headache; Neck pain; Hip Hurts; freezing; This is a spontaneous ...
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Feeling terrible; Chills; Achiness; headache; Neck pain; Hip Hurts; freezing; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received second dose of bnt162b2 (PFIZER-Biontech Covid-19 Vaccine, Solution for injection, Lot Number: EW0182, Expiration date: 31Aug2021), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 18:30 (Batch/Lot Number: EW0182; Expiration Date: 31Aug2021) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14May2021, the patient experienced feeling terrible, chills, achiness, headache, neck pain, hip hurt, freezing. Caller reported dry skin and scaling inside to the outside of the ear after receiving the first dose of the Pfizer COVID-19 vaccine. She mentioned it's getting worst since the second dose. Caller is calling about the vaccination. She clarified it as the Covid vaccine. She is curious about the side effects. She got this on Thursday and still feels terrible. She still feel chills and achiness and freezing. She feels terrible from Thursday and everything is hurting her. The other thing, its a weird thing did anyone report dry and scaly-ness on the ear. She mentioned it to her cousin and her cousin mentioned she felt terrible as well and has Hives on her ears. They both had the same thing- dry skin and scaly-ness from the inside of the canal to the outside. She would like to know how to treat it. She has been putting things on it and its not going away and she wanted to know if someone else had the same thing. The other thing, its a weird thing did anyone report dry and scaly-ness on the ear. She has been putting things on it and its not going away and she wanted to know if someone else had the same thing. Feeling terrible treatment: no she thought it would wear off, it has been going on since thursday and now its monday, time: 1pm on Friday. For the chills treatment: she has been putting on extra cloths, time: she does not know exact time on Friday. Achiness treatment: none, time: friday in the afternoon. Headache, treatment: none, time: Friday in the afternoon. Neck pain caller stated its ongoing, outcome of event: Attempted to clarify with caller she stated she she still has it. It's not as bad as it was, treatment: none, time: Friday in the afternoon. Hip hurt caller stated it went away, outcome: caller stated unknown, treatment: none, time: afternoon. Dry and Scaly-ness of the Ear: Start - caller stated this is the second dose that started. The first dose she had 3 weeks ago. Stop - Its ongoing. Its gotten worse she is wondering if its related to the second dose of the vaccine. Treatment: steroid cream. She had it prescribed for something else. It didn't go away. She though it may heal this sore too. serial by the barcode - 51672404819. NDC: Prescription label on product. Caller unable to find NDC at this time. lot: 342227, exp: 09/2022, time: from the first one not the last one her ears are itching more since the second one. The clinical outcome of feeling terrible, chills, headache, freezing were not recovered, of the achiness, neck pain were recovering and of the hip hurts was unknown. Follow up attempts are needed. Further information has been requested.
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| 51 | 2021-05-27 | depression, disturbance in attention, confusional state, feeling abnormal |
Muscle tightness and pain, joint pain, headache, nausea, severe back pain, abdominal pain, scratchy ...
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Muscle tightness and pain, joint pain, headache, nausea, severe back pain, abdominal pain, scratchy sore throat, emotional, depressed, shortness of breath, severe fatigue, confusion, foggy head, lack of focus, lack of concentration, eye sensitivity, skin sensitivity
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| 51 | 2021-05-28 | anxiety |
Patient received the 1st COVID vaccine ( Pfizer, lot # EW0185, use by 06/24/21 at 0845) at 1313. Cli...
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Patient received the 1st COVID vaccine ( Pfizer, lot # EW0185, use by 06/24/21 at 0845) at 1313. Client reported to EMT that she felt a headache coming on, and was a little nauseous. The client was given a bottle of water and RN was notified immediately. RN assisted the client to the anti-gravity chair, was placed in a semi-fowler's position, while RN assessed the client. The client was alert and oriented x 4. Vital signs were taken simultaneously at 1400, HR- 84, RR-16, BP-158/90, oxygen saturation at 98%. At 1402 the client stated, " My headache is a little better and my nausea is gone." Denied shortness of breath, chest pain, difficulty swallowing, lightheadedness, or feeling flushed. Denied drinking much water prior to coming to the site. Vital signs taken at 1405, HR- 86, RR-16, BP- 160/88, oxygen saturation at 99%. Client reported having an allergic reaction to codeine (anaphylaxis) and having type II diabetes mellitus, asthma, and a heart murmur. The client reported currently taking singulair, victoza, trulicity, lantus, metformin, and fenofibrate. Vital signs taken at 1410, BP- 160/88,HR-87, RR-16, oxygen saturation at 98%. The client was speaking in full sentences and was in no apparent distress. The client continued to drink water. The client reported not seeing a primary care provider for over a year. Denies any vision changes, headache, or lightheadedness. Vital signs taken at 1415, BP- 160/ 88, HR- 86, RR-16, oxygen saturation-98%. RN educated the client about V-safe, Emergency Room precautions, and to follow up with her primary care provider. RN advised the client to stay on site until 1430. The client stated, " I might be a little anxious, I'm sorry, I'm not trying to be a bother." The client was reassured to always tell the medical personnel on site if she felt unwell in anyway. EMT and PM remained in the observation area. At 1431, the client stated, " I feel a flutter in my chest that feels bounding." The client was cold and clammy, RN called 911 immediately at 1431. Vital signs taken at 1431, BP- 156/84, HR-83, RR-18, oxygen saturation- 99%. The client remained in the semi-fowler position, was alert and oriented x4, and was speaking in full sentences. Denied difficulty breathing, vision changes, shortness of breath. No rash or hives were present. Vital signs taken at 1436, BP- 140/88, HR- 80, RR-16, oxygen saturation- 99%. Client stated, " The heart fluttering is feeling better." The client was no longer cold or clammy. Vital signs taken at 1441, BP- 142/88, HR- 82, RR-16, oxygen saturation- 99%. EMS arrived on site at 1443. The firefighter/paramedic assessed the client, had the client stand up from the anti-gravity chair, asked her how she felt, and she stated, " I feel a lot better." The firefighter/ paramedic asked the client if she still had the fluttering sensation in her chest, the client stated, " No." The EMS team did not complete a set of vitals or complete an EKG on the client. The firefighters left the site at 1447. RN re-educated the client about following up with her primary care provider and educated the client about emergency room precautions. Client ambulated to her car where her family members were waiting for her, she had an even and steady gait.
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| 51 | 2021-06-01 | anxiety |
Patient started coughing and complained of difficulty breathing 15 minutes after getting the vaccine...
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Patient started coughing and complained of difficulty breathing 15 minutes after getting the vaccine. Observation room nurse checked her vital signs immediately. BP 170/100; HR 75; O2 sat 99%; RA pain 0/10. No signs of allergic reaction noted at this time. No major medical problem, history or any type of allergic reaction per patient. Patient was instructed to remove the mask and try to inhale through the nose; exhale through the mouth (to help with breathing) and decrease anxiety level. Did not notify the paramedic since patient vitals were stable and stated she is feeling better. Patient was instructed to lay down and checked her BP again. BP was 150/97. Patient was monitored for 15 minutes in the observation room; educated on symptoms of allergic reaction and encouraged to follow up with her HCP regarding high BP.
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| 51 | 2021-06-03 | loss of personal independence in daily activities |
have not been able to work; cough; having breathing issues with asthma s/s; having breathing issues...
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have not been able to work; cough; having breathing issues with asthma s/s; having breathing issues with asthma s/s; fever; chills; This is a spontaneous report from a contactable other hcp (Patient). A 51-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: En5318), via an unspecified route of administration, administered in Arm Left on 27Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history included cold and exercise induced asthma. The patient had no known allergies. Concomitant medications received within in two weeks of vaccination included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); biotin (BIOTIN); magnesium (MAGNESIUM); cyanocobalamin (B12 [CYANOCOBALAMIN]); fexofenadine hydrochloride (ALLEGRA). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EJI686), via an unspecified route of administration, administered in Arm Left on 06Jan2021 (at the age of 51years) as SINGLE DOSE for covid-19 immunization. The patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 28Jan2021, the patient reported that the first two days she had fever, chills, etc. and on day 4 cough started and would not stop. Patient saw doctor and was having breathing issues with asthma. Patient was having couple years ago with cold and exercise induced asthma, however never had issues with having to take steroids or breathing treatments. Patient was now on nebulizer every 4 hrs, have not been able to work, on steroids and other medicines. Patient said it was unknown if it would be a permanent issue with her lungs. Therapeutic measures were taken as a result of having breathing issues with asthma, fever, chills as medicines and nebulizers. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 51 | 2021-06-04 | feeling abnormal |
Feeling extremely out of it; light headed/dizzy; nausea; abdominal cramping; This is a spontaneous r...
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Feeling extremely out of it; light headed/dizzy; nausea; abdominal cramping; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6202), via an unspecified route of administration on Left arm on 05Mar2021 at 12:30 PM (at the age of 51-year-old) as a single dose for COVID-19 immunization. The patient had medical history included hypertension and hypothyroidism. Concomitant medications included Labetalol, Nifedipine, Levothyroxine and Amoxicillin (all received within two weeks of vaccination). Patient previously took Doxycycline and had allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021, patient experienced, feeling extremely out of it, lightheaded/dizzy, nausea and abdominal cramping. Patient did not receive any treatment for the events. Outcome of all the events were Not resolved. No follow-up attempts are possible. No further information is expected.
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| 51 | 2021-06-06 | anxiety |
pt complained of feeling sweaty and lightheaded approximately 10 minutes after receiving the vaccina...
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pt complained of feeling sweaty and lightheaded approximately 10 minutes after receiving the vaccination. pt was given water and taken to a cool area to sit. pt stated that she was feeling somewhat anxious (which she has a history of). upon sitting for a few minutes, pt stated that she feeling better. pt was kept for 30 min observation and then left on her own accord.
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| 51 | 2021-06-06 | feeling abnormal, sleep disorder |
At time of injection I got an instant headache. Next day felt odd, headache still there, injection ...
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At time of injection I got an instant headache. Next day felt odd, headache still there, injection site very sore, noticed extremely puffy lymph nodes in left armpit. Took Tylenol 500mg, no help. That night armpit more puffy and noticed lymph?s in left side of neck were puffy, still had headache. Could not sleep on left side because of pressure of body on arm. Next day still had headache and even more puffy lymph?s in arm and sore, took 600mg ibuprofen, eased headache, took 1000mg Vita C. Later took another 600mg ibuprofen, headache went away. Overnight still too puffy and sore to sleep on that side. Next day took 1000mg Vita C, 600mg ibuprofen. Went to work, noticed in the afternoon that the puffy swelling had reduced a little and not tender in the armpit, Neck still the same.
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| 51 | 2021-06-06 | impaired work ability |
After 2nd shot, I developed a fever (102.4), bad headache, nausea, body aches, chills. These sympto...
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After 2nd shot, I developed a fever (102.4), bad headache, nausea, body aches, chills. These symptoms lasted approx 60 hours. On May 29th, I developed diarrhea. On May 30th, I developed a fever (101.8), body aches, chills and a bad headache. I rarely, if ever, get sick. This was the first I had to call off from work in over 5 years.
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| 51 | 2021-06-06 | mental impairment, confusional state, feeling abnormal |
I had the vaccine and after 3 hours I was exhausted, I was confused, couldn't think through, fever, ...
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I had the vaccine and after 3 hours I was exhausted, I was confused, couldn't think through, fever, swelling on my arm. I slept all night long until the next day and I had like flu like symptoms. In that period my husband tried to woke me up and I would eat something but it felt like I was in a dream, I felt like a zombie. For about a week after I was sick but not sick to not go to work . I had swelling on my neck, clavicle, and armpit, they were obviously lymph nodes. I was thinking about cancer because my dad died of Cancer. I made an appt with a doctor for a cancer check instead of going for the covid. Which after about 15000 tests I am cancer free. I found out that those symptoms could actually be part of the vaccine. They took a good look at it and order some tests and they said it was a reaction to an infection and I told them I had just had the vaccine and they did some tests and they said it was most likely the vaccine. After 2 weeks the lymph nodes started to go down. After the second shot I had the same symptoms but not as intense.
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| 51 | 2021-06-08 | anxiety, poor quality sleep |
Twitching in both legs, (calves, thighs, quads) beginning approx 3 weeks after second done. Seems t...
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Twitching in both legs, (calves, thighs, quads) beginning approx 3 weeks after second done. Seems to be worsening /progressing. The twitching is now preventing restful sleep. Present all the time now. Causing anxiety. Leading to tense muscles and fatigue.
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| 51 | 2021-06-08 | impaired work ability |
Immediate dizziness the morning after my 1st shot. It is not constant. Can be triggered by tilting m...
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Immediate dizziness the morning after my 1st shot. It is not constant. Can be triggered by tilting my head in certain positions. Laying up and down in bed and tilting recliner triggers the dizziness frequently. Going to get blood work tomorrow. Thus is almost week 5 and no relief. The dizziness is the same. No nausea. I just got over dizziness from a scuba accident that occurred in 2018. My dizziness was completely gone last fall. The dizziness is definitely different now. I am concerned this will be a long term effect that doesn't go away. It has affected my job.
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| 51 | 2021-06-08 | insomnia, anxiety |
After my Pfizer vaccine I experienced a low grade temperature, bilateral leg and bone pain, insomnia...
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After my Pfizer vaccine I experienced a low grade temperature, bilateral leg and bone pain, insomnia , hot flashes, night sweats, fatigue for 3 weeks, chronic cough, fatigue 3 weeks in duration, diarrhea, stomach pain, air hunger., anxiety. body pain. joint pain have gotten worst since vaccination.
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| 51 | 2021-06-08 | loss of personal independence in daily activities |
Within an hour of getting the vaccine, started to hurt on her right arm and then spread to her back,...
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Within an hour of getting the vaccine, started to hurt on her right arm and then spread to her back, swelling then started increased to softball size in rt arm. Area hard and hot. Later that night she had problems with nausea, tylenol was taken for pain. The symptoms lasted longer than a week, "I was in bed for a week, the pain in the arm lasted longer than that."
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| 51 | 2021-06-10 | panic attack, anxiety, depression, nervousness |
Severe anxiety and depression; Severe anxiety and depression; Had a very bad panic attack; Very scar...
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Severe anxiety and depression; Severe anxiety and depression; Had a very bad panic attack; Very scary; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6200, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 24Feb2021 14:15 (at the age of 51-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included scleroderma, RA (rheumatoid arthritis), hashimotos, asthma, GERD, acid reflux, gastroporesis, fibromyalgia, sulfa allergy and shellfish allergy all from an unknown date. Concomitant medications included adalimumab (HUMIRA), methotrexate, levothyroxine sodium (SYNTHROID), verapamil and cetirizine hydrochloride (ZYRTEC) all taken for an unspecified indication, start and stop date were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL8982, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 03Feb2021 08:15 (at the age of 51-years-old) for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 10Mar2021, the patient experienced severe anxiety and depression, had a very bad panic attack and very scary. The adverse events resulted in doctor or other healthcare professional office/clinic visit.Therapeutic measures were taken as a result of the events included counseling and medications. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information expected.
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| 51 | 2021-06-10 | sleep disorder |
Woke with heart attack like symptoms out of a deep sleep. Throbbing, pressure and pain on my left si...
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Woke with heart attack like symptoms out of a deep sleep. Throbbing, pressure and pain on my left side by shoulder blades, shoulder. Would not go away for 10 min. then got up to use the bathroom and felt better, googled and said could be this, so leaned forward and was ok. Slept. the next night had same wake up, but had taken advil. was not as intense, leaned forward and was fine again. Saw a cardiologist on Monday and had ultrasound, EKG and bloodwork and was fine. After 3 days of advil, I guess it was temporary.
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| 52 | 2020-12-31 | anxiety |
10MINS AFTER THE VACCINATION LEFT SIDED FACIAL NUMBNESS . HIGH B/P 172/112 O2 SAT 98% HR 72, RR18. ...
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10MINS AFTER THE VACCINATION LEFT SIDED FACIAL NUMBNESS . HIGH B/P 172/112 O2 SAT 98% HR 72, RR18. ANXIETY. SMILE SYMETRICAL PROTRUDING TOUNG CENTERED. @10:45AM B/P 153/93 @10:58 AM B/P 146/89 @11:15AM EMERGENCY SERVICES WERE OFFERED SEVERAL TIMES BY RPH ( PATIENT REFUSED) . PCP WAS NOTIFIED BY FNP - B C . MEDICAL DIRECTOR DR SPOKE TO PATIENT OVER THE PHONE DIRECTLY. NO PARLYSIS WAS DETERMINED. PATIENT COULD FEEL A PINCH IN THE AFFECTED AREA. PATIENT STATED THE REACTION ABATED BEFORE THE END OF THE CLINIC @12:30PM
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| 52 | 2021-01-04 | feeling abnormal, excessive sleepiness |
1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received...
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1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received COVID POC test and was negative. Left to go home and had loose stool then chills, body aches, hot spells, and extremely tired. Could not stay awake and was in brain fog. Slept all day, all night and all day on 1/5/21. No appetite, stuffy nose, headache, chills and hot spells, no fever, Again unable to stay awake.
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| 52 | 2021-01-04 | feeling abnormal |
Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see prov...
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Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see provider and CXR and EKG normal. States low-grade fever lasted couple of days.
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| 52 | 2021-01-05 | confusional state |
Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated p...
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Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated pupils), loss of BP, rapid heart rate, uncontrollable rigors/trembling. Rushed down hall to ED via stretcher. Received IV fluids, IV steroids, IV benedryl, IV pepcid, IV ativan.
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| 52 | 2021-01-05 | feeling abnormal |
10 minutes after administration, back of tongue and soft palate started feeling strange sensation wi...
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10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; Other vaccine was received on same date vaccine date 30Dec2020; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EJ1685), intramuscularly on 30Dec2020 at 12:30 PM on Right arm at single dose for COVID-19 immunization in hospital. Other vaccine was received on same date vaccine date 30Dec2020. The patient medical history included known allergies: Shellfish. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications within two weeks of vaccination. The patient experienced 10 minutes after administration on 30Dec2020 at 12:40 PM, back of tongue and soft palate started feeling strange sensation with some swelling. After 30 minutes, the sensation eased up but the swelling stayed the same, not getting any worse. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL). The outcome of the event 'feeling strange sensation' was recovering, outcome of events 'back of tongue and soft palate swelling' was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
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| 52 | 2021-01-05 | nervousness | RAPID HEART RATE 150-160, SHAKY FEELING 10 MIN POST VACINATION |
| 52 | 2021-01-07 | feeling abnormal |
Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Ski...
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Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Skin is sore from the fever. Headache, temp 100.3. Weak and loopy, slept all day. Hurts under the arm. SOB.
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| 52 | 2021-01-07 | feeling abnormal |
First dose of Pfizer COVID-19 vaccine administered to this individual. She reported dizziness and h...
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First dose of Pfizer COVID-19 vaccine administered to this individual. She reported dizziness and head feeling "fuzzy". Had patient drink water and juice. VS were BP 137/90 HR 91. She stated her HR routinely runs in the 90s. Observed her for greater than 30 minutes. Symptoms didn't worsen. She was awake, alert with a steady gait. Patient was released to home.
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| 52 | 2021-01-07 | impaired work ability |
SEVERE FATIGUE AND WEAKNESS, LEFT AXILLARY PAIN AND EDEMA, HOT TO TOUCH, SINCE 1/8/2021 UNABLE TO GO...
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SEVERE FATIGUE AND WEAKNESS, LEFT AXILLARY PAIN AND EDEMA, HOT TO TOUCH, SINCE 1/8/2021 UNABLE TO GO TO WORK DUE TO SYMPTOMS
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| 52 | 2021-01-07 | impaired work ability |
Dizziness, Headache, Myalgia & Diarrhea Narrative: Vaccinated in the morning 12/20. Fell asleep ear...
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Dizziness, Headache, Myalgia & Diarrhea Narrative: Vaccinated in the morning 12/20. Fell asleep early due to fatigue. Woke up not feeling well: headache, body aches, dizzy. Unable to go to work that day. By Tuesday able to return to work though experiencing loose stools.
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| 52 | 2021-01-08 | feeling abnormal |
HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after r...
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HYPERtension throat tightness, paresthesias in extremities, muscle spasms Narrative: Shortly after receiving the vaccine she felt uneasy and experienced the sensation of throat tightness and numbness and tingling in hands and feet, also some rigidity/clonus in the hands. No rash, no wheezing, O2 sat 99%+. The team at the vaccination clinic checked her vital signs and her systolic BP was elevated to 220's. A rapid response was called and she was taken to the emergency room. In the emergency room, she received a neurology consult and head CT to rule out hypertensive bleeding. The scan was negative. She was given labetalol 10mg IV to lower BP, and also solumedrol 125mg, benadryl 25mg. No epinephrine given. Serum potassium was found to be low as well; given oral potassium repletion. Discharged from ER by noon same day, BP down to 160/79.
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| 52 | 2021-01-08 | hallucination |
Nausea, fatigue, hallucinations? Was under observation, emt was called, vitals were normal. Recove...
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Nausea, fatigue, hallucinations? Was under observation, emt was called, vitals were normal. Recovered within 3 hours with no further intervention.
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| 52 | 2021-01-09 | feeling abnormal |
Headache hour after vacation, then as day progressed, continued headache, approx 4pm pounding heada...
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Headache hour after vacation, then as day progressed, continued headache, approx 4pm pounding headache, nausea, lightheaded, fatigue and just feeling bad. Next day dizziness, fatigue, headache and body aches. Symptoms continued with some shortness of breath. Nyquil taken at approx 5-6pm. 3rd day woke up had dizzy spell fell on the floor. Still having some fatigue lightheadedness and nausea.
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| 52 | 2021-01-10 | disturbance in attention | Chills, muscle and joint pain, fever, headache, fatigue, light headed, difficulty concentrating |
| 52 | 2021-01-10 | impaired work ability |
52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccin...
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52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.
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| 52 | 2021-01-10 | impaired work ability |
Shaking chills, fever, severe headache, joint pain and body aches limited my ability to work Start...
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Shaking chills, fever, severe headache, joint pain and body aches limited my ability to work Started 12 hours after second dose of covid vaccine. No reaction to first dose.
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| 52 | 2021-01-11 | impaired work ability |
woke up at 4 am the day after vaccination with pain in injection site arm 8/10. Had general muscle/...
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woke up at 4 am the day after vaccination with pain in injection site arm 8/10. Had general muscle/joint pain that made it difficult to get out of bed. Nausea and low grade fever. Unable to go into work. Felt I was not able to get out of bed to even take medication. Fianlly took 600mg of ibuprofen at 1:30 p.m. Was able to sleep and at 4pm was able to get out of bed. Still felt very fatigued. Slept well then next night and felt 90% better the next morning. Feeling much better today. No s&s.
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| 52 | 2021-01-12 | insomnia | Insomnia, headache, fever, aches, skin pain |
| 52 | 2021-01-12 | sensation of foreign body |
At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Use...
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At the time of the vaccine administration there is a numb tongue, heavy trachea and a numb face. Used medication for asthma. Flovent inhaler for 5 times. Used xyzal 5mgs via oral. These medications are used by doctor's orders.
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| 52 | 2021-01-13 | anxiety |
Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/...
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Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/29 around noon she started feeling tachycardic (resting heart rate was 107-125 bpm). She vomited and felt anxious. Developed fever of 101.8 and was very achy. Day 2: low grade fever treated with ibuprofen. Day 3: fever free but dizzy feeling. Day 4: symptoms resolved. Of note, patient was 30 days out from having had COVID-19 at the time of vaccination. Patient states her course of COVID was "serious" but did not require hospitalization.
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| 52 | 2021-01-14 | anxiety, sensation of foreign body |
1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor ...
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1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor as she was anxious prior to receiving vaccine 1444 states sxs are getting worse, still no swelling or SOB noted 1445 States she now feels like tongue is swelling and lump in throat is worse, cough noted. 99.5F, 97% RA, 102HR, 22 Resp, 146/99 BP 1448 Hoarseness in voice noted as associate getting into wheelchair 1449 Turn over care to ED
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| 52 | 2021-01-14 | insomnia |
Nauseous; threw up a little; she keeps falling down, has had 3 falls; hit her head; she has a huge b...
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Nauseous; threw up a little; she keeps falling down, has had 3 falls; hit her head; she has a huge bump on her face that is very painful; she cannot walk straight or without assistance anymore; Vertigo; Weakness in the muscles; a little arm soreness; Body aches; Chills; Could not sleep; Fever; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine), Batch/lot number: EK9231, Expiry Date: 31Mar2021, via an unspecified route of administration on 06Jan2021 09:00 at single dose in deltoid right for COVID-19 immunisation. Medical history included heart attack from Jul2019. Concomitant medication included diltiazem from 2019 and ongoing at 120mg tablet taken daily for abnormal heart rhythm she did not know of until had heart attack, acetylsalicylic acid (BABY ASPIRIN) from 2019 and ongoing at 81 mg tablet taken daily for heart attack. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 17Dec2020 for COVID-19 immunisation; she got the Flu vaccine every year and got shingles vaccine in Mar2020 for immunization. She did totally fine after receiving Flu vaccines and the Shingles vaccine. She had no side effects from the Flu vaccines except maybe a little arm soreness; she had arm soreness for a couple of days after the shingles vaccine; maybe a slight fever and took it easy. This Emergency Room Nurse (patient) received her second dose of Pfizer BioNTech COVID-19 Vaccine on 06Jan2021 around 9:00am. She went back to work, worked around 6-8 more hours that day and was fine. She went home and around 8-10 hours after she got the second dose on the evening of 06Jan2021 she had a little arm soreness and body aches. Last night all night she had chills; she could not sleep; fever. This morning: 07Jan2021 she was so nauseous that she got up and tried to get to the bathroom where she threw up a little. She reported as of 07Jan2021 she kept falling down: She fell in the bathroom this morning first when she was trying to get to the bathroom to throw up; During the second fall she was going on the stairs and fell, and hit her head; she had a huge bump on her face that was very painful now that she thought was from that second fall; and she had the third fall this evening; she cannot walk straight or without assistance anymore, she had been on the couch all day. She has had vertigo all day and weakness in the muscles. Chills was described as unbearable, heavy chills that she could not control. Fever: Temperature of 102-102.4 degrees Fahrenheit. The high fever hit around 3:00am on 07Jan2021. When her high fever hit around 3:00am she thought she would go to the emergency room but she did not want to scare her family so she stayed home and tried to pull through it. Today she took a Tylenol after she threw up this morning just to get through the day. Since she cannot walk without assistance or walk straight today that's the only lingering symptom that really worries her; she may go to the emergency room tonight if she did not get any better. She just did not want to scare her family and the emergency room was another copay cost so she really did not want to go to the emergency room at her workplace; but she may go there tonight and be kept overnight under observation. Prior to taking this second dose of Pfizer BioNTech COVID-19 Vaccine she was completely fine. She expected to have body aches, chills and fever; but she never thought the Pfizer BioNTech COVID-19 Vaccine would put her into a place where she is falling like this with the nausea and vertigo; she has never in her life had vertigo or falling like this. She reported she had no other vaccinations on the same date as Pfizer BioNTech Vaccine second dose. Has had no other vaccines in the recent past. She had never felt like this before with any other vaccines; she had never felt so weak in her muscles and never fallen down like this with any other vaccines. Seriousness criteria and outcome of all events unknown. The reporter considered all events were related to Pfizer BioNTech COVID-19 Vaccine.
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| 52 | 2021-01-17 | sleep disorder |
EXISTING TINNITIS TO LEFT EAR BECAME EXPONENTIALLY LOUDER, UNABLE TO FALL ASLEEP, AND OR AWOKEN FROM...
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EXISTING TINNITIS TO LEFT EAR BECAME EXPONENTIALLY LOUDER, UNABLE TO FALL ASLEEP, AND OR AWOKEN FROM HIGH PITCH INTENSITY.
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| 52 | 2021-01-20 | loss of personal independence in daily activities |
I received the vaccine on Thursday 1-14-21, on Saturday I started feeling very thirsty and then seve...
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I received the vaccine on Thursday 1-14-21, on Saturday I started feeling very thirsty and then severe dry mouth and cold on Sunday and Monday. I just made sure to stay hydrated. On Tuesday I felt better but when I got up on Wednesday morning, I felt dizzy. It progressed into the day and became worse. I had to go home from work and was unable to drive. Today, I feel slightly better but still dizzy if I get up quickly.
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| 52 | 2021-01-20 | nervousness |
The episode came on very quickly. Felt like I was going to pass out. Became very flushed, heart wa...
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The episode came on very quickly. Felt like I was going to pass out. Became very flushed, heart was racing and very shaky. I work at a clinic, so my blood pressure was taken and it was 160/100, pulse was 120. Had a bad head ache and continued to have waves of this for about an hour.
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| 52 | 2021-01-20 | sleep disorder |
She woke up thinking she didn't sleep; Nausea; sore arm; was really tired; This is a spontaneous rep...
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She woke up thinking she didn't sleep; Nausea; sore arm; was really tired; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the right arm on 09Jan2021 at single dose for COVID-19 immunization. The patient had no medical history and there were no concomitant medications. The patient took the first dose of the Covid-19 vaccine and was fine. The lot for the first dose of the vaccine was EH9899. She received it on 19Dec2020 (at the age of 51 years). She took the second dose on Saturday (09Jan2021). She experienced nausea and had a sore arm on 10Jan2021. It was not death defying. She was also really tired on 10Jan2021. She was advised by her employer to report this information. She took some Tylenol and relaxed. She was no longer nauseated or tired. Her arm was not sore only tender. She woke up thinking she didn't sleep on an unspecified date. The patient added that her boss said she might have to be tested. The patient asked if that was something that she needs to do. The outcome of the events nausea and tired was recovered on 11Jan2021. The outcome of the event sore arm was recovering. And the outcome of the event "She woke up thinking she didn't sleep" was unknown.
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| 52 | 2021-01-21 | memory impairment |
Once I received the shot and went to my car I noticed I had a rash on my face so I immediately took ...
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Once I received the shot and went to my car I noticed I had a rash on my face so I immediately took benadryl. When I woke up the next morning I was extremely dizzy and fell in the shower. It was more than just being dizzy it was like I couldn't see and it was hard to pick myself up. I may have fainted because I didn't recall falling just noticed I was on the shower floor. I thought I had gotten up but then again I was still on the floor. I made it back to bed and slept for a few hours. After that I seemed fine.
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| 52 | 2021-01-24 | loss of personal independence in daily activities, insomnia |
The evening of injection, started with muscle spasms and aching in deltoid. Over the next day the p...
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The evening of injection, started with muscle spasms and aching in deltoid. Over the next day the pain worsened and spread up into my neck, shoulder and down into elbow and forearm. The pain is intense 7/10 and constant. Pain is disrupting my daily activity and sleep. I?ve tried ibuprofen, Tylenol, voltaren gel, lidocaine patches, icy hot, Celebrex, bio freeze, steroid injection, toradol injection, tramadol, multiple massages, hot showers, ice, tens unit, cbd oil. All of these treatments have done very little for the pain
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| 52 | 2021-01-26 | feeling abnormal |
Reports usual chest pressure related to lupus condition but after getting Covid vaccine it is now a ...
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Reports usual chest pressure related to lupus condition but after getting Covid vaccine it is now a sharp pain, reports dizziness 6/10 and "different". Increased pain with deep breaths. denies nausea. Taken to ED with RR
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| 52 | 2021-01-26 | impaired work ability |
The day after my vaccine went into A-fib and had to go home then on Saturday 01-23-2021 the A-fib wa...
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The day after my vaccine went into A-fib and had to go home then on Saturday 01-23-2021 the A-fib was gone
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| 52 | 2021-01-27 | feeling abnormal |
Customer received SECOND dose of COVID-19 vaccine at 0910 in medical center and transferred to post ...
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Customer received SECOND dose of COVID-19 vaccine at 0910 in medical center and transferred to post vaccine observation. At 0935 provider notified that customer was feeling sweaty with tingling in her tongue. Customer appears mildly flushed, calm. States that she chose to wait a little longer in the observation room because she does not ?feel right.? Customer moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. She reports ?tingling? in the middle of her tongue and is feeling hot and diaphoretic ? different from the same menopausal symptoms that has been experiencing prior to this appointment. BP 120/78, HR 71, O2 95% RA, RR 18. Lungs CTA, RRR. Customer accepts Benadryl 50mg PO @ 0939. No rash, hives noted on exposed skin or at site of injection in left arm. Customer monitored at site. Over the course of the next 40 minutes, she reports feeling better. BP 120/70, HR 78, O2 97% RA, RR 16 @ 1022. She states that her tongue is still a bit tingly but denies feeling other worrisome symptoms she was previously experiencing. She denies feelings of facial/tongue/throat swelling, CP, SOB. Reports slight dizziness that she feels is related to Benadryl. Customer's husband (medical provider) present to drive her home. Customer states she will not be home alone. Customer aware that this provider will notify PCP Team of incident for post vaccine check in. Customer denies questions/concerns at this time. Customer released from site at 1025 ambulating independently with steady gait, no escalation of symptoms reported, no obvious s/sx of distress.
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| 52 | 2021-01-27 | feeling abnormal |
By that evening my right arm went numb and I had a lot dizziness and brain frog. I was slow to stop ...
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By that evening my right arm went numb and I had a lot dizziness and brain frog. I was slow to stop at stop sign, and my daughter in law told me she wanted to drive me because I was scaring her and I was being mean to her, very snappy. The next morning I had a fever 100, muscle ache, heart racing, headache and I stayed in bed all day. I took 2000mg Ibuprofen, 800mg Tylenol, Benadryl 10mg. On the 20th I was still lethargic had body aches and heart was racing, I took 800mg Tylenol that day. The 21st I had dizziness, brain fog, heart racing, lethargic. The 22nd I contacted the work Nurse and let her know what was going on, my heart rate was 140. They told me I was probably having a reaction and would go away in a couple days. On the 24th,25th,26th,27th I started having chest pain, lethargy. I had a clinic visit with my PCP on the 28th and she said my BP was 160/90, I never had BP issues. She ran test. The 29th I still had brain frog, lethargy, chest pain. I could feel my heart beat in my ear especially at night, I have never has BP issues in my life. On the 30th my heart ponding sound was in my ear. January 16th I went to the ER my heart was 130 and BP 187/108, they did a full work up on me. She started me on Metprolol-50mg(extended release). I seen the cardiologist on 1/20 and told me I had left atrial enlargement , mitro-valve regurgitation . I had an echo- cardiogram on 1/25. The medicine has definitely helped me .
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| 52 | 2021-01-27 | excessive sleepiness |
chills; dizzy; body aches; fever 99.5; fatigue; joint aches; jaw hurts more on Rt side (lower behind...
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chills; dizzy; body aches; fever 99.5; fatigue; joint aches; jaw hurts more on Rt side (lower behind12 yr molars); Slept a lot so far; injection arm very sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1283), intramuscular on 13Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. The patient medical history was not reported. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]), colecalciferol (D3), estradiol (ESTROGEN), progesterone, "bioidenticle" and multivitamin, reported as "Other medications in two weeks: Multi vitamin, vitamin E, D3, bioidenticle estrogen/progesterone"). The patient previously took iodine, metronidazole (FLAGYL), doxycycline and telithromycin (KETEK) and experienced allergies to all. No other vaccine in four weeks. Facility type vaccine was hospital. The patient received the first dose on 23Dec2020 04:45 PM (lot number: EL0140), intramuscular on the right arm and patient felt slightly light headed. Within 5 minutes right (Rt) hand got red & hot, numb, heat in Rt arm and Rt side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. Patient took benadryl. Next few days was reported as "v fatigued & on p.m. of 24th it hurt to open my mouth (gland by Rt ear felt swollen). I got a line of inflammation in my Rt inside cheek & a tissue mound that has not gone away". On 14Jan2021 (reported as today), the patient experienced chills, dizzy, body aches, fever 99.5, fatigue, joint aches, injection arm very sore (started yesterday on 13Jan2021), jaw hurts more on right (Rt) side (lower behind12 yr molars). Patient took Tylenol and slept a lot so far. No treatment was received (If treatment AE: No) - pending clarification. Outcome of the events was recovering. Patient has no COVID prior vaccination. Patient was not tested for COVID post vaccination.
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| 52 | 2021-01-27 | excessive sleepiness | Arm pain, nausia, vomiting, fatigue and slept for 18 hours straight. |
| 52 | 2021-01-28 | impaired work ability, feeling abnormal |
Vaccine was on Wednesday 1/27/21 at 8:30. Felt a little off and sore arm during the day Wednesday....
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Vaccine was on Wednesday 1/27/21 at 8:30. Felt a little off and sore arm during the day Wednesday. Started with some body ache during night ( approximately 13:30 a.m.) at sleep. Woke up at 5 a.m. with fatigue, significant nausea and a headache. Unable to go into work. Headache improved by mid day. The fatigue and nausea continued and gradually decreased, lasted until laterThursday evening. Returned to work at 6:30 a.m. on Friday.
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| 52 | 2021-01-28 | impaired work ability, sleep disorder |
Extream fatigue and chills unable to continue work. I am on day 3 now at home coming in and out of ...
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Extream fatigue and chills unable to continue work. I am on day 3 now at home coming in and out of sleep and freezing cold. Hoping it won't last much longer.
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| 52 | 2021-01-28 | sleep disorder |
Headache first, Injection site swelling, then hives in the middle of the night at injection site, wo...
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Headache first, Injection site swelling, then hives in the middle of the night at injection site, woke up with muscle aches everywhere, diarrhea started mid day, fever 100.4
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| 52 | 2021-01-29 | impaired work ability |
Within 10 minutes, sensation of very cold skin through out my body, lasted 4 hours. Transient elevat...
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Within 10 minutes, sensation of very cold skin through out my body, lasted 4 hours. Transient elevated systolic BP, better within 30 mins. Also mild body itching, still having. Woke up this morning, ~24 hours post- injection with sever joint and muscle aches, chills etc. had to cancel work.
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| 52 | 2021-01-30 | anxiety |
Pt received Pfizer COVID-19 vaccine. Approximately 8 minutes after administration, pt alerted me to ...
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Pt received Pfizer COVID-19 vaccine. Approximately 8 minutes after administration, pt alerted me to feeling hot with mild chest tightness. She stated she has anxiety and was anxious about receiving vaccine. She confirmed no swelling of the tongue, no SOB, no itching or other signs of anaphylaxis. Pt given diphenhydramine x2 and famotidine x1 along with a cup of water. Pt requested O2 and BP be monitored. O2 sat never below 97, BP was high initially at 153/112. Pt also had jacket on initially. Pt advised to breath and relax. Pt reassessed after 10 minutes. Removed jacket for BP check which had come down to 132/94 which pt states is baseline for her as she does have a bit of high BP. She also reported at that time feeling better and had calmed down. She stated she really felt it was anxiety. She left with instructions to call 911 or seek emergency attention if Sx reoccur.
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| 52 | 2021-01-31 | abnormal dreams | Fatigue Vivid dreams Mild headache |
| 52 | 2021-01-31 | confusional state | Fever, confusion, dizzines resolved with Tylenol in approxiamately 24hrs. |
| 52 | 2021-01-31 | excessive sleepiness |
5 minutes post vaccine: nausea and dizziness, hypoglycemia ( EMTs at immunization site offered ER, w...
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5 minutes post vaccine: nausea and dizziness, hypoglycemia ( EMTs at immunization site offered ER, went home) 30 minutes post: severe chills ( resolved after 3 hours) 30 minutes post: headache (resolved by 3rd day) 30 minutes post: severe hypersomnolence ( slept the remainder of that day and through that night) 30 minutes post: body pain ( felt like it was in my bones rather than muscular)resolved after 3rd day 3 hours post: injection site pain (lasted about 5 days)
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| 52 | 2021-01-31 | sleep disorder |
In the evening - about 12 hours after vaccine, I got nausea - severe. It lasted throughout that whol...
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In the evening - about 12 hours after vaccine, I got nausea - severe. It lasted throughout that whole night (couldn't sleep it was so bad) until about 10:00 -11:00 morning. And then it went away on it's own. I didn't take anything from it. First dose I had felt extreme fatigue (and that was only symptom that lasted for the same amount of time or 12 hours more). Did not get fatigue with second dose.
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| 52 | 2021-01-31 | sleep disorder |
initially felt very nauseated, later that day had cold chills, felt like she had a fever, always run...
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initially felt very nauseated, later that day had cold chills, felt like she had a fever, always runs 96.6, temp was 99.5, went to bed, woke up thru the night with 'restless legs' could not get comfortable, joint/body pains, fatigue, as of today 2/1/21 still has joint pains and restless leg syndrome, needs sleep aids, taking several supplements for inflammation, omega 3, turmeric, vit C, apple cider vinegar, Tylenol and Advil (starting to upset stomach), going to MD this week
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| 52 | 2021-02-01 | abnormal dreams |
fever 102.9; Severe joint pain; body aches; headache; chills; weird vivid dreams; nausea; This is a ...
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fever 102.9; Severe joint pain; body aches; headache; chills; weird vivid dreams; nausea; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL1284/expiration date: unknown), via an unspecified route of administration, on 16Jan2021 09:45 AM (at the age of 52 years old) as a single dose on left arm for COVID-19 immunisation. Relevant medical history was none. Historical vaccine history included first dose of BNT162B2 vaccine (Pfizer product) on 26Dec2020 (lot number: EL1284) on right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), ergocalciferol (VIT D), ascorbic acid (VIT C) and Zinc. The patient did receive other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 05:30 PM, the patient experienced severe joint pain, body aches, headache, fever 102.9, chills, weird vivid dreams, nausea. No treatment was received. The outcome of the events severe joint pain, body aches, headache, fever 102.9, chills, weird vivid dreams, nausea was not recovered.
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| 52 | 2021-02-01 | disturbance in attention |
I felt weak; hard to focus; fatigued; This is a spontaneous report from a contactable healthcare pro...
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I felt weak; hard to focus; fatigued; This is a spontaneous report from a contactable healthcare professional (the patient). A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 19Jan2021 at 12:45 (at the age of 52-years-old) as a single dose for Covid-19 immunization. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient's concomitant medications included omeprazole (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 19Jan2021 at 13:30, the patient experienced felt weak, hard to focus, and fatigued. It was reported that the shot was at 12:45 pm, the patient had to lay down until she went to bed. Felt 80% better in the morning. The patient did not receive any treatment for the events. The clinical outcome of the events asthenia, disturbance in attention and fatigue was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 52 | 2021-02-01 | insomnia | Fever chills nausea vomiting headache can't sleep. Body hurts |
| 52 | 2021-02-01 | insomnia |
general feeling unwell; chills; tiredness; she was trying to do a walk but could not; pain at inject...
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general feeling unwell; chills; tiredness; she was trying to do a walk but could not; pain at injection site; pain at injection site; That side was hot; headache got worse after getting the COVID 19 vaccine; joint pain; muscle pain continued to get worse; preventing her from sleeping/ she could not sleep; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at the left arm on 18Jan2021 13:33 at a single dose for COVID-19 immunization. Medical history included back pain (a lot of time due to physical work). She had COVID in Aug2020 and she had muscle pain and was sick. The patient also had headache started initially the day before got the vaccine on 17Jan2021. The patient also has ongoing grass allergy. Concomitant medication included acetylsalicylic acid (ASPIRIN), ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and unspecified pain medicine for back pain. She had the flu shot and Tetanus shot 2 months ago (2020) both for immunization. The patient started to notice the muscle pain on 18Jan2021 while diving back from the place she received the vaccination. She normally has muscle pain, but she thought this was something normally occurring. However, the muscle pain continued to get worse. She went to sleep, and the muscle pain continued to occur when she was trying to sleep. The muscle pain was occurring in the middle of the night and she was in so much pain it was preventing her from sleeping. She took a muscle relaxant for the pain and felt better. She noticed the pain at injection site initially around 6PM on 18Jan2021 but noticed it more when she was going to bed like 11PM. She tried to sleep on that side and it hurt. That side was hot, so she placed some ice on it. The headache started initially the day before got the vaccine 17Jan2021, but it got worse after getting the COVID 19 vaccine. It was worse on 18Jan2021, on 19Jan2021 it was better. She noticed the joint pain on 18Jan2021 but does not know really what time. She thinks it was around time noticed muscle pain. She woke up at 3AM something from the pain because she could not sleep. The chills started 4AM or 5AM on 19Jan2021. She noticed she felt tired, so tired when she woke up on 19Jan2021. She mentioned she was trying to do a walk but could not on 19Jan2021. She also mentioned she works at 1PM and would have to call out 2 hours before. She commented she needed her glasses to read the lot written on the patient card. Also was feeling unwell on an unspecified date. The events did not require Emergency Room nor Physician Office visit. The outcome of the events was recovering.
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| 52 | 2021-02-01 | insomnia |
passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-co...
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passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 at single dose on unspecified date for covid-19 immunization. Patient had one of the worst nights, fever/chills on 18Jan2021. Got up at 1:30 on 19Jan2021 to use the bathroom, passed out and hit chin on the sink. Then vomited. Still low fever. Patient didn't receive treatment for events. Outcome of all events was recovering. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report was considered as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 52 | 2021-02-01 | sensation of foreign body |
she had positive COVID test; she had positive COVID test; This is a spontaneous report from a contac...
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she had positive COVID test; she had positive COVID test; This is a spontaneous report from a contactable nurse. A 52-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly in the left arm on 28Dec2020 16:00 at a single dose for covid-19 immunisation. The patient's medical history included tested positive for covid on 06Nov2020. The patient had recent physical in Dec2020, patient did blood work. Twelve years ago (2009) she had a partial thyroidectomy and at the physical they noticed a lump. The goiter was enlarged on her neck. She doesn't know if it a result from COVID, but she has Hashimoto's disease in Dec2020. She has to have surgery to removed the goiter, but she can't because of COVID. She has looked it up and it is an autoimmune disease. She had a fine needle biopsy and it was negative and she had a full thyroid work up that was fine in the beginning of Jan2021.The patient's concomitant medications were not reported. On 14Jan2021, the patient's test came back positive for covid. It was further reported that the patient tested negative on the Friday after holiday. She has been getting tested twice weekly since that time and they had all been negative. Patient was scheduled to get her second dose of the vaccine today (18Jan2021). The outcome of the event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
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| 52 | 2021-02-02 | impaired work ability |
I exp fever greater than 100.9, fatigue, screaming headache,chills,weakness lasting about 4 day. Als...
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I exp fever greater than 100.9, fatigue, screaming headache,chills,weakness lasting about 4 day. Also around the injection site was extreme pain. I missed 2 days of work.
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| 52 | 2021-02-03 | feeling abnormal, impaired work ability |
allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vac...
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allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. They evaluatedI started feeling better towards the end of last week. Additional information for Item 18: allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination. I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats. me for another 15 minutes and they recommended that I be evaluated in the ED. The right arm was noticed to be red. The injection site was painful. I was evaluated by the MD and given medications per their protocol (epi, Benadryl, famotidine, steroid). I was discharged home around 1830 (with a ride) after my throat seemed to be getting better. I was discharged with an Rx for steroids, blockers and and epi pen. Later that night at about 2200, I woke up with my face/scalp itching. I continued feeling achy, intense headache, hot/cold, foggy mind. I called in sick for my shift on 1/19. I returned to work on 1/20 with minor symptoms.I was evaluated by my MD on 1/21 and had minor expiratory wheezes (I have asthma). I seemed to be feeling better until Saturday and then stomach cramping/muscle cramping (noticeable on the right hand/injection side), bad headaches, fatigue have resumed. ; 2/2 I started feeling better towards the end of last week. Still feeling off but able to do my normal routines.
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| 52 | 2021-02-03 | feeling abnormal, nervousness |
Chills/Teeth chattering; Phlegm congestion in nose and throat; Phlegm congestion in nose and throat;...
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Chills/Teeth chattering; Phlegm congestion in nose and throat; Phlegm congestion in nose and throat; Felt shaky/nervous; She felt fatigue; Tightening her muscles; Her joints ached; Muscle and body aches; Muscle and body aches; Brain fog; She then started to have a headache after that; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982), via an unspecified route of administration on 19Jan2021 (at the age of 52-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history was not reported. Ongoing concomitant medications included biotin (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN),and cyanocobalamin (VITAMIN B12); all from unknown dates. The patient also took multivitamins from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 (at the age of 52-years-old; Lot Number: EL942 or EL0142) on 29Dec2020 in the left arm for COVID-19 immunization and experienced headache and fatigue. The patient did not receive any other vaccines within four weeks prior to the vaccination except the first dose of the vaccine. On 19Jan2021, the patient experienced shaky/nervous, chills/teeth chattering, muscle and body aches, fatigue, tightening her muscles, brain fog, phlegm congestion in her nose and throat, joints aches, and headache. On 20Jan2021, she stayed well hydrated, but she slept a lot. However, she felt fatigue, had the headache off and on, tight and sore from muscle aches. Therapeutic measures were taken for the chills/teeth chattering, muscle and body aches, joint aches, and headache and included treatment with ibuprofen (ADVIL LIQUIGELS). The clinical outcomes of chills/teeth chattering and phlegm congestion in her nose and throat, were recovered on 21Jan2021 and Jan2021, respectively. The clinical outcomes of the felt shaky/nervous, fatigue, tightening her muscles, and joint aches were unknown; while that of the muscle and body aches, headache, and brain fog were not recovered.; Sender's Comments: Linked Report(s) : same reporter/patient, different vaccine dose and event.
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| 52 | 2021-02-03 | insomnia |
felt a tinge of pain in my sacral area/It got worse each hour/ It worsen daily/It became painful; Be...
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felt a tinge of pain in my sacral area/It got worse each hour/ It worsen daily/It became painful; Became limited in movements such trying to picking up items from the floor; difficulty running or walking fast as I usually do; Lots of spasms in the sacral area; Difficulty sleeping; Difficulty sleeping and going from sitting to standing; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), via an unspecified route of administration in the left arm, on 09Jan2021 15:30, at single dose, for COVID-19 immunization, at the pharmacy. There was no medical history and no known allergies. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN), diphenhydramine hydrochloride (BENADRYL), herbal nos, minerals nos, nutrients nos, vitamins nos (CATALYST) and "Muscle Strength". The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not have other vaccines in four weeks. The patient reported that on 12Jan2021 at 14:00, "I ardently felt a tinge of pain in my sacral area. Then it got worse each hour. Then I became limited in movements such trying to picking up items from the floor and difficulty running or walking fast as I usually do. It worsened daily. I would workout and then I experienced lots of spasms in the sacral area. It became painful. The patient experienced difficulty sleeping and going from sitting to standing." The events resulted to "Doctor or other healthcare professional office/clinic visit". Treatment for the events included prescription muscle relaxants (unspecified), ibuprofen and "topi". The patient was recovering from the events.
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| 52 | 2021-02-03 | mental status changes |
The patient developed dizziness, diffuse skin redness, mild facial itching dysphagia with a feeling ...
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The patient developed dizziness, diffuse skin redness, mild facial itching dysphagia with a feeling of swelling in the throat. She is not having shortness of breath, nausea, vomiting, diarrhea. Patient was given 10 mg of dexamethasone IV at 18:04, Benadryl 25 mg IV at 18:04 and epinephrine 0.3 mg IM at 18:12. Patient was observed for approximately 3 hours and discharged from the ED to home in stable condition.
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| 52 | 2021-02-03 | sleep disorder |
Day of shot, slightly sore arm. Next day, very sore arm so much so that I was unable to sleep on tha...
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Day of shot, slightly sore arm. Next day, very sore arm so much so that I was unable to sleep on that side, plus mild headache, feverish, chills, and body aches. The headache, feverish, chills and body ache lasted all day until I took 400 mg of ibuprofen.
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| 52 | 2021-02-06 | feeling drunk, impaired work ability |
1.1/14/2021- first dose Pfizer COV19 vaccine injection - day#1- left arm (injection arm) feel so...
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1.1/14/2021- first dose Pfizer COV19 vaccine injection - day#1- left arm (injection arm) feel soreness and ache - day#2- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish - day#3- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish, plus irregular heart beat - day#4- feel entire back/neck aching, entire left side down to my toes feel pain. Headache and nausea, feverish intensified - day #5- body ache subsided, Headache and nausea continued to feel intensified. Fever now turn into chills - day#6- unbearable headache and worse nausea feeling, chills, need to leave work in the afternoon. Throwed up and shaking. Took many headache medications and antinausea medications but nothing work. 2. 2/5/2021 @1630- received 2nd dose Pfizer COVID 19 vaccine - day#1, 1 hour into receiving vaccine, feeling dizzy and "hangover" type reaction. 2 hours into receiving vaccine, developed irregular heart beats. Left arm injection pain and sore arm. - day# 2: entire body ache, joint pain, headache and nausea - day#3: severe headache and feeling nauseous. Took many headache and antinausea medications. - will continue to follow adverse reactions.
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| 52 | 2021-02-07 | feeling abnormal |
lump on injection site, hot, redness size of hand, fever 100.0 for 2 days on and off, swelling of ar...
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lump on injection site, hot, redness size of hand, fever 100.0 for 2 days on and off, swelling of arm, fatigue, hangover feeling
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| 52 | 2021-02-07 | insomnia |
As described to this writer- patient was home at 11PM, got out of bed as she couldn't sleep and wen...
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As described to this writer- patient was home at 11PM, got out of bed as she couldn't sleep and went into the kitchen to make coffee. She states she woke up 15 minutes later and had lost consciousness. She went to her husband who said her words were slurred. She did not seek medical help until the following day when urged by her co-workers to do so. Then she brought a note back to work that stated she had a concussion and nothing of how or why she got the concussion. On February 4th i received a copy of her office visit that state she is alright to return to work and get the 2nd dose of vaccine with stipulations of having the following day off from work.
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| 52 | 2021-02-09 | disturbance in attention | Pain, weakness, fatigue, abnormal mentation, tongue throbbing, cough, hoarse voice |
| 52 | 2021-02-09 | feeling abnormal |
felt a weird sensation in my throat; It felt like it was swelling and it felt different when I swall...
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felt a weird sensation in my throat; It felt like it was swelling and it felt different when I swallowed; felt a weird sensation in my throat; It felt like it was swelling and it felt different when I swallowed; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 22Jan2021 16:30 at single dose for covid-19 immunisation. The patient's medical history included breast cancer from Jul2020 and currently cancer free. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medication included anastrozole, fluoxetine, calcium, and ergocalciferol (VIT D). On 22Jan2021, about 5 to 10 minutes after vaccination administered the patient felt a weird sensation in her throat. It felt like it was swelling, and it felt different when I swallowed. The patient could breathe fine so she waited an additional 15 minutes and it eased a bit. Since the patient had no trouble breathing she felt although her throat still felt weird. The patient went home and took Benadryl. All symptoms eased. The outcome of the events recovered.
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| 52 | 2021-02-09 | impaired work ability, loss of personal independence in daily activities |
Extremely sore arm post vaccination which left me unable to work for one day. Side effects abated an...
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Extremely sore arm post vaccination which left me unable to work for one day. Side effects abated and then reoccurred 9 days after injection. Been 2 days of pain with certain arm rotations. Unable to lift arm above my head without pain. Ibuprofen helps but pain inhibits driving, sleeping, getting dressed, exercising, etc.
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| 52 | 2021-02-09 | impaired work ability |
After 1 vaccine Fatigue and headache approx 8 hours after shot - resolved without medication. Did no...
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After 1 vaccine Fatigue and headache approx 8 hours after shot - resolved without medication. Did not miss work After 2 shot, Fever and chills approx 14 hrs after the shot. Resolved after 24 hours - took fever reducing medication- combination Advil and Tylenol Headaches, pain at the injection site, arm pit pain missed one day of work
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| 52 | 2021-02-10 | impaired work ability |
the second injection caused my flare to worsen; fatigue; multiple joint pain; This is a spontaneous ...
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the second injection caused my flare to worsen; fatigue; multiple joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EK9231), via an unspecified route of administration in right arm on 08Jan2021 10:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included psoriatic arthritis, sub clinical hyperthyroidism and allergy to bees. She had her first dose of bnt162b2 (lot EK5730) on 18Dec2020 in her right arm. No other vaccine in four weeks and no Covid prior vaccination. Concomitant medications included methimazole, meloxicam (MOBIC), apremilast (OTEZLA), atenolol and melatonin. She previously took Ceclor and Biaxin and had drug hypersensitivity. Her psoriatic arthritis was starting to have a flare prior to her first injection. She believed the second injection caused her flare to worsen to the point she had difficulty working due to fatigue and multiple joint pain on 10Jan2021. Tramadol was given as treatment. The events were reported as serious- disability or permanent damage. The outcome of events was not recovered.
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| 52 | 2021-02-11 | crying, anxiety |
02/11/21@1435-Pt complaing of naueas and headache then stated she was short of breath after vaccine ...
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02/11/21@1435-Pt complaing of naueas and headache then stated she was short of breath after vaccine given. RN contacted, pt given Benadryl 12.5 mg. Pt stated she has anxiety. Pt became upset and started crying. Pt closed observed. O2 sat 94% P-73; BP 152/92. Pt states she also get migraines and feels like one is starting. Tylenol 320 mg oral liquid given. Pt started vomiting at 1450, stated she vomited Tylenol. 1453-BP 144/100; p-70; O2 95%. Pt states she has not eaten since yesterday afternoon and hasn't really been taking much fluids. Offered pt a cookie to eat and water to drink. Pt stated she felt better. Continued to observe pt. NP came out to assess pt. Pt states she would like to go to ER to be seen. Pt was instructed to go to the ER, pt refused. AMA form completed and signed. 1530- Pt's BP 164/110 right arm, 162/102 left arm. Pt started vomiting again and stated she does not feel good. Transport called and arrived. Pt's BP done by fire and rescue was 176/104. Pt taken via ambulance. gp,rn
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| 52 | 2021-02-11 | feeling abnormal, disturbance in attention |
meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; T...
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meniere's ringing in right ear; head felt fuzzy; unable to concentrate; Nausea; Vomiting; Vertigo; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN and Meniere's disease. Patient was not pregnant at the time of vaccination. Concomitant medication included amlodipine and hydrochlorothiazide. No other vaccine was received in the four weeks. The patient experienced head felt fuzzy, unable to concentrate, Meniere's ringing in right ear, nausea and vomiting, vertigo on 25Jan2021 10:30. Events resulted in emergency room/department or urgent care. Meclizine, IV Fluids, Maalox and Zofran were given as treatment for the adverse events. Outcome of the events was recovered. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.; Sender's Comments: The patient had medical history of Meniere's disease. The reported event was more likely due to underlying disease, and less likely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 52 | 2021-02-11 | feeling abnormal |
12:30 EE state feeling "weird" dizzy and shaky. EE was seated with legs elevated. Provided juice an...
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12:30 EE state feeling "weird" dizzy and shaky. EE was seated with legs elevated. Provided juice and cool compress HR 68 RR 16 12:43 feeling "back to normal" Increased sneezing and nasal congestions NKA continue to monitor 13:00 Hr 80 RR 18 SPO2 100% BP 184/89 EE reportedly hypertensive at baseline 13:05 Benadryl 25mg po provided 13:10 Continues to feel "back to normal" Ambulating well. Escorted to parking structur by RN.
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| 52 | 2021-02-18 | crying |
There was pain at the location after the first shot that lasted a day or two but just a little stick...
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There was pain at the location after the first shot that lasted a day or two but just a little stick when actually receiving the shot. With the second shot it hurt a lot going in, while being given the shot, right after the shot, and while waiting 15 minutes to leave after the shot. It burned a little when receiving it and while waiting afterwards. The pain gradually lessened but a different kind of pain, like the pain I felt after the first one, continued into the next day and night. That is where I am now with that. Arm is still soar. With the second shot after I left my waiting period and drove away I started to cry, during part of the drive, which was only about 7 minutes or so, I started sobbing. When I arrived at my destination, I sat in the car and sobbed. Not from pain or anything that had happened, it was just some kind of reaction my body was having. After about 10 minutes I was okay. The next day, today, I felt kind of not so happy. Not depressed or anything, just kind of blah. I don't know if that is any relation to the shot because I have days like that occasionally with spending so much time at home due to working from home during COVID. It's night time now, the day after the second shot. My arm hurts and I have some tension through my upper back.
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| 52 | 2021-02-21 | feeling abnormal, sensation of foreign body |
ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx t...
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ed in ER: given predisone and breathing treatment and was was released at 1:36 pm. Was given an Rx to take 50 MG of Prevacid to take 1x a day for 5 days. Saturday: 2/20/2021 -- Took 50 mg of prevacid at 9 am and 10 mg of pepcid 4:50 pm. Eyes swelled, lump in throat Went to ER Was admitted for observation at hospital. Received predisone and benedryl through IV 1:30 bottom lip started to swell was given 25 mg of benadryl by mouth Around 7:30 am scalp started to itch - Was given 20 mg of predisone orally Around 9 am rash on face was given 50 mg of benadryl Around 2:30 pm Doctor came into room because my throat felt tight. She looked at it and said "its not too bad." She had the nurse give me benadryl via interveniously Was discharged around 3:30 pm on Sunday, February 21, 2021 Monday: 2/22/2021 Around 1:15 pm felt lump in throat, felt like my neck was swollen, took 25 mg of benadryl. Called Doctor. Took another 25 mg of Benadryl. Still didn't feel right. Went over to Dr office, my asthma and allergy doctor. At Dr office, I was given two injections of medication. (He told me what it was, but I cant recall the names.) He sent me home with the following instructions: zyretc 10 mg am and pm bendryl 25 mg every 4 hours as needed pepcid 20 mg am and pm predisone 20 mg 3x1 day tomorrow take 20 mg of predisone I am to call his office after 1 pm tomorrow 2/23/2021 to give status report on how I am doing
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| 52 | 2021-02-22 | feeling abnormal |
nausea, fatigue, headache used otc acetaminophen 500mg 2tabs q 12hours & headache gone morning 2 ....
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nausea, fatigue, headache used otc acetaminophen 500mg 2tabs q 12hours & headache gone morning 2 ... night 3 of nausea, took ondansetron 4mg i had from old RX once and otherwise, tolerated the little nausea left until gone night 4..brain fog for 4 days- remained without remaining headache
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| 52 | 2021-02-23 | anxiety |
Cuyamaca team 2 was notified of a potential adverse reactions of a patient whom just received the se...
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Cuyamaca team 2 was notified of a potential adverse reactions of a patient whom just received the second dose of vaccine. The patient was found in her car with husband onscene appearing to be in minor distress. Per the patient she has a history of anxiety and feels that she is having a anxious epsiode. Patient admits to having a similar effect post first dose. Patient admitted to " fluttering in the chest" as well as numbness in the fingers, patient was slightly tachypnic upon inital contact. Patient was advised of calming measures and symptoms began to subside. A full 911 response was started and performed a AMA, Heartland CAD # 2021-00012209. "PFIZER COVID 19 VACCINE EUA"
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| 52 | 2021-02-25 | anxiety |
Progress Notes (Nurse Practitioner) Pt called for follow up s/p covid-19 vaccine done on 02/24/2...
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Progress Notes (Nurse Practitioner) Pt called for follow up s/p covid-19 vaccine done on 02/24/21. She reports doing well and better today. She still has a sore arm where the injection site is. No redness or swelling nor fever. She also states that her cotton mouth sensation is gone. She is overall well. Pt is appreciative for the phone call. Denies any other concerns. Progress Notes (Nurse Practitioner) Attempt to reach patient for follow up. No answer. Progress Notes (Nurse Practitioner) Cosign Needed Expand AllCollapse All Date: 2/24/2021 Subjective Pt is a 52 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience chills/shaking "as if my internals are trying to come out.". She also reports of R arm pain "as if someone socked me in the arm" at injection site. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency room area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, hypotension, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. PMH: depression/PTSD, recovered alcoholic and pill user x 8 years come this April. Currently on Zoloft, Abilify, Wellbutrin. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills, muscle aches (R arm pain where injection site was) and headaches (she developed a headache later while she was in the bay about 15 minutes into her visit. Rates pain at 8/10) Patient denies fever, malaise/fatigue, facial swelling, ear pain, itching in ears, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin and abdominal pain She reported about 15 minutes into her visit with me of "Sudden onset of dry mouth.": Previous Reactions: when she was younger, she had an adverse reaction, unable to recall what, to the chicken pox vaccine. She's only been able to get one shot. She's tolerated other vaccines w/o issues. Objective Vitals Vitals: 02/24/21 0907 02/24/21 0926 02/24/21 0943 02/24/21 1000 BP: 135/84 128/71 120/73 101/71 BP Location: Left arm Left arm Patient Position: Sitting Sitting Pulse: 93 82 68 SpO2: 97% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is obese. She is not diaphoretic. Comments: intially appeared fatigued, not as alert. After drinking water, eating a granola bar. She started to come around HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Comments: R arm inspected. Warm, no erythema, swelling nor rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Affect is flat. Comments: initially flat/anxious. Pt was able to have normal mood by end of visit. Assessment/Plan Treatment included: water, snacks and ibuprofen for headache Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Doing well after observation. She has a ride. She was able to ambulate out to the front with co-worker. She is aware of precautions to watch for. Advised to place warm compress or ice to R arm. F/up with pcp as needed. Electronically Signed 2/24/2021 12:50 PM
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| 52 | 2021-02-28 | confusional state |
Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arm...
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Anaphylaxis developed over the hours, preceded by confusion, rapid heart rate, tingling of face/arms/chest, and feeling like moving through water.
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| 52 | 2021-02-28 | insomnia | Severe diarrhea, chills, lack of balance, weakness, arm pain. Pain in the back of my head. |
| 52 | 2021-03-01 | insomnia |
?Pfizer-BioNTech COVID-19 Vaccine EUA? fatigue, chills, fever (101 degrees), joint pain (all joints...
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?Pfizer-BioNTech COVID-19 Vaccine EUA? fatigue, chills, fever (101 degrees), joint pain (all joints including fingers, headache, 2 inch bruise at injection site, lymph node/underarm swelling, insomnia
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| 52 | 2021-03-02 | anxiety, nervousness |
chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her a...
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chest pain; her lips were swollen/it is on and off; Palpitations off and on; she had a rash on her arms; she had an abnormal feeling in her throat/abnormal feeling in her throat comes and goes, off and on; maybe she is nervous and anxious; maybe she is nervous and anxious; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left deltoid, on 19Dec2020, at single dose, for prevention/COVID-19 immunization, at the hospital. Medical history included allergies and allergies to propylene glycol 3350, polysorbate 20, polysulfate 20. It was reported that the patient had a "quick test" and confirmed she has allergies to propylene glycol and polysulfate 20. Her allergist gave her a list of things to stay away from and said to avoid those ingredients. She stated that COVID-19 vaccine has propylene glycol 3350. She clarified and said her allergist told her to stay away from propylene glycol products. Her allergist told her not to use the COVAX. On 19Dec2021, the patient got her first vaccine shot. Within 3 minutes of getting the vaccine, she had rash on her arms. 3 hours later, she had an abnormal feeling in her throat. She was told to go the emergency room and she was given a quick medicine (unspecified). The patient was unable to clarify what medication she received at the emergency room. On 20Dec2021 (the next day), her lips were swollen, on and off. The patient stated she uses dark shampoo and conditioners and maybe it has PEG in it or maybe she is touching something at the hospital. On 20Dec2020, the patient experienced palpitations. She asked the doctors and nurses about her palpitations and they said maybe she was nervous and anxious since she had a COVID patient in the unit. The patient reported that she thinks palpitation started when she went to pick up over the counter medications on 20Dec2020. On 02Jan2021, the patient experienced chest pain. The outcome of rash and palpitations were recovering; oropharyngeal discomfort, lip swelling, and chest pain were not recovered; and nervousness and anxiety were unknown. Information on the Lot/batch number has been requested.
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| 52 | 2021-03-02 | loss of personal independence in daily activities |
Unable to move arm the day after. Had to get help getting dressed. Tingling feeling in arm, similar...
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Unable to move arm the day after. Had to get help getting dressed. Tingling feeling in arm, similar to how a body part feels if it had fallen "asleep". Tingling feeling ended March 2nd. Arm still feels tender.
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| 52 | 2021-03-03 | disorientation |
Day 1, 26 Feb 2021; headache began at noon; severe fatigue at 6:00 pm; 103 degree fever at midnight ...
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Day 1, 26 Feb 2021; headache began at noon; severe fatigue at 6:00 pm; 103 degree fever at midnight Day 2, 27 Feb 2021: 103 fever for 3 hours, reduced and maintained at 100 with alternating extra strength Tylenol with 800 mg Motrin every 4 hours; continued severe fatigue; continue headache, nausea started at 5:00 pm Day 3, 28 Feb 2021: Nausea, diarrhea, muscle pain, vomiting, headache, 100 degree fever for 24 hours, 6:00 pm passed out for less than 1 minute when standing to go to bathroom to vomit (aware, controlled fall); 2nd episode of passing out sometime after midnight, tried to stand, completely blacked out, woke up disoriented, called 911, transported to ER; bruised upper left arm, left side jaw/neck hitting furniture in fall, hit head on floor
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| 52 | 2021-03-04 | feeling abnormal |
aggravated and upset; she is angry; is miserable everyday/ felt like she was in a car accident, that...
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aggravated and upset; she is angry; is miserable everyday/ felt like she was in a car accident, that is how bad she felt; cold chills; she runs low like 96.6 to 96.8 and she took her temperature/ she was 95.5; joint pain/joint hurting; restless leg syndrome; fatigue; she got sick; nauseous; threw up; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included seasonal asthma diagnosed when she was a child and has a rescue inhaler she only uses once in a while if she needs it; she stated her thyroid was giving her problem, she takes a thyroid medicine; and stated weight was thanks to menopause. Concomitant medications included ascorbic acid (VITAMIN C), fish oil (OMEGA 3), and curcuma longa (TURMERIC). The patient reported that she was aggravated and upset on an unspecified date. She reported that she was not feeling bad before taking the shot and nobody was telling her what to do about it. She was asking what she should do about her symptoms of joint pain, restless leg syndrome and fatigue after getting her first vaccination on 22Dec2020. She was crying and stated that her boss can't tell her anything, she doesn't want to go to her doctor because, what was he going to tell her. She doesn't want to waste a copay. She reported taking Advil and Tylenol for her joint pain without relief and asked what else she should do. She stated she wanted directions, she doesn't want people reading off of a card. She stated she shouldn't have to pay a copay and she doesn't want more medicine to mask her symptoms, she wanted an answer. Additionally, the patient was calling about Pfizer COVID shot, she took first dose 22Dec2020, had a reaction, 35 minutes after she sat for 30 minutes, she works at a hospital, and she walked out to her car, she got sick and nauseous, then after the shot, she had flu like symptoms that lasted, and the next day was terrible, it lasted another week and a half, then she took the second shot 11Jan2021, to this day, she still has restless leg syndrome, fatigue, and her joints were hurting her. She had the same thing before, but this hurts a lot worse, and it was not going away, she was taking Turmeric, everything, and everyone says to just keep taking Tylenol or Advil but she can't keep taking it because now it was upsetting her stomach, or like arthritis medicine, she was taking Omega 3, vitamins, she was 52 years old, she does Spartan races, Cross fit, she does paleo and keto eating, if one looks at her they wouldn't know she was 52, and she was hurting everyday and doesn't know what else do to, and doctors weren't knowledgeable, she doesn't want a stupid answer. She called work, the CDC knows about it, now VAERS, and they said to call Pfizer, when she calls her doctor she doesn't want to pay a copayment and get an idiotic answer. She got this because she works at a hospital and she was trying to protect herself and everyone else, she doesn't like feeling this way, it was to the point she was getting angry, not at Pfizer, but she gets up and runs, with her dog, she was busy all the time, she has 3 boys in the military, and she meets up to do obstacles with them, but she doesn't feel like doing crap and was miserable everyday. She was a CNA in nursing school. She doesn't know if she even wanted to see her doctor, she doesn't want to get an idiotic answer. She hasn't seen him in while, she switched insurance, been primary for years. Stated this was her first day speaking to DSU before she decides what else to do after this, she was angry. Stated about 35 minutes after the first shot, after 30 minutes they said she could go, she said ok, she walked out to her car, was nauseous and threw up and didn't eat that morning, and the next day, she felt like she was in a car accident, that was how bad she felt, she had cold chills, flu like stuff that night before, she runs low like 96.6 to 96.8 and she took her temperature, she got in a blanket and went to bed that night, she was 95.5, and didn't bother taking another temperature, she took a bunch of Advil and went to bed, and Benadryl to go to sleep. This all started on 22Dec2020, and it took about 2 weeks, she just had joint pain, not like now, but those days she didn't feel good, but by the third week she was ok, and she went to take the second shot next time, and all hell broke loose. The second shot was 11Jan2021, and that night it she noted her joints were starting all over again, and she had restless leg syndrome, cold chills and everything, so she went to bed, she didn't have Benadryl, so she got up, and that night took Tylenol, she didn't get very much sleep, and she was very annoyed the next day, she felt like the first time, that like she got it an accident, feeling terrible, that night, and she can lay on the couch to relax, but with the restless leg syndrome, and her joints all day long, she just went yesterday to buy Advil Arthritis, and she never had arthritis before or anything. Restless leg syndrome depends, sometimes it was better than other time. Joint pain was not improving, she was so aggravated about that, she was not feeling 100%, people look at her and say she doesn't look like she feels good, she doesn't, and she was ready to bite their heads off, she was very active, always in the gym or something, she has 3 kids in the military, and was always meeting up with them to do military runs and just this was ridiculous. Stated she took a picture of the vaccine card, as she sent it to a few people. This was definitely the Pfizer vaccine, she has told many people, many people know do not take this, she was so irritated, it's not even funny. The case was reported as non-serious. The outcome was not recovered for the events joint pain, restless leg syndrome and fatigue; and unknown for the rest of the events.
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| 52 | 2021-03-04 | feeling abnormal |
feel tired/more tired; mind felt foggy; feel achy throughout body; This is a spontaneous report from...
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feel tired/more tired; mind felt foggy; feel achy throughout body; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration (at the age of 52-years-old) on 01Feb2021 12:30 at a single dose in left arm for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Bactrim and clarithromycin and experienced allergies. The patient experienced feel tired/more tired, mind felt foggy, feel achy throughout body all on 01Feb2021 14:30 with outcome of recovering. The patient reported that "Approximately 1 hr (as reported) after receiving the vaccine, I started to feel tired, and my mind felt foggy. A few hours later, I began to feel achy throughout body and more tired. Next morning continued to feel achy but not as tired." No treatment received for the events. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed as non-serious.
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| 52 | 2021-03-04 | insomnia, feeling abnormal, irritability |
she was very annoyed the next day; felt like the first time that like she got it an accident; feelin...
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she was very annoyed the next day; felt like the first time that like she got it an accident; feeling terrible; Restless leg syndrome/same thing before, but this hurts a lot worse, and it not going away; Restless leg syndrome/same thing before, but this hurts a lot worse, and it not going away; Fatigue; Her joints are hurting her/Fatigue/same thing before, but this hurts a lot worse, and it not going away; Cold chills; didn't get very much sleep; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE/PFIZER COVID SHOT; lot number: EL1284; expiration date: unknown) at vaccination age of 52-year-old via an unspecified route of administration in the left arm on 11Jan2021 at a single dose for prevention, she works in a hospital (covid-19 immunization). Medical history included seasonal asthma, cross fit (exercise adequate), and paleo and keto eating, thyroid is giving her problem, menopause. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE/PFIZER COVID SHOT; lot number: EH9899) at vaccination age of 52-year-old via an unspecified route of administration on 22Dec2020 at a single dose for prevention, she works in a hospital (covid-19 immunization) but got sick and was nauseous, flu like symptoms, restless leg syndrome, fatigue, joints are hurting her, she doesn't feel like doing crap and is miserable everyday, threw up, felt like she was in a car accident, that is how bad she felt, cold chills and anger. Concomitant medications included fish oil (OMEGA 3), ascorbic acid (VITAMIN C), Apple Cider Vinegar, thyroid medicine and vitamins. She reported that she took the second shot 11Jan2021 (to this day), she still has restless leg syndrome, fatigue, and her joints are hurting her. She had the same thing before, but this hurts a lot worse, and it not going away. She is taking Turmeric, everything, and everyone says to just keep taking Tylenol or Advil but she can't keep taking it because now it was upsetting her stomach, or like arthritis medicine, she is taking Omega 3 and vitamins. She added that she went to take the second shot next time, and all hell broke loose. That night (11Jan2021), she noted her joints were starting all over again, and she had restless leg syndrome, cold chills and everything, so she went to bed. she didn't have Benadryl, so she got up, and that night took Tylenol, she didn't get very much sleep, and she was very annoyed the next day (12Jan2021). She felt like the first time that like she got it an accident, feeling terrible that night, and she can lay on the couch to relax but with the restless leg syndrome, and her joints all day long. She just went yesterday to buy Advil Arthritis, and she never had arthritis before or anything. She mentioned that the restless leg syndrome outcome depends, sometimes it is better than other time, as for the joint pain, it was not improving, she is so aggravated about that, she is not feeling 100%, people look at her and say she doesn't look like she feels good (she doesn't) and she is ready to bite their heads off since she is very active, always in the gym or something. She started Turmeric since she is desperate, this has been going on since 11Jan2021, anything she is doing now is not doing anything. She does not know what to do as every doctor will say maybe she should see this doctor, but she didn't feel like this before this shot. She was tired of feeling this way, she didn't feel this way before the shot, and if anyone met her, they know it. The outcome of the event restless leg syndrome was recovering, arthralgia was not recovered while the outcome of the other events was unknown.
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| 52 | 2021-03-06 | confusional state | Out of body experience, exhaustion, body aches, confusion, head aches, diarrhea |
| 52 | 2021-03-07 | nervousness |
Within minutes after vaccine, became dizzy, shaky, stated felt nasal congestion, reported she has bl...
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Within minutes after vaccine, became dizzy, shaky, stated felt nasal congestion, reported she has blood pressure, then passed out. Called for Paramedics and assisted to floor, elevated legs, monitored symptoms, no swelling noted, continued to breathe normally throughout with 100% oxygenation and came back to consciousness within a minute. Paramedics responded. Stable, pt agreed to be transported to local ER for further evaluation.
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| 52 | 2021-03-08 | feeling abnormal | About 2 weeks after 2nd dose... extreme fatigue and brain fog |
| 52 | 2021-03-08 | sleep disorder |
I had slight tenderness from the 1st shot still and received the 2nd dose in the same arm. It hurt q...
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I had slight tenderness from the 1st shot still and received the 2nd dose in the same arm. It hurt quite a bit. My arm started hurting right away. Over the course of the afternoon, I felt achy and tired. I went to bed about 9:30 pm. During the night I suffered nausea, headache (on the left side), bad chills and then sweats. Fever of 102.4. Arm so sore can even sleep on it. By the am, 10:20 am, still massive fatigue, aches, fever (still between 100.9 and 102.4), chills and earache. .
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| 52 | 2021-03-09 | anxiety |
patient presented with alot of anxiety about vaccine. Vaccine was administered at 10:50am. We discu...
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patient presented with alot of anxiety about vaccine. Vaccine was administered at 10:50am. We discussed vaccine and she was happy to get it. After giving her her dose, she called nurse over to say that she didn't feel well. Patient continued to state that her throat felt weird, she felt like throwing up, it was hard to swallow, and that she was sweaty. She said she had a nervous cough. At 10:20 Am we checked her BP - it was 141/115 and her pulse was 63. She asked for epipen but didn't truly need at the time - said her breathing was fine. At 10:31 Am her pulse was 59 and BP 128/84. She got an ice pack after offering a couple times at 10:31. 911 Was called at 11:05 Am because patient still stated she didn't feel right.
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| 52 | 2021-03-09 | panic reaction |
about 2 minutes after receiving the vaccine i felt a heatwave starting at left arm going through my ...
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about 2 minutes after receiving the vaccine i felt a heatwave starting at left arm going through my whole body, with dizziness and and a feeling of panic. was about to ask for water but panic feeling subsided after roughly one minute. slight dizziness remained. 15 minutes later I felt a slight numbness in my face and right hand
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| 52 | 2021-03-11 | feeling abnormal |
Receive 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of...
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Receive 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of the recommended 1.8 ml normal saline. Tingling/numbness on same arm as injection. Reports feeling odd. Observed and symptoms resolved within 20 minutes. Released home
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| 52 | 2021-03-11 | sleep disorder, loss of personal independence in daily activities |
Fever 102, Severe Chills, Feeling hot, Aches & Pains, Extreme Tiredness (thursday 3/11), Sore Arm w...
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Fever 102, Severe Chills, Feeling hot, Aches & Pains, Extreme Tiredness (thursday 3/11), Sore Arm where it was difficult to lift (only lasted 4 hours), Extremely weak unable to reach for my cell phone, Headache, Very bad neck pain, Feeling like I had the flu, Sweating, nauseous and couldn't eat. Did not sleep at all Wednesday 3/10 night due to the aches and pains, could not get comfortable. Couldn't lie down or sit up comfortably and barely able to stand. I slept most of the day on Thursday 3/11 and was so tired I would fall asleep in mid sentence. Took ibuprofen 200mg and helped SLIGHTLY and wore off very quickly. Couldn't wait to get to the four hour mark to take more. I was so sick my husband wanted to take me to the ER. I woke up on Friday 3/12 feeling back to myself. I was told by my Rheumatologist to stop take HP Acthar Gel and Xeljanz for one week after the vaccine.
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| 52 | 2021-03-12 | sleep disorder, feeling abnormal |
I felt a little funny about an hour after the vaccine and then that seem to pass, I went to bed and...
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I felt a little funny about an hour after the vaccine and then that seem to pass, I went to bed and was awoken by an erratic heart beat
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| 52 | 2021-03-13 | feeling abnormal |
Symptoms Not feeling right -within 5 minutes Heaviness in appendages-15 minutes little dizziness 20 ...
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Symptoms Not feeling right -within 5 minutes Heaviness in appendages-15 minutes little dizziness 20 min Heart Rate increase 25 min Pressure on chest 25 minutes Severe shivers-30 minutes
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| 52 | 2021-03-13 | impaired work ability, feeling abnormal |
dizzyness for 4 days. Was seen by the paramedic on Sunday 2/28/21 at the immunization site and the...
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dizzyness for 4 days. Was seen by the paramedic on Sunday 2/28/21 at the immunization site and they checked all my vital signs and said nothing was overly concerning they made we wait a bit and then released me. Monday night I felt poorly and went to bed early. Tuesday I went to work, still feeling bad and then the dizziness seemed to worsen. I'm a teacher, the school called the paramedic, they came checked my vital signs again and said it was clearly a reaction to the vaccine, and sent me home. I subsequently slept for two days, and the symptoms are mostly gone. I little foggy still, and infrequent bouts of dizziness when I move my head to quickly. I am concerned about taking the second shot.
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| 52 | 2021-03-13 | insomnia |
Within an hour of shot, fever, dizziness, nausea, hot flashes, sleeplessness, body pain, arm pain, h...
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Within an hour of shot, fever, dizziness, nausea, hot flashes, sleeplessness, body pain, arm pain, headache, leg cramps, and feeling like it was the worst flu I've ever had (minus respiratory issues). On day 5, it started to lessen to general malaise and a slight headache.
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| 52 | 2021-03-13 | insomnia |
Nausea, diarrhea, chills, tingling and numbness,in feet and hands, could not sleep, all within 24 ho...
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Nausea, diarrhea, chills, tingling and numbness,in feet and hands, could not sleep, all within 24 hours 48 hours tingling and numbness but not as severe, body aches, sore
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| 52 | 2021-03-13 | panic reaction, incoherent |
This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265]. Both va...
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This is a report after my 2nd vaccine. I received my 1st vaccine on 2/10/21 [Lot # EL9265]. Both vaccines gave me a reaction, and both around the same time the next morning. My reaction to my 1st vaccine included slight fever, aches, and chills. Both doses were administered around 3:30pm and reaction was approximately 10:30-11am the next morning. On this 2nd dose, roughly 40 minutes after waking from sleep, I became mildly nauseas. I sensed I would vomit, so I sat down on the commode with a bucket in front. I started getting the sweats, got very cold, and my arms starting shaking. I started to feel the room spin, saw big black dots, and after banging on the wall to alert my husband something was happening, I fainted and passed out cold. My husband saw me fall face down, and after waking me, I was in a panic, did not know where I was, or how I was on the floor. I passed out a 2nd time, at which point, my husband was able to get me to the car and he took me to the local hospital. I was incoherent on the car ride, moaning, and not knowing what was happening. My eyes remained closed until I was wheeled into the emergency area and they asked me my name. I was taken to a private room, where they hooked up a blood pressure cuff, an oxygenator on my finger, and took several viles of blood. I was then taken to the cat scan room for a brain scan, and several hours later, was given a chest xray. I remained in the room for approx 6 hours, where I was becoming more and more aware of where I was. I had not eaten/drank anything, except a cup of water. I had not used the lavatory. The PA came to me hours later stating all my tests came back negative, and they could not determine what happened, xrays and blood tests were good, and cat scan was good. He said that while they couldn't determine what happened, they would recommend a stay, so they can do more extensive testing. I contacted my husband via cell, told him what they said, and after another 1 1/2 hours, I made the decision to release myself as I was feeling more like myself again, albeit tired. I went home that evening, ate a small dinner, went to bed, and by 12 Noon the next day, I was fine again.
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| 52 | 2021-03-16 | anxiety |
I have to say my symptoms started with my first dose vaccine 12-18-2020, lot#: EH9899 and it has con...
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I have to say my symptoms started with my first dose vaccine 12-18-2020, lot#: EH9899 and it has continued on to my second dose vaccine. On 12-23-2020 after my first dose I started to have daily headaches. I received my second vaccine in 01-08-2021, also experienced daily headaches. I went to see my PCP on 02-19-2021 who referred me to a neurologist. I saw a neurologist on02-22-2021 and was diagnosed with occipital neuralgia and migraine headaches. I tried different medications but they have not yet worked. I also had a occipital nerve block with no improvement. My BP is high probably secondary to the pain and anxiety I experience from my daily headaches. Today I am still having the daily headaches.
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| 52 | 2021-03-17 | feeling abnormal |
vertigo/felt like she was going to fall out of bed; Headache; just a little fuzzy; localized injecti...
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vertigo/felt like she was going to fall out of bed; Headache; just a little fuzzy; localized injection pain; tired; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for three patients. This is the first of three reports. A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318, expiry date: unknown), via an unspecified route of administration on 30Jan2021 15:30 (at the age of 52 years old) at a single dose in the upper right arm for covid-19 immunisation. Medical history included Hashimoto's from 2010 and ongoing (estimates she has had this since 2010, about 11 years ago). Ongoing concomitant medications included levothyroxine (has been taking for six to seven years or more), estradiol (has been taking for 15 to 16 months), and progesterone (Has been taking for 15 to 16 months). The patient previously took flu vaccine on unspecified date (reported as in Sep or Oct) for immunization. The patient had no prior vaccination in four weeks. The patient reported after administration of Pfizer vaccine, on 30Jan2021, she came home and was fine, she stated she was tired but had just traveled and flew home from the east coast so it was no surprise. On 30Jan2021, about one to two hours after the patient got the vaccination, she experienced localized injection pain. This went away by Monday morning, 01Feb2021 and she did not have the pain anymore. On 31Jan2021 0330, she had woken up to go to the bathroom she noticed the headache, but she did not have the vertigo yet, but had the headache, she debated taking something but she was tired so she just went back to sleep. When she woke up later on Sunday she took one ibuprofen (MOTRIN) unknown milligrams, in the morning and one later in the morning around 11:30 or 12. She continued by saying her headache was basically gone, just a little fuzzy (31Jan2021) but nothing she felt like she needed to do anything about. On 31Jan2021 0700, Sunday, she had extreme vertigo which she had never had before and the symptom is still continuing. She rolled over in bed, not sitting up. She felt it in bed. She stated the vertigo is a little better, but partly because she knew how to manage it, she did not move her head. The patient had a virtual visit with her doctor on 01Feb2021 and was going to prescribe meclizine and the patient asked if it was comparable to dimenhydrinate (DRAMAMINE) which the doctor clarified it was. She took DRAMAMINE yesterday (01Feb2021) morning around 9:30am and during the day she felt much better. She has a prescription of meclizine waiting, but she has not picked it up or taken it yet. She also took two paracetamol (TYLENOL). When she was falling asleep she said felt like she was going to fall out of bed, she was lying down in bed half asleep and had the sensation she was going to roll right off the bed. That is when she took the two regular TYLENOL. Therapeutic measure was taken as a result of the events vertigo, headache and localized injection pain. Outcome of the event vertigo was recovering. Outcome of the event headache was recovered on 31Jan2021. Outcome of the event localized injection pain was recovered on 01Feb2021. Outcome of all the other events was unknown.;
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| 52 | 2021-03-17 | nervousness | Tightness in chest, short of breath. Assessment VS B/P 142/78, HR 62, O2 Sat 100%. |
| 52 | 2021-03-18 | confusional state |
Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue...
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Fever of 102, Shooting pain in extremities, migraine, red flushed and swollen face, enlarged tongue, increased heart rate, wheezing, joint pain, severe nausea, diaherra, possible seizure, confusion.
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| 52 | 2021-03-18 | feeling abnormal |
feeling off; light body ache discomfort; light body ache discomfort; left arm swollen-pain; left arm...
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feeling off; light body ache discomfort; light body ache discomfort; left arm swollen-pain; left arm swollen-pain; headache; fatigue; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261), via an unknown route of administration on 03Feb2021, 13:15, Left arm at single dose for covid-19 immunisation at Hospital. The patient was not pregnant. Medical history included Diabetic type 2, HBP (high blood pressure), Depression. Not aware of known allergies. Concomitant medications received in two weeks included losartan 50mg, escitalopram 10mg. The patient didn't received any other vaccine in four weeks. Historical vaccine included first dose (at the age 52 years) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on Left arm on 13Jan2021 19:00 at single dose for covid-19 immunisation. The patient experienced fatigue, headache, feeling off, left arm swollen-pain, light body ache, discomfort on 03Feb2021 at 19:00. No covid prior vaccination. Covid wasn't tested post vaccination. No treatment was received for events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 52 | 2021-03-20 | impaired work ability |
Patient received the Covid Vaccine then sat at the observation area for15 min. for monitoring with n...
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Patient received the Covid Vaccine then sat at the observation area for15 min. for monitoring with no s/s of adverse effects. Patient proceeded to go back to work at the factory. Nurse was flagged down by staff stating patient came back because complaint of vomiting in the restroom, slight dizziness. Patient was offered to lay down. Ice pack was placed on the back of patients neck. Nurse encouraged fluids, took VS and noted to be stable. Patient was monitored for 30 mins before departure. Patient took the rest of the day off and nurse instructed patient on signs, Symptoms of Severe Adverse Reactions to report to health care provider or to go to the emergency room. Patient verbalized understanding.
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| 52 | 2021-03-21 | feeling abnormal |
Patient described feeling a "fluttering feeling" in her stomach. Vital signs were taken and shown BP...
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Patient described feeling a "fluttering feeling" in her stomach. Vital signs were taken and shown BP 148/108; heart rate 88. Temperature 100.5. Patient stated she felt like she might pass out. Patient's head lowered and she experienced a vasovagal reaction 2 minutes following vaccination. After recovery, the patient was given a granola bar and a bottle of water. Patient's symptoms improved after 30 minutes. Patient was released home with her husband.
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| 52 | 2021-03-21 | excessive sleepiness |
Immediately after vaccine I became nauseous and dizzy with a headache. I went home and slept for the...
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Immediately after vaccine I became nauseous and dizzy with a headache. I went home and slept for the next three days. My body ached but the dizziness subsided. Today 03/22 I still feel nauseous and mildly aches. However my left elbow has now swollen up. It hurts to bed it and pressure hurts. I have pins and needles going through my wrist into my fingers along with a full ache.
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| 52 | 2021-03-22 | anxiety | shortness of breath, difficulty swallowing, headache, chest pain, anxiety, and tremor |
| 52 | 2021-03-22 | sleep disorder |
Sudden onset of both severe HTN and severe tinnitus 36 hours after dose #2. BP taken with regular u...
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Sudden onset of both severe HTN and severe tinnitus 36 hours after dose #2. BP taken with regular use cuff and was 210/175 and tinnitus used to wax and wane in past but no problems, and this acute on chronic onset was severe, 24/7, non-stop and interferes primarily with sleep. Very loud non-stop bilateral tinnitus. I treated elevated BP for 2 weeks with Losartan 25 mg qd, then daily BP came back to normal and Losartan stopped. Tinnitus has not changed.
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| 52 | 2021-03-23 | feeling abnormal |
Had vaccination shot #2 in right deltoid. Went to the observation area for the 15 minute period. Aft...
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Had vaccination shot #2 in right deltoid. Went to the observation area for the 15 minute period. After approximately 7 minutes, I felt my throat "swelling." I got up and went to the RN who administered shot. They called the RN over. Vital signs were stable, airway intact, able to speak full sentences. No shortness of breath. It took more effort to swallow. Right arm sore. They monitored me for another 15 minutes. No worsening symptoms. Swelling not improving. Recommended going to the ER (I'm an RN and this was administered at my hospital). Was escorted to ER. Hooked up to monitor. Slight redness noticed on both arms. No hives. IV started. Given IV Benadryl, famotidine, solu-medrol. No improvement. Hooked up to a monitor and given epi sub-Q. Monitored for approximately 60 minutes with improvement of throat swelling. Discharged to home with prescription for prednisone, famotidine and Benadryl x 5 days. At home, approximately 8 hours after shot, work up feeling itchy, took Benadryl PO with relief of symptoms approximately 45 minutes later. Followed up with MD on 1/21. No change in medications. Asymptomatic during the course of medications. Finished course of medications on the morning of 1/23. Later that evening started feeling tired, had chills, swollen glands. Went to bed early. On 1/24 symptoms continued including lack of appetite, increased fatigue, brain fog. Symptoms continued until 1/25 and gradually improved over the week.
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| 52 | 2021-03-23 | insomnia |
Severe joint pain: knees, ankles, hips, elbows, wrists, shoulders. Only at night when lying down. Th...
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Severe joint pain: knees, ankles, hips, elbows, wrists, shoulders. Only at night when lying down. The pain was such that I could not go back to sleep; Severe joint pain: knees, ankles, hips, elbows, wrists, shoulders. Only at night when lying down. The pain was such that I could not go back to sleep; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9267) via an unspecified route of administration on 12Feb2021 (at the age of 52-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Restless Legs Syndrome, anxiety/depression, and cold sores. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included gabapentin and venlafaxine. The patient previously received sulfa and hydrocodone from unspecified dates for unspecified indications and experienced allergy. The patient received dose 1 of BNT162B2 (lot number EL9261) on 20Jan2021 at 09:30 as a single dose in the left arm for COVID-19 immunization. On 15Feb2021 at 03:00, 56 hours after the second dose of BNT162B2, the patient experienced severe joint pain in the knees, ankles, hips, elbows, wrists and shoulders. It was only at night when lying down. The pain was such that she could not go back to sleep. It happened for several days then stopped. The patient had an appointment scheduled with her doctor but the symptoms resolved so she cancelled it. The patient did not receive any treatment for the events. The outcome of severe joint pain and could not go back to sleep was recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 52 | 2021-03-23 | insomnia |
her arm was swollen/ hand was also swollen; the joint in her shoulder felt like it was going to spli...
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her arm was swollen/ hand was also swollen; the joint in her shoulder felt like it was going to split off. It was extremely painful; her arm was swollen/ It was extremely painful; had been awake two nights unable to sleep due to pain; The pain was also creeping up her neck; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (pregnant: no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En7200), via an unspecified route of administration in left arm on 16Feb2021 at 14:00 at single dose for covid-19 immunisation. The relevant medical history included latex allergy and bee allergy, all from an unspecified date. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), modafinil and unspecified thyroid medication. The patient stated that her arm was swollen and the joint in her shoulder felt like it was going to split off. It was extremely painful. Her hand was also swollen and she had to remove her rings. She had been awake two nights unable to sleep due to pain. The pain was also creeping up her neck. The events started on 18Feb2021 at 22:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment included steroids and pain killers sling for arm. No covid prior vaccination and no covid tested post vaccination. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
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| 52 | 2021-03-24 | anxiety |
After 15 minutes of observation, patient complained of left arm pain and chest pain. Patient was tak...
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After 15 minutes of observation, patient complained of left arm pain and chest pain. Patient was taken into an exam room, EKG performed and reviewed by Dr. EKG was normal however given patients previous history and symtoms, 911 was called and patient was transported to the Hospital. Patient was later discharged based on "suspected anxiety and perhaps minor reaction to vaccination are at play here."
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| 52 | 2021-03-24 | irritability |
Fever and moderate headache off and on for first 24 hours. Hot flashes starting day 2 around 1pm...
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Fever and moderate headache off and on for first 24 hours. Hot flashes starting day 2 around 1pm off and on. Rapid heart rate with chest pressure and sweating (measured 129) at about 5pm day 3. Lasted 25 minutes. Severe irritability at about 8am day 3 and ongoing
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| 52 | 2021-03-25 | feeling abnormal, loss of personal independence in daily activities |
4 days after injection of vaccine felt awful nausea, dizzy , headache, body aches and relentless fat...
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4 days after injection of vaccine felt awful nausea, dizzy , headache, body aches and relentless fatigue. The other stuff got better but the fatigue and dizzy/ headaches are still happening. I work out hard every day and can't even go for a walk without having crazy fatigue wash over me. I cannot work out with weights or high intensity AT ALL.. exhausted by evening and then dizziness and headache get worse in evening. Today ill be 19 days of this happening. VERY scary. I am a very active person and I can't be active I have no energy.
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| 52 | 2021-03-25 | feeling abnormal |
Severe muscle pain at injection site at 630pm. By 10pm my body started to ache from neck, shoulders,...
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Severe muscle pain at injection site at 630pm. By 10pm my body started to ache from neck, shoulders, body down to legs. Severe chills with shivering for almost 2 hours. Low grade fever 99. Could not walk or stand. Took tylenol at 11pm with little effect, then again at 330am due to chills, muscle aches n spasms in legs, slight headache, very tired and miserable feeling. Slept and woke up at 8am sweating under blankets and feeling less sore muscles. Hydrated with water, and by 9am just feeling tired. Soreness of injection site gone as well as body aches. Just fatigue feeling. Will still go to work on 3-26-2021 after thinking there was no way I can move my body. Not feeling 100% at 943am but much better than earlier flu type feeling.
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| 52 | 2021-03-25 | feeling abnormal |
Complaints of headache, cool to touch, "body feels weird". Bp 140/90, HR 78, pulseox 100%. Rechec...
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Complaints of headache, cool to touch, "body feels weird". Bp 140/90, HR 78, pulseox 100%. Recheck at 5:35 BP 128/84 , HR 77 99%puse ox.
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| 52 | 2021-03-25 | excessive sleepiness |
When leaving walking in parking lot very dizzy felt like I was drunk ( I do not drink at all) same w...
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When leaving walking in parking lot very dizzy felt like I was drunk ( I do not drink at all) same when I got home. Slept 2 days, woke up little wheezing, BAD headache....lasted 3days . Next day I had bad muscle pain, some bone pain, arm sore that wasn?t bothersome. EXTREME FATIGUE .....couldn?t get off couch bout 8 days. When I did very dizzy would stagger to the right. Fell into other couch trying to get up bout the 3 day. Fatigue was getting worse, hard to move body, VERY SLEEPY . Family insisted I go to ER or they would call EMS. I only will go if on death bed. This was 1st time in life I waited 8 days to shower, I?m a very clean person, I will even do my makeup almost daily. My biggest concern is the MALAISE AND FATIGUE WAS WORSENING AS DAYS WENT ON. I DO HAve Hx. Of reactions to tetanus but nothing like this. I?m waiting to go to dr to have labs drawn because of this. Thanks you
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| 52 | 2021-03-25 | insomnia |
My mother had a really bad itchy sensation all over her arms and body in the middle of the night. Sh...
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My mother had a really bad itchy sensation all over her arms and body in the middle of the night. She woke up from her sleep and used lotion to try to calm her body down. She didn't tell me until the next day, but she couldn't sleep that night. Her left arm that received the vaccine was also very sore for her all day and it still is the next day. She doesn't feel the itchy sensation anymore though.
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| 52 | 2021-03-25 | loss of personal independence in daily activities, excessive sleepiness |
Nauseated, headache, feel feverish but no actual fever, muscle soreness, very fatigue, sore throat. ...
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Nauseated, headache, feel feverish but no actual fever, muscle soreness, very fatigue, sore throat. Started on 3/22/21. And has continued until today 3/26/21. I?m unable to function as normal. Very fatigued and tired and sleeping in afternoon. Nauseous gets better and worse.
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| 52 | 2021-03-26 | feeling abnormal |
After 30 minutes of observation, patient started to leave and didn't feel good. Her face complexion ...
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After 30 minutes of observation, patient started to leave and didn't feel good. Her face complexion turned white and said her chest started to get tight. Staff couldn't get a BP reading. Patient was lowered to the ground as she passed out. An Epi Pen was administered at 11:02am and she woke up immediately. Patient was slowly transferred her to a stretcher and monitored her vitals until EMS arrived at 11:20am. Patient refused to go to hospital after being observed by EMS and her husband came to pick her up.
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| 52 | 2021-03-26 | impaired work ability |
Muscle pain in injected arm. Severe difficulty in moving injected arm, and tiredness lasted 2 days....
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Muscle pain in injected arm. Severe difficulty in moving injected arm, and tiredness lasted 2 days. Was unable to work or do other tasks for 2 days. Slight pain in injection site, lasted a week.
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| 52 | 2021-03-27 | excessive sleepiness |
Started over night. Worst flu feelings, headache, chills, aches from the top of head to soles of fee...
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Started over night. Worst flu feelings, headache, chills, aches from the top of head to soles of feet. Feeling the need to vomit always. Up and down fever of 101.5 Sleep for 6 hours awake for 1. This has been for 4 entire days now! Tonight I am feeling slightly better
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| 52 | 2021-03-28 | hallucination, restlessness, feeling abnormal |
Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath ...
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Night of vaccine felt heaviness on chest - using elliptical machine as usual and felt out of breath very quickly within 15 minutes. Normally do 30 minutes and can speak through it. Just thought I was tired. Overnight joint pain significant in knees, fingers and shoulder blades. Husband told me I was moaning throughout the night and turning from side to side. Got up to go to the bathroom once and head felt foggy. Morning got up as usual and quickly became light headed. Started to black out to the point where sitting down and putting my head down didn?t help. Was blacked out and yelled for my husband. Husband carried me to the couch what I was saying he thought I was hallucinating. Began to have whole body trembling - not necessarily chills just trembling. After about an hour subsided. Blacking out lasted on and off throughout the day. O2 stats between 91 and 94 throughout the day, fast heart rate 90+. No fever. Stayed in bed all day, barely moved. Restless and couldn?t get comfortable - very bad headache. Going in and out of sleep. Treated with Tylenol arthritis and ibuprofen. Drank water and some hot tea. Very hard to even drink anything. Next day felt like I had been sick although by 5pm seemed to be back to baseline.
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| 52 | 2021-03-29 | loss of personal independence in daily activities, impaired work ability |
2/26 First dose of Pfizer Covid vaccine: Within 15 minutes -tingly and achy from injection site to w...
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2/26 First dose of Pfizer Covid vaccine: Within 15 minutes -tingly and achy from injection site to wrist and fingers. Extremely sore at site. I was very, very tired by 4PM. 2/27: site is very red, round, raised. I am extremely tired and achey. This persists all day. 2/28 Severe headache and nausea. Site is extremely sensitive (cannot tolerate touch), still red and about double in size. Cannot do daily activities, but can still tolerate food and water. I feel very unwell. 3/1 Headache and nausea persist. I have to take a sick day; I cannot work. By the evening I'm feeling less nauseous. 3/2 By evening I am much improved - only slightly nauseous, but the aches return. 3/3 Runny nose emerges with significant congestion. (The app is about to time out. -- I have more to add. I also had a strong reaction to the second injection on 3/21/2021.)
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| 52 | 2021-03-30 | anxiety |
Systemic: anxiety-Mild, Additional Details: 52 yo female pt reported anxiety after vaccine, reporte...
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Systemic: anxiety-Mild, Additional Details: 52 yo female pt reported anxiety after vaccine, reported sensations of claustrophobia. Was given water, provided reassurance, and aobserved for 25 minutes. Pt and caregiver (husband) reported that she was feeling better.
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| 52 | 2021-03-30 | depression |
Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing...
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Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing; Extreme weakness; exhaustion; abnormal mentation; cough; hoarseness; gum pain; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included type one diabetic and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, tramadol hydrochloride (TRA), levothyroxine and pramlintide acetate (SYMLIN). On 31Jan2021 18:00, The patient experienced severe pain throughout body, esp head, stomach, and tongue throbbing. extreme weakness, exhaustion, abnormal mentation, cough, hoarseness, gum pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
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| 52 | 2021-03-30 | feeling abnormal |
runny nose; headache; Stomach ache; positive COVID-19 test with symptoms; her head felt heavy/foggy;...
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runny nose; headache; Stomach ache; positive COVID-19 test with symptoms; her head felt heavy/foggy; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 04Mar2021 (at the age of 52-years-old) approximately at 14:00 (maybe 14:30), at single dose for covid-19 immunisation. The patient had no relevant medical history and no concomitant medications. On 09Mar2021 the patient was tested positive for COVID-19. On the same day the patient had sore throat, body aches, headache, back ache and stomach ache. On 11Mar2021 the patient experienced arm pain and sneezing and on 12Mar2021 she had runny nose. The patient reported that she received the dose with her husband and she was a few days behind him and had the same symptoms. At the time of reporting she had a sore throat and runny nose, but the body aches and headache were gone. She stated that she was still experiencing symptoms. Body aches were not severe, she took paracetamol (TYLENOL) and then they were gone. She reported that the arm pain was for a short amount of time, maybe half of the day on Thursday, 11Mar2021. She stated that it felt like muscle aches. The body aches and back ache were not severe. She reported that she took a couple of Tylenol and they were under control. The headache was never major except for maybe one night. She stated that other than that one occurrence, her head felt heavy/foggy and that she didn't feel like herself. She has been experiencing a sore throat in the middle of the night and stated that it was pretty heavy the night before reporting. She stated that she has had a minor sore throat during the day but it was worse at night from the air being dry. She sneezed some on 11Mar2021 but that it was worse today. Mentioned during the day she was congested. She took Tylenol and that it helped with the headache and body aches, denied taking any other medications. The patient reported also that she received the covid test at a drive through testing site. Headache and stomach ache were resolved, runny nose was not resolved and the outcome of other events was unknown.
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| 52 | 2021-03-31 | disorientation |
Presents to virtual urgent care with a complaint of she received her 1st COVID 19 vaccine on Friday,...
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Presents to virtual urgent care with a complaint of she received her 1st COVID 19 vaccine on Friday, she states since then, she has felt dizziness, nausea, and feeling a bit disoriented. She had an episode of seeing bright lights, she feels she can't see correctly. She states it feels like she felt when she had west nile virus. She denies any fever or chills, no pain. Advised pt she will need an in person exam and possible some lab work. Patient opted to go to PCP instead of in person urgent care. Referred to eye center and MRI and diagnosed with vaccine related symptom triggered migraine.
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| 52 | 2021-03-31 | disturbance in attention | Day 1 and 2 extremely tired; hard to focus Day 3 very tired Day 4 diarrhea |
| 52 | 2021-04-02 | sleep disorder |
Several days after my first dose a broke out in hives/rash all over my arms legs and body. I have in...
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Several days after my first dose a broke out in hives/rash all over my arms legs and body. I have intense uncontrollable itching and skin is burning and painful. I feel hot (flushed), achy and unwell. This has disrupted my daily activities and interfered with sleep I went to my regular doctor first and was started on prednisone. I went back 2 days later because I didn?t see an improvement. They gave a medrol dose pack of steroids. Later that night it continued to get worse so I went into the ER. Was treated there with solumedrol, and benedryl by IV. Left that night but returned again to the ER the next day because of unbearable pain in stomach and violent throwing up that wouldn?t stop. They treated me with pain medication, solumedrol, benedryl and epinephrine. On March 24th I was able to see the allergist Dr and he treated me with 2 antihistamines and steroid. 3 days later I was worse so he saw me again and gave me injection of dexamethazone steroid shot. That helped me get through the weekend. So by the next week he dropped to taking 6mg if dexamethazone and continuing this whole time with the antihistamine regimens he prescribed. Dr has diagnosed me with a ?type IV delayed allergic reaction?. Unfortunately these take weeks or even a couple months to resolve. It calms and flares again repeatedly.
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| 52 | 2021-04-03 | feeling abnormal, nervousness |
Headache, fatigue, brain fog, shaking feelings, racing heart Tachycardia all started the same day wi...
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Headache, fatigue, brain fog, shaking feelings, racing heart Tachycardia all started the same day within 30 minutes of shot Symptoms persisted with additional trouble breathing started on April 3. I went to Urgent Care for assistance. Was given albuterol, EpiPen, and steroids. Asked to follow up with Primary doctor on Monday.
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| 52 | 2021-04-04 | insomnia |
Sore Arm immediately. Body aches, chills, sweats, high blood pressure 156/105, sore joints, severe h...
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Sore Arm immediately. Body aches, chills, sweats, high blood pressure 156/105, sore joints, severe headache, nausea, swollen glands in neck and under arm pits and in breasts, could not lift arms without pain, walking hurt, swallowing hurt, chest and ribs hurt to breathe, insomnia, jitters, entire body was in pain, every ounce of my body and it hurt to even roll over in bed or get up and walk. This lasted for 5 days in a row and started the evening that I got the shot. I was perfectly well before the shot.
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| 52 | 2021-04-04 | insomnia | Swollen hands and feet, high blood pressure, jitters, insomnia for 7 days. |
| 52 | 2021-04-04 | nervousness, feeling abnormal |
Fatigue, my arm is painfully sore and uncoordinated dizziness, i had jittery and shaking feeling at ...
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Fatigue, my arm is painfully sore and uncoordinated dizziness, i had jittery and shaking feeling at first.
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| 52 | 2021-04-05 | anxiety |
For 3 weeks now, I have had loose stools. I have had between 3 to 5 bowel movements a day. They are...
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For 3 weeks now, I have had loose stools. I have had between 3 to 5 bowel movements a day. They are usually immediately following eating. Because of my dairy allergy and some anxiety I have been experiencing, I didn?t think about this all being connected to the vaccine. I have never had loose bowel movements that have lasted like this unless I was sick with something else. Today, I am experiencing some cramping with it as well. I read about an ingredient in the vaccine that may cause this so I decided to contact someone.
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| 52 | 2021-04-05 | insomnia, anxiety, fear |
About 2Am I could not sleep it did not feel like anxiety or insomnia. I was awake then I started to ...
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About 2Am I could not sleep it did not feel like anxiety or insomnia. I was awake then I started to get very cold then my body was shaking uncontrollably. My teeth were chattering this was not a chill it was 3-4 hours of intense fear. This stopped and my body turned rather red and was very hot to the touch this was about 3 hours. I could not get in the shower to warm up when I was cold I was too weak. Then about 11-1 the next day it all stopped. It was really frightening and kind of like a PTSD moment for me that caused increased anxiety.
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| 52 | 2021-04-06 | feeling abnormal, loss of personal independence in daily activities, disturbance in attention |
weakness; nausea/her stomach is kind of queasy; She spent 2 days in bed, unable to get out to do any...
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weakness; nausea/her stomach is kind of queasy; She spent 2 days in bed, unable to get out to do anything other than pee, get something to eat and go back to bed; brain fog; she can't concentrate, it is affecting her head; dizziness/dizzy; exhausted/tiredness/tired; faint episode; achy arm; abdominal pain; her sugars really shot up in couple of hours, went to 220s; shivers, cold.; shivers, cold.; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [22Mar2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 18Mar2021 (at the age of 52-year-old) at single dose for COVID-19 immunization. Medical history included Diabetes, ongoing PoTS diagnosed around Dec2020 or Jan2021, MTHFR (methylenetetrahydrofolate reductase genetic mutation) genetic mutation, Genetic/Chromosomal abnormalities and lost some weight. The patient had prediabetes for long time, in last year gotten little bit bad; back under control sugars running 125-130. That's not why she is feeling like this. Measures her sugar 3 times daily keeps Diabetes diet controlled mostly. With regards to her MTHFR: methylenetetrahydrofolate reductase genetic mutation. This genetic mutation makes her not methylate well, they told her she is a poor meythelator. Family history included diabetes and high blood pressure. Her dad passed away from either Diabetes or Lung cancer; she is not sure which-he had lung cancer but afterwards when patient talked to her sister, sister mentioned dad's diabetes got really bad after the chemo and everything; but that is neither here nor there in the end; it could have been from Diabetes or lung cancer. He was a smoker for his entire life, even though chemo he could not quit the cigarettes, could not give it up even on his death bed. Concomitant medications included ergocalciferol (VIT D), cyanocobalamin (VIT B12), and ongoing ascorbic acid (VITAMIN C); all were taken for vitamin supplementation. The patient previously received varicella zoster vaccine rge (cho) (SHINGRIX) on 19Feb2021 for immunization and experienced achy arm and tired for a day. About 15 years ago when having her daughter, the patient had severe reaction to Magnesium sulfate for preeclampsia. They gave her Magnesium sulfate twice which made her comatose twice, she does not know why they gave it to her the second time. She also had a reaction to calcium levomefolate (DEPLIN), like a methylfolate thing. She reported she was on Glimepiride for Diabetes previously which was stopped a couple of weeks ago because she was having a lot of blood sugars that did not sit well with her. This consumer is the patient who called regarding symptoms she experienced following first dose of Pfizer-BioNTech COVID-19 Vaccine administration on 18Mar2021. The first symptoms she had were an achy arm later on that day of 18Mar2021. On 19Mar2021, the next morning she woke up totally exhausted. She spent 2 days in bed, unable to get out to do anything other than pee, get something to eat and go back to bed. Some of the symptoms lifted yesterday, 21Mar2021 during the day. She kind of got up, was still kind of tired but pushed through it thinking she couldn't just sit in bed. She spent a little time outside while her daughter was at the pool; she was sitting in a chair away from other people. When she came home she was really tired and dizzy on 21Mar2021 and decided to go to bed. The patient also experienced weakness and nausea on unspecified date. After the Pfizer BioNTech COVID-19 Vaccine injection/shot on Thursday, 18Mar2021 she had a faint episode. They thought the faint episode was probably from anxiety, reason unknown; but she had a lot of faint episodes before she went to bed. She woke up 1-2 hours later on 18Mar2021 with really bad abdominal pain all night, shivers, cold. When she got up in the morning she was really tired; she had to take her daughter to school and barely drove to school half-way coherent because her daughter was talking to her. She was not doing great, she came back home, she is still tired, has been on the couch all day; her stomach is kind of queasy, not good. This is day 4 so she is concerned a little bit. She is too tired to go downstairs during this call; this thing is kicking her butt; she is having a brain fog with this thing, she can't concentrate, it is affecting her head. She has other medical condition Diabetes: After she got the Pfizer-BioNTech COVID-19 Vaccine her sugars really shot up in couple of hours, went to 220s on 18Mar2021; sugars back down the next day (19Mar2021). She is terrified of what is going to happen after the second dose of Pfizer-BioNTech COVID-19 Vaccine. She verified she has not had any visit to physician's office, emergency room or hospitalization related to these events; not yet, but she is considering whether to go or not. The outcome of the event exhausted/tiredness/tired was not recovered, and the outcome of the remaining events was unknown. Information about the Lot/batch number has been requested.
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| 52 | 2021-04-06 | feeling abnormal |
Severe dizziness started morning of March 29 Nausea & vomiting Brain fog Headache Fatigue Mild che...
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Severe dizziness started morning of March 29 Nausea & vomiting Brain fog Headache Fatigue Mild chest pain All these lasted until April 6th
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| 52 | 2021-04-06 | insomnia, feeling abnormal |
This is a spontaneous report from a contactable consumer. A 52-year-old non-pregnant female patient ...
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This is a spontaneous report from a contactable consumer. A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm left on 17Feb2021 at 10:30AM as a single dose for COVID-19 immunization. Medical history included Known allergies: Penicillin. Concomitant medications included plecanatide (TRULANCE) for an unspecified indication. Historical drug included BNT162B2 on 20Jan2021 at10:30 AM. The patient experienced Arm/shoulder pain - diminished mostly after 4 days, "Foggy" thinking. Shoulder pain is worse at night, difficult to sleep, Six days after vaccine, still "foggy." Not just sleepy from lack of sleep on 17Feb2021 at 2:00. Taking oral steroids and it is improving. The patient has said that It worsened for a couple days, then started to get better after about 4 days. Then it started worsening probably on 22Feb2021. Patient went to the doctor 26Feb2021. Seems the inflammation went into my rotator cuff. Taking oral steroids and it is improving. The outcome of event was recovering. Information on the lot/batch number has been requested.
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| 52 | 2021-04-06 | sleep disorder |
At 3:30 pm, pain in left side under ear/jaw area, pins and needles in jaw area starting. By 5:30 pm,...
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At 3:30 pm, pain in left side under ear/jaw area, pins and needles in jaw area starting. By 5:30 pm, pins and needles moving between jaw, top of head, left finger tips, and left cheek/sinus area. Took 1 Ibuprofen for neck/arm pain. Laid down at 5:30 pm. Fatigue. Cold enough to get a blanket but no chills. Laid down rest of the evening until bedtime. Woke up many times overnight from arm pain.
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| 52 | 2021-04-07 | disorientation |
Disorientation; Extreme fatigue; runny nose; shoulder pain; This is a spontaneous report from a cont...
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Disorientation; Extreme fatigue; runny nose; shoulder pain; This is a spontaneous report from a contactable Other HCP. This 52-year-old (at the time of vaccination) female Other HCP (patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6200) via an unspecified route of administration on 21Feb2021 at 01:00 pm at single dose on left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital facility. Medical history included anxiety (dates unspecified), known allergies; no. Concomitant medications included citalopram 100 mg one time a day. Other vaccine was not administered in four weeks. Patient experienced extreme fatigue, disorientation, runny nose, shoulder pain on 21Feb2021 at 1:30 pm. Treatment for adverse events was not given. Patient did not have covid prior vaccination and covid was not tested post vaccination. The outcome of events was not recovered.
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| 52 | 2021-04-07 | feeling abnormal |
I had an allergic reaction (anaphylactic) after both shots, Doses 1: I had taken Claritin the night ...
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I had an allergic reaction (anaphylactic) after both shots, Doses 1: I had taken Claritin the night before, I received the vaccine at 4:00 PM and I had red, hot and inflammation on my face 11 min before the shot, they let me in observation for 30 min. Doses 2: it was at 9:15 Am, I had taken Claritin the night before and 1 Benadryl 30 min before shot, I took another Benadryl just before vaccination and had allergic reaction (mild red, hot, and inflammation on my face) just few seconds after second shot, they let me in observation for 30 min. 3 hours after second shot, I had again allergic reaction: red, hot, and inflammation on my face, I took 2 Benadryl.
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| 52 | 2021-04-08 | confusional state | Confusion, extremely severe ringing in ears, lisping |
| 52 | 2021-04-08 | feeling abnormal |
About 1 minute after receiving the vaccine patient reported dizziness and "feeling funny", she alert...
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About 1 minute after receiving the vaccine patient reported dizziness and "feeling funny", she alerted nursing who then called the PA to evaluate. Patient RR and HR stable however, BP was elevated on initial read at 192/139 (L arm) then repeated on opposite arm with 216/136. Patient stated that she did not take her antihypertensive medications this AM (lisinopril) in addition to the day before. After five minutes, repeated blood pressure at 199/118- she denied any symptoms other than dizziness and possibly some nausea. Patient was transported to the ED by wheelchair
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| 52 | 2021-04-08 | nervousness | Shaky and dizzy |
| 52 | 2021-04-09 | disturbance in attention |
On April 26th, I had fever, chill's, nausea and body aches. It took over the whole weekend for the ...
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On April 26th, I had fever, chill's, nausea and body aches. It took over the whole weekend for the body aches to subside. The nausea has still not gone away. I have noticed that I have started and now lost my ability to spell. I can see the word but I have a hard time getting out. I am now experience sever tremors.
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| 52 | 2021-04-09 | loss of personal independence in daily activities |
Pain in shoulder joint that began immediately after injection and continued for 10 days, until I vis...
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Pain in shoulder joint that began immediately after injection and continued for 10 days, until I visited my internist. The soreness was not really muscle pain but centered in the shoulder joint. The injection site was actually quite high on my arm. Following the vaccination, I could not lift my left hand, brush hair, get dressed etc. without assistance. Driving with two hands was difficult, because it hurt to lift my left hand to the steering wheel. I could not lift my left hand above waist level. Pain was not relieved by over the counter pain relievers, and did not diminish in the 10 days following vaccination.
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| 52 | 2021-04-09 | sleep disorder |
Intense chills and shivering that awakened me from sleep, fever reaching 102, body aches, nausea diz...
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Intense chills and shivering that awakened me from sleep, fever reaching 102, body aches, nausea dizziness headache for 4 continuous days post injection
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| 52 | 2021-04-10 | depression | Painful throat, swelling of nasal, sinus, throat passages, fatigue, malaise, depression, |
| 52 | 2021-04-10 | feeling abnormal |
headache started at 4pm. But 10 pm couldn't bare the pain of headache. felt like i could feel each v...
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headache started at 4pm. But 10 pm couldn't bare the pain of headache. felt like i could feel each vein of blood pumping through my head. started throwing up. could barely get in car. Husband drove me to the ER. Had to be put in wheel chair.
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| 52 | 2021-04-10 | impaired work ability |
About 11 minutes after getting the shot, I began to feel light headed. Laying down did not help. T...
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About 11 minutes after getting the shot, I began to feel light headed. Laying down did not help. They kept me for observation and over the next hour checked my blood pressure several times and it was very high. I think the highest reading was 187/110. I have never had high blood pressure before. They let me leave and said that I should see a doctor or go to the ER and that I probably just had high blood pressure now. After I left I used a CVS model BP3MW1 -1W (800229) blood pressure cuff at home. my blood pressure was now down to 153/83 The next morning I felt OK and went to work but left at 1 pm. Shortly after had exhaustion, muscle aches, headache, and chills all evening and night heart rate was up to 128 beats per minuter . Felt better the next day. Am still experiencing, headaches and tiredness. BP has been between 128/73 and 154/83. I'm wondering if it is safe to get the second dose?
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| 52 | 2021-04-10 | sleep disorder |
Vertigo off and on yesterday. Loud tinnitus in left ear last night for 3 hours until subsiding. Wo...
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Vertigo off and on yesterday. Loud tinnitus in left ear last night for 3 hours until subsiding. Woke me from sleep.
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| 52 | 2021-04-11 | insomnia |
Felt arm slightly cold running down toward fingers. Slight nausea. Arm became progressively painful ...
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Felt arm slightly cold running down toward fingers. Slight nausea. Arm became progressively painful from site of injection down to fingers. Unable to sleep, swelling along arm down to fingers. Swelling going down very slowly, can now bend elbow and make fist but still painful if used.
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| 52 | 2021-04-12 | anxiety | ANXIETY, DIFICULT TO BREATH, DIZZY, HEAD EACH, |
| 52 | 2021-04-12 | disorientation |
Patient reported history of fainting after vaccines and pharmacist instructed the patient to sit be ...
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Patient reported history of fainting after vaccines and pharmacist instructed the patient to sit be monitored for 15 minutes or longer after receiving the vaccine. Patient refused to wait and left immediately after the vaccine and fainted in the front entrance of our facility. She was awake and breathing but disoriented and needed assistance to get up. Patient husband and patient both refused to have EMTs evaluate the patient before leaving.
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| 52 | 2021-04-12 | insomnia, abnormal dreams | Soreness at the site. Extreme sore throat. Exhaustion. Sleeplessness. Very vivid dreams. |
| 52 | 2021-04-13 | nervousness |
Pt yelled she was having trouble breathing; Assisted to seated position; EMS activated; VS placed EM...
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Pt yelled she was having trouble breathing; Assisted to seated position; EMS activated; VS placed EMS started IV and gave Benadryl. Transported to ER and Evaluated. All WNL and MD says nervous attack.
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| 52 | 2021-04-13 | sleep disorder |
Got out of bed at 12:30 am to take Tylenol for the fever and chills. Went to bathroom and came out ...
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Got out of bed at 12:30 am to take Tylenol for the fever and chills. Went to bathroom and came out and immediately felt dizzy and nauseated. Put my head down on counter for a minute and then stood up to open door and collapsed hitting the counter on the way down. Hitting my head on the floor. My fiancee came in and helped me sit up, but i could not stay up because i was dizzy and nauseated. Fell back over and then he helped me back to bed. Took tylenol and tried to sleep. Flu like sympotoms and body aches + pain from falling.
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| 52 | 2021-04-14 | feeling abnormal |
Employee taken to the ED. 52 y.o. female presenting with numbness and tingling around her throat, t...
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Employee taken to the ED. 52 y.o. female presenting with numbness and tingling around her throat, tongue, and lips after receiving the first dose of the Pfizer covid vaccine at approximately 12:15 pm and subsequently was sent to the ED about a half hour later. She stated that after receiving the vaccine, her tongue felt "full" and her lips had some tingling - overall it just felt funny. She received 50 mg of Benadryl - this made the numbness and tingling decrease slightly but it hasn't caused it to completely resolve. She also had a slight headache that started shortly after this. She denied any shortness of breath or rash. She has never had any symptoms like this with a previous vaccine although she has had urticaria with penicillins
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| 52 | 2021-04-14 | insomnia |
1st shot sore are tire for 2 days 2nd shot tired on the 2nd day 3rd day start getting getting headac...
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1st shot sore are tire for 2 days 2nd shot tired on the 2nd day 3rd day start getting getting headache, dizzy, nausea, sick to my stomach, tightness of chest, rapid heartbeat on and off, couldn't eat, didn't sleep well, tingling in hands and feet, didn't feel like I was going to make it through though the night. Not bad enough to go to the emergency room. I have been to urgent care and to internal medical to get checked still not feeling good I had covid in December and I feel like this shot has made me sick and I just can't get back to myself
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| 52 | 2021-04-15 | feeling abnormal | None stated. |
| 52 | 2021-04-16 | crying |
A few hours after receiving the second dose, I was overcome by uncontrollable emotions. This involve...
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A few hours after receiving the second dose, I was overcome by uncontrollable emotions. This involved spontaneous crying that lasted for over 2 hours. This is not typical behavior for me and the only thing that was different was that I received my second dose of the vaccine. This situation could be a disaster for someone who is less aware of their condition and symptoms. The emotions were so intense that there was the potential for self-harm.
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| 52 | 2021-04-17 | insomnia, restlessness |
Restlessness, insomnia I was extremely fidgety all night and unable to settle. My mind seemed calm...
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Restlessness, insomnia I was extremely fidgety all night and unable to settle. My mind seemed calm but I couldn?t hold still. I felt a strong need to move my body. I kept thinking this what be what it?s like to be ?crawling out of your skin.? It felt like restless leg syndrome but for my whole body. If I got out of bed and walked around, I was fine. I took Benadryl, hoping it would make me sleepy. It did but it didn?t settle the restlessness. I was so tired but so unable to settle. As a middle-aged woman, I know insomnia that keeps me awake, thinking and alert. This was entirely different. My mind was calm and sleepy but my body wouldn?t settle. I?ve never had this before. I have had a few experiences with something I think is similar to restless legs but that was intermittent and never persisted. Prior to this, 15 and 16 April, I had aches, chills, lethargy, weakness, and burning in my nostrils. All of this seemed very normal for dose 2. I was able to work throughout but took a nap one day.
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| 52 | 2021-04-17 | insomnia |
Tired/fatigue; unable to sleep throughout the night; headache; dizziness; This is a spontaneous repo...
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Tired/fatigue; unable to sleep throughout the night; headache; dizziness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on 01Apr2021 at 10:15 (at 52-year-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunization. On 01Apr2021 in the evening, the patient became very tired and laid down for about a half an hour which seem to help around 5 PM. When she did go to bed at nine, she slept for only a few hours and then she was unable to sleep throughout the night. She was experiencing a headache, dizziness and it has continued through 01Apr2021 along with the fatigue. The time currently was 12:36. She had been drinking a lot of water this morning and that seemed to have helped a little. The outcome of the events was unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained.
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| 52 | 2021-04-17 | irritability |
I became easily agitated and my right shoulder and joint became stiff and painful (9 out of 10 pain)...
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I became easily agitated and my right shoulder and joint became stiff and painful (9 out of 10 pain) since the first injection 3/12/21. I was in a fair mood prior to the second injection. Shortly afterwards I experienced the normal side affects but also the irritability x 1 day. Right shoulder and injection site continues to hurt (7 out of 10) with movement.
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| 52 | 2021-04-17 | memory impairment, confusional state |
Got my first CV vaccine yesterday AM at 11:30. For those of you in town, Medicine is running an amaz...
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Got my first CV vaccine yesterday AM at 11:30. For those of you in town, Medicine is running an amazingly efficient site at the theater (I was in and out in 20 minutes). So after the vaccine, I felt 100% ok. Walked over to store to pick up a few things, then headed to the subway to go home. I remember going down the stairs to the subway station, and then I remember nothing until I was unlocking the front door of my house. After that the next thing I remember is waking up on my couch ~6PM. I was feeling totally confused. I picked up my phone and saw that I messaged one of my besties to let her know that I received my first dose ? I have no recollection of sending the message. I also noticed that my hair was wet, which was weird. I went upstairs to my bathroom saw evidence that I had taken a bath with some of the bath salts I had bought at store?.no memory of that either. I went to bed ~8 and woke up at 9:30 this AM. I?m not at all looking forward to my second dose.
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| 52 | 2021-04-17 | sleep disorder |
The first nite after receiving the shot on April 15 at 10:36 am I had fever, chills and a headache....
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The first nite after receiving the shot on April 15 at 10:36 am I had fever, chills and a headache. Couldn?t sleep all night that night. Had one Tylenol that same night. Didn?t help. The second night I went to sleep and took two 82 mg aspirins for the lingering headache.- it worked slept well. Two days after the vaccine at around 2:30 pm I experienced vertigo- especially laying my head down made the sensation of spinning . I went to sleep to take a nap and try and sleep it off. One hour later I woke up and still had vertigo and also tinnitus- a ringing in my ear. The vertigo has gotten better - still feel it on the third day and still have the ringing in my ear which made sleeping quite difficult on the 3rd night.
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| 52 | 2021-04-18 | loss of personal independence in daily activities |
On day 16 after my first Pfizer shot, I had the first episode of vertigo in my life where I could no...
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On day 16 after my first Pfizer shot, I had the first episode of vertigo in my life where I could not stand or move unassisted and felt like vomiting. This lasted about two hours. After that, I had severe dizziness which developed into a bad headache. These symptoms have not abated since they began. I have a close friend who had the exact same reaction which lasted two weeks. There are numerous medical website boards in addition to Facebook groups where many people are reporting the same experiences. I have chosen to cancel my 2nd shot because I am unable to function in my normal life and am waiting for these symptoms to end. Please list vertigo as a possible common symptom, so others will know that it is a possibility instead of forcing us to search the internet for answers.
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| 52 | 2021-04-18 | sleep disorder |
Pain in left arm slowly began after the vaccine, even though the vaccine was given in the right arm....
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Pain in left arm slowly began after the vaccine, even though the vaccine was given in the right arm. I am right handed. The pain increased to the point of not being able to lift a glass of water with my left hand, use my arm, and the pain awakened me in the middle of the night. It hurt while in a resting position. I have not done anything to strain it following the vaccination. I am sheltering at home, and have lifted nothing heavy, and use my right arm to carry groceries. I only did some light gardening the week before the vaccine, but no heavy lifting or anything that would cause this kind of pain. I took advil, and it made no difference in the pain. Extreme fatigue for three days.
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| 52 | 2021-04-20 | sleep disorder |
I woke up at 4:00 am after tossing and turning during the night and not having a comfortable deep sl...
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I woke up at 4:00 am after tossing and turning during the night and not having a comfortable deep sleep. I took a few steps in my living room and felt I was about to faint any seconds. Since I live by myself I rushed to my door and laid down outside my apartment door on the floor and put my feet up on the wall to get more blood flow to my brain. The reason I went outside my apartment was because I felt like I could get unconscious and wanted people to find my dead body in case I died. I could not get to my phone in my kitchen to call 911. I laid there for 20 minutes and I was sweating profusely. Then tried to get up after that and I felt I was about to faint again. So I laid down there for another 20 minutes . Then I slowly crawled back to my apartment and slept on the floor for 3 hours. It was around 7:30 when I tried to get up and start the day, but as I got up I was feeling that could faint again. So I went back to sleep again until noon.
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| 52 | 2021-04-20 | sleep disorder |
4/4/2021 - 4/7/2021 - Low fever (99.9 degrees), but oddly only in evening and overnight; severe enou...
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4/4/2021 - 4/7/2021 - Low fever (99.9 degrees), but oddly only in evening and overnight; severe enough to disrupt sleep - took Tylenol 4/5/2021 - 4/14/2021 - Two canker sores appear suddenly on my bottom inside lip on the left on 4/5;extremely dry mouth; tongue is swollen and pale; feels like I have cuts on my tongue; constantly drinking water; swollen tender lymph nodes all along the left side of the neck; sores in the back left side of tongue on 4/6. Took Advil intermittently, didn't reduce swelling of either the nodes or tongue, but helped with pain. 4/5/2021 - 4/10/2021 - Fatigue, aches, and chills through these days; took nap in the afternoon on Saturday 4/10 and suddenly felt much better after 4/8/2021 - lost taste for just one day; couldn't taste sweet in the morning and then couldn't taste salty in the afternoon 4/15/2021 - 4/21/2021 - canker sores and "cuts" on tongue reducing over these days; when I look at these sores/cuts on my tongue, I can't really see any cuts or sores...just looks like little bumps or swollen taste buds 4/15/2021 - 4/18/2021 - Lymph nodes on left side of neck still swollen but no longer tender and painful 4/15/2021 - 4/19/2021 - Severe headaches that made me take two Advils every 4-6 hours. Touching hair was sensitive and coughing or sneezing really hurt. 4/19/2021 - 4/20/2021 - Number of swollen lymph nodes slowly reduced in number; not painful. 4/20/2021 - Mostly feel good. No more headaches. Tongue just had two places where it felt like it was cut. Again, can't really see anything wrong when I looked at it. 4/21/2021 - Today I was mostly good. Just only one small swollen lymph node at base of neck on left side (not painful); one "cut" on the tip of my tongue on the left (little painful).
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| 52 | 2021-04-21 | disorientation |
As soon as fluid was injected- a wave of heat flowed thru my blood from head to toe. Then came heart...
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As soon as fluid was injected- a wave of heat flowed thru my blood from head to toe. Then came heart palpitations, shortness of breath, sweating, and feeling of faint (NO fainting occured). Feelings in head of disorientation/ disconnect. Sent to observation room to lay down. Provided with water- was able to drink it/ no tongue swelling or throat closing. Monitored by paramedic for 1 hour. Before release, oxygen was 100%/ pulse 74%.
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| 52 | 2021-04-21 | feeling abnormal |
couldnt move - open eyes headaches fuzzy brain feeling servere joint pain stomach/bathroom system i...
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couldnt move - open eyes headaches fuzzy brain feeling servere joint pain stomach/bathroom system issues throat hurt soar very very soar - no relief eyes strained
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| 52 | 2021-04-21 | impaired work ability, restlessness, sleep disorder |
Sore arm shortly after administration. Soreness continued into evening and developed headache withi...
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Sore arm shortly after administration. Soreness continued into evening and developed headache within a few hours. Sleeping was uncomfortable due to sore arm and restlessness. Next day very sore, headachy and tired. Stayed home from work and slept a lot. Headache and sore arm subsided within a 3-4 days. Next days following some minor headaches and tiredness.
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| 52 | 2021-04-21 | sleep disorder |
Started to have body aches and return of arm soreness on 4/5 (eight days after the vaccine) Left fla...
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Started to have body aches and return of arm soreness on 4/5 (eight days after the vaccine) Left flank intermittent pain, eventually traveling to the left back on 4/9 (interrupted sleep) 4/10 Continued pain, intensifying but manageable with Naproxen (assumed it was a kidney stone) Pain moved to right back and flank on 4/11, supplement NSAID with Tylenol to control the pain but pain grows severe (message PCP) 4/12 See PCP in afternoon, elevated heart rate + pain, suspects kidney stone, suggests ER for quicker CT scan, but ER is a 5+ hour wait, so I scheduled appt. with urologist for 4/13. Get CT scan for stone, lungs present with ground glass opacities like Covid. 4/14 Covid test (plus my partner is Partner is also tested. Isolate at home awaiting results. Pain is now only on the right side, experiencing shortness of breath, assume it's related to the pain. 4/15 get negative Covid results around midnight, message PCP. 4/16 PCP insists on ER, CT scan with contrast reveals pulmonary embolism, clots ib both lungs, admitted to hospital for observation, ultrasound of legs reveals no problems with the veins, etc. Start Lovenox 4/17 released that evening with Xarelto, follow up with doctor 4/22
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| 52 | 2021-04-22 | sleep disorder |
acute pain in shoulder after vaccination, getting worse over the days after vaccination. Pain in sho...
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acute pain in shoulder after vaccination, getting worse over the days after vaccination. Pain in shoulder for about 5 weeks after vaccination. Not able to lift up arm, not able to sleep on right shoulder. Having to take Ibuprofen for weeks, do exercises. Condition improved after 5 weeks. Visit to doctor's office on March 5.
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| 52 | 2021-04-24 | feeling abnormal, memory impairment |
severe sinus issues; she is still not feeling good; flu-like symptoms; head is foggy right now, cant...
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severe sinus issues; she is still not feeling good; flu-like symptoms; head is foggy right now, cant remember her doctors name; sick/ended up really ill yesterday; vomiting; forgetfulness/cant remember her doctors name; Tired; Sore throat; body aches/body aches and pains; chills without fever; severe diarrhea; nausea; She was not able to eat yesterday as well; she mentioned that she still has a bad lack of energy/stayed in bed all day; burning lungs; severe migraine due to her bad sinuses/migraine headache; severe migraine due to her bad sinuses; crusty eyes; Arm was sore where she got the shot for a few days after the Vaccine; This is a spontaneous report from a contactable consumer reported for herself. This 52-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727), via an unspecified route of administration in the upper muscle of left arm on 29Mar2021 at single dose for COVID-19 immunization. Medical history included ongoing heavy smoker smoking for at 32 years or more, not drink anymore, agoraphobia started when COVID pandemic came a year ago, pneumonia, anxiety, severe depression, bipolar, panic attacks due to trauma, on disability since her mother passed away 6 years ago. Her family was alcoholic and her dad was an alcoholic, it was just something she did. She went on a 6 year drinking binge over 10 years ago, but she has been sober for 10 years. The patient had pneumonia, anxiety, severe depression, bipolar, panic attacks For years and believed these were related to abuse from years ago. The patient also believed panic attacks was related to her mother passing and her nephew having a car accident in Oct2020. Concomitant medications included gabapentin (NEURONTIN, NDC: 16714033202) from an unspecified date and ongoing for about 32 years for anxiety; lurasidone hydrochloride (LATUDA) from at least 2 months ago and ongoing for depression; vilazodone hydrochloride (VIIBRYD) ongoing for 5 years to help her sleep and for depression and bipolar; clonazepam from an unspecified date and ongoing for anxiety and panic attack, being on it off and on for 32 years for panic attacks and anxiety; valproate semisodium (DEPAKOTE ER, NDC: 16714048502) from an unspecified date and ongoing for about 5 years for bipolar; escitalopram oxalate (LEXAPRO), benzatropine mesilate (BENZOTROPINE), benzatropine mesilate (COGENTIN); clonazepam (KLONOPIN) ongoing for anxiety and panic attack, being on and off for 32 years; a lot of Psychiatric drugs. The patient to change her antidepressant a lot because if being on it for so long it stopped working. The patient had the Pneumonia Vaccine about 1 year ago and flu vaccine about a year ago not at the same time. She reported not having any problems with that. The patient reported tetanus shot years ago and she got a sore arm. The patient had no prior vaccinations (within 4 weeks). The patient mentioned that she received her 1st dose of the Pfizer COVID19 Vaccine on 29Mar2021. She ended up really ill yesterday on 04Apr2021 at 2: 00 am, with body aches and pains, chills without fever, burning lungs, forgetfulness, vomiting, severe migraine due to her bad sinuses, migraine headache which she rarely got, crusty eyes, severe diarrhea and nausea. She was not able to eat yesterday as well on 04Apr2021. As of calling, she mentioned that she still had a bad lack of energy, probably to being sick on 04Apr2021, and a little bit nauseated but not as bad as yesterday on 04Apr2021. The burning lungs, diarrhea, and migraines were gone. She was asking if these were common to appear after this time because the paperwork from her facility stated that most side effects were to be expected with 24 hours. She also mentioned that her boyfriend got his 2nd dose of the Moderna vaccine with no reactions 3 days before she got ill and was asking if she could've gotten it from him. She was COVID-Phobic and took as many precautions as she could. She mentioned that 2 of her friends, experienced side effects on their 2nd dose. She waited the 15 minutes before she left after getting the shot, with no problem. She hoped no one else has to go through this. She was sick yesterday and today, but it was better today than yesterday. The patient was high risk due to heavy smoking, She said that on the 04Apr2021, at 02:00, she woke up with chills with no fever, body aches and pains, a migraine headache which she never got, severe sinus issues, diarrhea, nausea, and stayed in bed all day. She felt bad enough to go the doctor but did not go to the doctor, had really gone out since COVID started but, she did not go due to agoraphobia. From what she had heard from other people the 1st dose did not affect most people, it's the second. She was scared though and did not want to get sick like she did. She wanted to know if it's safe to get the second shot because she didn't want to experience this again. The patient said that she was still not feeling good. At the time of reporting, the patient still felt nauseated and had body aches and her lungs were burning on 04Apr2021 and she was not sure why. She reported these symptoms were not on the sheet she got. They gave her the sheet from the health department. She had heard of reactions within 48 hours and but, it had been week since she got the 1st shot. The patient said that she had bad chills and did not understand how you have chills without a fever. She was not sick like that ever in her life. It was the worst experience. She said that even with the flu bug she was able to function even with throwing up and all of that other stuff. She had never had problems with an immunization before. She wanted to get the second shot. She didn't know how you get a fever with no chills. Caller confirmed her symptoms were flu-like symptoms and are described as the symptoms she gave earlier in the call. She scared of suffocating to death rather than getting the next shot. The patient asked if it was an allergic reaction or a shot reaction she had, she never experienced anything like that. The patient had no problem with the flu like symptoms like the nausea, the vomiting. The only reason she asked was because she was afraid. She had been house bound for about a year and she only went to the physician and psychiatrist. She was able to go to the health department and get the shot because she did not want COVID. The patient reported her head was foggy right now, can't remember her doctors name because she was still sick. This started after getting the shot along with the flu-like stuff. She can't even remember her doctors information because of how bad she felt. She said that she can't believe that she cannot remember the name of her doctor's office, that was how bad she felt. The patient clarified that the fogginess started after she received the vaccine. She reported she had had severe panic attacks for years due to abuse. Even though she was with a good man now she still had panic attacks and the COVID did not help. She tried sleeping as much as possible last night. The flu-like symptoms started at 0200 in the morning, all her symptoms on 04Apr2021. The fogginess, body aches, diarrhea, pain were still here today, but no headache today 05Apr2021. Her chills were keeping her up yesterday, she had never had chills with no fever before. She had no chills today 05Apr2021, they were gone its 70 degrees here, it was bad. Her burning lungs were gone when she woke up this morning she didn't feel it. If it would have gotten worse she would have went to the ER, but she was able to breath. She was able to take her meds again today 05Apr2021. 1st day in years she did not smoke was yesterday on 04Apr2021. The COVID vaccine gave her a sore arm were she got the vaccine but it only lasted a few days after the shot. About an hour after she got the shot, it lasted a few days and was not bad enough for Tylenol of Motrin it was just a slight ache. She did not seek treatment for the flu-like symptoms but, would have went to ER if burning lungs got worse to where she could not breathe. The patient said that she forgot numbers because of the medications she on and also got the shakes. She was not sure which medications are causing it, but she thought she was taking Depakote, Klonopin and Neurontin could be the cause. The shaking was irreversible, she can't even write her name without shaking. The patient stated yesterday she was so sick, she ended up with like her lungs were burning, body ache, she had chills with no fever, mild sore throat, headache won't go away and she was wondering if that's normal. The patient had to get her second Covid shot 17th and she was so scared, she was sick and tired. Outcome of the events 'head is foggy right now, cant remember her doctors name', 'body aches', 'diarrhea', 'body aches/body aches and pains', 'sick/ended up really ill yesterday' was not recovered, of the event 'Arm was sore where she got the shot for a few days after the vaccine' was recovered, of the other events was unknown. No follow up attempts are needed. No further information is expected.
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| 52 | 2021-04-25 | feeling abnormal |
Within 10 minutes of vaccination, client began having a metallic taste in her mouth, then states she...
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Within 10 minutes of vaccination, client began having a metallic taste in her mouth, then states she "wasn't feeling right." Client advanced to dizziness and acute onset of fatigue to the point of almost lethargic, started to complain of pain in back, radiating to from of chest and "feeling cold" with shaking all over.
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| 52 | 2021-04-25 | memory impairment |
4 days after shot blood glucose elevated up to 400 and higher. Memories decreased.. at first thought...
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4 days after shot blood glucose elevated up to 400 and higher. Memories decreased.. at first thought maybe I forgot to give my injection. Had a friend help me with it. No, nothing ,I was doing. Had forgotten I had The vaccine until my friend told me we had it together . Then was told needed to report issues, just Incase. Increase memory loss and elevated Blood sugar. Returning on migraines .
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| 52 | 2021-04-26 | feeling abnormal |
Patient c/o chest pressure "feels like cat sitting on my chest" (per patient statement), feels worse...
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Patient c/o chest pressure "feels like cat sitting on my chest" (per patient statement), feels worse with deep breaths, left arm feels funny Per Dr request for further evaluation - Ambulance requested for 12 lead EKG - Pt vitals per EMS - @ 1000 BP 170/91 HR 77, O2 97% on RA Based on EKG Dr recommended patient be transported to Hospital for further evaluation. Pt vitals per EMS@ 1015 - BBP 140/75, HR 77, O2 96% on RA, RR 20, radial pulse strong and steady 1017 - Patient transported to Hospital
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| 52 | 2021-04-26 | excessive sleepiness |
About 20 minutes after I received the vaccine, I developed severe heartburn that lasted 8+ hours. (...
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About 20 minutes after I received the vaccine, I developed severe heartburn that lasted 8+ hours. (I didn't eat or drink anything half hour before or after being vaccinated.) I also got cankers in my mouth the same day I was vaccinated and continued to get more for about a week. (Less than 10 total cankers.) I was extremely fatigued and slept a lot for about 48 hours after, too.
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| 52 | 2021-04-26 | nervousness |
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details:...
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: pt had gotten her vaccine and started feeling light headed like she was going to pass out. we got her a fan and a drink. she said she may have had low blood sugar and was nervous about shot
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| 52 | 2021-04-27 | sleep disorder |
Starting at 1:00 a.m. and lasting for approximately 8-9 hours, I had a fever and was sweating; I cou...
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Starting at 1:00 a.m. and lasting for approximately 8-9 hours, I had a fever and was sweating; I could not sleep; my right arm was very painful; my entire body ached. It felt like a very bad flu. I took 800 mg of Advil, which helped, and felt well enough to go to work by noon. I had COVID-19 approximately 90 days before my vaccination. I have never had an adverse reaction to a vaccine in my life.
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| 52 | 2021-04-28 | impaired work ability |
pt says she developed body aches and pains, dizziness, extreme fatigue, chills. She was lightheaded...
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pt says she developed body aches and pains, dizziness, extreme fatigue, chills. She was lightheaded and the fatigue was so bad that she felt like she had been drugged. Her right arm and hand were swollen and painful. There was a large knot around the injection site. The pain and swelling in right arm affected her mobility to work. Large varicose veins appeared on her forehead. These symptoms lasted about 4 days. She is better but says she still get large veins that appear on her forehead from time to time.
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| 52 | 2021-04-28 | memory impairment, loss of personal independence in daily activities, excessive sleepiness |
Fever, nausea, blinding migraine DEBILITATING fatigue, chills with teeth chatter (5 hours), body sk...
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Fever, nausea, blinding migraine DEBILITATING fatigue, chills with teeth chatter (5 hours), body skin hot to touch, severe pain at shoulder cradle and unable to lift Or use arm, leg tremors, torniquet-tight feeling in lower leg right below knee that turned to numbness then pins nd needles, underlying headache every day since first dose, sleeping 12 hours a night although my usual is between 6-7 hours, no energy, have trouble performing most physical tasks, losing words as I'm speaking, forgetting simple I formation such as my son's fiance's name. Moat of these are ongoing
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| 52 | 2021-04-30 | confusional state, mental status changes, agitation |
She was admitted on 4/29 for altered mental status. She received her second dose of COVID vaccinatio...
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She was admitted on 4/29 for altered mental status. She received her second dose of COVID vaccination on 4/27 at 0700 and her son reported that 2h after the vaccination she started to act strange with labile mood, but mostly intermittently tearful. Later that evening after 5pm she became confused (at times not recognizing who her son was) with worsening intermittent agitation, labile moods, singing, and reporting visual hallucinations. Denied SOB, chest pain, fevers, chills, n/v/d, new medications... Per son she is A&Ox4 at baseline and no history of mental illnesses.
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| 52 | 2021-05-04 | feeling abnormal |
allergic reaction; wasn't able to lift her hands; blood pressure was very low at about 80/59; tired;...
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allergic reaction; wasn't able to lift her hands; blood pressure was very low at about 80/59; tired; light headedness; Didn't feel very comfortable; weak in the legs; She was warm or cold, hot then suddenly cold; chills; fogginess; fainting reaction 15 minutes after getting the shot; palpitations for an hour; numbness in her lower jaw/bottom jaw was half numb; weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking; weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking; inner side of her leg, calf, and thigh was feeling hot; kind of a tightness in her chest/Every next breath was getting weaker and they disappeared after an hour. She felt like someone was holding her chest, do not let her to deep breath; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 52-year-old female patient received BNT162B2, dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 08:30 (Batch/Lot Number: ER8729; Expiration Date: 31Jul2021) (at the age of 52-years-old) as single dose for COVID-19 immunisation. She reported says she was getting it because people who were vaccinated are being less cautious and putting her at risk for COVID. The vaccination facility was organized through a pharmacy was not administered in a military facility. Medical history included measles on an unknown date (she was sick only once with measles). The patient reported no family medical history but the only thing to put about her probably was that she has maybe rare in a good way immune system. She thought children infections that kids usually get, some of them are very contagious, she was sick only once with measles. She says she has never had chicken pox, she was not vaccinated for chicken pox, she was in contact with multiple people with chicken pox, has antibodies with chicken pox but she never had symptoms, she was never sick. She said she was never sick with any children's infection, she usually did not get sick at all, no flu, no cold things, never. She was not sure if it was measles or if it was rubella as she was translating from another language. There were no concomitant medications. The patient previously took lidocaine and experienced allergy with symptoms of cold sweat and palpitations. She says this allergy started a very long time ago. She said it was affecting only dental procedures and that they know about so they just don't use it on her. She says they consider it not be the lidocaine but due to the ephedrine inside of the lidocaine. She lists her symptoms as cold sweats and palpitation, no pain. She reported they thought the reaction was just too strong, she had 2 episode in 2 different offices, they don't use it on her. The patient had no prior vaccinations within four weeks. The patient declined being sick at the time of vaccination. On 08Apr2021, the patient experienced fainting reaction 15 minutes after getting the shot , palpitations for an hour, numbness in her lower jaw/bottom jaw was half numb, weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking, inner side of her leg, calf, and thigh was feeling hot; kind of a tightness in her chest/every next breath was getting weaker and they disappeared after an hour. she felt like someone was holding her chest, do not let her to deep breath, not destructions with breathing, tired, lightheadedness, didn't feel very comfortable, weak in the legs, she was warm or cold, hot then suddenly cold, chills, and fogginess. On 14Apr2021, the patient experienced blood pressure was very low at about 80/59, wasn't able to lift her hands, weak again and dizziness. The patient's second dose was supposed to be next Friday but her healthcare provider thought it was an allergic reaction (unspecified date) and advised her to not get the second dose. The patient wanted to know what would Pfizer advise. The patient did not know if it was because of COVID but thought those were the effects of any kind of vaccines. The patient clarified her jaw was only half numb. She reported the events started after 15 minutes, the jaw was later, palpitations started after she broke the pattern of her thinking, that wasn't right. She said we had the list but it was missing that it started with one symptom and was replaced by another symptom. She said the only 2 that were together was the jaw part and the palpitations. She says the jaw part was a very short period of time, she felt it and thought what was this, she did not know how long it was, maybe one minute, less than one minute. She reported her palpitations were periodical palpitations, every next breath was getting weaker and they disappeared after an hour. The patient also reported her legs part was after the palpitations were gone. She had talked to multiple nurses and she realized from telling the story 5 times that the symptoms started from up to the bottom; the reaction was from her head to her legs. She reported that she doesn't feel very comfortable, she doesn't know what will happen to her, no one knows. She says all symptoms were on the same day, she was able to move and felt comfortable to move after an hour and a half. She says she started to move after symptoms in the legs started to disappear, she was not able to take deep breath but she was able to breathe without destructions. She says she felt like someone was holding her chest, do not let her to deep breath, not destructions with breathing. She tries to explain the temperature situation, saying the feeling during this time was warm or cold, hot then suddenly cold, that there was no one explaining what happened with her. She says she she remembers noticing that suddenly she had chills. cold, she was talking to someone and she felt cold, she can't exactly say what. She says this probably lasted half a day, maybe 12 hours: She says she was very dizzy on that day, suddenly, and at night she measure her pressure to see what is going on. She says she she has been known for low blood pressure earlier in her life. She says 110/70 was her normal and she had around 80 something, 86/59, something like that, she hasn't had such a low blood pressure in 30 years, maybe since her pregnancy. She stated that she has recovered completely from everything. She says she is not sure if its coming back, she did not expect to have low blood pressure, but right now she is totally fine, a normal person. The patient confirmed her blood pressure was, she thought 86/59 on 14Apr2021. She said she took her blood pressure 2 times, a couple times, the first time was even lower on 14Apr2021. She says on the actual 08Apr2021 she took her blood pressure and it was 120 over something, a little bit higher than it usually would have been. She said she was usually running towards the lower acceptable range, 110 to 70, 110 to 75, something like at doesn't get more than 113. The events did not require a visit to emergency room nor a visit to physician's office. The patient wanted to know if these side effects were known to Pfizer and what happens to those side effects. She asked do they have information on if they increase with the second vaccine. The outcome of the events fainting reaction 15 minutes after getting the shot, palpitations for an hour, numbness in her lower jaw/bottom jaw was half numb, weakness on her bottom lip which was difficult to move, causing her to have difficulty in talking, inner side of her leg, calf, and thigh was feeling hot; kind of a tightness in her chest/every next breath was getting weaker and they disappeared after an hour. she felt like someone was holding her chest, do not let her to deep breath, not destructions with breathing, tired, lightheadedness, didn't feel very comfortable, weak in the legs, she was warm or cold, hot then suddenly cold, chills, and fogginess was recovered on 08Apr2021; outcome of events weak again, dizziness, wasn't able to lift her hands, blood pressure was low was recovered on 14Apr2021; while outcome of allergic reaction was unknown.
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| 52 | 2021-05-19 | insomnia, impaired work ability, excessive sleepiness |
Swollen glands in neck and loss of voice, weak, lightheaded, vomiting, chills, body aches, extreme t...
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Swollen glands in neck and loss of voice, weak, lightheaded, vomiting, chills, body aches, extreme thirst, constant sleep, heart rate high within 48 hours. At 48 hours, severe breathing issues and small sores on upper arms and chest. Now on day 5, shortness of breath continues, spells of sweating, no sleep for 2 days, and a fluid filled Knoton lower front neck. Had to miss a day and a half of work so far this week
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| 52 | 2021-05-20 | sensation of foreign body |
Approximately 20 minutes after injection, I experienced tingling sensation of tongue with mild swell...
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Approximately 20 minutes after injection, I experienced tingling sensation of tongue with mild swelling, pharyngeal pruritis, increased mucus production causing coughing, nasal congestion, and constant throat clearing, globular sensation when swallowing, voice became hoarse. I reported to nurse monitoring patients post injection. Was asked regarding symptoms and told to take medications that I had brought with me. Medications were Pepcid 20 mg, Benadryl 50 mg, Prednisone 10 mg. I was monitored for another 90 minutes. Symptoms began to resolve approximately 30 minutes after taking medications. Full resolution of symptoms occurred approximately 8 hours after taking medications. Followed nurse's instructions and immediately notified PCPs office upon returning home. PCP recommends to not receive 2nd Pfizer vaccine.
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| 52 | 2021-05-23 | sensation of foreign body |
I developed a tightness in my throat that is still present today (May 24, 2021) The same arm that I ...
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I developed a tightness in my throat that is still present today (May 24, 2021) The same arm that I received the vaccine in has now developed a soreness all the way down to the elbow. This developed on May 23, 2021- 2 weeks after the vaccine. There has been no know injury to this arm other than receiving the shot which caused extreme soreness for two day afterwards. I also had severe chills and body aches for 24 hours afterwards. The most concerning is the lump in my throat and when I swallow now for going into the 3rd week, I have had this ailment. I'm very concerned.
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| 52 | 2021-05-25 | feeling abnormal |
April 5th 10-15 minutes after dose: tight throat and chest, congested, feeling out of it within 10-...
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April 5th 10-15 minutes after dose: tight throat and chest, congested, feeling out of it within 10-15 minutes after dose Later that day: tachycardia, burning sensation throughout body, tingling in nasal passage, arms and legs, lower back pain, lightheaded, joint pain, chills April 6th additional symptoms to above and ongoing at various degrees: migrating shock sensation, cold extremities, swollen lymph nodes, shaking, ear ringing, fatigue, muscle cramping and stiffness, unsteady while sitting and standing, back weakness, periodic cough, nausea
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| 52 | 2021-05-26 | anxiety, sleep disorder, impaired work ability |
On 04/15/2021 at 6:15pm, experienced severe joint pain, sharp headache, and felt pain/pressure in th...
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On 04/15/2021 at 6:15pm, experienced severe joint pain, sharp headache, and felt pain/pressure in throat area - it was difficult to swallow. No fever. Symptoms not present next morning but returned around 4:30pm on 04/16/2021 and continued on a nightly basis for over a week. On 04/30/2021 joint pain disruptive to sleep, work, regular activities, and also developed extreme night sweats, fatigue, severe anxiety, tremors, unintentional weight loss, and throat pain was increasing. Saw Dr. on 04/30/2021 and labs were ordered. Anxiety continued to increase, getting a deep breath almost impossible, and I could not work so went back to Dr.
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| 52 | 2021-05-27 | feeling abnormal |
Immediate dizzyness followed by headache. Next day slight fever, fatigue, flare up of arthritis, sw...
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Immediate dizzyness followed by headache. Next day slight fever, fatigue, flare up of arthritis, swelling in ankles and by 3rd or 4th day, diarreha. 2nd dose had consult with on site doctor about my lingering symptoms. Doctor asked me a few questions. I already had Covid-19 back in January 14th, 2021. Doctor determined i should be fine. It got worse. I honestly felt like i had Covid-19 all over again, only worse beccause I was vomiting the next morninng. I had all the same exact symptoms that I had originally in January, only worse, besides vometing, arthritis flare up, feel like I have carpal tunnel syndrom, couldn't do anything with my right hand for 2 days, and the swelling of ankles/feet and hands. Do not let me forget about the fatigue and shortness of breath. I feel like i have been hit by a truck. I even had the fever for 1 day. It was only around 99, however, I naturally run at 97.7, so 99 is high for me. Personally, I feel like I received the vaccine too soon after actually having Covid-19. I am just praying that this arthritis and carpal tunnel symptoms go away. Oh and the random shooting pains all through out my body. I am still having that as well and it has been 8 days since my 2nd dose.
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| 52 | 2021-05-27 | loss of personal independence in daily activities, disturbance in attention |
couldn't even function; I have been having really bad breathing problem; Loss of appetite; I just go...
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couldn't even function; I have been having really bad breathing problem; Loss of appetite; I just got bruised; double vision; couldn't stand; couldn't even focus; her eyes could not focus; could not see to drive, all of sudden my vision was gone away; diarrhea; blurred vision; vertigo; continuous dizziness; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 26Apr2021 (at the age of 52 years-old) (Batch/Lot Number: EW0169; Expiration Date: Aug2021) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included syncope Unspecified syncope, migraine Chronic Migraines, concussion history of severe chronic migraines and unspecified syncope due to have a concussion 3 times. The patient received first dose BNT162B2 for COVID-19 immunization on 06Apr2021 at the age of 52 years old. Caller said that since the second dose she has diarrhea that is coming and going, but she has been having it for 2 weeks and is treating it with Imodium AD. She has been having blurred vision, vertigo, and dizziness continuously. She has never had this before. She said that within an hour of getting the second dose, she was taking her dog for a walk and only made it a block before she had to come home because she thought she was going to fall. She states on Mothers Day she felt like she could not get her bearings and states it was "very, very scary." She said that she cant even walk down her staircase or drive her vehicle. Consumer further stated, I have been having a loss of appetite too not feverish or anything and you know I had the shot, I had no reaction there. I just got bruised and I had no hurt or anything. I have been having symptoms. I had several symptoms from Pfizer but the second vaccine I had been having sever symptoms, they haven't gone away. I was vaccinated for second vaccination on second dose was on 26Apr2021. I am pulling it on my screen here because I have a V-safe. I have been having really bad breathing problem. I have brain situation that my neurology check. I have underlying medical conditions. My pulmonologist asked me to get the Pfizer so that's what I did. I had the first dose 06Apr2021, I had the second dose 26Apr2021. Now basically just the second dose, I started having visions problem really bad and dizziness, it's kind of little vertigo. I had severe diarrhea for at least I guess I am still having it little bit. So it was really severe for about a week or so. But I have it, I am having it still couple of days, 3 weeks still, 3 and a half days and week. The vision on modern days I had like double vision and dizziness and I got vertigo, the whole day. So my brother left with my granddaughter. I had to hold on to the banished couldn't stand. I couldn't even focus. I have unspecified think to the give more and I have a severe chronic migraine (Intent: History) since I am 4 years old but I have never had this happened to me until after I took the Pfizer second vaccine. The day that I took the Pfizer second vaccine, I went with my dog outside I only was able to walk a block and a half and then I had to walk back home because I felt dizzy. Now this is about an hour after I took the second vaccine. Also the next day I drove my car to the park, this is about maybe 10 minutes away and I was getting home run around the park and about an hour after that I had going to car and and surrounded and could not even get my barring's. She states the next day she took her dog to the dog park and experienced the same thing so she had to lay down in her car and states she "couldn't even function." She states that when she was driving later, she states her eyes could not focus and she could not see to drive. As she was driving home, all of sudden my vision was gone away, from what happen was is I had to call my son. Then I started to cry because I couldn't able to see. Now this has been continuing since the vaccine. Therapeutic measures were taken as a result of diarrhea. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 52 | 2021-05-28 | feeling abnormal |
headache; fatigue; weakness; joint pain; pain and redness at injection site; pain and redness at inj...
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headache; fatigue; weakness; joint pain; pain and redness at injection site; pain and redness at injection site; fever; fogginess; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6198 and Expiry date were not reported) dose 1, via unspecified route of administration, administered in left arm on 03Mar2021 at 17.30, single for COVID-19 immunization. The patient's medical history included a Covid-19, ankylosing spondylitis, hashimoto's thyroiditis, seasonal allergies, dander allergies, indoor allergies, chronic sinusitis, asthma. The patient had allergies with medication prochlorperazine, food chocolate. The patient did not receive any treatment. The patient was not Covid tested post vaccination.The patient took unknown concomitant medications in two weeks. On 03Mar2021 at 07:00 PM(1.30 mins after vaccination), the patient experienced a headache, fatigue, weakness, joint pain, pain and redness at injection site, fever, fogginess. The outcome of events were not recovered. No follow-up attempts are possible. No further information is expected
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| 52 | 2021-05-28 | impaired work ability |
Instantly hurt and never stopped hurting at the injection site. My entire shoulder, joint and next a...
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Instantly hurt and never stopped hurting at the injection site. My entire shoulder, joint and next are in extreme pain where I can not do my job properly without over the counter pain medication.
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| 52 | 2021-05-30 | delirium | I had trouble breathing, slight delirium and dizziness but was fine after 30 minutes... |
| 52 | 2021-05-31 | insomnia |
fever around 100; chills; fatigue; headache; profound body aches; Insomnia; Nausea; This is a sponta...
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fever around 100; chills; fatigue; headache; profound body aches; Insomnia; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6203) via an unspecified route in the left arm on 10Mar2021 at 13:00 pm as a single dose for COVID-19 immunisation. The patient medical history included migraine disease and slight hypertension since an unknown date. No allergies to medications food, or other products were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within 2 weeks of vaccination included estradiol patch, liraglutide (SAXENDA), verapamil and colecalciferol (VITAMIN D). On day 6, patient experienced fatigue, chills, profound body aches, fever (around 100), insomnia, nausea, headache on 11Mar2021 at 12:45 am. The adverse reactions treatment done with rest, fluids, paracetamol (TYLENOL) and diazepam. The clinical outcome of the events was not recovered. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No follow-up attempts are needed. No further information is expected.
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| 52 | 2021-05-31 | sensation of foreign body |
30minutes after injection having a sensation in back of throat--lump--no difficulty talking, swallow...
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30minutes after injection having a sensation in back of throat--lump--no difficulty talking, swallowing, breathing no itchiness vitals stable 97%, HR84 gave oral benadryl, patient refused. observed in car for 45 minutes
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| 52 | 2021-06-01 | depression, insomnia |
had a flu.; vertigo; severe pain.; depression; mental health; Severe pain in my right ear and sudden...
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had a flu.; vertigo; severe pain.; depression; mental health; Severe pain in my right ear and sudden loss of hearing in my right ear; Severe pain in my right ear and sudden loss of hearing in my right ear; her ear started ringing; she started to lose sleep.; This is a spontaneous report from a contactable consumer reported for self. This 52-year-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02May2021 at the age of 52-year-old (Lot number: EW0172) arm left as 2nd dose, single for covid-19 immunisation. Medical history included COPD, asthmatic when was a child. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Apr2021 at the age of 52-year-old (LOT#: EW0158) for covid-19 immunisation. After her 1st dose, she said she had a robust reaction. After the 2nd dose, she said she felt like she had a flu. Then on Tuesday night, 2 days after the 2nd dose (04May2021), her ear started ringing, and her right ear was in pain. She said that her ear was ringing so loudly that she started to lose sleep. She said she had a sudden loss of hearing in right ear that has caused her emotional damage. She was sudden loss of hearing in right ear, along with ringing and severe pain for 13 days now. She said that her ear has become so sensitive ever since she received the vaccine. She also mentioned that she was given Prednisone to treat the symptoms. She also said that her ENT told her that tinnitus can be caused by a previous traumatic injury to the ear and head injury. She said she had neither, so she is sure that this is really from the vaccine. She also said she had vertigo and was in severe pain. She said her daughter saw something on social media about vaccinated people being able to stick magnets to their arms, so she tried it as well. She said she can now also stick a magnet to her left arm from where she received the vaccine, and she wants to know why this is happening. She said she has searched about these symptoms, and said that it was all over google. She stated, "On 04May2021 in the evening, ears started ringing very loudly. started getting a severe pain in right ear and lost hearing on right ear." She went to doctor. She was referred to an ENT. Got a hearing test. The doctor told that what he was seeing is going on with right ear is usually seen, when a person has fluid their ears which the patient did not or if they have a traumatic ear injury which the patient also didn't have and he has given Prednisone (treatment) today, need to go back to another hearing test. Dose of Prednisone, consumer stated, "He got me 60 mg for 3 days. Step down the doses and then for 4 days I have to take 1 pill, then for 3 days I have to take 2 and then step down to half." She added, "Because she was truly deaf, it is kind of a 'depression' because it did kind of ruined part of it, you know quality of my life. She was probably in need of hearing aids, It is very upsetting. She experienced mental health on 18May2021. Lab data included Weight 88.45 kg. Outcome of the events was unknown.
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| 52 | 2021-06-01 | feeling abnormal |
The patient was diagnosed with acute hepatitis B approximately five weeks after the vaccination. She...
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The patient was diagnosed with acute hepatitis B approximately five weeks after the vaccination. She started feeling poorly - achiness, lassitude, etc - approximately 2 weeks after the vaccine.
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| 52 | 2021-06-03 | agitation |
lost a lot of weight; agitated; unable to control her blood sugar with insulin/fore I went to bed it...
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lost a lot of weight; agitated; unable to control her blood sugar with insulin/fore I went to bed it was 168. Now I'm waking up with 390-490; headache; dizzy; pressure went up; trouble speaking; cannot walk fast; had tests and I was 5.9, now almost 15 (did not specify which test, but probably referring to HbA1c); trouble breathing/shortness of breath; feels like something is on her chest like her heart is going to stop; feels like something is on her chest like her heart is going to stop; This is a spontaneous report from a contactable consumer (the patient). A 52-year-old female patient, dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included open heart surgery in 2010 and since then I have taken care of myself and I have had no problems anymore, heart problems the doctor said I have cardiac rheumatism from an unknown date and unknown if ongoing, covid-19 from 24Apr2020 to an unknown date she had Covid on 24Apr2020 and she spent 15 days in the hospital and was left at home with oxygen for one month. She came back negative. When she had Covid was 209 and she has lost 30 pounds. Clarified that she lost weight before the vaccine and she lost weight and was at 186. Historical vaccine included received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Apr2021 09:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE and her blood sugar spiked/blood sugar went up. The patient's concomitant medications were not reported. The patient experienced trouble breathing/shortness of breath and feels like something is on her chest, like pain but not exactly, like her heart is going to stop in Apr2021, unable to control her blood sugar with insulin/fore I went to bed it was 168. now I'm waking up with 390-490 on 03May2021, headache in Apr2021, dizzy in Apr2021, pressure went up in Apr2021, trouble speaking in Apr2021, cannot walk fast in Apr2021 and had tests and I was 5.9, now almost 15 (did not specify which test, but probably referring to hba1c) in Apr2021. Her levels are 490-500. She is on a really strict diet and has lost a lot of weight. Stated that she woke up today at 490 and ate one boiled egg and one tea and one simple cookie and two hours later was up to 514. Stated that it is still increasing and at this pace she will get at diabetic coma. Stated she gets her insulin through a pump and it is not helping her or lowering it. Stated that she woke up on 06May with it at 239 and kept it like that until she ate lunch and it increased to 320. Stated that they changed her insulin and she is taking two insulins. Stated that she took Humalog and Basaglar last night. Stated that she got dizzy with the second shot and her pressure went up. After the second dose my blood sugar also increased, but now insulin didn't help me. Usually I have half a bottle of insulin left, but now I finished 4 bottles and I don't have any more. In Mar2021 I had a glucose test and I was fine. On 24Apr2021 I received the second dose, on the 23May2021 I woke up with my glucose on 111, before I went to bed it was 168. Now I'm waking up with 390-490, even though I don't eat all day and it stays high. Last year I had Covid and now I feel agitated like when I had Covid, but I took a test and it came back negative. The patient underwent lab tests and procedures which included blood glucose: 390-490 on Apr2021 I'm waking up with 390-490, even though I don't eat all day and it stays high, blood glucose: 111 on 23Apr2021 on the 23rd I woke up with my glucose on 111 , blood glucose: 168 on 23Apr2021 before I went to bed it was 168 , glucose tolerance test: fine in Mar2021 March I had a glucose test and I was fine, glycosylated haemoglobin: 15 in Apr2021 I had tests and I was 5.9, now almost 15, sars-cov-2 test: negative, sars-cov-2 test: positive in 2020. The event blood sugar spiked was reported as worsened. The outcome of breathing/shortness of breath and feels like something is on her chest like her heart is going to stop, headache, dizzy, pressure went up, trouble speaking, cannot walk fast and tests and I was 5.9, now almost 15 (did not specify which test, but probably referring to hba1c), weight loss and agitated was unknown and not recovered for unable to control her blood sugar. Information about Lot/Batch number has been requested.
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| 52 | 2021-06-06 | disturbance in attention |
Dizziness started several days following first dose. It has been 2 months and the dizziness continue...
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Dizziness started several days following first dose. It has been 2 months and the dizziness continues daily. I did not have this condition prior to the vaccine. This effect impacts concentration and reading. The dizziness is worse while laying down, but continues throughout the day. I am concerned this may be permanent.
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| 52 | 2021-06-07 | confusional state, disorientation, impaired work ability, loss of personal independence in daily activities |
An hour after the vaccine I was driving home and experienced flashing lights in my eyes and then con...
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An hour after the vaccine I was driving home and experienced flashing lights in my eyes and then confusion and dizziness. It got worse as the day progressed and I became extremely nauseous and disoriented. I was unable to drive or think straight or work for almost three weeks. The dizziness subsided after a week, but confusion and disorientation (couldn't speak clearly/find words in my head) for weeks after that. I saw my doctor 4 days after vaccination and she did full physical and sent me for MRI and opthamologist to rule out stroke or other eye-related problem. All came back negative. I had a pretty severe case of West Nile Virus in summer of 2005 with the same neurological conditions...not sure if it is at all related.
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| 52 | 2021-06-07 | impaired work ability |
Approximately 22-24 hours after receiving the shot I developed upper abdominal pain and exhaustion....
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Approximately 22-24 hours after receiving the shot I developed upper abdominal pain and exhaustion. The pain continued to get worse over the next several days. I then developed chest pain and ended up in the emergency room. It has now been 2 weeks since the day I got the vaccine and I am still not better. The doctor thinks the chest pain was my esophagus having a spasm. I have had an EKG, an ultrasound, extensive blood work, a rectal exam, a blow test and 2 exams and I still do not have a definitive answer as to what is wrong with me. I missed several days of work. I also have Vertigo since getting the vaccine, although this is something I?ve experienced before. I also had an increase in heart palpitations and on Sunday I developed palpitations that I could not get to stop for quite some time, and then my face started to go numb as well as my feet and arms. This lasted about 5 minutes. It was very scary and I do not know what was going on with that. As of today I am mainly just dealing with the upper abdominal pain. I am taking a prescription medication that I started yesterday for acid relief but so far it?s not helping. I will not be getting the second dose. I was healthy with no issues before the vaccine. I am confident this is a result of how my body reacted to the vaccine.
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| 52 | 2021-06-08 | loss of personal independence in daily activities |
I need to go back to my records because this was so long ago. Bare with me, I kept track of all of m...
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I need to go back to my records because this was so long ago. Bare with me, I kept track of all of my symptoms. It started out with fever and chills at the same time just hours after the vaccine. The fever wasn't a major part at the time, the chills and diarrhea and throwing up all at the same time. Everyone kept saying it would subside within a few days but it didn't. For almost ten days I was bed ridden. Head pounding and everything like that for ten days I was bed ridden. Everyone I know just kept saying, "yea yea that is normal". The major, major symptoms were chills but running a fever at the same time. Every muscle, even ones I did not know I had, Hurt like I had been run over. Like I had said I was throwing up and also diarrhea. I even had to call my husband away from work. He had to stay home and take care of me. And I am still not back to normal. And since that first shot I still am not back to normal, I do not have a full appetite. I was supposed to get my 2nd shot on Friday at 21 days. But I missed the appointment, and I am not sure if I should even get it but my DR says to go ahead. I saw my DR and she knew what was going on during this time.
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| 53 | 2021-01-03 | anxiety |
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness,...
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Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
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| 53 | 2021-01-03 | feeling abnormal |
At pre-vaccine screening patient reported no contra-indications so had the vaccine. Roughly 45 minut...
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At pre-vaccine screening patient reported no contra-indications so had the vaccine. Roughly 45 minutes later patient reported shortness of breath, not feeling good and not being able to hear properly. Blood pressure was taken immediately at 1.38pm - 189/96mmHg and pulse -88bpm, and again at 1.43pm -180/90mmHg. Emergency services were contacted and came immediately within 3-5mins. After assessing patient they took her to hospital.
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| 53 | 2021-01-04 | agitation, feeling abnormal |
heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrena...
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heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrenaline rush; Nasal congestion started after 30 min; within 3 min after injection, became flushed; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 19Dec2020 07:30 AM at left arm, at single dose for covid-19 immunization. Medical history included Type 1 diabetes, hx of anaphylaxis to allergy shots and allergies to Latex, avocados, fluorescein dye (anaphylaxis), cats/dogs, environmental. Concomitant medication included ascorbic acid (VIT C), ergocalciferol (VIT D), fexofenadine hydrochloride (ALLEGRA), insulin lispro (HUMALOG), tocopherol (VIT E). The patient was not pregnant at the time of vaccination. Within 3 min after injection, the patient became flushed from 19Dec2020 07:33 AM; heart began racing, dizziness, lightheaded, felt foggy, became winded/short of breath and felt an adrenaline rush, was observed by med personnel x 30min from 19Dec2020 08:00 AM. Nasal congestion started after 30 min on 19Dec2020 08:00 AM. No treatment was received for all events. These events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 53 | 2021-01-04 | anxiety |
Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Withi...
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Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Within 5 minutes of receiving it, serial blood pressure readings began rising, her arm felt heavy, and she developed an uncontrollable tremor primarily in her left arm with what appears to be generalized shivering. Associated with significant anxiety. She has never had an allergic reaction before. No associated shortness of breath or wheezing. No lip tongue or throat swelling. No pruritus or hives. No nausea or vomiting. She was treated for possible dystonic reaction initially with two doses of Benadryl 25mg IV, then 1mg of IV lorazepam, and finally 125mg solumedrol. Symptoms improved significantly with Benadryl, and then resolved entirely after lorazepam. She was discharged home to complete 4 more days of 50mg prednisone.
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| 53 | 2021-01-04 | anxiety |
Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her l...
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Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her left trapezius, and headache. She experienced a warm sensation travelling down her left arm. She described a feeling of muscle spasms in her left upper and lower extremity and was unable to bear weight on her left lower extremity due to the altered sensation. She endorsed acute nausea and vomiting. She was transferred from vaccine clinic to emergency department at 1420. Patient received diphenydramine 12.5mg IV @ 1722, prochlorperazine 10mg IV @1733, Lactated Ringers 250mL IV bolus @ 1733, ondansetron ODT 4mg @1445. Patient was diagnosed with an acute anxiety attack in the setting of a novel vaccine administration. She was discharged at 1854.
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| 53 | 2021-01-04 | impaired work ability |
The next day 12/18 felt weak, fatigue and had to rest in between my activities. I exp headaches for ...
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The next day 12/18 felt weak, fatigue and had to rest in between my activities. I exp headaches for 2 days and on 12/20 feeling 100 ft walk was tired. Then on 12/21 started my exp body ache lasted 2 days. I spoke with my PCP and had a appt on 12/28. On 12/31 it felt as of my symptoms was subsiding. I started feeling better on 1/2/21. I missed 6 days of work.
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| 53 | 2021-01-05 | sleep disorder, impaired work ability |
Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and w...
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Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events "tested positive for COVID after receiving the vaccine" was not recovered. Information on lot/batch number has been requested.
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| 53 | 2021-01-07 | feeling abnormal |
After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Pat...
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After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Patient denied dyspnea, nausea, DM/hypoglycemia issues, known heart issues, swelling/itchiness, adverse event with first vaccine, and no adverse event to previous other vaccines. Patient had eaten lunch, but just come off of a shift and thought she might be dehydrated. Water was provided to the patient. Patient stated that she had intermittent lightheadedness/dizziness. Patient denied performance of vasovagal maneuver. Patient also experienced tachycardia and was clammy. Cool pack was provided to patient. Clinical course below: 1530 145/81, 105, 97%, 15 1535 119/81, 88, 96% 1540 126/75, 87, 96% 1542 pt felt another wave of lightheadedness, HR 103 1546 126/79, 90, 96% 1551 128/80, 91, 96% 1555 140/60, 79, 96% 1559 110/84, 87, 97% 1600 pt reports new scratchy throat 1602 25 mg Benadryl administered by RN 1603 discussed with Pharm D 1605 131/77 91, 97% 1611 145/79, 95, 98% Pt finished 12 oz of water and 4 oz of juice 1615 pt reports throat feeling better 1615 118/62, 69, 96% 1630 109/95, 99, 97% Pt stuck out tongue, no evidence of edema 1621 127/72, 84, 97% At 1642, patient was discharged to family's care and taken home.
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| 53 | 2021-01-07 | feeling abnormal | Headache, Arthralgia, foggy feeling, back ache Narrative: |
| 53 | 2021-01-07 | impaired work ability |
Symptoms - ? EE woke up this am with body aches, chills, headache (endorses hx of migraine), and fev...
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Symptoms - ? EE woke up this am with body aches, chills, headache (endorses hx of migraine), and fever (Tmax 101.8). Last day of work and shift - ? supposed to work tonight but called off due to feeling ill Home remedies? - Tylenol at 0740 and sleep Any improvement? ? mild improvement Recommendation? EE educated to continue to monitor symptoms and call vaccine support with further concerns or questions. EE educated of changes in RedCap Survey and educated will need to be fever free for 24 hours before returning to work. EE reports she called off of work tonight as she is not feeling well. EE educated to continue to manage her symptoms and to follow the guidelines outlined in the TCH Illness in the Workplace Policy. EE denied COVID-19 exposure without proper PPE and denied travel. EE verbalized back understanding and denied further questions at this time.
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| 53 | 2021-01-07 | restlessness, excessive sleepiness |
1/6/21: Received vaccine without any immediate reaction around 12:20pm. Took ibuprofen 400mg with di...
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1/6/21: Received vaccine without any immediate reaction around 12:20pm. Took ibuprofen 400mg with dinner that evening anticipating some body aches (which i had for 24h after dose 1). 1/7/21: Woke in the early AM with severe arthralgia, myalgia, restlessness, mild R arm swelling. Ate a small snack and took ibuprofen. All day 1/7/21: fatigue, myalgia, arthralgia (all of my large and small joints, my long bones, my intercostals, my large muscles stiff/ ached), and increasingly swollen R axillary lymph node(s) about the size of a large egg, extending into my upper chest. Food aversion at breakfast - could not tolerate eating more than a few bites. Slept almost all day except to re-dose ibuprofen and take a warm shower. Tolerating bland diet by evening. Tmax 99.3F forehead As of now 10:30am 1/8/21, myalgias are improving. Fatigue continues but is less. R axillary and chest lymph nodes are painful and swollen, up into my lower neck. Continuing to take ibuprofen with some food 3x per day
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| 53 | 2021-01-08 | anxiety |
Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer note...
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Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer noted to be frequently rubbing her eyes, initially denies feeling any symptoms. Symptoms of itching eyes persistent followed by customer clearing throat repeatedly. Continues to deny symptoms related to vaccine. States that she has anxiety. Customer noted to be hypotensive at 1226 98/68. Refuses epinepherine, transport to ED for monitoring. Customer accepts Benadryl 50mg PO @ 1227. O2 sat ~94-95%, pulse 79-84. Customer monitored at site, escort and significant other, at chairside. Customer persistent with her request to leave throughout observation, states she is fine. Customer and escort counseled to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer and escort in agreement with plan. Customer does not have resolution with dry throat symptoms but does not wish to remain in observation any longer. Vitals at 1307 consistent with baseline as documented previously in chart. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer denies questions/concerns. Escort verbalizes understanding of instruction and agrees to remain with customer for the next 24 hours. Customer released from site at 1315, ambulating independently with steady gait, no obvious s/sx of distress
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| 53 | 2021-01-08 | impaired work ability |
Muscle pain, joint pain, fever, chills, shortness of breath, headache, fatigue, starting the morning...
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Muscle pain, joint pain, fever, chills, shortness of breath, headache, fatigue, starting the morning after the vaccination that was provided around 4:30 in the afternoon, used Tylenol for the pain and fever. Better the next day but still not well. Missed work
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| 53 | 2021-01-08 | insomnia |
Swelling on my neck shoulder axillary and chest on same side as injection site along with swelling a...
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Swelling on my neck shoulder axillary and chest on same side as injection site along with swelling and pain at the injection site And under my arm. I have also had insomnia.
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| 53 | 2021-01-10 | insomnia |
90 minutes after the second vaccination in the COVID series, pfizer version, she developed right arm...
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90 minutes after the second vaccination in the COVID series, pfizer version, she developed right arm weakness. she could not lift her arm above her head. she then developed severe dull, aching pain. the pain became sharp with movement. she could not sleep because of the pain. no redness or edema at the injection site. she is slowly regaining strength and range of motion in the arm, however the pain still remains and full strength has not returned.
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| 53 | 2021-01-11 | feeling abnormal |
Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 wa...
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Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 was extremely tired. When getting out of bed in AM blacked out and fell to the floor. Was able to get up but head was cloudy all day long. She felt very sore and head hurt all day. The next am had headache.
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| 53 | 2021-01-11 | insomnia |
nausea; Headache; insomnia; This is a spontaneous report from a contactable healthcare professional....
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nausea; Headache; insomnia; This is a spontaneous report from a contactable healthcare professional. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 30Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. There were no allergies to medications, food, or other products. Concomitant medications included vitamin b complex (VITAMIN B), colecalciferol (VITAMIN D [COLECALCIFEROL]), and zinc. On 31Dec2020, the patient experienced nausea, headache and insomnia. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovering Information about batch/lot number has been requested.
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| 53 | 2021-01-12 | anxiety |
@0940 patient c/o anxiety, felt like she was having a rapid pulse, v/s 137/91 (her normal is 120s), ...
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@0940 patient c/o anxiety, felt like she was having a rapid pulse, v/s 137/91 (her normal is 120s), 95-96% RA, rr 22, hr 84, temp of 97.2, Reports feeling dizzy and light headed. Patient has a history of allergies, swelling. @1004 repeat vitals 123/81y, 98% RA, hr 77, RR 21, denies pain, remains anxious and light headed. About 15 minutes later, she reports feeling better, less anxious, no more light headedness.
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| 53 | 2021-01-12 | feeling abnormal |
12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND ...
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12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND DIZZY, THROBBING HEADACHE. CRAMPING/ACHING IN BACK OF CALVES. 12/24/2020 CONTINUED WITH DIZZINESS, THROBBING HEADACHE, BLOOD PRESSURE ELEVATED, CHEST PRESSURE 8:00 PM REPORTED FEELING THAT SHE WAS GOING TO DIE, WENT TO LAKE CITY MEDICAL CENTER- BLOOD PRESSURE ON ARRIVAL 184/101 HR. 117. GIVEN NITRO AND MEDICATIONS. ADMITTED, DISCHARGED 48 HOURS LATER ON 12/26/2020. DISCHARGED ON BLOOD PRESSURE MEDICATION 12/27/2020-LESS THAN 24 HOURS AFTER BEING DISCHARGED SHE WAS READMITTED TO MEDICAL CENTER WITH SAME SYMPTOMS. 36 HOURS AFTER ADMISSION, TRANSFERRED TO MEDICAL CENTER. FOR CARDIC WORKUP AND HIGHER LEVEL OF CARE.
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| 53 | 2021-01-12 | impaired work ability | muscle pain, severe joint pain. called in sick to work. |
| 53 | 2021-01-12 | impaired work ability |
After patient received Covid 19 second dose experienced fever for 4 days, severe joint pain, nausea,...
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After patient received Covid 19 second dose experienced fever for 4 days, severe joint pain, nausea, significant abdominal pain and abdominal cramping with nausea for 3 days, headache, body aches, fatigue. Unable to work . Injection site pain was minimal lasting 1 day.
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| 53 | 2021-01-13 | impaired work ability | dizzy, nauseous, tired that lasted 24 hours- missed a day of work |
| 53 | 2021-01-14 | insomnia |
Chills; body ache; headache; insomnia; This is a spontaneous report from a contactable healthcare pr...
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Chills; body ache; headache; insomnia; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on the right arm on 07Jan2021 16:00 at a single dose for COVID-19 immunization. Medical history included depression. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA). The patient experienced chills, body ache, headache, insomnia on 08Jan2021 02:00. Outcome of the events was not recovered. No treatment was given for the adverse events. The reporter assessed the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information of lot/batch number has been requested.
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| 53 | 2021-01-16 | feeling abnormal, impaired work ability |
Hair and clothes wet with diaphoresis the night of injection, woke up with nausea, vomiting. Tempera...
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Hair and clothes wet with diaphoresis the night of injection, woke up with nausea, vomiting. Temperature ranged 99.5-101.3, l check my temp daily. Sweating, chills, headache, body aches and fatigue. The symptoms began to decline approximately 24H after vaccine but headache, mild nausea and extreme fatigue continued. I felt so bad that I missed 2 days of work and got a COVID test to be safe, as I am a nurse, results were negative and employer was made aware of reaction.
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| 53 | 2021-01-16 | feeling abnormal |
Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the...
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Within 15 mins of the inj. started feel fuzzy, under conscious sedation, warm sensation going up the right arm and neck and right ear. The left arm felt like battery acid, hurt super bad. Felt like an outer body experience. Was given Benadryl. Was having a problem clearing her throat. Felt weird by her bellybutton, felt like she had on a corset on. Rash developed at sternum and bellybutton. Went over to her ER at work. The knee to the hip felt like she had cement on them. Her tongue started to swell. She was wheeled up to tramum2. She blackout at some point. Her body was doing one thing and her mind another. She had EpiPen stat. Right was twitching like Parkinson's. After 1 1/2 she started feeling a little better. 69/43 bp recorded. The next few days she felt like she had Mono.
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| 53 | 2021-01-16 | impaired work ability |
Was coughing , had chills back pain, fever, Stayed home wed, Thursday. Went back to wk Friday. Sa...
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Was coughing , had chills back pain, fever, Stayed home wed, Thursday. Went back to wk Friday. Sat at work she couldn't taste or smelled food. Took covid test, +for covid on 1/2/21. On 1/13/21 had another covid test it was negative. Congestion, h/a cough. Feels better and report back to work 1/18/21.
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| 53 | 2021-01-17 | sensation of foreign body |
AFTER VACCINE WAS ADMINISTERED PATIENT WAS SITTING IN THE WAITING AREA FOR THE RECCOMENDED AMOUNT OF...
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AFTER VACCINE WAS ADMINISTERED PATIENT WAS SITTING IN THE WAITING AREA FOR THE RECCOMENDED AMOUNT OF TIME. WHEN SHE STARTED TO LEAVE THE PATIENT FELT LIKE SHE WAS GETTING A LUMP IN THE BACK OF HER THROAT. THE PATIENT WAS SCARED TO LEAVE AND DRIVE HOME JUST IN CASE SOMETHING ELSE WAS TO OCCUR. THE PATIENT WAS BROUGHT BACK INTO THE WAITING AREA AND BECAUSE OF HER CONCERN AND THE POSSIABILITY OF AN ALLERGIC REACTION SHE WAS ADVISED TO ALLOW THE AMBULANCE TO TRANSPORT HET TO THE HOSPITAL. SHE AGREED AND AHE WAS TRANSPORTED TO HOSPITAL. I CALLED THE PATIENT TODAY AT 9:30 PM AND SHE STATED SHE WAS OK VIA TEXT.
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| 53 | 2021-01-18 | anxiety | c/o being anxious, jittery |
| 53 | 2021-01-18 | feeling abnormal, insomnia |
I experienced chills, body aches, back pain, dizziness, nausea, dry heaves and passed out. When I pa...
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I experienced chills, body aches, back pain, dizziness, nausea, dry heaves and passed out. When I passed out, I bit my lower lip and it bled quite a bit. I had brain fog, and couldn't come up with the correct words. Also, I could not sleep that night, at all without taking a few sleeping pills. It has been a week since this happened and I still can't sleep on my own. I used to be able to go right to sleep without any sleeping pills within about 5 min after laying down at night.
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| 53 | 2021-01-18 | insomnia |
Shot was at 2 pm on Friday the 8th. On Sunday night around 8pm I got sudden very bad stabbing consta...
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Shot was at 2 pm on Friday the 8th. On Sunday night around 8pm I got sudden very bad stabbing constant pain under my left rib. Lasted all night till Tuesday morning. Also on Monday evening I got very sudden bad headaches that came on with change on position. Standing or bending over or even rolling over in bed that night. They only lasted for about 10 to 15 seconds but even woke me up from sleep. All symptoms left by Tuesday the 12th before lunch time.
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| 53 | 2021-01-19 | feeling abnormal, insomnia |
Initial headache within approximately 10 hours of injection, then body aches, insomnia, injection si...
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Initial headache within approximately 10 hours of injection, then body aches, insomnia, injection site soreness, fatigue, slight mental fog.
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| 53 | 2021-01-21 | feeling abnormal, confusional state |
On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening e...
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On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening especially in back of neck, worsening headache. 1/7 awoke with nausea/vomiting lasting throughout the day and diarrhea also started. 1/8 continued vomiting but diarrhea stopped and also noted confusion and brain fog. 1/11 mostly recovered and back to work with slight headache and body soreness from exhaustion.
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| 53 | 2021-01-21 | insomnia |
shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grad...
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shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grade fever and chills, digestive issues weight loss body aches.
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| 53 | 2021-01-23 | sleep disorder |
At around 7pm I began to feel chills, body aches, no fever, injection arm beginning to hurt. During ...
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At around 7pm I began to feel chills, body aches, no fever, injection arm beginning to hurt. During the night I woke up because my body was shaking from chills even thought I was under my comforter in a warm room. My injection arm was hurting more and my arm pit of the injection arm felt throbbing and painful. In the morning I still had body aches, temp 99.2, my injection arm and arm pit are painful, my arm pit was swollen. I took 1,000 mg Tylenol. Now at 03:40pm I still have body aches, arm pit still painful but not as swollen as before, chills less frequent, temp 98.4.
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| 53 | 2021-01-23 | sleep disorder |
No temperature prior to Vaccine. Track daily - run 97.4-97.7F normally Friday 1/22/2021: 1930 starte...
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No temperature prior to Vaccine. Track daily - run 97.4-97.7F normally Friday 1/22/2021: 1930 started feeling very tired 2030-2230: started to feel cold, skin sensitivity, developed into shaking chills, entire body shaking. Headache. Temperature rising 99F -- 100.4F --- 101.5F about every 1/2hr or so. 2100 Took Advil 600mg Midnight: Chills, HOT, Temp 102.4F. Dozing off and on through the night. Shaking and Hot. Headache. Feeling Nausea 0400: Temp 101.6F, tried to take Ibuprofen but dry heaved them back up. Sips of water. Took warm shower. 0500: back to bed, slept 1 hour 0600: saltines, gingerale - took Advil 600mg - laid back down. Head throbbing. Less Nausea. 0830: woke: Temp 100.4F Headache and hot, feel achy all over never leaves, feel woozy. Spent most of Saturday 1/23/2021 (My 54 Birthday) Laying and sleeping. Started taking Tylenol 1000mg (1/23 at 6pm) alternating with Ibuprofen 600mg every 6 hours exactly. Woke Sunday Morning - feeling less achy, but still with Temp 100.4-99.6F -- As Sunday went on - by afternoon/evening achy, skin sensitive, and Temp 100.4F, HEADACHING! Neck aching. Took Ibuprofen 600mg. Drinking gingerale and water through the day. Toast. Now almost Midnight 1/24/2021 Headache and feeling achy. (Right ARM only slight hurt this time. 1st Pfizer - hurt 8/10 day 2 &3)
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| 53 | 2021-01-24 | feeling abnormal, impaired work ability |
I had, on the 21st, at about 6:00 pm or so I had left arm pain (upper). On the 22nd, at 5:00 am, I w...
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I had, on the 21st, at about 6:00 pm or so I had left arm pain (upper). On the 22nd, at 5:00 am, I woke up with chills, body aches and fever of 99.1 and then I took Tylenol. I had taken the morning off and I waited until 9:00 to see how I was feeling and I still wasn't feeling good. I ate breakfast and took another Tylenol and I was still having body aches, chills, fever was still 99.1. Had a little bit of headache also. So I called in work to cancel afternoon patients. At 1:00, I took two Tylenols because I had increased symptoms -about 99.3 or so fever. I went to sleep and woke up at 6:30 or so and was feeling better. After that I didn't have to use Tylenol. Arm pain was less stronger than the first dose on the second day (taken on the same arm).
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| 53 | 2021-01-24 | sensation of foreign body |
Four days ago the patient received her 2nd coronavirus vaccine. She received at the hospital pot. Sh...
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Four days ago the patient received her 2nd coronavirus vaccine. She received at the hospital pot. She received her 2nd Pfizer vaccine. She tolerated her 1st vaccine dose without incident. She did not have any problems approximately 15 minutes after her 2nd dose and she was then released to drive away. About 30 minutes after her 2nd dose she developed nonspecific symptoms of shortness of breath and a sensation of something sticking in her throat. She presented to the emergency department. She did not receive epinephrine. She was monitored and received intravenous fluids and diphenhydramine. She notes ongoing itching with rash and which she describes as exacerbation of asthma. She has known asthma with frequent exacerbations. She has been hospitalized numerous times in the past for asthma exacerbation. Now that it has been several days since her vaccination and she is still having rash and difficulty with her asthma we have discussed initiation of low-dose steroids for ongoing improvement.
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| 53 | 2021-01-25 | feeling abnormal |
patient swelled up really large. had to remove rings and clothing. also felt very badly with headach...
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patient swelled up really large. had to remove rings and clothing. also felt very badly with headache for the next few days.
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| 53 | 2021-01-25 | impaired work ability |
Dizziness, lightheadedness worse upon standing, HA, sore throat, body aches, muscle aches, bone ache...
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Dizziness, lightheadedness worse upon standing, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, facial flushing. Missed work for 2 days and went to urgent care. Treated with APAP, Motrin, and meclizine
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| 53 | 2021-01-26 | feeling abnormal |
I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting,...
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I was flushed, my arm hurt, palpitations, dizziness, foggy brain, fast heart rate, fever, vomitting, nausea, headache, stuffiness, congestion, swelling on the arm at the injection site, pain and rash around the injection site.
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| 53 | 2021-01-26 | sleep disorder |
I felt like I could run a marathon, up most of the night after the injection, all the next day and u...
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I felt like I could run a marathon, up most of the night after the injection, all the next day and up most of the second night. Other than that, felt ok. A lot of energy!!!!
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| 53 | 2021-01-27 | sleep disorder, nervousness, feeling abnormal |
Shaking in left arm 5-6 hours after vaccination, which later spread to abdomen and head. Felt like h...
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Shaking in left arm 5-6 hours after vaccination, which later spread to abdomen and head. Felt like head was vibrating or shaking on the inside, accompanied by nervous energy and feeling that something was not right. Interfered with ability to sleep. Seemed better in the morning but not completely resolved. Developed lower back/flank pain 5 days after vaccine.
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| 53 | 2021-02-01 | feeling abnormal |
Complained of feeling "off and feeling like legs are falling asleep" and upset stomach. at 14 35 ...
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Complained of feeling "off and feeling like legs are falling asleep" and upset stomach. at 14 35 BP 179/102, Pulse 73, 98% on room air. Rested for approximately 45 mins. Bp 171/95 at 1455. Patient reported feeling better and agreed to follow up with primary MD or go to ER is symptoms worsened.
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| 53 | 2021-02-01 | impaired work ability |
Employee reported that she began dry, burning lips and neck which started day after covid vaccine ad...
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Employee reported that she began dry, burning lips and neck which started day after covid vaccine administered. On day 2 following vaccine, employee reported lips began to swell and rash and hives developed on neck and chest. Lip swelling resolved on 1/31/2021 and employee still has rash on chest and neck, but is improving. Employee was using Benadryl cream for rash and itching and was also taking Benadryl orally 50 mg at bedtime and was taking Claritin during day. Did not have to seek emergency treatment but did miss 1 day of scheduled work. Employee is also reporting fatigue and pain in joints. Has a hx of lupus and RA and believes vaccine may have caused a flare.
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| 53 | 2021-02-01 | nervousness, feeling abnormal |
Approx. 25 mins after receiving vaccine. I experienced rapid heart, shaking, elevated BP. I was lea...
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Approx. 25 mins after receiving vaccine. I experienced rapid heart, shaking, elevated BP. I was leaving the hosp. and started feeling strange and my heart was racing and I felt shaky. I went to the ER at the hospital I received my vaccine at.
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| 53 | 2021-02-01 | sensation of foreign body |
Per Report: Client complained of lump in her throat and difficulty swallowing. Care initiated on s...
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Per Report: Client complained of lump in her throat and difficulty swallowing. Care initiated on site by Fire Rescue. Symptoms unchanged after treatment. Client transported to Hospital by EMS. Report states client began feeling better prior to arriving at ER.
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| 53 | 2021-02-02 | sleep disorder, feeling abnormal |
Woke up out of my sleep feeling horrible. For about 2 hours, from 3am until about 5am I was very col...
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Woke up out of my sleep feeling horrible. For about 2 hours, from 3am until about 5am I was very cold with excessive sweating and nausea. Did not vomit, but felt like I would and should. I had explosive diarrhea 4 times, each time thinking I was done, but then urgently having to go again. After the 4th time, I felt completely empty. During those 2 hours I felt horrible and was scared for the fact that I knew it was a result of the vaccine 12 hours earlier. I was able to get back to sleep and felt better the next day. I was tired, but not feeling sick for the rest of the day. I was 100% better the following day.
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| 53 | 2021-02-04 | abnormal dreams |
Nausea, headache, severe muscular and joint aches, night sweats, weird dreams, golf ball size red c...
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Nausea, headache, severe muscular and joint aches, night sweats, weird dreams, golf ball size red circle at injection site warm to touch, itchy with lump under skin.
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| 53 | 2021-02-04 | feeling abnormal | Scratchy throat and "weird feeling." |
| 53 | 2021-02-04 | nervousness, anxiety |
Quite Anxious; Patient received Pfizer vaccine #2 today. After the vaccine, the employee repo...
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Quite Anxious; Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following symptoms: shaky feeling inside Lot: EL3247 Time of Administration:1053 Time Symptoms Began: ~1104 _____ Patient alerted observer who took the them to the medical observation area. I was alerted and responded. Initial Assessment @ _~1115_: Patient is patient is AAO. The employee is sitting up in a chair with the observer. The employee is pink and does not appear to be in distress but is anxious. They are talking and making conversation. Vitals @:1115 HR: 103 BP: 151/85 O2:99 Vitals @: 1121 HR: 92 BP: 136/85 O2: 99 Discharged at 1121 without treatment. Pt feels much better. She thinks that she was anxious due to seeing her mother die from an anaphylactic reaction to an antibiotic in an ER in 2019. She was with her mom when the reaction occurred and when she died. She was being treated for a UTI. She thinks the abx was rocephin. She notes that her only allergy is sulfa-- it causes her skin to itch.
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| 53 | 2021-02-04 | nervousness |
1/6/21 Twitching in left eybrow and eyelid 1/16/21 Started with fatigue in legs, over next couple o...
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1/6/21 Twitching in left eybrow and eyelid 1/16/21 Started with fatigue in legs, over next couple of days muscle aches all over, bone pain, fatigue, 1/18 First Covid Test 1 Negative Continued symptoms 1/21 Went to PCP Covid rapid and Covid lab both negative Labs drawn all within normal limits Symptoms continued including occasional leg cramps, random muscle twitching, sharp needle like pain in foot, feeling shaky, waking to numbness hands
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| 53 | 2021-02-09 | feeling abnormal |
my system felt ramped up; my voice sounded worked up; I had slightly shallow breathing; My heart rat...
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my system felt ramped up; my voice sounded worked up; I had slightly shallow breathing; My heart rate went up, not extremely high but and EMT said it felt "racy".; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: RL3249) at left arm on 21Jan2021 12:15 AM at single dose for COVID-19 immunization. Medical history included asthma, allergies to sulfa, dairy, egg, peanuts. Patient is not pregnant. Other medications in two weeks included low dose naltrexone and salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) and Herbals. No other vaccine in four weeks. Patient previously took erythromycin and epinephrine and had allergy to them. Within 5 minutes (21Jan2021 12:15 AM), her system felt ramped up. Her heart rate went up, not extremely high but and EMT said it felt "racy". She was told that her voice sounded worked up. she had slightly shallow breathing. It lasted about 30 minutes then began to subside. The next day she felt it somewhat. she was totally normal after 12 hours. She had a sensitivity to epinephrine and the Pfizer dose reaction reminded her of a milder version of the epinephrine reaction. No Covid prior vaccination, no covid tested post vaccination. No treatment received for the events; patient was recovered from the events in 22Jan2021.
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| 53 | 2021-02-09 | restlessness |
Due to Lupus I typically have very slow matabolism, low appetite and sluggish, however after a few ...
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Due to Lupus I typically have very slow matabolism, low appetite and sluggish, however after a few hours of receiving the vaccine I experieinced unusual restlessness, pacing, high energy, fast speech and incredible appetite ( I had 3 separate meals in 2.5hrs as opposed to my usual 1 meal a day. My family were the one's who first noticed the change. However next day I was back to my usual self. I thought it was important to share as I anticipated due to lupus that my exposure to a foreign vaccine would have caused the more common symptoms but it was quiet opposite and unusual.
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| 53 | 2021-02-11 | impaired work ability, feeling abnormal |
Injection occurred at 4:50 pm on January 28th. On February 7th I took a hot bath with magnesium sulf...
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Injection occurred at 4:50 pm on January 28th. On February 7th I took a hot bath with magnesium sulfate Epsom Salts around midnight and went to bed. A few hours later, perhaps around 3 am I started to feel like I was coming down with the flu and feeling aches. By Morning at 7:30 am I felt awful. Significant muscle pain all throughout my body which was debilitating and made it difficult to get around. Very serious joint pain as well. Also very stiff and felt difficult to walk even. Took the day off from work and took ibuprofen and slept most of the day. Was very difficult to function in the morning and felt foggy in the head too. Couldn?t get out of my pajamas and stayed mostly in bed. Symptoms for better by about 5 pm and improved throughout the night. Felt much better the next morning and went to work. However yesterday, February 11th I felt some heart flutters which seemed out of place.
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| 53 | 2021-02-13 | impaired work ability |
Symptoms started January 21,3021 with Fever, Chills, Bodyaches, Weakness and Exhaustion. Symptoms c...
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Symptoms started January 21,3021 with Fever, Chills, Bodyaches, Weakness and Exhaustion. Symptoms continued January 22 and I was unable to go to work. Bodyaches , Weakness and Stomach Pain an Nausea occurred for another week . Shoulder and Back Pain with intermittent Headaches and Neck Pain continues currently as of today?s date 2/14/2021
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| 53 | 2021-02-14 | anxiety |
Pfizer-BioNTech COVID-19 Vaccine Employee complained of feeling hot, tongue felt swollen, and weak...
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Pfizer-BioNTech COVID-19 Vaccine Employee complained of feeling hot, tongue felt swollen, and weak. Patient was taken to Clinic for evaluation at onset of symptoms, approx 12 minutes after distributing vaccine. At Clinic, patient states her symptoms have improved. She states she thinks she got a little anxious and feels comfortable driving home at this time. Patient denies oral/throat/tongue/lip edema. No headache, vision changes, difficulty swallowing, difficulty handling oral secretions, chest pain, palpitations, shortness of breath, nausea/vomiting. No pruritus. Patient is siting comfortably in the chair and drinking water without difficulty. Discussed ED precautions. Patient verbalized understanding. Advised patient to follow up with her PCP to discuss the second dose of the covid vaccine. Patient agreed to the plan. Patient ambulated out of clinic without difficulty. 1/1/21: Pt received 2nd dose of vaccine. Experienced some dizziness and slightly high BP. Both symptoms resolved within 30 minutes and patient was discharged home.
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| 53 | 2021-02-21 | anxiety |
Tachycardia, palpitations, SOB, anxiety before, during and after injection. She did go to ER, sympto...
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Tachycardia, palpitations, SOB, anxiety before, during and after injection. She did go to ER, symptoms resolved quickly.
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| 53 | 2021-02-21 | feeling abnormal |
Patient reported, feeling "like I have to cough," dizziness, lightheadedness, headache. Patient eval...
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Patient reported, feeling "like I have to cough," dizziness, lightheadedness, headache. Patient evaluated by EMS staff. BP 167/95, P 116, O2 100%. Upon further questioning, patient reports h/o POTS syndrome, autonomic dysfunction, dual chamber pacemaker and low BPs on occasion. Re-evaluated by EMS done 15 minutes later, BP 170/95, P 100, O2 100% patient refused to go to ER. Patient monitored in clinic for an additional 30 minutes. Stated symptoms had resolved.
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| 53 | 2021-02-22 | impaired work ability |
Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure w...
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Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure was out of control; dizziness does not allow her to go to work; lingering dizziness; Get a tightening in her chest; Fatigue; Left side of temple toward the crown of head she has pressure on the left side of the body; Left side of temple toward the crown of head she has pressure on the left side of the body; lightheadedness; troponin kept increasing; Inflammation around heart; This is a spontaneous report from two contactable consumers or other non health professional (including patient self, a healthcare worker works with patients with lymphomas, a licensed massage/lymphatic therapist). This 53-years-old female received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expiry Date: 30Apr2021) at 0.3 ml single dose intramuscular injection in left arm on 22Jan2021 10:28 (also reported as 10:38) for Covid-19 vaccination. Medical history was none (also reported as no patient history). Concomitant drug was none (reported as no other products). Family Medical History Relevant to AE(s) was none. Historical vaccine included flu shot in Nov2020 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No other vaccines given the same day or 4 weeks prior. AE(s) following prior vaccinations was none. Patient never had a reaction to any vaccine or shot before. Patent experienced anaphylactic reaction on 22Jan2021, heart enzymes elevated on 22Jan2021, blood pressure was out of control on 22Jan2021, get a tightening in her chest on an unknown date, lingering dizziness on an unknown date, dizziness did not allow her to go to work on an unknown date, inflammation around heart on 22Jan2021, troponin kept increasing on 22Jan2021, fatigue on an unknown date, lightheadedness on an unknown date, left side of temple toward the crown of head she has pressure on the left side of the body on an unknown date. Seriousness for heart enzymes elevated and anaphylactic reaction was hospitalization from 22Jan2021 to 23Jan2021. The events anaphylactic reaction required a visit to Emergency Room, but not Physician Office. The event clinical course was as follows: patient received her 1st dose of the Pfizer vaccine she had an anaphylactic reaction. She was given 3-4 Epis on site (on 22Jan2021) before being transferred to the ER. In the ambulance, she was administered a 4th EpiPen (on 22Jan2021) before getting to the ER, and then admitted to the cardiac unit on 22Jan2021 for observation. Patient also reported Given 3-4 EpiPens on 22Jan2021 and EpiPen auto-injector was Lack of Effect. No Return Sample Received. When she first started having symptoms, her blood pressure was 128/73. When the symptoms got worse her blood pressure started increasing. Her blood pressure was 220/116, they had to admit her to the cardiac unit because her heart enzymes were elevated and her blood pressure was out of control. Her troponin kept increasing and had inflammation around her heart. Her symptoms of anaphylactic reaction went away that same day, 22Jan2021, at the vaccination from her anaphylactic reaction. Patient was discharged and released from the cardiac unit on that Saturday (23Jan2021 ) around 7:30pm. No one could tell her anything about this since she was still having lingering effects and was getting ready to locate a cardiologist and still has tightness in the chest. She mentioned the dizziness did not allow her to go to work. She experiences it on and off, not consistent but less severe than initially. She still had lingering dizziness and she had to drive for a majority of her day and that was concerning. She said that on the left side she will get a tightening in her chest. She said that no one knows what this means moving forward. Patient was concerned about the severity of the reaction and was still not back to normal. She had never had a reaction to any vaccine or shot before and has been in the military. She needed help, direction since she was still not at the full potential to work. She was still fatigued and has tightness of her chest and those are concerns for her. Patient mentioned a part of the symptoms she also had were lightheadedness and dizziness and that started after the vaccine and it's not as severe, but she still had it. On left side of her temple toward the crown of her head she had pressure on the left side of the body and that was the same side where she received the injection, on that left side. Outcome of anaphylactic reaction was resolved with sequel on 22Jan2021. Outcome of heart enzymes elevated was resolved on 23Jan2021. Outcome of blood pressure was out of control was resolved with sequel on 23Jan2021. Outcome of lingering dizziness was resolving. Outcome of left side of temple toward the crown of head she had pressure on the left side of the body, lightheadedness was not resolved. Outcome of tightness in the chest and fatigue was not resolved. Outcome of inflammation around heart and troponin kept increasing was resolved with sequel on an unknown date. Outcome of the other event was unknown.
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| 53 | 2021-02-23 | restlessness |
I had pain at the injection site which started about 2 hours after the shot. (I had had this after ...
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I had pain at the injection site which started about 2 hours after the shot. (I had had this after the first shot as well, but it happened faster this time and was a little more severe). About 12 hours after the injection, I started to feel feverish, and went to bed - fever seemed to spike during hours 12-16 post-injection. (I did not take my temperature because I was in bed and really not feeling well.) I had chills, sweating, muscle aches, restless sleep, and a headache. I remained feverish most of the next day and had a migraine level headache the entire day; temperature reads were in the 100-101 degree range for the entire next day, until about 10pm (a full 24 hours after the onset of symptoms, 36 hours from injection.), when it went down to 99 degrees, and then finally seemed to subside.
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| 53 | 2021-02-26 | anxiety |
Patient reports experiencing tightness in chest while at rest within 2 minutes after receiving vacci...
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Patient reports experiencing tightness in chest while at rest within 2 minutes after receiving vaccine. Pain persisted, 911 was called. BP of 186/96, SPO2 98, HR 92. Patient sweating, appeared very anxious. EKG negative for ST elevation. Patient transported to hospital.
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| 53 | 2021-02-28 | disturbance in attention |
Diarrhea, nausea, headache, chills, fever,--within first 24 hours after receiving the second dose. N...
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Diarrhea, nausea, headache, chills, fever,--within first 24 hours after receiving the second dose. Nausea and fatigue persisted, along with the loss of appetite (as of this date, still no appetite...only being able to handle orange juice and saltine crackers); emotions are still a wreck; concentration level is still small; multi tasking is not doable; seem to lose words along the way in conversation.
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| 53 | 2021-02-28 | excessive sleepiness, impaired work ability |
I started with fatigue the afternoon of my 2nd vaccine. Slept from 3:40 that afternoon until the fol...
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I started with fatigue the afternoon of my 2nd vaccine. Slept from 3:40 that afternoon until the following morning at 5am. Body aches/mild. Worked the next day but had to leave an hour early due to fatigue and body pain. That evening developed nausea. (2-26). The 27th I had a terrible headache upon waking with increased nausea. Started vomiting around 10am. Unable to take in any liquid until that evening late. The 28th mild headache, more of a heavy headed feeling. Today, March 1st, nausea without vomiting thus far, weak & drained feeling.
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| 53 | 2021-02-28 | sleep disorder, anxiety |
Since getting the vaccination, I notice I?ve been eating more sweets .I?ve gained weight and my slee...
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Since getting the vaccination, I notice I?ve been eating more sweets .I?ve gained weight and my sleep has been interrupted and I?m very tired. This is a couple of weeks into it now. Throughout the entire pandemic I?ve slept fine for the most part . I haven?t been feeling anxious. Since taking the vaccine I?ve been a bit anxious as well. I?m also still very tired. Today I woke up with bodyaches.
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| 53 | 2021-02-28 | sleep disorder |
abnormal sleep patterns; sleep problems/Sleep is worse after the covid vaccine; sleep problems/Sleep...
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abnormal sleep patterns; sleep problems/Sleep is worse after the covid vaccine; sleep problems/Sleep is worse after the covid vaccine; This is a spontaneous report from a contactable healthcare professionals. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on the left arm on 23Jan2021 12:45 at single dose for COVID-19 immunization. Medical history included depression anxiety and ongoing sleep problems. There were no concomitant medications. It was reported that the patient got the first dose and had abnormal sleep patterns on an unspecified date. It was reported that the patient was concerned that the Pfizer vaccine may contain something that could damage her brain and make it so she can't sleep. She stated she has existing issues with sleep so she is unsure if the vaccine has affected her sleep or not. She just wants to know if there is something in it that could affect her sleep. Added that she was able to fall asleep that night and then woke up in the middle of the night but that is not unusual. Added she has problems with sleep anyway and she is wondering if there is anything in the vaccine that could interfere with her sleep or could cause you to not be able to sleep. It was reported that the patient's sleep is worse after the COVID vaccine. She wanted to know if it is because of the vaccine. She is scheduled for the next dose on 13Feb2021.
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| 53 | 2021-03-03 | agitation |
March 2, 2021 1. At vaccination site, severe itchiness, dizzy, felt really hot, sweaty. Nurse too...
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March 2, 2021 1. At vaccination site, severe itchiness, dizzy, felt really hot, sweaty. Nurse took blood pressure 120 over 80. Stayed for 1/2 hour (9:10-9:41 a.m.). 2. Drove to work . All symptoms persisted, entire body turned bright red (like sunburn), extreme shaking. Checked in with school MA (nurse) . Blood pressure 140 over 80. Temperature 100. Extreme agitation and heightened senses. 3. sent me to Urgent Care seen at 11:35 a.m.. Same symptoms persisted. Blood pressure 143/94. Temperature 98.8. Was prescribed 2 Benedryl now, 1 every 4-6 hours as long as have itching. 2 at night for next 7 days. Prescribed Prednisone (10 mg) 4 one day, 4 next day - decrease dosage for 8 days. 4. Took prednisone- heightened senses, agitation increased. Migraine. Outer body exhausted, inner pure adreneline that would not decrease. March 3, 2021 1. Most symptoms lessened. Went to work . Checked in with MA (nurse) and told her that I wanted to stop the prednisone. She recommended that I take the dose. Took 4 tablets (10 mg) at 9:40 a.m. Heightened senses (light, sound, touch, taste), agitation, shakiness. brought me to in . Doctor told me to stop the prednisone as I have a history of anxiety. Exhaustion, heightened senses, agitation remained the rest of the day. March 4, 2021 1. Lessened symptoms. Four 20-minute recurrence episodes between the hours of 9 a.m. and 5 p.m.
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| 53 | 2021-03-03 | feeling abnormal |
Report feeling of fogginess. Treatment: none. Outcome: Continue to work without difficulty and does...
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Report feeling of fogginess. Treatment: none. Outcome: Continue to work without difficulty and does not interfere with ADLs.
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| 53 | 2021-03-04 | nervousness |
Within a few minutes of getting the injection my face began tingling. A few minutes after that the ...
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Within a few minutes of getting the injection my face began tingling. A few minutes after that the tingling turned into a burning feeling. My cheeks were slightly flushed but felt like I had a bad sunburn. At the same time my throat felt thick. I could talk and breathe but it definitely felt like it had swelled inside my throat. I also felt shaky. My hands were not shaky but I felt shaky on the inside. I didn't report this to the people working the vaccine clinic (but in retrospect I should have) The thick throat feeling resolved within one hour and the face burning feeling was gone by the next morning. Then I just had the typical sore arm, a few body aches and nothing else. Note: never a vaccine reaction but I had an anaphylactic reaction requiring treatment when receiving a 2nd dose of chemotherapy
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| 53 | 2021-03-07 | excessive sleepiness |
Ran a fever of 103.7 starting 8 hours after shot for 12 hours, 102 for another 9 and finally down to...
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Ran a fever of 103.7 starting 8 hours after shot for 12 hours, 102 for another 9 and finally down to 100/101 for another hour and finally broke fever at midnight on the 6th. My head hurt so bad, the pain was tremendous. My body hurt so bad, I didn't want to move or be touched. Nauseous, no vomiting. So tired. Slept the entire time. Tried using just Tylenol, it wasn't working so at the 12 hour mark, I took Advil with the Tylenol and it started to go down from there. Rotating every 3 hours of Advil then Tylenol. My joints hurt for 2 days after, along with still having a headache and very tired. IT. WAS. BAD.
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| 53 | 2021-03-08 | feeling abnormal |
My head felt heavy; it felt like my head was surrounded by water. Lots of pressure around my ears. ...
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My head felt heavy; it felt like my head was surrounded by water. Lots of pressure around my ears. My mind was very foggy; I could not think clearly. It was hard to concentrate and focus. It felt like I was extremely groggy but not sleepy. My think pattern was very slow. My appetite decreased; I felt nauseous a couple of times. No fever. I took 2 Tylenol tablets (regular dose), and laid down to rest for several hours. The longer the day went, the more severe the symptoms become. I took another 2 Tylenol tablets at bedtime, and went to bed earlier. During the day I drank lots of fluids, and ate light food.
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| 53 | 2021-03-09 | feeling abnormal | Soreness in arm, headache, fogginess |
| 53 | 2021-03-09 | impaired work ability |
Sick - throwing up, vomiting, and fever for five days and headaches, too. I didn't have any swelling...
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Sick - throwing up, vomiting, and fever for five days and headaches, too. I didn't have any swelling lymph nodes. I thought I would have to go to the hospital. I didn't go to work on Monday or Tuesday. I was taking Pedialyte and water so I wouldn't dehydrate. I had had COVD before and it was light symptoms compared to this - it was only 12 hours or so. I still get random bad headaches and I have issues with my stomach with it getting upset with queasiness and runs - that comes and goes, too. Stomach pains. I didn't have any of this before - I have only had this since the second injection.
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| 53 | 2021-03-09 | sleep disorder |
Starting shortly after the injection she had severe left arm pain. Symptoms have varied over the las...
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Starting shortly after the injection she had severe left arm pain. Symptoms have varied over the last 2 months, but she has noticed decreased ROM in the shoulder, pain sleeping on the left side at night, a lump at the site of the injection and ongoing pain. She has taken Aleve and ibuprofen intermittently with some relief.
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| 53 | 2021-03-12 | loss of personal independence in daily activities, mental impairment |
I HAVE HEADACHES AND NAUSEA THAT WAX AND WANE SINCE I RECEIVED MY SECOND SHOT ON JAN 31ST. THE HEADA...
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I HAVE HEADACHES AND NAUSEA THAT WAX AND WANE SINCE I RECEIVED MY SECOND SHOT ON JAN 31ST. THE HEADACHES ARE PRESSURE HEADACHES THAT ARE MOSTLY ON THE TOP OF MY HEAD BUT CAN MOVE AROUND MY HEAD AND FACE. THEY RANGE IN SEVERITY FROM SEVERE AND INTERFERE WITH MY ABILITY TO THINK TO MILD AND ABLE TO FUNCTION BUT THEY ARE ALWAYS PRESENT. I WAKE UP WITH THE HEADACHES AND NAUSEA. MY NEUROPAHTY ON MY LEFT ARM,WHICH RECEIVED THE SHOT, HAS GOTTEN WORSE WITH INCREASED TINGLING AND A FEELING LIKE A BAND IS SQUEEZING AROUND THE TOP PART OF MY ARM.
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| 53 | 2021-03-12 | loss of personal independence in daily activities, sleep disorder |
I woke up in the middle of the night with a terrible headache and body aches and chills. The next ...
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I woke up in the middle of the night with a terrible headache and body aches and chills. The next day these symptoms continued and I also had a fever (100.3). My lower back hurt so much that I felt as if I had fallen down a long flight of stairs. I had to take 1/2 day off of work and spend the remainder of the day in bed. Eventually I took 2 extra strength Tylenol which helped alleviate my symptoms. The next morning I woke up feeling totally fine.
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| 53 | 2021-03-13 | excessive sleepiness |
It was painful the injection at all point but I didn?t complaint as I was able to support the paint ...
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It was painful the injection at all point but I didn?t complaint as I was able to support the paint in my 15 min wait my pain in the arm was what I consider strong but still able to support, 25 min after the injection I started hot flash and redness in face and neck, The reaction was only 5% of the reaction I experimented with Chemo so I knew I was ok and I did not have to run to the medical center again. In the hour after the injection the paint in the arm intensified and it was from the base of the neck to the lower back, during the weekend I lost some moved of my arm and I took Tylenol every 8 hours as per the post vaccine indicator, and slept a lot as I was too tired and having a little of running nose, by the Monday (72 hrs) w Most of the hot flashes and running nose stopped and the pain was under my pain threshold and I managed to reduce Tylenol only to one before bed time, however last night pain intensity and arm movement reduce again. i will be calling my primary doctor on Monday to review
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| 53 | 2021-03-14 | feeling abnormal, insomnia, disturbance in attention |
Sore arm immediately upon injection. Soreness travelled to fingertips within 4 hours. No treatment ...
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Sore arm immediately upon injection. Soreness travelled to fingertips within 4 hours. No treatment required. Headache within 2 hours. Very distracting although not severe. Prevented sleeping. Took 1x advil 200mg. Resolved. Foggy head within 4 hours. Trouble focusing eyes and thoughts while having a conversation with neighbor. Resolved at 48 hours. Tiredness within 6 hours. Resolved at 54 hours. Chills but no fever starting at ~27 hours from shot and lasting 4 hours. Resolved.
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| 53 | 2021-03-14 | feeling abnormal |
General malaise, weakness of extremities, muscle pain, chills, foggy-headed feeling, perhaps slight ...
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General malaise, weakness of extremities, muscle pain, chills, foggy-headed feeling, perhaps slight fever which began at approximately 2:00 p.m. the following day after shot and lasted through the evening. Lingering foggy-headed feeling and stomach upset lasted 48 hours beyond that. Rested and slept as treatment. No medication taken for side effects.
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| 53 | 2021-03-14 | feeling abnormal |
Immediately after vaccine rec'd last Thursday, I immediately after shot I began to feel weird like s...
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Immediately after vaccine rec'd last Thursday, I immediately after shot I began to feel weird like something in my throat and it's still there, my arm was hurting, that night I was able to sleep, Friday it started getting more sore, Saturday I noticed I could not sit because my butt cheeks were hurting, then I started feeling leg and hand cramps on my left side, Then Sunday my arm, leg, back, spinal cord everything was hurting and I was extremely thirsty and I couldn't lay down, sit or even walk. I have not been feeling good at all. Also, I have lupus
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| 53 | 2021-03-14 | impaired work ability |
Headache, Myalgia, UrticariaPruritus, NauseaVomiting, Tachycardia, Reports had R knee pain (prior ...
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Headache, Myalgia, UrticariaPruritus, NauseaVomiting, Tachycardia, Reports had R knee pain (prior injury there) and took tylenol, naproxen and tramadol for symptoms which were intermittent for the next 10 days. Narrative: Employee directed to go to ED and declined. Employee is a physician. Employee took 2nd Pfizer Vaccine, EL1042 on 1/13/2021 and experienced L shoulder injection site pain, headache, body aches. Fever up to 101F. Tx with tylenol, Reports in bed all day. Missed work on 1/14/2021 and 1/15/2021. 1/15/2021 got up and severe burning all over body. Smell decreased and change in taste. Reports increased teeth sensitivity to cold, citrus tastes. Feeling more weak and fatigue. Neurologist diagnosed with Small fiber neuropathy R/ T Covid vaccine administration on 3/3/2021.
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| 53 | 2021-03-15 | anxiety |
Feeling of impending doom Throat tightening Tongue swelling Increased heart rate Increase in blood ...
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Feeling of impending doom Throat tightening Tongue swelling Increased heart rate Increase in blood pressure Dry mouth and throat Dizziness
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| 53 | 2021-03-16 | abnormal dreams | Arm pain within 2 hours, extreme fatigue, malaise, vivid dreams, headache lasting 10 hours |
| 53 | 2021-03-16 | feeling abnormal |
nausea, headache, diarrhea, general feeling of being unwell. Most concerning to me is the affect on ...
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nausea, headache, diarrhea, general feeling of being unwell. Most concerning to me is the affect on my left eye and eyes in general and headache. My left eye is wandering, like a "lazy" eye. It is as if my eye floats, and when this happens I am not able to focus. With the eye is also a frontal area headache and i get an uneasy feeling in my body just prior to this happening. My reaction started around 5 hours after the vaccine shot. It is now four days later and my symptoms are less but still present around my eyes and headache.
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| 53 | 2021-03-17 | hallucination |
Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chil...
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Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chills; funny taste; dizziness; itchy feelings; tired; discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202, expiry date not reported), via an unspecified route of administration administered in arm right on 26Feb2021 14:00 as single dose for covid-19 immunisation. Medical history included hypertension and known allergies: arrhythmia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced hallucinating, lot of pain all over her body, chills, funny taste, discomfort, dizziness and feel like her body is having a allergic reaction and itchy feelings and tired on 27Feb2021 01:00. The patient did not recover from the events.
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| 53 | 2021-03-17 | sleep disorder |
Rapid heartbeat for 15 minutes 9 hours after the injection. Heartbeat was so rapid woke me up from ...
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Rapid heartbeat for 15 minutes 9 hours after the injection. Heartbeat was so rapid woke me up from a sound sleep. I felt like I was having a heart attack. I am a runner and a healthy individual. My heart rate has never been like that.
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| 53 | 2021-03-18 | anxiety |
3-17-21 1:35PM 'DIZZY, HEADACHE, ANXIETY'. NO SOB/DYSPNEA, NO SWELLING OF THROAT. 1:53PM 'FEELS BE...
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3-17-21 1:35PM 'DIZZY, HEADACHE, ANXIETY'. NO SOB/DYSPNEA, NO SWELLING OF THROAT. 1:53PM 'FEELS BETTER AND OK TO GO HOME WITH HUSBAND'. HUSBAND TO DRIVE PT HOME. NO ACUTE OR OBVIOUS DISTRESS NOTED. 3-19-21 8:30AM TC: 'FEELS FINE NOW'.
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| 53 | 2021-03-18 | feeling abnormal |
received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minute...
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received vaccine @930 am, 3:30 pm felt weak, mild pain behind my eyes, sniffles, slept for 40 minutes. Symptoms increased and continued through out the night, childs and sweats , overall feeling of weakness. Mentally slow processing, feeling foggy. Symptoms Cleared on Monday evening around 9pm. New symptoms on March 19th swollen glands roof of my mouth, neck, underarms. Painful, brain fog, exhaustion, chills and sweats, stuffy nose, headache.
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| 53 | 2021-03-19 | confusional state, excessive sleepiness |
On mar 18 late afternoon i started with a burning in my neck and the pain kept getting worse then it...
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On mar 18 late afternoon i started with a burning in my neck and the pain kept getting worse then it went to my head and my head started killing me. I tried to eat cuz i thought i might be hungry, i was also very confused and i ended up passing out at the food place at the table, i never ate i woke up cuz i had to puke them i ran outside and threw up a total of 4 different times from that point on for the next 3 days i couldn?t keep my eyes open i was beyond tired i had no control my eyes would close and i would fall asleep for hours at a time. It?s day March 20 and I?m still exhausted tired trying to fight the fatigue.
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| 53 | 2021-03-19 | confusional state | Vertigo, Confusion, Projectile Vomiting, Nausea for 3 days, Headache |
| 53 | 2021-03-19 | loss of personal independence in daily activities |
Fever of 102 degrees F, muscle and joint pain, sharp headache, fatigue. Lasted 48 hours. Patient w...
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Fever of 102 degrees F, muscle and joint pain, sharp headache, fatigue. Lasted 48 hours. Patient was too tired to get out of bed for the first 36 hours. No noticeable reaction to the first dose of Covid vaccine. No history of noticeable reactions to any vaccines in the past.
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| 53 | 2021-03-21 | feeling abnormal |
The patient had her covid 19 vaccine. Shortly after that she got hot in the face, fuzzy headed, and ...
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The patient had her covid 19 vaccine. Shortly after that she got hot in the face, fuzzy headed, and nauseated. Her pulse ox was 99 percent. Pulse 73. BP 134/93. Once we laid her down and got her some juice and crackers, her symptoms quickly resolved. Her current meds are lisinopril 20mg, synthroid, and isosorbide.
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| 53 | 2021-03-21 | insomnia, restlessness | slight headache productive cough stuffy nose heart palpitations trouble falling asleep/restlessness |
| 53 | 2021-03-22 | anxiety |
Client verbalized feeling anxious after receiving the vaccine. Client was evaluated by onsite Param...
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Client verbalized feeling anxious after receiving the vaccine. Client was evaluated by onsite Paramedics. Client was evaluated for additional 15 mins. Per Paramedics, client symptoms resolved and released to go home at 9:02 am.
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| 53 | 2021-03-22 | loss of personal independence in daily activities |
Extreme fatigue first 3 days that I couldn't get off bed for long; with body aches, arms pain where ...
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Extreme fatigue first 3 days that I couldn't get off bed for long; with body aches, arms pain where the shot was given, head aches, sore throat, chills, but had no fever. Arm pain went away after 3 days, body ache wasn't as bad after one week but still had it. But head ache and sore throat every day in the evening. off and on chills continues. and fatigues hits from normal chores. Just walking in grocery stores floors me, or just cooking something.
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| 53 | 2021-03-23 | feeling abnormal | EXTREME debilitating fatigue 4 about 9 days. Unsteady on feet, brain fog |
| 53 | 2021-03-24 | anxiety, nervousness |
Dizzy, anxiety, R.S., feels lightheaded, Hot, Rested, gave water, calmed pt down, pt is nervous, no...
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Dizzy, anxiety, R.S., feels lightheaded, Hot, Rested, gave water, calmed pt down, pt is nervous, normal behavior for pt per the pt. Nervous for the last 3 days
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| 53 | 2021-03-24 | anxiety | Anxiety, syncope, abnormal feeling in her throat |
| 53 | 2021-03-24 | anxiety |
immediately after receiving the vaccine however she "felt dizzy and the room was spinning". It impro...
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immediately after receiving the vaccine however she "felt dizzy and the room was spinning". It improved right away, but the mild dizziness stayed for 20 minutes. She also verbalized lots of anxiety about the vaccine.
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| 53 | 2021-03-24 | feeling abnormal, nervousness |
staff member was asked by writer if she had any anaphylactic reaction to any previous vaccines in th...
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staff member was asked by writer if she had any anaphylactic reaction to any previous vaccines in the past and she stated NO but was nauseated and felt funky from the flu shot. covid vaccine given at 1523 and approx. 3 -4 minutes after in the observation area she started stating that she felt numbness in her mouth and felt funky. she also was a little tachy and shaky of her upper extremities. we followed standard protocol for infusion reaction and gave 1 dose of epinephrine stat and activated emergency response system. she started to feel better but was nauseous. EMS arrived and no other doses of epinephrine administered. EMS transferred to ER.
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| 53 | 2021-03-24 | insomnia, anxiety |
Pfizer-BioNTech COVID-19 Vaccine EUA 24-48hrs after: injection site pain spread to whole-body muscle...
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Pfizer-BioNTech COVID-19 Vaccine EUA 24-48hrs after: injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious/choking amounts of mucous from nose & throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F), sweating, chest pressure & back pain on left side from waist to neck, difficulty breathing, severe insomnia. 48-72hrs after: all of the above EXCEPT coughing/sneezing/mucous/vomiting/diarrhea. Soft stools w/loss of bowel control. Growing anxiety due to chest pressure/back pain on left side from waist to neck, difficulty breathing & severe insomnia.
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| 53 | 2021-03-25 | anxiety, confusional state |
Severe chest pain; Severe headache; Racing Heartbeat; Vomit; Pain in my left side of my arm; Pain in...
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Severe chest pain; Severe headache; Racing Heartbeat; Vomit; Pain in my left side of my arm; Pain in my left side of my arm, Shoulder; Dizziness; Very tired; Sleepy; Anxiety; Not knowing where she was; This is a spontaneous report from a contactable healthcare professional (patient). This 53-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) on 22Jan2021 at 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included anemia, gastritis, and peptic ulcer. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient previously received penicillin from an unknown date for an unknown indication and experienced allergy. On 23Jan2021 at 21:00 the patient experienced severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month. The patient went to a doctor or other healthcare professional office/clinic visit as a result of the events. The patient did not receive any treatment for the events. The outcomes of severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month were recovered with lasting effects. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 53 | 2021-03-25 | depression | Severe depressive episode that lasted two days, and then repeated 7 days later for one day. |
| 53 | 2021-03-25 | feeling abnormal |
Extreme flushing and fatigue, nausea, cough, headache, brain fog, burning sensation in both lungs. T...
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Extreme flushing and fatigue, nausea, cough, headache, brain fog, burning sensation in both lungs. The fatigue and nausea still present one week after vaccination.
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| 53 | 2021-03-26 | anxiety | Patient experienced stomach cramps/pain, anxiety, increased pulse/high blood pressure |
| 53 | 2021-03-26 | anxiety |
03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face ...
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03/23/21 Redness of face, neck, anxiety, rapid heart rate. 03/24/21 Vomiting, red dots on my face especially around my eyes and slight swelling of my eyes, weakness.
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| 53 | 2021-03-26 | feeling abnormal, panic reaction |
Client waited for 15 minutes after vaccine, said she felt "off," but proceeded to her car. Once in h...
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Client waited for 15 minutes after vaccine, said she felt "off," but proceeded to her car. Once in her car she noticed she was red, flushed, had one hive on her chest. AT 2:20 She proceeded back into the building and was taken to the emergency area for observation. 2:30 pm, she had bilateral redness in cheeks, BP 138/85, 97% O2, 74 HR., red spot on chest. 2:47pm 97% O2, BP 178/98. 2:55 BP 182/102, Dr called for consultation. Dr. gave verbal order to proceed with IM Benadryl, and monitor for another 15 minutes to see if epi pen was indicated. 3:01, Benadryl given IM in left deltoid. Lot# 080012, expiration: 08/2022. 3:03 O2 97%, HR 80. 3:04, patient became panicked that she could not swallow, Nurse administered Epinephrine autoinjector into left thigh. Lot # 0FM534, Expiration: 9/2022. EMS called 3:06pm. Vital signs stable, client reported feeling cold and had chills. Client reported ease in swallowing almost immediately. Client taken to hospital around 3:15.
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| 53 | 2021-03-28 | excessive sleepiness |
Approximately 103 degree fever in 53 year old excessive sleep, chills, headache, aches, etc. Second ...
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Approximately 103 degree fever in 53 year old excessive sleep, chills, headache, aches, etc. Second day fever was closer to ~101+ Fever did not break for 3 days It took 5 days to feel back to original state
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| 53 | 2021-03-31 | feeling abnormal |
Eight hours after injection I had normal injection arm pain. 29 hours after injection I fainted but ...
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Eight hours after injection I had normal injection arm pain. 29 hours after injection I fainted but did not lose consciousness. I am prone to fainting so I didn't think anything of it, however my husband also fainted (he was at home, I was not) at roughly the same time and he has never fainted in his life. The day after fainting I ran a low-grade fever of 99 and was foggy all day, enough to make me not drive and conversations were a little slow in the thinking process.
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| 53 | 2021-04-02 | feeling abnormal |
Fever, and chills for 12 hours. fatigue, brain fog, body aches for three days. Injection site pain f...
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Fever, and chills for 12 hours. fatigue, brain fog, body aches for three days. Injection site pain for 5 days.
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| 53 | 2021-04-02 | impaired work ability |
About 5 hours after vaccination, I started feeling very tired that I had to tell my employer that I ...
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About 5 hours after vaccination, I started feeling very tired that I had to tell my employer that I wouldn't be able to continue working much longer. I work from home at a computer. After 6 hours after vaccination (4 pm), I was so exhausted that my mouth muscles were too weak to be able to speak strongly. My muscles were too relaxed that I needed to lie down at this point. Inside my mouth, near my lips, there was a warming sensation (no pain). I've never experienced that before. It didn't last long. After about 6.5 hours after vaccination as I was in bed, I felt a little pain in my right thigh for an unknown reason. For a few seconds I felt a little nauseated so I kept a kidney dish near my head in bed. I slept in a deep sleep for at least 2 straight hours. I woke up groggy and with a very dry mouth. I usually drink a lot of water in my typical day, but after my vaccine I do not recall being unusually thirsty. I may have inadvertently dehydrated myself. That night after my vaccination I had a very dry mouth while sleeping. When I woke up each time, I would drink a little water. That carried over to the 2nd night after my vaccination, despite drinking a lot of water that day. Meanwhile, I had not had any alcohol, coffee, nor any caffeine during this entire time.
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| 53 | 2021-04-04 | anxiety, emotional distress |
53 y/o woman presented for her first COVID vaccine. She had hx of allergic reaction to IV Contrast i...
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53 y/o woman presented for her first COVID vaccine. She had hx of allergic reaction to IV Contrast in 2006 and 2014 - within minutes of receiving IV contrast for an imaging study she developed throat closing, difficulty breathing and vomiting. She has tolerated vaccinations and IV medications in the past without any problem. She also tolerated bowel prep for her colonoscopy a few years ago. Denies known allergy to PEG. I sent secure chat to her PCP and received approval to proceed with vaccination today. The patient was warned of the increased risk of allergic reaction to the COVID vaccine due to her allergic reaction to IV Contrast in the past. She expressed understanding and stated she still wanted to receive the vaccine despite the increased risk. 10 min after receiving the vaccine she developed significant nausea and dry heaving. Vitals were within normal limits. Physical exam was unremarkable except for anxiety and vomiting. 18 min after the vaccine she developed lightheadedness and a headache. 27 min after the vaccine she developed diaphoresis and a sore throat. Vitals and physical exam were monitored closely. 30 min after the vaccine she developed itching of her ears, nose and posterior pharynx. She also c/o burning sensation from her nasal passage to her throat. She had coughing and throat clearing. Vitals were unremarkable. Exam revealed increased distress. 35 min after the vaccine she suddenly developed tightness of her throat associated with worsening throat itching and difficulty breathing. Vitals: HR 110, Spo2 94%, BP 136/80, RR 20 PE: A&Ox4, appears anxious and is in acute distress, she had hands around her throat. Cardio: tachycardic rate, regular rhythm, radial pulse 2+ Pulm: Tachypnea noted, lungs clear to auscultation, no wheezing, cap refill < 2 sec Skin: facial flushing noted, diaphoresis resolved, no urticaria, no swelling or erythema at injection site. Expressed to patient that I was concerned about an allergic reaction occurring and described my next steps of administering EPI and calling EMS. She was agreeable. EMS was called by CMA. Epi Autoinjector 0.3 mg injected into RIGHT upper outer thigh at 10:57 AM Her throat tightness, throat/ear/nasal itching, throat clearing, cough, lightheadedness and headache all resolved within 10 min after the EPI was given. Oral benadryl 25 mg was given. EMS arrived at 11:18 AM and took over care. The patient was agreeable to be transferred to ER for further monitoring.
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| 53 | 2021-04-04 | anxiety |
1845: Pt. received vaccine in rt. arm. and was instructed to wait in Covid vaccine clinic waiting ro...
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1845: Pt. received vaccine in rt. arm. and was instructed to wait in Covid vaccine clinic waiting room for 15 min. for monitoring of adverse reaction. 1850: While waiting in waiting room of clinic, pt. reports starting to feel itchy and anxious, causing her to feel SOA. Pulse oximeter shows saturation of 98%, HR 86, BP 150/100. Pt. reports the high BP is normal for her and that it is time for her to take her BP medication, which is at home. Discussed need for continued monitoring for adverse reaction and evaluation in ED. Pt. refuses treatment or eval. in ED at this time. Pts. husband is with her in clinic. Pt. agrees to take Benadryl PO. 1858: Benadryl 25 mg tab admin. PO at this time, explained to pt. that she needs to stay for continued monitoring, she agrees. 1910: Pt. reports decreased anxiety, denies SOA, still feels "a little" itchy on face. O2sat 99%, HR 78, BP 146/92. Pt. requesting to go home with Husband. Reviewed S&S to call for and ED treatment. Pt. verb. understanding and denies current questions. 1921: Pt. ambulatory out of clinic, accompanied by her husband. Pt. stable at time of departure, mild c/o itchiness.
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| 53 | 2021-04-04 | impaired work ability |
After my first dose Pfizer vaccine, I felt light headed and developed slight pain to the left side o...
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After my first dose Pfizer vaccine, I felt light headed and developed slight pain to the left side of my neck. I had slight headaches and felt fatigued. For several days I had headaches and the left side of my neck was sore and I felt very fatigued. I also had an episode of shortness of breath with dizziness. I went to play top golf with my kids and after playing I felt very fatigued, tired and this went on for about one week. I missed three days of work. I also then developed a migraine headaches to the point that i vomited profusely. I took headache medication which temporarily relieved my pain. I also started to have blurry vision, vertigo and I spent two days in bed. I had no fever. Of and on, I keep getting SOB upon light exertion. On the past Wednesday and Thursday I experienced dizziness and I had to stay in bed because I felt sick to my stomach and I continue with the pain to the my left side of my neck. I still have not gotten my second dose Pfizer vaccine.
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| 53 | 2021-04-05 | feeling abnormal |
At 45 minutes approx after the vaccine was given in my right arm, my lips and the area of my face ar...
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At 45 minutes approx after the vaccine was given in my right arm, my lips and the area of my face around my mouth were tingling and felt "rubbery". More specifically its as though a 2 inch wide circle around my mouth and my lips were affected. My tongue and throat were no affected at all. There was no constriction of breathing. There was no swelling or nothing discernable. This sensation stayed with me for about 1 hour. I want to note that the fist shot had slighter but similar symptoms. For the first shot I felt a much more mild version of what happened for the second shot.
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| 53 | 2021-04-06 | sleep disorder |
Body aches beginning in the middle of the night, in process of subsiding now but back and body is st...
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Body aches beginning in the middle of the night, in process of subsiding now but back and body is still sore Intense itching/burning of hands and feet, beginning about midnight and waking me about every twenty minutes until dawn. Gone now.
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| 53 | 2021-04-07 | anxiety |
Patient reported feeling anxious, having trouble breathing, and like her tongue was tingling approxi...
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Patient reported feeling anxious, having trouble breathing, and like her tongue was tingling approximately 30 minutes after receiving her vaccine. We called paramedics, they determined that she did not need to be transported to the hospital. Patient stayed another 30 minutes and felt fine.
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| 53 | 2021-04-07 | crying |
Almost immediate severe suicidal thoughts. Within hours. Crying. Anger. Inability to control thou...
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Almost immediate severe suicidal thoughts. Within hours. Crying. Anger. Inability to control thoughts of self-harm and crying. I thought I was contacting a help line by clicking this link, but it?s just a long form. It?s upsetting. So many mental health issues since getting COVID. I hope everyone reading this is well.
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| 53 | 2021-04-07 | feeling abnormal |
At approx. 1339, pt reported fogginess and dizziness. Airway, and breathing were clear. Vitals were...
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At approx. 1339, pt reported fogginess and dizziness. Airway, and breathing were clear. Vitals were 130/90 BP, 90 BPM (strong), 99% O2 room air, and 14 RR. Pt reported only having orange juice at 1200. Pt was asked to drink water and stay for further observation for 15 minutes. Pt reassessed at 1355. Vitals were 120/80, 85 BPM regular, RR 12 and 99% O2 room air. Pt stated she felt better and left facility with steady gait and unlabored breathing at 1400.
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| 53 | 2021-04-07 | sleep disorder |
vasovagal response; nausea; stomach pains; vomited; diarrhea; severe headache; neck and shoulder ach...
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vasovagal response; nausea; stomach pains; vomited; diarrhea; severe headache; neck and shoulder aches; neck and shoulder aches; 100.5 fever; tired; slept all day next day; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318), via intramuscular route of administration in the right arm on 13Feb2021 09:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. Concomitant medications included levothyroxine (manufacturer unknown), at 25 ug, daily, escitalopram (manufacturer unknown), 5 mg, daily, fish oil (manufacturer unknown) and calcium carbonate, colecalciferol (VITAMIN D 2000). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL8982), via intramuscular in the right arm on 23Jan2021 at 10:30 AM After administration of 2nd vaccine, the patient developed nausea, stomach pains, vomited, diarrhea, severe headache, neck and shoulder aches, 100.5 fever, tired, slept on 14Feb2021. Also had vasovagal response 14Feb at 1:00 pm and almost passed out. The patient underwent lab tests and procedures which included Body temperature: 100.5 on an unspecified date. The reported events were considered as non-serious by the health authority. The outcome of the events were recovering. No follow-up attempts are needed. No further information is expected.
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| 53 | 2021-04-08 | anxiety |
53 yo female with a history of PE 12 years prior after 22 hour flightreceived her first dose of Pfiz...
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53 yo female with a history of PE 12 years prior after 22 hour flightreceived her first dose of Pfizer BioNTech vaccine on March 20. She tolerated the vaccine without report of systemic adverse events including headache, fevers, chills, myalgia, malaise or nausea. Eight days later (March 28) she experienced light-headedness and uneasiness reminiscent of her prior PE prompting her to visit the emergency room. Per patient D-Dimer was extremely elevated and PE protocol CT chest with IV contrast diagnosed multiple pulmonary emboli. This time, no immediate precipitating factors were identified. She has normal BMI (23), exercises regularly, is a never-smoker. She was placed on therapeutic lovenox 80mg BID. She indicated that is undergoing a workup for a hypercoagulable state and was told she may have antiphospholipid antibody syndrome, although the data and records to support this evaluation are not available for confirmation by undersigned.
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| 53 | 2021-04-08 | sleep disorder |
Pfizer-BioNTech COVID-19 Vaccine EUA. Symptoms: joint aches, fever, chills at night, dull headache...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Symptoms: joint aches, fever, chills at night, dull headache, fatigue, general malaise (?fogginess?), diminished appetite, slight nausea. Joint aches, dull headache and fatigue started about 11 hours after the vaccine was administered around 8:15 a.m. on Monday, 4/5/2021. Fever and light chills set in overnight, interrupting sleep. Fever of about 100.9 on Tuesday morning. Took 1 dose of ibuprofen in the morning and 1 dose of acetaminophen in the afternoon. Fatigue, joint aches, light headache, diminished appetite and malaise throughout Tuesday. Fever and a few chills overnight. Fever of 101 degrees Wednesday morning, with diminished appetite and slight nausea, along with general malaise and aches and fatigue. Took 1 dose of ibuprofen mid-morning. Symptoms improved throughout Wednesday, so that by about 7 pm, they seemed mostly resolved.
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| 53 | 2021-04-09 | insomnia, anxiety |
Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache;...
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Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache; Coughing; Sneezing; Copious amount of mucous from nose/throat; Copious amount of mucous from nose/throat; Nausea; Vomiting; Diarrhea; Chills; Lightheaded/dizzy; Fever (99.1-99.3F); Sweating; Chest pressure; Back pain on left side from waist to neck; Difficulty breathing; Severe insomnia; Soft stools with loss of bowel control; Soft stools with loss of bowel control; This is a spontaneous report from a Non-contactable consumer (herself reporting). This 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Not reported) via an unspecified route of administration in left arm on Mar2021 as a single dose for COVID-19 immunisation. The patient was allergic to mycin,neosporin/bacitracin. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. After 24 to 48 hours of vaccination the patient experienced injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious amount of mucous from nose/throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F)/sweating, chest pressure and back pain on left side from waist to neck, difficulty breathing, severe insomnia. After 48 to 72 hours of vaccination the patient experienced Soft stools with loss of bowel control. Growing anxiety due to chest pressure and back pain on left side from waist to neck, difficulty breathing and severe insomnia and all the above events except coughing, sneezing, mucous, vomiting and diarrhea and the patient was sent to emergency room/department or urgent care and hospitalized for one day. The patient received IV, EKG (electrocardiogram), blood panels, X-ray, Ibuprofen, Ativan (lorazepam) as treatment for the events. The patient underwent unknown COVID test post vaccination in ER (emergency room) which shown negative result. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-04-10 | feeling abnormal | Vertigo, Brain Fog, Headache, Unsteady gate, dizziness |
| 53 | 2021-04-12 | anxiety, nervousness |
Client received the 1st dose of COVID vaccine by Pfizer lot #EW0161 and expiration 4/14/2021 at 10:5...
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Client received the 1st dose of COVID vaccine by Pfizer lot #EW0161 and expiration 4/14/2021 at 10:58AM. At 11:30AM client reported to EMT that she felt shaky and anxious. Nurse responded and found client sitting upright and talking to EMT. Client has a history of high blood pressure and diabetes and had COVID during Christmas. Client is taking Lisinopril and bulsgar. Client reports no history of anxiety. Provided client with water and repeated sets of vitals. Client alert and oriented x 4. At 11:30 am the first set of vitals were taken: Blood pressure: 120/70, Pulse: 88, Oxygen 95%. At 11:40 am vital signs were: Oxygen 96%, pulse86 and blood pressure: 115/70. Client reports she had a tightness in her chest at 11am but states it rapidly went away. client reports no headache or chest pain at this time. Client reports she has constant dizziness and blurred vision due to her diabetes. Client reports she sees her provider every three months. Provide client with emergency precautions. At 11:49am last set of vitals taken blood pressure: 115/70, oxygen: 95%, pulse:88 and client reports symptoms resolved and does not want to wait. At 11:50am client left facility with a steady gait.
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| 53 | 2021-04-12 | feeling abnormal |
Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/...
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Started to have tremors within minutes of shot; observer made me go to EM as said I did;t look good/was very pale and noted shaking. EMT took BP which was high (I'm typically on lower end of average). Observed me for 45 minutes as BP came down to normal range and asked if wanted to go to hospital. Declined as had appointment later that day with my electrophysiologist at Hospital. As day went on, became increasingly tired and had bouts of uncontrollable shaking. Thought it would wear off so just went home to rest. On 3/31/21, BP was high again, tremors were getting worse, had leg weakness, double vision, brain fog, dropping things, loose stools, felt off. Went to Hospital and was admitted for 3 days. Neurloigst, Dr., said it was due to Covid vacccine and NOT to get the second shot, and the hospital internist agreed (MRI of brain and cervical spine showed no new lesions). Wanted todo heart procedure but they are not my private cardio group so checked myself out and went to Hospital the next day (admitted 4/3-4/5/21)
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| 53 | 2021-04-13 | feeling abnormal, loss of personal independence in daily activities, impaired work ability |
Beginning 4 hours after the injection I experienced flu-like symptoms; muscle aches and pains, feve...
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Beginning 4 hours after the injection I experienced flu-like symptoms; muscle aches and pains, fever (took Tylenol to control did not go over 100), brain fog, fatigue, abdominal pain and diarrhea. These symptoms lasted for 3 days. In addition, during that time I started to experience difficulty walking; stiffness in my legs, cramping, burning in my feet, toes, aches and pins and needles in my toes and hands and fingers, overall shaky, with poor balance. The fever, brain fog, fatigue, abdominal pain and diarrhea resolved by Day 4; however all of the other symptoms difficulty walking, stiffness, cramping, burning, pins and needles throughout my body remain. The pain level has been as high as a 9 on a scale of 1 to 10. The widespread pain continues all day and night. Prior to the vaccine I was cycling an hour a day and now I have difficulty walking in my house and performing daily tasks and have so much pain in my hands I'm having trouble with computer skills for my job.
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| 53 | 2021-04-13 | impaired work ability |
Tuesday Feb 9, 102 Fever, sweats , Migraine headache, Chills, Same symptom's10th 11th 12 Nausea, Vo...
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Tuesday Feb 9, 102 Fever, sweats , Migraine headache, Chills, Same symptom's10th 11th 12 Nausea, Vomiting Diarrhea , Went to ER. Symptoms continued for another week. Went to ER again Feb20, same got worse returned to ER, they performed MRI, found liver & spleen enlarged on February 23rd, was admitted for 5 days of fluids. Was advised that something had triggered CMV in my body. After eye exam they found CMV Retina, I am still being treated for this condition currently with Valganciclovir. Per Dr. I may have to take meds for 6 months. I was released from Hospital on Feb27th, I still had fevers over 100 and could not take tylenol or advil, I had to ice down my body for over a week fevers continued. They finally went away and I was able to return to work on March 5th with restrictions as I was not fully recovered
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| 53 | 2021-04-13 | impaired work ability |
On the day following dose #2, developed the following symptoms: chills, fever (Tmax 103F) -- require...
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On the day following dose #2, developed the following symptoms: chills, fever (Tmax 103F) -- required OTC tylenol, resolved after 24 hours myalgias with severe muscle weakness that impaired my ability to walk up and down stairs -- weakness resolved after 24 hours, but myalgias resolved after 72 hours headache -- resolved after 24 hours nausea/anorexia -- resolved in 72 hours fatigue -- resolved in 24 hours Symptoms severe for the first 24 hours that I was unable to work
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| 53 | 2021-04-15 | anxiety | heart felt it was beating fast, feel anxious |
| 53 | 2021-04-15 | anxiety |
205/94, HR 70, Resp. 70, Chest discomfort, anxious, anxiety. Pt. complain of chest discomfort after ...
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205/94, HR 70, Resp. 70, Chest discomfort, anxious, anxiety. Pt. complain of chest discomfort after receiving second dose of vaccine. Emergency personnel. Pt. was transferred to Hospital for further evaluation.
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| 53 | 2021-04-15 | feeling abnormal |
I felt an immediate flush to my whole body and my throat started to tighten and swell. But it stopp...
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I felt an immediate flush to my whole body and my throat started to tighten and swell. But it stopped after about 1 minute. I felt the same thing again after maybe 5 minutes and then about 45 minutes (on my way home). Since then, I have been experiencing allergic reactions to many foods and medicines that I have eaten/taken for years. I feel constant pressure/swelling on my throat and neck. I was hoping it would calm down after a few days. On monday April 12th I accidently consumed a few drops of milk, which normally would just cause stomach upset, but this set off another round of pressure in my throat. I tried to rest and took some benadryl, but on Tuesday I went to the walk-in clinic. They prescribed me some steroids (3 pills), and gave me a steroid shot. I have stopped taking the pills, as I seem to be reacting to something in them. The reaction is the same, throat swelling, flushed feeling, red face. This does not seem to be fading, as I had hoped.
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| 53 | 2021-04-15 | hallucination | Swelling at injection site Pain Fatigue Fever - 102 deg F Chills Muscle Aches Hallucinations |
| 53 | 2021-04-15 | sleep disorder |
After patient received the vaccine the following events occurred: - Office visit with PCP 4/14/2021...
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After patient received the vaccine the following events occurred: - Office visit with PCP 4/14/2021. Complaints consisted of chest pain, SOB, left shoulder and left breast soreness and pain, difficulty sleeping. CT and EKG test ordered and performed. - CT result showed bilateral Pulmonary Embolism. - Lower extremity doppler ultrasound was also performed and negative. Patient is still admitted to hospital and awaiting overall outcome.
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| 53 | 2021-04-16 | insomnia, nervousness |
numbness/tingling in hands and feet specs in urine Water feeling in the left ear nervousness feeling...
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numbness/tingling in hands and feet specs in urine Water feeling in the left ear nervousness feeling in my body like jitters and I can see some twitching Back, abdominal, and right side pain insomnia heartburn slight fever for one day Blood pressure elevated and slightly lower lip soreness diarrhea
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| 53 | 2021-04-17 | anxiety, nervousness |
Headache; Suicidal; weird feeling, bad feeling in her head that was getting worse; Anxious; Nervous;...
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Headache; Suicidal; weird feeling, bad feeling in her head that was getting worse; Anxious; Nervous; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 19Mar2021 11:00 (Batch/Lot Number: EP7534) as SINGLE DOSE for COVID-19 immunization at the pharmacy. Medical history included ongoing dilated pulmonary artery diagnosed 2-3 years ago. Concomitant medications were not reported. The patient received the vaccine on 19Mar2021 11:00. After 5 hours, she had a weird feeling, bad feeling in her head that was getting worse. She was completely suicidal the next day (20Mar2021) and the day after that that lasted for like 3 days maybe. She also had a headache on 26Mar2021 that has lasted for 2 weeks. She was not suicidal anymore, but still felt anxious. She did not treat her symptoms in any way, but finally got alprazolam (XANAX) from her doctor. She was due for second one and was a little nervous. The patient recovered with sequlae from suicidal on 23Mar2021; recovered from headache on 09Apr2021; unknown for nervousness while not recovered from the remaining events No follow-up attempts are possible. No information is expected.
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| 53 | 2021-04-18 | anxiety |
reported upper lip tingling & anxiety due to vaccinator asking and telling her about news / social m...
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reported upper lip tingling & anxiety due to vaccinator asking and telling her about news / social media describing adverse events / deaths . R/T Covid vaccines & relaying he/she didn't get & won't get vaccinated. no other S/S; lip is not swollen; TX- support emotionally & issue taken to Medical Dr.
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| 53 | 2021-04-18 | sleep disorder |
A little over 24hrs after my 2nd shot I just started to hurt all over. My left arm had been sore, bu...
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A little over 24hrs after my 2nd shot I just started to hurt all over. My left arm had been sore, but that is normal with most vaccines. This was the "my everything hurts" . It did not matter if I was moving or sitting still. Also, my normal body temp was up 1 degree. This started around 6pm the day after the shot. I went to bed around 11pm, and had a glass of chocolate milk, as that helps with sore muscles after a hard workout. I awoke around 4am in a sweat. My temp was down, and the all over hurt was gone.
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| 53 | 2021-04-19 | anxiety |
4/20/2021 Patient was observed post Covid-19 immunization for 30 minutes . During the observation...
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4/20/2021 Patient was observed post Covid-19 immunization for 30 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness. Assessment : Time of assessment 1620 Alert and oriented and Anxious. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Jiuce given, VS at 1620- BP- 137 98, P- 11, O2- 99%, recheck of VS at 1634, BP- 145/94, P- 97, O2- 100% Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/20/2021 3:37 PM
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| 53 | 2021-04-19 | disorientation, disturbance in attention |
She got the vaccine, within the first night she woke up around 9:00 to 10:00 as she felt more fatigu...
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She got the vaccine, within the first night she woke up around 9:00 to 10:00 as she felt more fatigued. She had pulsing ringing (already has tinnitus), really loud ringing. Her skin was really hot (sunburn hot), tongue was sore, her eyes hurt (tissue burning sensation) feeling. Heft left arm was extremely painful, but went away. The headache all through the front, part of her forehead, eyes, head, and took 2 Tylenol. About 3 days after that her right wrist started hurting, throbbing pain. She has never had any joint pains. She has been taking Turmeric, the right wrist is still hurting. She did have body aches, throat, and all symptoms, felt like she had a flue/cold. She is completely dizzy, disoriented and not able to use her phone. She is not able to regain her balance at this point. The lingering effects are she cannot read, she always feels like she has been lost in space. The pain is improving, but is still present. When she looks down the dizziness is a lot worse. She has pushed back the 2nd vaccine. She has called her doctor and reported this who told her to call us. She took Claritin and it stopped a lot of the symptoms.
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| 53 | 2021-04-19 | feeling abnormal |
Stomach cramps, gastrointestinal issues, diarrhea, loss of appetite, lethargy, fatigue, occasional d...
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Stomach cramps, gastrointestinal issues, diarrhea, loss of appetite, lethargy, fatigue, occasional dizziness, brain fog, shakiness
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| 53 | 2021-04-19 | feeling abnormal | Severe fatigue, fever, muscle aches, severe brain fog |
| 53 | 2021-04-20 | anxiety |
4/21/2021 Pt was observed post Covid-19 immunization for 15 minutes . During the observation peri...
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4/21/2021 Pt was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness, weakness and low blood sugar. Assessment : Time of assessment 113pm. Alert and oriented, Anxious and Diaphoretic. Actions taken: Vitals sign taken form obtained and completed by RN. VS at 113pm BP- 152/81, P- 68, O2- 98%. Recheck at 128pm, BP- 102/65, P- 69, O2- 100%, Recheck at 140pm, BP- 136/65, P- 68, O2- 100%. Juice given x 2, Fan place on patient to circulate air. Medications administered: none Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 1:10 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc
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| 53 | 2021-04-20 | feeling abnormal |
Systemic: tachycardic and uncontrollable shaking-Medium, Systemic: Shakiness-Medium, Systemic: Tachy...
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Systemic: tachycardic and uncontrollable shaking-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: 30-35 min post injection...patient complained of feeling strange and her heart was pounding. Measured BP at 160/95 and P at 117. Had patient sit in armed chair and drink some water. Continued taking vitals every 5 minutes. At about 45 minutes post injection patient started shaking uncontrollably. About 15 minutes later vitals returned to normal range. Had patient sit for another 10-15 minutes then had her stand to check for orthostatic hypotension. Advised patient to contact PCP.
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| 53 | 2021-04-21 | impaired work ability |
Very bad Chills ans shaking first night. Nausea day 2 and 3. Normal on day 4. Severe diarhhea days 5...
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Very bad Chills ans shaking first night. Nausea day 2 and 3. Normal on day 4. Severe diarhhea days 5 and 6 along with all over body aches. Unable to eat due to nausea days 6-8, Day 7 severe nausea, body aches with uncontrollable shaking all night, Entire body of nerve in excruciating pain. Day 8 (today) Felt like I needed to go to the ER last night. Can't go to work. In bed all day with continued bouts of chills and shaking. Fever has been low grade or none during all this.
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| 53 | 2021-04-21 | insomnia | headache, joint pain, chills, swollen lymph gland (right armpit), low grade fever, fatigue, insomnia |
| 53 | 2021-04-21 | sleep disorder |
Full body muscle and joint pain, headache, low-grade fever, chills, fatigue, nausea. My skin even hu...
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Full body muscle and joint pain, headache, low-grade fever, chills, fatigue, nausea. My skin even hurt. All symptoms woke me up in the middle of the night about 14 hours after receiving the vaccine and lasted for about 24 hours.
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| 53 | 2021-04-24 | nervousness |
Patient had some difficulty with the 1st dose of this vaccine at a different location. She was very...
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Patient had some difficulty with the 1st dose of this vaccine at a different location. She was very nervous(highly anxious) about receiving the 2nd dose. She had a fair amount of pain on injection and on administering the vaccine. Quite unusual for 0.3ml dose. While waiting in area, she became very hot, thirsty, her husband got her some water, she was becoming very pale, I was clearing a spot in immunization room for her to lay down and elevate her legs to help with that, before I could get the location prepared, her husband noticed she was about to pass out. At that point she did pass out for a very short time, I prepared and administered a dose of 0.3mg EpiPen in the left outer thigh. I did this at approximately 01:33pm. All the events occurred very rapidly, she responded to the epi pen as far as her consiousness was concerned, then we called "911"! While waiting for the paramedics she began vomiting and continued that until they arrived and after they arrived. They administered a dose of andansetron and fluids IV. They then took her to the hospital for further treatment and observation,
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| 53 | 2021-04-24 | sleep disorder |
Fever of 102 degrees, backache so severe it brought her to tears, woke up at 3 in the morning, Gener...
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Fever of 102 degrees, backache so severe it brought her to tears, woke up at 3 in the morning, General malaise, pain at injection site
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| 53 | 2021-04-24 | sleep disorder |
Left arm hurt like hell for 3 days could not use it, raise it and throbbed from shoulder to elbow , ...
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Left arm hurt like hell for 3 days could not use it, raise it and throbbed from shoulder to elbow , couldn?t sleep without pain medication
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| 53 | 2021-04-25 | sleep disorder |
Severe body aches, entire body. My scalp hurt, my ribs, everything. This started 13 hours after inje...
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Severe body aches, entire body. My scalp hurt, my ribs, everything. This started 13 hours after injection. Fever, chills, unable to walk or stand, exhaustion but unable to sleep. My vision also seems to be impaired. I'm not seeing as well as I should be. Random heart palpitations. Sore arm at injection site, red and warm to the touch.
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| 53 | 2021-04-26 | impaired work ability, disorientation |
Received the shot on Friday, 4/16/2021, between 10:15-1030 am.. Woke up feeling sick to my stomach, ...
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Received the shot on Friday, 4/16/2021, between 10:15-1030 am.. Woke up feeling sick to my stomach, Sunday morning, 4/18/2021, at 04:00 am.. Very nauseated. Threw up 7 times between Sunday and Tuesday, 4/20/2021. Had dry heaves when I couldn't throw up any more. I couldn't keep water down. Cold chills. Fever. First fever was 100, then 101 and 99. Very disoriented. Ate chicken broth and crackers threw that up on Tuesday, 4/20/2021. All I could do was lay in bed. Missed 2 days of work. Worked from home on Wednesday, 4/21/2021. Worked half day in office on Thursday, 4/22/2021 and Friday, 4/23/2021. On 4/24/2021, Saturday still had a little bit of nausea. My first day without nausea completely was yesterday, Monday, 4/26/2021. There was no treatment. I couldn't take my medication for 3 days because all I was doing was throwing up. Drank sips ginger ale, water and pedialite.
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| 53 | 2021-04-27 | feeling abnormal |
Started feeling funny on my drive home. Severe headache, brain fog, overwhelming fatigue, nauseated,...
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Started feeling funny on my drive home. Severe headache, brain fog, overwhelming fatigue, nauseated, ached all over, fever of 101. It felt like I had Covid all over again like last July. Drinking lots of water, not hungry, ibuprofen every 6-8 hours. Still feel very ill.
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| 53 | 2021-04-27 | sleep disorder | 4 days of chills, nausea, not sleeping but constantly tired. |
| 53 | 2021-04-28 | feeling abnormal |
Began with rash, severe body aches, loss of smell and taste, brain fog, unsteadiness, nausea, diarrh...
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Began with rash, severe body aches, loss of smell and taste, brain fog, unsteadiness, nausea, diarrhea that eventually led to dehydration and finally colitis that resulted in ER visit for fluids; sent home; next day, passed out at home, back to ER and was admitted for the colitis.
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| 53 | 2021-04-28 | excessive sleepiness |
After shot 1, I had severe brain fog and a flare-up of my sarcoidosis with itching shins, fatigue, s...
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After shot 1, I had severe brain fog and a flare-up of my sarcoidosis with itching shins, fatigue, swollen lymph nodes. After shot 2, my system was initially fine. No reaction at all, in fact. But within 4 days, the sarcoidosis flare-up kicked in and has been building with nothing stopping it that normally works - rest being the big thing. I've slept 9-10 hours a night, plus naps as possible, and it has gotten progressively worse. Joints, lymph nodes in areas that aren't usually swollen joining the usual areas, facial swelling, itchy shins, and an incredible brain fog. I am beginning a course of prednisone today.
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| 53 | 2021-04-28 | nervousness |
1815: Fifteen minutes after injection given the patient felt, "hot, shaky, ears itching, swollen lip...
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1815: Fifteen minutes after injection given the patient felt, "hot, shaky, ears itching, swollen lips, itchy all over." She was given 100mg total of Benadryl. Patient AOx3 1830: Continues with increased heart rate, complaining of swollen tongue. Patient's personal Epi pen given and EMS called. Patient AOx3 1845: EMS arrived 1855: EMS departed for Emergency Room.
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| 53 | 2021-04-29 | disorientation |
4/20 diarrhea and nausea, loss of appetite; 4/21 cold sweats, fever, chills, fatigue, loss of appeti...
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4/20 diarrhea and nausea, loss of appetite; 4/21 cold sweats, fever, chills, fatigue, loss of appetite; 4/22-4/23 fatigue, intermittent fever, headaches; 4/24 cognitive difficulties, disorientation, highly susceptible to suggestions that were counter to self interest and needs, headache, fatigue
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| 53 | 2021-04-30 | feeling abnormal |
swollen joints; her back condition and may have "pinched a nerve or something; describes it as the w...
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swollen joints; her back condition and may have "pinched a nerve or something; describes it as the worst pain; the leg pain that she is experiencing and would like to know if it is possible that it could be related to a blood clot; leg pain; also has some tingling on the skin; It feels like a Charley's horse; had a horrible flu; Her every muscles and every joint hurt, and her head hurt; Fever; body aches; chills; joint pain; Her every muscles and every joint hurt, and her head hurt; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 07Apr2021 at 14:00 (Batch/Lot number was not unknown; Expiration Date: 31Jul2021), at age of 53 year-old, as 0.3 mL single, for Covid-19 immunisation. Medical history included liver disease from 2016 and ongoing. There were no concomitant medications. The patient previously took the first dose on 17Mar2021 for Covid-19 immunization and experienced fever. The patient received her second dose of the Pfizer BioNTech COVID-19 vaccine on 07Apr2021 and reports having side effects after. She is specifically worried about the leg pain that she is experiencing and would like to know if it is possible that it could be related to a blood clot and if she needs to be worried about it. She stated that with the "swollen joints" and everything from the vaccine, it is possible that it worsened her back condition and may have "pinched a nerve or something." She describes it as the worst pain she's ever felt in her life and states it "comes out of the blue" so she does not have time to prepare for it. She likens it to a "Charley horse" but a "really bad one" that goes away and has no pain afterwards. She states she is scheduled for an MRI next week of her lower back to investigate. The patient also mentions that she thinks she had COVID-19 at the time of her vaccine because "when I got the shot, I had a super strong response." On 07Apr2021, the patient had body aches, chills, she was on the couch for quite a while. The joint pain was incredible, even in her toes. She felt like she had a horrible flu. Her every muscles and every joint hurt, and her head hurt. She was on the couch for like 4 days. On day 3 or 4 she developed intermittent pain in the leg and shin on 08Apr2021. It feels like someone is drilling a jackhammer in it. It feels like a Charley's horse, but not, more like it's in the bone. She didn't associate it with the vaccine at first, even though she had never had this pain before until she got the vaccine. She said that she has had some back problems and scheduled a MRI to see if she had pinched nerve or something. On 08Apr2021, she also has some tingling on the skin. She read about side effects of blood clots and doesn't know if this leg pain could be related to a blood clot. She assumed it could be from her back. She read that with blood clots there is usually an ache and discoloration, which she does not have now. She also read that intermittent Charley's horse could have something to do with blood clots. She has pins and needles on the skin. She also had a headache after the vaccine, but she does not have it now. She said that the pain in her leg that shoots on and bangs in her tibia hurts when bending over, lifting her leg to her chest, squatting to pick up something, and going up and down the stairs. She said that the pain is horrible and it is worse than leg pain, it is worse than a charley horse, it is the worst pain she has ever felt in her life. She cannot stop screaming when it happens. States with the joint pain that she had, there may be a nerve that's being pressed on her back. She said that with all of the information being reported in the news about blood clots, she asked is that something she needs to be concerned about. She said that she did a virtual visit with her doctor and notified her of the leg pain and asked the doctor to schedule her for an MRI because of the pain. She stated her hemoglobin and hematocrit, MCV are high. She also said that the clotting is affecting her red blood cells. She ran a fever with the first vaccine, but she had a high fever between 103-104 degrees Fahrenheit after the second vaccine that stopped on 12Apr2021 or 13Apr2021. Her high fever lasted for about 3 days. She had a low grade fever that lasted for about a week. Her body aches resolved completely on 12Apr2021 or 13Apr2021. Her joint pain is in her back and elbows. She also had lot of joint pain in her shoulder and arm and radiates to her neck on the left side. She still has some muscle pain in her leg, but overall her muscle pain is gone. For treatment she used Ibuprofen 600 mg by mouth and fluids. The day before her shot, her son called and told her he tested positive for covid. She got a PCR test immediately on 07Apr2021 and the next day she was told it was negative. She thinks she might have tested too soon. She also says her response to it was so strong, she must have been getting covid and didn't know it. She might have tested negative because she had the first shot already. She wasn't worried about exposing others and went to get her second shot, but she got really sick after that and it kicked her butt pretty hard. The outcome of the events for leg pain and tingling on skin was not recovered, fever, body aches and headache recovered in Apr2021, chills on 11Apr2021, muscle hurt/pain on 12Apr2011, joint pain was recovering, and outcome of other events was unknown.
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| 53 | 2021-05-01 | insomnia |
Severe myalgia, muscle cramp, headache, chills and fatigue. Progressively worse. Severe restrictio...
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Severe myalgia, muscle cramp, headache, chills and fatigue. Progressively worse. Severe restriction of rom in both arms. Right in particular. Unable to sleep 2/2 pain.
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| 53 | 2021-05-09 | confusional state |
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Light...
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild, Additional Details: Notified by another vaccinated person waiting that pts "eyes were rolling to the back of their head". RPh went over and pt was having difficulty speaking, difficulty breathing. Husband translated that she was saying she could not breathe. RPh instructed staff to call 911, grab epinephrine, grab pulse ox and BP cuff. Epipen was NOT administered although box was open and dose was taken out (EMS can confirm this as well). EMS arrived on scene when pts BP was 130/105, pulse 103, O2 sat 92.
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| 53 | 2021-05-19 | emotional distress, feeling abnormal |
Woozy and stumbled that evening. Next day extreme body aches and fatigue requiring bed rest. Same ...
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Woozy and stumbled that evening. Next day extreme body aches and fatigue requiring bed rest. Same for the day after (Sunday). Bedridden for majority of the two days after second dose of vaccine. Miserable suffering. I've experienced the flu with a sinus infection. This felt more than twice as bad.
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| 53 | 2021-05-19 | feeling abnormal |
pneumonia; I've been very very sick; body ache; chills; nausea; so tired/very exhausted; fever 99.3F...
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pneumonia; I've been very very sick; body ache; chills; nausea; so tired/very exhausted; fever 99.3F; a very strong headache; sore throat; The arm is very hot and swelling; The arm is very hot and swelling; pain in the back, neck and everything; pain in the back, neck and everything; shortness of breath; My eyes are so hot and burning; earache; she is not feeling very well; she had a really sore arm in the area of the shot; her head is foggy this morning and all day; This is a spontaneous report from a contactable consumer. A 54-year-old female patient (Age at time of vaccination 54 years) received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 04May2021 at 16:00 (Batch/Lot Number: EW0176) as SINGLE DOSE for covid-19 immunization. Medical history included back injury, neck injury, Knee Surgeries, 2 Bulging Discs, Heel Spurs and Sciatic all on the left ongoing since 2010 and Covid-19 on 29Mar2020. The patient's concomitant medications were not reported. The patient experienced pneumonia, i've been very very sick, body ache, chills, nausea, so tired/very exhausted, fever 99.3f, a very strong headache, sore throat, the arm is very hot and swelling, pain in the back, neck and everything, shortness of breath, my eyes are so hot and burning, earache, she is not feeling very well, she had a really sore arm in the area of the shot and her head is foggy this morning and all day all on 05May2021. Consumer reported "Since this morning I've been very very sick. I'm sick. I have body ache, chills, nausea, so tired, fever 99.3F, a very strong headache, sore throat. The arm is very hot and swelling. I had Tylenol this morning nothing is working. The body ache is so horrible, pain in the back, neck and everything. I had covid on march 29 last year, I had pneumonia. I have lingering issues, body ache and pain, I still get very tired, shortness of breath; I feel like it's coming back after getting the vaccine. My eyes are so hot and burning, you know the sensation when you have a fever. Commented how she felt like she was getting covid again after getting the vaccine. Yesterday, 04MAY2021, she was vaccinated with the Pfizer Covid Vaccine. States it was her first dose and she is having a lot of side effects. Her temperature is 99.2, she has body aches, earache, headache, a little bit of shortness of breath, very tired, very exhausted and she is not feeling very well. She is wondering if this is a normal reaction for the first vaccine? States it feels like when she had Covid. Clarifies at she was fine last night other than she had a really sore arm in the area of the shot and it is really hot, like if she has a fever in the area. States at 9:30-10:00 a.m. this morning she started having a headache, chills, and nausea. She took a hot shower, and had some tea and took Tylenol. It is progressing worse and worse. States she has body aches and fever getting warmer and warmer, and her throat feels a little bit sore. States all of them are getting worse. She is staying home and laying down not trying to do a lot, drinking water and staying hydrated. States she spoke to a friend and she said she is not supposed to get these side effects with first one. Her body aches are horrible, it feels like when she got the virus, all the aches and pains. Her head is foggy this morning and all day, and she has issues with pain all over, so much body aches. States she is reporting her side effects and she read the side effects but it seems like when she had Covid last March and she is still going through a lot of issues with it, the pain Covid left her with. States she did a Covid test, and she had antibodies, but this feels like the virus again. States she has the same symptoms as when she got the virus. Treatment: Took 2 Tylenol and nothing seems to help. UPC and Expiration: Unknown Lot: 110856. Caller states the UPC and Expiration got erased because she has had it for awhile. Tylenol Rapid Release 500mg.Caller states she took a hot shower, and had some tea. Caller states she is staying home and laying down not trying to do a lot, drinking water and staying hydrated. The outcome of the event pneumonia was unknown. Outcome of all the other events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 53 | 2021-05-19 | feeling abnormal |
Brain fog, Right face numbness. Right arm injection site pain, charly horse and still with pain with...
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Brain fog, Right face numbness. Right arm injection site pain, charly horse and still with pain with movement now. Right arm numbness down to right leg numbness at times. Left side cheek, throat numb feeling. Tongue feels numb and down thoracic spine.
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| 53 | 2021-05-19 | loss of personal independence in daily activities |
Started having a surge/relapse of symptoms associated with Meniere's Disease. Vertigo, nystagmus, lo...
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Started having a surge/relapse of symptoms associated with Meniere's Disease. Vertigo, nystagmus, loss of balance, bobble-headedness, headaches . Lasted over 5 weeks. Had to restrict driving and physical activities.
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| 53 | 2021-05-21 | anxiety, feeling abnormal |
fluctuating rapid heartbeat / my pulses goes from like 67 to 134; its feels like my muscles in my fa...
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fluctuating rapid heartbeat / my pulses goes from like 67 to 134; its feels like my muscles in my face not working well ,specially in my mouth itsreally concerning to me; almost collapsed while cooking; light headed and dizzy; cold tingling extremities; cold tingling extremities, buzzing , tingling and vibrating feeling; fatigue and exhaustion; tremors in face; my thyroid is been out of range though I am trying to get that back but I amreally worry; felt horrible; muscle weakness; instable in walking; chills; I am really worry; super strong neurological side effects/Having major neurological symptoms; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0172), via an unspecified route of administration, administered in Arm Left on 28Apr2021 at the age of 53 years as 2nd dose, single for COVID-19 immunization. Medical history included hypothyroidism, hypoglycaemia, small intestinal bacterial overgrowth, Epstein-Barr virus infection, mononucleosis (three times when I was younger), hearing impairment, and post menopausal from an unknown date. The patient reported that she was in good shape. Prior to all this she could walk 15000 steps a day and was in a good health. Concomitant medications included thyroid (ARMOUR THYROID) taken for hypothyroidism; valaciclovir hydrochloride (VALTREX) taken for Epstein-Barr virus infection; cetirizine hydrochloride (ZYRTEC) taken for sinus disorder, manganese taken for supplementation therapy; fish oil (OMEGA 3) taken for supplementation therapy; vitamin B6 taken for supplementation therapy; and vitamin B12 taken for supplementation therapy, all start and stop dates were not reported. The patient previously received the first dose of bnt162b2 on 07Apr2021 (lot number: ER8729) at the age of 53 years for COVID-19 immunization and experienced neurologic symptoms, body ache, chills, extreme fatigue, tingling in my extremities, like a buzzing sensation, vibrating sensation in my body, heart palpitation, cold extremities, extreme muscle weakness, "to the point even if even after making dinner I would feel like I was going collapse, and I could barely open my hand muscles", fluctuating rapid heart beat, muscles in my face not working, thyroid is been out of range, super light headed. The patient also received a flu shot on an unspecified date for immunization and had the flu. The patient reported having serious side effects to the vaccine. On 29Apr2021, 30 hours after the second dose, the patient had super strong neurological side effects/having major neurological symptoms. On an unspecified date after the second dose, the patient reported that she had fluctuating rapid heartbeat/my pulses goes from like 67 to 134, feels like my muscles in my face was not working well, especially in my mouth its really concerning, almost collapsed while cooking, light headed and dizzy, cold tingling extremities, buzzing, tingling and vibrating feeling, fatigue and exhaustion, tremors in face, thyroid has been out of range though I am trying to get that back but I am really worry, felt horrible, had muscle weakness, instable in walking, and chills. The patient underwent lab tests and procedures which included blood count: unknown results, Epstein-Barr virus test (viral load): heavy load, heart rate: 67, then 134, thyroid function test: out of range all on unspecified dates. The patient had a heart rate : 130 on 09May2021. The patient reported no treatment for the events. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 53 | 2021-05-23 | memory impairment, feeling abnormal, confusional state, disturbance in attention |
Confusion, inability to concentrate. "Brain Fog", very forgetful. Example, difficulty navigating nor...
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Confusion, inability to concentrate. "Brain Fog", very forgetful. Example, difficulty navigating normal local routes while driving; placing bread in toaster oven while still on paper plate; can't recall if daily medication was taken or not
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| 53 | 2021-05-25 | disorientation |
pt says she became very disoriented and dizzy. She had to put her hand out to catch herself while s...
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pt says she became very disoriented and dizzy. She had to put her hand out to catch herself while she was sitting. She kept getting these random episodes of dizziness. She went to her PCP on 1/18/21. She was told she had water behind her but she told him her ears were fine. She was given antibiotic and steroid. On 1/21/21 she started feeling a fullness with in her ear and began having tinnitus. It started with the right ear but eventually moved to both ears. On 1/25/21 she went back to her PCP and she was given another Medrol pack which did not help. She was still having episodes of a high pitch sound and humming noise like a machine. She went to ENT on 3/16/21. They did a hearing test and she was sent for a VNG test. VNG was abnormal. No DX was given. She returned to ENT on 4/5/21 and was told she needed to try the epley maneuver. Pts last visit was on 4/16/21 but does not seem to think this procedure helped any since she is still having symptoms. Now on 5/26/21 she is still having episodes of dizziness but feels like they are less frequent.
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| 53 | 2021-05-28 | insomnia |
itchy rash; itchy rash that looked like hives and was bumpy; itchy rash that looked like hives and w...
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itchy rash; itchy rash that looked like hives and was bumpy; itchy rash that looked like hives and was bumpy; she is not comfortable; She cannot sleep/has not gotten enough sleep; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 12May2021 16:45 (Lot Number: EW0183) as 1st dose, single for covid-19 immunisation (going to be traveling soon and needed it for work). The patient medical history was not reported. Concomitant medications included ongoing vitamin c [ascorbic acid] (VITAMIN C), ongoing vitamins nos (MULTIVITAMINS) and zinc with therapy date not reported, all for unknown indication. The patient has no previous immunization with the Pfizer vaccine considered as suspect or received additional Vaccines Administered on Same Date of the Pfizer vaccine. The patient did not receive other vaccines 4 weeks prior to vaccination. The patient mentioned that she had the vaccine yesterday, 12May2021 at 4:45pm in a hospital. She stayed for the 15 minutes after, and didn't feel anything but when she got home, she had an itchy rash (also reported as 02:30 am), like hives and she took some allergy pills. She further reported that when she got home, she felt something. It looked like hives and were bumpy, when she scratched it, it was like hives. It was in the middle of her body in the back, front and in her neck, that was 2:30 this morning. This afternoon, it was in her armpits, groin and all over. It happened again at 2:30am (13May2021), she had the itch again and took another pill. It has been on and off and is now all over her body and she is not comfortable. After lunch, again she took a pill and it hasn't stopped itching and is continuous. She mentioned that she has never had the flu shot. She was not planning to have this one, but her work said she had to get this. She did not have any allergic reactions to any vaccines in the past. She mentioned that she does not know what to do since the allergy pill does not work and she thinks she needs an injection. She added that her family (daughter is a nurse) is telling her this is not allergies it is the vaccine. The patient mentioned that the treatment used included allergy pills, an antihistamine, diphenhydramine, the generic form of Benadryl. She took the pills 3 times, every 3 hours. The adverse events did not require emergency room or physician office visit. The patient further mentioned that she just needs something stronger. She can't get any medicine for this and she would like to ask if she can get a steroid for this. She is not comfortable and has not gotten enough sleep. The patient is also going to ask for a prescription for Atarax, hydroxyzine. She added that she cannot sleep and the more she scratches it the worse it gets. Daughter told her she had to call because it is not just allergies. She took a shower to help the itchiness and it helped for a little bit. The outcome of the events was not recovered.
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| 53 | 2021-05-30 | agitation |
On May 2nd, approx 5 days after 1st Pfizer dose, I noticed a change in my mouth - roof of mouth and ...
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On May 2nd, approx 5 days after 1st Pfizer dose, I noticed a change in my mouth - roof of mouth and tongue especially, I have had a different taste ever since, a mineral-ish taste in my mouth since that day that has not gone away. On May 19th, the next evening after my second dose, I had intense radiating arm pain (not just like the sore arm I had the first time), more like what I imagine the radiating arm pain must be like when one suffers a cardiac event, it was very intense and scary and lasted for 15 to 20 minutes. Before and after the radiating arm/possible cardiac-like event, I noticed I was also extremely agitated before and after it happened. I was agitated to a state I am not accustomed to experiencing. It was all very unusual and unnerving for me.
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| 53 | 2021-06-01 | crying |
pain all up the arm/As time passed the pain progressed up her arm. She couldn't straighten arm at al...
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pain all up the arm/As time passed the pain progressed up her arm. She couldn't straighten arm at all/When she lifts her arm up, it is still sore/her right arm wrist also has pain; now she also has pain in her right wrist/pain has started to increase in her left arm wrist/her right arm wrist also has pain; swelling at the injection site; left shoulder inoculation site edema/edema is minimal; left ear was burning; left eye had floater; left hand and wrist were double the size of right hand/it was so swollen it was a bite/because of the swelling. She couldn't even bend her knuckles at all; swelling in the right wrist/wrist doubled the size of right hand/it was so swollen it was a bite; entire arm where the vaccine was given was red and swollen/swelling in her left arm has increased; entire arm where the vaccine was given was red and swollen.; arm was warm; she has cried; intramuscular pain; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0182), intramuscular at the age of 53-year-old administered in arm left on 06May2021 10:40 at single dose for covid-19 immunisation. Medical history included chronic anemia, pulmonary embolism in both lungs (doesn't remember the years but she had 4 or 5 of them/maybe between 2016 and 2019), didn't have a bladder from Apr2020 (cystoscopy performed in Apr 2020), dehiscence of wounds, gastric bypass from Jul2007, two major blood clots in right arm from 2019 (because of infiltrated IV. One was 7mm and one was 8mm. A piece broke off of one of them within 24 hours and went into right lung), Smoker, allergy to antibiotics, slightly topical itch reaction to Morphine, cat scratch infection, had a reaction to IVP dye for kidney scan where her eyes started swelling. Concomitant medication included gabapentin (NEURONTIN) taken for left knee nerve pain from Mar2021 and ongoing. The patient previously took Doxycycline and experienced anaphylactic reaction, morphine and experienced slightly topical itch reaction. She received her first Pfizer COVID19 Vaccine on 06May2021 which was a Thursday. Everything was fine. Shot was in left arm. Wednesday, last week, which was six days later she woke up with her entire left hand and wrist doubled the size of right hand on 12May2021. A friend of hers is her in home nurse because caller has underlying health issues. They thought because it was so swollen it was a bite. Caller did Benadryl and RICE treatment. As the day progressed, she had pain all up the arm on 17May2021. She had an appointment with physical therapy. They said to get to the hospital. Her nurse met her for lunch and caller's arm was warm in May2021 and her nurse said to get to the ER. They wanted to rule out a blood clot. They didn't want to admit her, but she had severe issue with her arm that day. She was given pain medication, Benadryl, and had CT scan to rule out blood clot in ER. She couldn't move her neck to the left. She was there 8 hours. While there, her left ear was burning (on 12May2021) to the point it felt someone was ripping it off. In her left eye she had floater on 12May2021, like black fuzzy lines. Everything was on the left side. She didn't hit anything in the time between receiving the injection and 6 days later. She had not done nothing out of her normal routine. It is too much of a coincidence that this is the only thing she has had in the left arm. For 2 or 3 days since last Wednesday the entire arm where the vaccine was given was red and swollen in May2021. She didn't have an immediate side effect, but 6 days later she had a great amount of side effects. She can't say it is the vaccine. She has had a flu shot every year and pneumonia shot every 5 years with no side effect. She is anaphylactic or resistant to every oral antibiotic. Even with IV antibiotics there are only certain ones that can be use, but she has to be pretreated with 50mg of IV Benadryl. She was on Doxycycline all last summer oral and IV. After 4 weeks on it she was sent home with a temp medline for IV infusion. Within 3 hours of her giving herself the next dose she had an anaphylactic reaction. Her body does not immediately react to any side effects or adverse reaction. It can be days out and it hits all of a sudden. On last Wednesday she woke up around 7AM. She felt like it woke her up because of the swelling. She couldn't even bend her knuckles at all. As time passed the pain progressed up her arm. She couldn't straighten arm at all. Everything was on that Wednesday and on the left side. She had full range of motion on the right side. The hospital said it was intramuscular and she read that could possibly be side effect. This was her first dose. Left hand and wrist were double the size of right hand: It resolved. She noticed it around 7AM as the day progressed the swelling went down a little bit. That is when the arm started hurting and the swelling would come back. The swelling wasn't as significant as it was first thing in the morning. She has pictures she can provide if needed. Pain all up the arm: the pain has resolved except for the top of the arm where she received the vaccine. When she lifts her arm up, it is still sore. It wasn't sore the first 2 to 3 days or immediately following the inoculation. It is still very mildly sore. They also did an ultrasound when in the ER. At home she takes, not for this issue, Gabapentin 3 times a day. It was just filled and is in the pharmacy vial and she doesn't have NDC, lot, and expiry. Caller clarified that it is Neurontin 300mg not Gabapentin. She has been on Neurontin since Mar2021. She takes it for left knee nerve pain. For the pain meds she was given in the ER and the Benadryl she doesn't have NDC, lot, or expiry. The hospital administered 100mg of Benadryl. When they did the CT scan they did it with contrast. 40 years ago she had a reaction to IVP dye for kidney scan where her eyes started swelling. Anytime she has contrast solution she is always treated with 50mg of IV Benadryl. She has a slightly topical itch reaction to Morphine. In the ER, they gave her 40mg of IM morphine because they couldn't get a line going. She basically has no veins. They gave her 50mg of Benadryl subcutaneously in the inner area. Then before the CT with contrast, they gave her another 50mg of Benadryl. What she took at home was off brand. It is called Banophen Diphenhydramine HCI 25mg antihistamine. She took one when the reaction happened. The manufacturer is Major. NDC: 09045551-59. When providing NDC caller states, "Come on eyes." Lot number: P121325. Expiry: Aug 2022. Caller just found a sugar cookie from Panera Bread to eat. She was in (withheld) in mid October to late October. Unfortunately when she was down there with her best friend her cat scratched her and caller ended up in the hospital because of cat scratch infection. Even though they were very cautious and following all the CDC guidelines and wearing mask when she came home for 5 days she had many COVID symptoms. She went for a rapid test and it came up negative. She has been tested 15 times since last year because she has had so many surgeries. The reason she got the vaccine was with her underlying health conditions she doesn't want to die. What is interesting is her husband and son both after she felt ill coming home had the same symptoms she did. She is scheduled to get her next dose 27May2021. Is that normal to be scheduled 3 weeks apart? Her greatest concern is her nurse provider is not familiar with her. Her GI doctor and orthopedic surgeon said she should be ok. She wants to receive both as recommended. Her concern with the second vaccine is if the side effects that she experienced could be dramatically worse or result in a horrible outcome. When she spoke to the physician and the nurses and the medical care team they said there are no studies or reports where the vaccine is causing blood clots and what she was experiencing was not associated with the vaccine. When she looked up the vaccine, it said that intramuscular issues could be a rare side effects. Her thought was that it wasn't reported that it hasn't happened. Could intramuscular issues be a rare side effect? Caller clarified that she does not have the Doxycycline or any other antibiotics that she is resistant to or had reaction with to provide NDC, lot, and expiry. The last time she had it was when she had the temp medline put in. She had the reaction and spoke to the infectious disease doctor only in hospital. She threw all the vials and all the bags away. She torn up the lot numbers. The actual bottles she soaked them and then flushed the labels down the toilet. She has chronic anemia. It has been brought to her attention lately that she has critically low iron saturation. Low saturation should be 18 and her iron saturation level was a three. She had the blood test on the same day of the vaccine on 06May2021. On the 7th she had iron infusion. The vaccine was given at 10:40AM. The blood work was drawn at 02:40PM. The iron infusion was at 9:30AM on 07May2021. She received one unit. Adds she previously reported she had gotten the Pfizer COVID 19 vaccine and six days later she had severe side effects. States she was encouraged by her health care professional to go to the ER to rule out a blood clot which she did and the result was negative. Adds when she had the first dose of the vaccine 06May2021, intramuscular in the left shoulder; she had no side effects or anything. Six days later her left hand was swollen to double the size of the right had. She took a 25mg Benadryl that did nothing, which she previously reported. Adds at lunch yesterday she spoke to a friend who is an in home care nurse who has taken care of her before because of her other medical problems; and she encouraged the caller to do RICE treatment; rest, ice, compression and elevation for her wrists. This friend saw the hand at lunch and noticed that the caller was unable to straighten the left elbow and arm; she had great pain in the left elbow and from the hand up the arm. All of these events were previously reported. Caller mentions she is in so much pain and her symptoms are getting worse. New events reported today include the pain has started to increase in her left arm wrist; swelling in her left arm has increased. Caller mentions the physical therapist saw the edema especially on the left shoulder at the vaccination (inoculation) site on 17May2021 and said there is still swelling and she had not noticed this before. Caller clarifies later that day around 1700PM 17May2021, the caller attended a physical therapy treatment and the therapist noticed swelling at the injection site on 17May2021 which was not previously reported. Adds as the day went on yesterday, her right arm wrist also has pain; since yesterday through last night and today it has been at a 10. Adds she has cried in May2021. Mentions she feels she has limited use of her fingers that she noticed yesterday when she had the wrist pain; even picking up things or trying to chop chicken, she can't; she doesn't think she mentioned particularly the left wrist yesterday. Her main concern today is that the pain in her left wrist has increased and now she also has pain in her right wrist on 17May2021. Caller adds she put muscle rubs on; and ice. Her pain in her wrists has not responded to the Gabapentin. She applied three different topical solutions with no improvement in her pain: Generic muscle rub from store; Natureplex Ultra Strength muscle rub; NDC 67324002-01; Jul2022;Topical 5% pure lidocaine cream; Lot 20G13C1; Jul2022; OTC from the pharmacy, no box. Voltaren Gel; Dec2019; lot WN791; unable to locate NDC due to pain in her wrist. Adds the swelling on both wrists is minimal but the pain is incredible; excruciating. Just the edema is minimal; she has kept ice on it on and off; 20 minutes on and off. Adds she has never had pain like this before. Caller mention she did speak with doctor yesterday. Adds she was greatly upset when they told her after she had explained all of her symptoms, that intramuscular joint pain had been detected in May2021. The events results in Emergency Room Visit. The patient underwent lab tests included blood test: unknown results on 06May2021, Iron saturation: low (Low saturation should be 18 and her iron saturation level was a three) on unknown date, CT scan (to rule out blood clot): unknown results, ultrasound: Unknown results, COVID test: negative. The outcome of event left ear was burning and left eye had floater was recovered on 12May2021, the outcome of event Swelling of wrists, Vaccination site oedema and Wrist pain was not recovered and other events was unknown.
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| 53 | 2021-06-02 | feeling abnormal, memory impairment |
Hemiplegic migraine; Forgetful; Peeing more often; Heavy tongue; Slurred speech; Aura; Bleary vision...
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Hemiplegic migraine; Forgetful; Peeing more often; Heavy tongue; Slurred speech; Aura; Bleary vision; Left eye twitching on and of; black and blue eye; Hands shaky; swollen black and blue eyes; Depth perception problem on right side; Headache; Fatigue and very tired; This is a spontaneous report from a contactable patient. A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: unknown) via unspecified route of administration on 04Mar2021 at 10:30 am (at the age of 53- years) as a single dose for COVID-19 immunisation. The patient's medical history included asthma, seasonal allergy, Transient Ischemic Attack (TIA) in 2014 and migraine. The concomitant medication includes erenumab aooe (AIMOVIG) for migraine from unknown dates. Patient previously took botulinum toxin type A (BOTOX) for migraine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Mar2021 at 08:00 am, the patient experienced fatigue for 1-3 days, headache, until she had gone to urgent care. The patient also reports swollen black and blue eyes, tiredness, left eye twitching on and off, blurred vision, slurred speech, was forgetful, depth perception problem on right side and heavy tongue, hands shaky, aura, peeing more often (sometimes she had to sit longer) and hemiplegic migraine. It was also reported that, the events migraines and headache she had after the vaccine was intolerable. At the time of report the events of mild headache and blurred vision was ongoing. The adverse events resulted into healthcare professional office/clinic visit and emergency room/department. Therapeutic measures for the reported adverse events included treatment with metoclopramide, methylprednisolone and "nr" from unknown dates. The clinical outcome of the events of fatigue, headache, swollen black and blue eyes, tiredness, left eye twitching on and off, blurred vision, slurred speech, was forgetful and heavy tongue, hands shaky, aura, peeing more often and hemiplegic migraine was reported as recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Updated reporter details (reporter name, for correspondence contact in slide#2, Health care professional leave blank; Protect confidentially and Correspondence contact was checked). Patient details added (Patient's first name and age/units). For concomitant drug "amogiv" was considered as typo and coded as Aimovig. Concomitant therapy leave blank since the concomitant drug was coded via WHO drug in product tab already. Deleted duplicate reported Indication of BNT162B2. Lot# UNKNOWN was removed from dosage regimens tab. Best doctor/Health care professional information such as phone number and email were added in vaccine administration tab. Treatment received was ticked as Yes for events. Physician Office Visit and Emergency room visit were checked. "Depth perception problem on right side" was added as AE.
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| 53 | 2021-06-02 | loss of personal independence in daily activities, feeling abnormal |
Chest pain and pressure, back pain and severe shortness of breath. Weakness and brain fog. The sho...
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Chest pain and pressure, back pain and severe shortness of breath. Weakness and brain fog. The shortness of breath has lasted 2 weeks and caused me to not be able to do activities.
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| 53 | 2021-06-04 | feeling abnormal |
I drove over two hours to get the vaccine. About 1.5 hours into the drive I get a bad head rush. I...
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I drove over two hours to get the vaccine. About 1.5 hours into the drive I get a bad head rush. I had to pull over on the freeway.; This is a spontaneous report from a contactable consumer or other non-health care professional. A 54-Year-old female non-pregnant patient started to receive first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EN6199 and Expiration date: Unknown) via an unspecified route of administration and administered in right arm on 06Mar2021 15:00 as 1st dose, single dose for COVID-19 immunization. The patient medical history included high cholesterol. The patient's concomitant medications were not reported. There was no known allergies and did not experience Covid-19 before vaccination. The patient experienced drove over two hours to get the vaccine. About 1.5 hours into the drive the patient had a bad head rush and to pull over on the freeway on 06Mar2021 (at16:45). The patient was not tested for Covid-19 on post vaccination. The patient didn't receive any treatment as a result of event. The outcome of event was considered as recovered. No follow-up attempts are possible. No further information is expected
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| 53 | 2021-06-04 | feeling abnormal |
Liquid diarrhea; Soreness; headache; brain fog; This is a spontaneous report from a contactable cons...
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Liquid diarrhea; Soreness; headache; brain fog; This is a spontaneous report from a contactable consumer. A 53-year-old non-pregnant female consumer received first bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: En6199), via an unspecified route of administration, administered in right arm on 05Mar2021 03:45 PM (at the age of 53-year-old) at single dose for COVID-19 immunization at the hospital. The patient medical history included Bc 2017; thyroid 2020; hbp 2010. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications in two weeks included tamoxifen, levothyroxine sodium (SYNTHROID) and Lisinopril-all medications taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient did not received other vaccines. On an unspecified date the patient experienced liquid diarrhea, 02hours after continued soreness, headache and brain fog. The patient did not received any treatment for the adverse events. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-06-05 | nervousness |
Patient DOB: 11/09/1967. Received her first dose Pfizer vaccine (LOT#: EW0187 EXP: 8/2021) at 15:26...
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Patient DOB: 11/09/1967. Received her first dose Pfizer vaccine (LOT#: EW0187 EXP: 8/2021) at 15:26 on 6/01/21. Patient alerted EMT at 16:05. Patient stated that she felt a closing sensation in her throat. Patient was able to talk and did not have SOB. Patient stated she also felt nauseous and shaky. Patient stated that she felt very nervous before receiving the vaccine. PHN asked patient to stay an extra 30 minutes for further observation. Patient agreed to stay. EMT took patient vital signs. BP: 120/65, pulse: 76, O2: 96%. PHN assessed patient. PHN offered patient Diphenhydramine. Patient stated she was allergic to Diphenhydramine. Patient could not recall signs and symptoms that occurred with Diphenhydramine intake. Patient refused Diphenhydramine at 14:12. PHN offered patient EpiPen. Patient denied EpiPen at 16:13. Patient stated she was feeling better. PHN gave patient water. Patient was able to swallow water without any trouble. Patient stated her throat no longer felt like it was closing. Patient was talking the entire time with PHN and EMT. Patient denied any SOB or difficulty swallowing. EMT reassessed patient and retook vital signs at 16:25. BP: 120/68, pulse: 79, O2: 97%. Patient stated that she no longer felt any of her initial symptoms. EMT reassessed and retook patients vital signs at 16:36. Patient stated that she no longer had any symptoms. Patient completed her 30 minutes of observation. Patient was educated on worsening signs and symptoms of the vaccine side effects and when to call EMS or go to the ED/urgent care. Patient verbalized understanding of education. Patient left vaccination site at 16:40 unassisted and with a steady gait.
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| 53 | 2021-06-07 | feeling abnormal |
I couldn't breathe and I felt horrible. I went to the ER. I was hospitalized for 3 days. I had a mas...
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I couldn't breathe and I felt horrible. I went to the ER. I was hospitalized for 3 days. I had a massive migraine. When I went home, I couldn't walk. I saw my doctor. They said I had a horrible reaction to the vaccine. I was still sick a week later. I called my doctor again. I went back to the hospital for another X-Ray. They told me had I had deflated air pockets in my lungs. My doctor thought I had pneumonia. I was prescribed two inhalers. The combination of both inhalers provided some relief. I take a lot of supplements to try to give myself relief as well. I still get really winded most days - its sometimes difficult to walk up the stairs, walk to the parking lot, or move around at work & most places. I'm going back to the doctor in July.
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| 53 | 2021-06-08 | feeling abnormal |
throat started to hurt like it was swollen; It felt more muscular.; a couple episodes of trouble swa...
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throat started to hurt like it was swollen; It felt more muscular.; a couple episodes of trouble swallowing.; it felt like the very back of my tongue was also swollen.; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer (patient) reported that who received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: En6198 and expiry date was unknown) via an unspecified route of administration on 04-MAR-2021 19:00 as a single dose for COVID-19 immunisation. Medical history was Psoriatic arthritis, osteoarthritis, fibromyalgia, asthma, allergic to Several Antibiotics, deet. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08-MAR-2021 17:00 her throat started to hurt like it was swollen. Did not have a sore(irritated) throat. It felt more muscular. She had a couple episodes of trouble swallowing. Tuesday night it felt like the very back of my tongue was also swollen. This problem was not constant. She have episodes of it happening. No treatment was received due to events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-06-08 | loss of personal independence in daily activities | Pain in my bones making it difficult to stand, sit, squat, lay down. There is no relief |
| 54 | 2021-01-01 | loss of personal independence in daily activities |
Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe head...
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Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe headache, muscle and joint pain, chills, fever (temperature-102.8),and exhaustion. Redness, pain, and swelling at injection site that has continued to worsen even after 48 hours. Could not perform regular activities of daily living. I could not drive home from work the day after the injection because the adverse reactions were getting more severe, especially after the 24 hour mark. Treatment: treated my symptoms at home with medications (I am a nurse), after researching possible adverse reactions. I figured there was not anything someone else would to treat me besides treat my symptoms.
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| 54 | 2021-01-05 | feeling abnormal, anxiety |
c/o lightheadedness, sob for short period. resolved. stated, "feeling weird, maybe I'm anxious." Vit...
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c/o lightheadedness, sob for short period. resolved. stated, "feeling weird, maybe I'm anxious." Vitals stable, Given Juice PO. 145/89, 74, 20, 100% O2sat. D/C'd after 30 minutes in stable condition 117/67, 65, 20, 100% O2 sat..
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| 54 | 2021-01-05 | feeling abnormal, loss of personal independence in daily activities |
One week after the vaccine I was find until....I got out of my car after driving and started stagger...
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One week after the vaccine I was find until....I got out of my car after driving and started staggering and could not function. Severe dizziness, heavy headedness , nausea and vomiting and a horrible headache. My husband had to physically muscle me back to my car. He wanted to take me to the ER and I would not let him because of the waiting room is full of COVID positive patients. I threw up along the way home and multiple times to the point I had drive heaves. I am a Registered Nurse and felt the symptoms I were experiencing were Vertigo. I had one bout with Vertigo in 2015 and it was extreme. I had Meclizine on hand and and took one tablet and slept. The severity of this was so bad I could not walk unassisted or sit up without falling over. After 6 hours of sleeping I got up, dizziness continued, and vision a little off. I still do not feel 100% I have had a headache since. It never dawned on me this could be from the vaccine I had taken a week before.
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| 54 | 2021-01-05 | impaired work ability |
I received the covid vaccine in my left arm yesterday morning at 8:00 am. I felt fine until noon w...
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I received the covid vaccine in my left arm yesterday morning at 8:00 am. I felt fine until noon when my arm became sore, which I expected to happen so I took Tylenol. By mid afternoon, my 4th and 5th finger on my left had began to tingle and I was having difficult typing with that hand on my keyboard. By late afternoon, the left side of my face began to tingle like paresthesia. I took more Tylenol at dinner but the sensation in my face lasted until I went to bed around 10:00. I woke up in the night and my face felt fine but my 2 fingers were still tingling and I felt like I had no control over them. When I woke up this morning, I took to more Tylenol and the symptoms have subsided. Also, when the nurse swabbed my arm with alcohol, I asked?Isn?t that a little high for the injection, and he said no?it?s right in the deltoid. It felt like the injection site was close to the bones in my shoulder but that may have had nothing to do with these symptoms.
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| 54 | 2021-01-05 | loss of personal independence in daily activities |
patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joi...
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patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics. Pain radiated through her upper body and at times was shooting. she was unable to perform ADLs. She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes. Covid test was negative, CRP was 3.6 and sed rate was 25. all other labsl WNL, symptoms resolved after 5 days
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| 54 | 2021-01-06 | feeling abnormal |
her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her le...
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her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID. The patient medical history included Primary Essential Tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it. The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020. The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-06 | sleep disorder |
shoulder pain... which didn?t seem connected to the vaccine... which progressed to pins and needles ...
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shoulder pain... which didn?t seem connected to the vaccine... which progressed to pins and needles in the L shoulder, numbness into both hands...of the left arm. And neck pain... cervical radiculopathy in the L arm... pain and pins/needles into L thumb. It reached its peak with 4 nights of disturbed sleep starting on the date mentioned. I didn?t keep track of the symptoms other than that because I didn?t initially associate the symptoms to the vaccine until early this week. Symptoms have since improved and are (almost) resolved; I was advised to have the the 2nd vaccine today as scheduled - which was recommended lower on the deltoid and on the opposite shoulder.
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| 54 | 2021-01-07 | feeling abnormal |
Joint pain; brain fog; This is a spontaneous report from a contactable Nurse (patient). A 54-year-ol...
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Joint pain; brain fog; This is a spontaneous report from a contactable Nurse (patient). A 54-year-old female patient (not pregnant) received BNT162B2 (Pfizer, lot number: EL0140) first dose on 29Dec2020 10:45 via intramuscular on right arm at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications in two weeks included dexlansoprazole (DEXILANT) and escitalopram oxalate (LEXAPRO). The patient had allergies to Erythromycin. No other vaccine in four weeks. Facility type vaccine was Hospital. Patient had Joint pain and Brain Fog on 31Dec2020 01:15 PM. No treatment. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the event was not recovered. The serious was reported as no.
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| 54 | 2021-01-07 | impaired work ability |
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting & Tachycardia Narrative: Vaccine received on 12-1...
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Headache, Myalgia, Fever, Diarrhea, NauseaVomiting & Tachycardia Narrative: Vaccine received on 12-19-20. Symptom onset several hours later, needed to miss work on Monday 12-21-20 on account of symptoms. No immediate medical intervention required. Self-managed with tylenol.
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| 54 | 2021-01-07 | sleep disorder |
At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fati...
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At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fatigue went away but I start with a rash and very itchy and noticed my face swelling up. I took some prednisone I had home and Benadryl and went to the ER. They monitored me and medicated me and told me to keep with the Benadryl. On the 24th I started with the rash and on the 26th no more rash. My second dose is scheduled on the 13th and I will see my PCP on the 12th to decide if I should have the second dose. I am not allergic to anything and thought I would die on 12/24. I was swelling up in less than a minute after I woke up it was awful. I also have a consultation with an allergist on Tuesday before the vaccine.
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| 54 | 2021-01-08 | feeling abnormal |
Dose 1 - headache mild 12 hours Dose 2 - foggy brain, sore eyes within 6 hours, severe headache, tem...
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Dose 1 - headache mild 12 hours Dose 2 - foggy brain, sore eyes within 6 hours, severe headache, temp 101.2, myalgias within 10 hours lasting for 18 hours and fatigue lasting 48 hours
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| 54 | 2021-01-09 | feeling abnormal |
Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-l...
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Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-like sx) with first dose. She began experiencing feeling like she was outside of her body about 10 min after receiving her booster. BP was taken and was slightly elevated 140s/90s. Ice packs were provided for hot flashes. Warm blankets provided for chills. BP was trending up to SBP 160s then started to decline to normal. Patient was accompanied to restroom by clinic staff and was able to walk without incident. Patient was observed in covid clinic for total of 2 hours and reassured that she was not likely to have worsening of sx at this point. Patient was walked to mother's car by clinic staff and left feeling better. 1/10 - patient presented to ED with low grade fever (100.4), chest pain, severe joint and muscle pain, nausea and "fog brain." She reports BP being 187/101 in ED. Given 1L of normal saline, zofran, toradol, and dilaudid. Observed until BP drcreased to SBP 140s. Nausea improved enough to allow her to eat. Labs were WNL, CK normal. Discharged home with diagnosis of "adverse effect of COVID-19 vaccine"
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| 54 | 2021-01-10 | restlessness |
Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps ...
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Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps in arms and legs. Feelings of restless, stomach upset. Knee charley horses.
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| 54 | 2021-01-11 | feeling abnormal, impaired work ability |
crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; havi...
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crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; having no energy; feeling tired/Tiredness; kidney stone; pain in her back; did not feel good; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140) intramuscular on 31Dec2020 16:00 at a single dose on left arm for Covid-19 prophylaxis. Medical history included rheumatoid arthritis. There were no concomitant medications. The patient wanted to know if she could receive the second dose of the COVID-19 vaccine if she presented the following side effects with the first shot: feeling tired/tiredness on 02Jan2021; having no energy on 03Jan2021; muscle pain, joint pain, and flu like symptoms/feeling like she has the flu, on 04Jan2021. She went to work on Monday and has taken the last couple of days off because she did not feel good on Jan2021. She did have rheumatoid arthritis, but it was different and has not been like this. She went to the doctor on Monday after she got off of work and thought at first maybe she had a UTI; treated herself with AZO, but had a urinalysis that was negative on an unspecified date. She was told some of the pain in her back might have been a kidney stone on Jan2021 because they found crystals in her urine on 04Jan2021, but she did not know about that. She noticed having no energy on Sunday. She wanted to know if it was recommended that she get the second vaccine since she was having side effects. The events required a visit to physician office and did not require a visit to Emergency Room. Prior vaccinations within 4 weeks was noted as none. Family medical history relevant to the events (AE) was noted as none.The outcome of the events of feeling tired/tiredness was not recovered; of having no energy, muscle pain, joint pain, flu like symptoms/feeling like she has the flu was recovering; of the rest of events was unknown.
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| 54 | 2021-01-11 | feeling abnormal |
Overnight early am 7th woke up to shaking chills fever >101, muscles, joints aches, headache, nause...
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Overnight early am 7th woke up to shaking chills fever >101, muscles, joints aches, headache, nausea sinus congestion Treated fevers for 3 days. Felt horrible missed 3 days wrk and call due to symptoms. Tested for COVID-19 was negative on01- 11-21 FLU test done also NEG..01-11-21
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| 54 | 2021-01-11 | impaired work ability |
developed muscle aches post vaccine. 48 hours post vaccine had to leave shift early and was unable ...
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developed muscle aches post vaccine. 48 hours post vaccine had to leave shift early and was unable to work shift 72 hours post vaccine due to aches and fatigue
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| 54 | 2021-01-11 | mental impairment |
Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right...
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Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right after injection for 2 days Moderate Pain at the injection site for 5 days Muscle weakness and aches, mild for 2 days Difficulty with concentration Feeling tired for a few weeks
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| 54 | 2021-01-13 | confusional state |
Approximately 20 hours after the vaccine I woke up very confused. I was dizzy. I had a very poor s...
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Approximately 20 hours after the vaccine I woke up very confused. I was dizzy. I had a very poor sense of balance and could only walk by holding onto walls. This resolved after approximately 10 hours
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| 54 | 2021-01-13 | feeling abnormal |
The first day I had a weird headache . Three days later I felt like I could go into chills and had l...
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The first day I had a weird headache . Three days later I felt like I could go into chills and had low grade fever of 99.6/99.7, feeling like I didn't feel right. I had terrible cramping in my abdomen and had diarrhea twice . My employer sent me to the ER to test for Covid, Flu, RSV. By the 22nd I was feeling fine about 5-6 days later.
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| 54 | 2021-01-13 | feeling abnormal |
She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; s...
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She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; shake/her hands were shaking so hard; they took her temperature and it was 100/her fever went to 101/temperature had gone to 102.6; heart rate was elevated at 100/heart rate was 110/heart rate went to the high 120s; headache; backache; nauseated; chest was hurting; The initial case was missing the following minimum criteria: Invalid for unspecified adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration in deltoid left on 29Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history included ongoing sleep apnoea (diagnosed about 3-4 years ago, wear her CPAP religiously), Hashimoto's hypothyroid, and chronic low vitamin d (lack of sunlight). Concomitant medication included levothyroxine sodium (SYNTHROID) from 2016 and ongoing for Hashimoto's hypothyroid, ergocalciferol (VIT D) from 2018 for chronic low vitamin d; lack of sunlight (She did not take it religiously, but was supposed to take it everyday). At 10:30 AM (29Dec2020), she started to get cold and shake. She thought that this was insane and it was in her head. It became so severe she could not use her computer her hands were shaking so hard. She went back up to where they were giving vaccines, they took her temperature and it was 100. It had been normal the morning before she got the vaccine. Her heart rate was elevated at 100. They put a blanket on her and said they wanted to watch her for 15 minutes. In that time her fever went to 101 and her heart rate was 110. They took her to the ER. She was there for 5 hours. Her heart rate went to the high 120s. They did a 12 lead EKG. Her temperature had gone to 102.6, which was the highest. They gave her a liter of Normal Saline. She also had a headache, backache, and felt nauseated. The liter of fluid helped, no doubt. She was not admitted. She was wiped out the next day (30Dec2020) with aches and pains still. Their concern was they said they did not give her epinephrine because her heart was too high. She had no breathing issues. Just extreme cold. At one point she had woke up in the ER (29 or 30Dec2020) and her chest was hurting, she knows from her heart rate being too fast. She was so cold. She had on 6 blankets. The next day (30Dec2020) she still had the aches and pains, she was tired, and had brain fog. It all went away on 30Dec2020. She had nothing after that. What scared her was the heart rhythm. The ER doctor says its not great, but felt that getting the second dose was better than her having COVID. The Electrophysiologist she saw, said she was unsure if she should get the second dose. The hospital said that for this next dose, they would give her the injection, wait 15 minutes, then send her home, expecting that she would have the same thing happen. When after the first dose, she was in the ER on a 12 lead EKG with an intravenous (IV). She had no arm pain the whole time. The reporter assessed all events related. She felt fine prior, walking in to get the vaccine. But she was much better the next day and recovered completely. She was just worried about the second dose. The outcome of events was recovered on 30Dec2020.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-13 | impaired work ability |
1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this...
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1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this document 1/14/21 08:00 07:30 increased dry cough, scratchy throat 08:30 sore throat 09:30 mild headache and muscle aches, sore throat, cough when talking 10:30 increasing muscle aches and headache, laryngitis, cough resolving, mild intestinal discomfort 11:00 left work 11:30 all symptoms at 10:30 continuing, increasing fatigue; took 1000mg acetominophen slept most of the time noon - 4 pm 4pm cough resolved, muscle aches continued, headache improved, laryngitis continued. mild fatigue 6:00 pm noted loss of smell (could not smell cooked garlic - my husband could) Laryngitis & muscle aches continued throughout evening 7:30 pm 2nd dose 1000mg acetaminophen 1/14/20 - 06:00 am laryngitis resolved Ongoing scratchy throat, mild muscle aches, mild nausea/intestinal discomfort. Laryngitis and cough mostly resolved - but i am not talking much; speech is an irritating factor for both symptoms. Fatigue improved. Headache mostly resolved. Took 1000 mg acetaminophen.
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| 54 | 2021-01-13 | insomnia, feeling abnormal |
sore arm, headache,fuzzy head, neck pain, body aches, insomnia, tiredness, and just not feeling we...
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sore arm, headache,fuzzy head, neck pain, body aches, insomnia, tiredness, and just not feeling well
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| 54 | 2021-01-13 | restlessness |
Started getting dizzy on my way home from work around 6pm, when I got home I was feeling nauseous. W...
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Started getting dizzy on my way home from work around 6pm, when I got home I was feeling nauseous. Went to the bathroom and had diarrhea and then began to vomit. My temp spikes to 102.6. Had a restless night but by the next evening I was fine, no issues or fever.
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| 54 | 2021-01-14 | anxiety |
1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SV...
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1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SVT with first dose of some new medications. Pt reports intermittent SVT and PVCs post ablasion. HR 136, regular rhythm. 1828: 176/101 (119), HR 108, Resp 22, 99% on room air Pt reports feeling like her HR is returning back to normal, hand tremors continue. Reports mild shortness of breath, which is typical with her SVT episodes. 1831: 151/82 (98), HR 81, regular rhythm, Resp 12, 98% on room air. Denies any worsening or any additional symptoms. Hand tremor no longer present. 1839: 151/104 (113), HR 76, regular rhythm, Resp 10, 98% on room air. Pt reports headache and mild nausea that is typical with her SVT episodes. Pt appears relaxed sitting in chair. 1845: HR 78, regular rhythm. Pt remaining in monitoring area for 15 additional minutes. No s/s further distress. Pt calling husband to take her home. 1905: BP 157/91 (107), HR 87, regular rhythm, 98% on room air, Resp 14 Pt c/o numbness to L arm with some L chest tightness. Reports this sometimes happens with her SVT episodes. 1907: No further chest tightness or L arm numbness. Pt reports feeling anxious. Does not want to go to the ED for further monitoring. Continues to report that her symptoms feel typical after her SVT episodes with some additional nausea. 1910: 132/112 (117), HR 78, regular rhythm. Pt reports improvement of symptoms. Pt relaxed in chair. Instructed pt to stop and call 911 if she has any concerning symptoms after leaving clinic including difficulty breathing or HR abnormalities.
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| 54 | 2021-01-14 | feeling abnormal, memory impairment |
Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea....
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Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea. This started 8 hours after injection and lasted for 24 hours. Extreme exhaustion followed the next 24 hours. Severely blood shot eyes developed during first 24 hours and remains still after 78 hours. Still having brain fog after 78 hours.
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| 54 | 2021-01-14 | feeling abnormal |
I waited for 30 minutes; I walked to my car and didn't feel well; I thought maybe I was hungry I ate...
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I waited for 30 minutes; I walked to my car and didn't feel well; I thought maybe I was hungry I ate 1/2 banana and drank some water. I started to drive home. It felt like a huge cold railroad spike was being driven up the top of my shoulder to my neck, it was a cold sensation anteriorly and posteriorly on my neck. Then my face (left side) started to go numb, it started just about the top of my left ear and went all the way to my lips. It stopped midline. It felt like a dental block. I could still swallow and breathe. I started shaking, felt nausea, my upper esophageal sphincter started to spasm. I kept checking my tongue and airway to see if I should pull over and call 911. I drove to the ER. My left side of face was numb, I was trembling, tremoring. They gave me small dose of IV Bendadryl (12.5 mg) and Pepcid, I slowly started to feel better and the feeling came back to my face moving from midline lip to cheek. It still felt "funny" but much better. I was in the ER for around 2 hours. I have had more tremoring since my vaccine in my neck and hand (I do have primary essential tremors but it is tremoring much more now) and more neck pain (could be due to the increased tremors)
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| 54 | 2021-01-14 | loss of personal independence in daily activities |
Headache neck pain Dec 28 , 29, then extreme muscle weakness in right leg and right hand . The weakn...
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Headache neck pain Dec 28 , 29, then extreme muscle weakness in right leg and right hand . The weakness in my right hand had become progressively worse since dec 30 or 31 st . Had the second shot on Jan 11 . In last 2 data I am having trouble holding a mug or iPhone in right hand . It feels very numb From Jan 12 to today my right hand is having trouble gripping pen , hair brush , difficult to open doors .
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| 54 | 2021-01-14 | panic reaction, anxiety |
Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She ...
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Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She felt a sudden weakness from head to toe and felt an impending sense of doom. She began to feel dizzy and panicked. EE moved to evaluation area at 1333. HR78 BP 174/96 O@ 97%RA. Pt was anxious and noted BP was high for her. FNP continued chatting to EE. EE declined the ED at this time. A&O x4. 1350 HR 75 BP 151/94 O@97%. EE reports feeling much beter. EE opted to wait in the observation area an additional 30 minutes, declining again to go to ED for further evaluation. EE will call if her condition changes.
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| 54 | 2021-01-15 | sleep disorder |
No treatment from medical professional. I took Tylenol and drank water. I had the vaccine at 10 am....
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No treatment from medical professional. I took Tylenol and drank water. I had the vaccine at 10 am. I felt perfect as I did with the first vaccine until I woke at midnight with a high fever , diarrhea, severe fatigue and muscle aches. Hard for me to move or walk. Needed assistance from husband to get to the bathroom. The symptoms lasted until approximately 9 am. Then I felt tired but fine. Today I feel tired but no symptoms. Back to normal.
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| 54 | 2021-01-17 | anxiety | c/o chest tightness, SOB, anxiety |
| 54 | 2021-01-19 | anxiety |
Patient complaint of "warm feeling" in chest and feeling anxious. Nurse checked vitals, monitored fo...
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Patient complaint of "warm feeling" in chest and feeling anxious. Nurse checked vitals, monitored for 15 minutes and check vitals again. Vital signs within normal limits. Patient stated warmth in chest completely resolved. Patient monitored for 30 minutes total, the discharged to home.
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| 54 | 2021-01-19 | disorientation, feeling abnormal |
On Sunday, January 17, 2021 I started having severe joint pain in my wrists, elbows, knees, hips and...
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On Sunday, January 17, 2021 I started having severe joint pain in my wrists, elbows, knees, hips and shoulders. Along with aching all over. Over the course of the day, I started to feel bad. Then on Monday January 18, 2021, in addition, to the joint pain, I started feeling disoriented, dizzy like spells of vertigo. I went to my PCP who did lab work and all was normal. He said it muse be delayed reaction to the vaccine. Later in the day, I was having difficulty putting words together and more dizzy and very lethargic. I laid down and slept until the next morning. (Tuesday 1/19/21) On Tuesday 1/19/21, they symptoms were improved but still had some dizziness. On Wednesday 1/20/21, the symptoms have improved except for an occasional dizzy spell.
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| 54 | 2021-01-19 | impaired work ability | body ache, headache, cough. called in sick to work. |
| 54 | 2021-01-19 | restlessness | LOW GRADE FEVER, BODY ACHES, HEADACHE, RESTLESSNESS, TIREDNESS. TOOK TYLENOL EVERY 6 HRS AND REST. |
| 54 | 2021-01-21 | anxiety |
Pt. complained of nausea and mild headache, she appeared to have some mild erythroderma of face and ...
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Pt. complained of nausea and mild headache, she appeared to have some mild erythroderma of face and both arms, but unclear if it was baseline. She seemed anxious about the vaccine, and wanted to leave as her husband was waiting for her.
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| 54 | 2021-01-21 | insomnia |
was extremely tired and could not stay awake fell asleep at 10 am for 5 hours to wake at 3 pm with s...
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was extremely tired and could not stay awake fell asleep at 10 am for 5 hours to wake at 3 pm with slight low blood sugar , known by slight tremor in hands and body and also resolving 30 min after eating proteins and drinking orange juice. A few hours later around 5pm began getting headache, ate dinner and did not resolve so I took 100mg of Tylenol . could not sleep and was awake until 1am woke at 930 am with low sugar again resolved after eating and drinking orange juice. Had a headache less severe only took 500 mg of Tylenol it resolved. Stayed awake all day was fatigued. no other remarkable symptoms the rest of the day. the next day was about the same only less severe and by the fourth day I only noticed being tired during the day. I think it resolved completely by the 7th or 8th day I lost track due to my step mother coming out of rehab after having had COVID in December. as I write this I am fine and it is 1/22/21
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| 54 | 2021-01-22 | sensation of foreign body |
Received vaccination at 11:10. Waited 12 minutes in observation and left because felt fine. At 11:45...
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Received vaccination at 11:10. Waited 12 minutes in observation and left because felt fine. At 11:45 while driving home, experienced numbness and tingling in my whole face like receiving a novacaine injection at the dentist. A few minutes later experienced tachycardia. A few minutes later, experienced a walnut sized lump in my throat that was more evident with swallowing. Voice was also raspy, but did not experience any difficulty breathing. Got off the highway and went to a hotel lobby to call 911 as my cell phone battery was about to die. This was around 12 noon. BP was 160/94 which is high for me; usually runs 90-95 systolic. Was transported to the ER. Next BP was 150/84. Upon arrival to the ER, the symptoms described had not worsened. Was discharged later that day around 5 PM. No treatment was administered. The next day, arm very sore, had joint aches and felt tired. By 1/23/2021 had mild arm soreness without other symptoms.
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| 54 | 2021-01-23 | impaired work ability |
Joint pain, fever, chills, headache, body aches, exhausted Started approx 24 hours after vaccine. T...
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Joint pain, fever, chills, headache, body aches, exhausted Started approx 24 hours after vaccine. Took Tylenol for fever and pain. Stayed in bed the entire day. Symptoms lasted approximately 24 hours afterwards I had no residual symptoms. I did miss 1 day of work the day of reaction.
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| 54 | 2021-01-25 | sleep disorder, impaired work ability |
1/13/21 woke at 4am with neck pain 1/14 Pain worse, could not move neck, radiated on both sides of n...
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1/13/21 woke at 4am with neck pain 1/14 Pain worse, could not move neck, radiated on both sides of neck to back of head, saw doctor, was given a muscle relaxant, pain worsened, went to ER was given valium and sent home 1/15 called doctor, was given hydrocodone, increased pain, went to ER due to pain, was hospitalized 1/19 discharged from hospital, off work till 2/3/2021 per PCP
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| 54 | 2021-01-26 | disorientation |
Patient complained of feeling light headed and dizzy 3-5 minutes after receiving Pfizer COVID-19 vac...
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Patient complained of feeling light headed and dizzy 3-5 minutes after receiving Pfizer COVID-19 vaccine. (per son accompany by patient for vaccine). Pt then became SOB and complained of chest pain. Patient appeared disoriented. EMS already station on the scene was notified by staff. Patient evaluated by EMS.( Patient's son reported patient had mild reaction after 1st vaccine but recovered quickly). Patient was taking to ER by EMS for further evaluation.
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| 54 | 2021-01-26 | feeling abnormal |
1638: Lightheadedness - Reports happening with 1st shot as well. BP 136/60. HR 53. Given water. ...
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1638: Lightheadedness - Reports happening with 1st shot as well. BP 136/60. HR 53. Given water. 1651: no symptoms BP 111/86, HR 54 1705: Hands colder than normal 1708: observed for 30 minutes; BP 127/68; HR 53; still cold hands. off balance, neck pain. 1717: continues to report feeling off and didn't wan tto leave. moved to chair for more observation and given crackers. 1726: Warming up, felt normal, felt okay to leave. Release home.
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| 54 | 2021-01-26 | feeling abnormal |
Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little we...
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Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little weak. Thought I was imagining things. Walked outside took elevator to the car felt increasingly more dizzy and weak. Got to car and started it, drove a few feet then knew it was dangerous to drive. parked and called My husband. He alerted people he knew . I then called 911. Symptoms progressively worsened. Thought I was going to code. Went to Er by ambulance. Trembling, dizziness, fast heart rate continued. Felt like i was going to die and my heart was going to jump out of my chest. In emergency room, they did an ekg and chest X-ray which were normal. They did some blood work. My potassium was very low ? 3.3. My TSH was 0.05; glucose 108;auto absol basos 0.1. Other results were normal. They told me the reaction was due to my low potassium and TSH levels. ER doctor recommended to change my levothyroxine dose with my pcp. Was in ER from approximately 1 pm - 6 pm on 1/7/21. They had me drink potassium and sent me home. Some symptoms subsided but still felt weak and dizzy when I left.
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| 54 | 2021-01-27 | panic reaction, nightmare |
three nights of very vivid nightmares; waking up with Panics with worm head; This is a spontaneous r...
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three nights of very vivid nightmares; waking up with Panics with worm head; This is a spontaneous report from a contactable pharmacist (patient). A 54-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 11Jan2021 at 13:15 at a single dose in the hospital for COVID-19 immunization. The first dose was received on 19Dec2020 at 13:15 on the left arm for COVID-19 immunization. The reaction with the first dose was losing taste and smell for two days. Medical history included sulfa allergies. Patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The reaction with the 2nd dose was three nights of very vivid nightmares to the point of waking up with panics with worm head. This is not usual and happened the night of the vaccination (11Jan2021) and subsequent two nights. The patient did not receive treatment for the events. Outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
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| 54 | 2021-01-28 | anxiety |
Patient felt anxious, flushed, and itchy. She reports hives over her chest and feeling lightheaded,...
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Patient felt anxious, flushed, and itchy. She reports hives over her chest and feeling lightheaded, though this was likely secondary to anxiety. Denies any other symptoms, SOB, throat swelling, abdominal pain, or nausea.
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| 54 | 2021-01-28 | feeling abnormal | Feeling foggy |
| 54 | 2021-01-28 | insomnia | Whole body hot, then general malaise, cephalgia and insomnia. |
| 54 | 2021-01-28 | panic attack |
About 15 minutes after vaccination she reported feeling light headed and nauseous like the start of ...
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About 15 minutes after vaccination she reported feeling light headed and nauseous like the start of a panic attack. She tried to walk outside for fresh air, but had to sit down after about 20 feet of walking. She reported more nausea, feeling very hot, and had a hard time communicating. She was given a cool washcloth and fanned while being held up by a support person. Her blood pressure was initially high, and rose significantly over a period of about 5 minutes. Blood sugar was checked and was 475 mg/dL. 911 was called, and after about 10 minutes of supportive care paramedics transported her to the hospital. She was fairly limp at time of transport and had a hard time standing. The facility staff updated me several hours later that they had heard that she was doing well. It appeared to be a panic attack.
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| 54 | 2021-01-28 | sleep disorder |
After I received my first dose around 8PM the pain in my right arm started. I could not move my arm,...
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After I received my first dose around 8PM the pain in my right arm started. I could not move my arm, the pain was unbearable, like someone had hit me several times with a baseball bat or something similar. I couldn't sleep due to the pain. It lasted for about 2 days. No other symptoms other than the awful excruciating pain.
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| 54 | 2021-01-29 | anxiety |
20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing...
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20-30 minutes post vaccine, some prickling/tingling around nose and mouth, with some facial flushing. Did not progress, waxed and waned. Had more flushing later, took benedryl. Went to Urgent care, advised benedryl to continue, but did not feel there was any cause for concern. Day after injection, mild flushing at times, and diffuse mild itching including scalp, face, particularly borders, and general arms, legs, torso. No rash, hives, and itching not aggressive, just mild. Persisted for about a week. Feel anxiety may have played role. Continued with benedryl. Had telehealth visits with PCP and with allergist. Resumed taking zyrtec daily with additional dose in pm- symptoms resolved. Not felt to be "serious" reaction by either MD, feel it is ok to have 2nd dose.
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| 54 | 2021-01-29 | impaired work ability |
Received 2nd Covid-19 vaccination as a RN at a drive through site. About 4 hours post shot had fever...
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Received 2nd Covid-19 vaccination as a RN at a drive through site. About 4 hours post shot had fever of 101 degrees Fahrenheit. Nausea. Headache. Body/muscle aches. Information posted in my daily cdc email registration text i received. Illness lasted 24 hours and I did miss work due to fever. Medcated with over counter tylenol and benadryl.
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| 54 | 2021-01-31 | impaired work ability |
I had my first covid vaccine 12/22/20. On 12/24/20 I noticed I could not see as well as normal with...
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I had my first covid vaccine 12/22/20. On 12/24/20 I noticed I could not see as well as normal with my RIGHT eye. I had a sore left arm and headache, which I attributed to the vaccine. By 12/27/20, I called the emergency number at my primary ophthalmologist as was seen. They thought I had a posterior vitreous detachment and asked me to see my primary eye doctor in a week. By 12/30/20 I could not see to work and called the eye doctor and they decided I should see my retinal specialist who deals with problems with my left eye. He could see nothing to explain my decreased acuity and told me to keep my follow up at the other office. I saw a Dr on 1/4/21, who takes care of my left eye cataract and glaucoma. He called in an associate. My vision had further declined and they thought I had ocular neuritis. I couldn't see the big E on the eye chart at all at my worst. I was scheduled for an MRI of the head, which showed ocular neuritis in my right eye. Dr assumed care and I started IV steroids on 1/13 for 3 days, followed by oral prednisone taper. I also was referred to a neurologist to rule out MS. I saw Dr. 1/28/21. After the steroids, my vision improved, but I still can't work or drive. Neurologist does not think I have MS and is ruling out NMO but doesn't think I have that either.
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| 54 | 2021-01-31 | poor quality sleep |
Same symptoms as after 1st vaccine. starting about 12 hours post injection I developed chills, feve...
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Same symptoms as after 1st vaccine. starting about 12 hours post injection I developed chills, fever, could not get warm, joint pain-specifically low back, hips, shoulders, achy all over, headache, nausea. Slept poorly. Woke up the next morning with headache, achy. All symptoms passed about 18 hours post vaccine. of note I have never been tested for covid but my husband had a severe case in March. I tested positive for antibodies twice with the most recent time 12/14/20. I have never had symptoms of covid (until I got the vaccine)
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| 54 | 2021-02-01 | feeling abnormal |
I had my second covid vaccine on Thursday wake up Friday at 2:00 am body ache and fever Friday and S...
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I had my second covid vaccine on Thursday wake up Friday at 2:00 am body ache and fever Friday and Saturday.Sunday I woke up with headache and back pain I came to work today Monday I still dont feel good I still have the headache and back pain I will call employee health this morning
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| 54 | 2021-02-01 | feeling abnormal |
heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irrita...
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heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irritation in throat; Diarrhea; felt funny; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (BNT162B2 reported as Pfizer COVID 19 vaccine; lot number: EL3302; expiration date: unknown), via an unspecified route of administration left arm on 15Jan2021 09:30 at a single dose (reported as unknown dosage with a needle to left arm one time) to prevent Covid 19 and build up antibodies to Covid 19 (COVID-19 immunization). The patient has no medical history and concomitant medications. The patient reported that last Friday (15Jan2021) at 9:30 she took the first dose of vaccine and felt funny, so she waited for 15 minutes. She mentioned that she had not eaten before so they gave her glucose tablets. She then mentioned that later on that night (15Jan2021) that she had a fever of 102 [unit unspecified], elevated heart rate of 160 [unit unspecified], had chills and felt like she had Covid. She further stated that she had irritation in her throat that started after the vaccine. She stated that her doctor mentioned that she may be positive for Covid 19 and did not know it before she had the vaccine. The patient mentioned that she had the nasal swab for Covid and they drew her blood on an unspecified date, but all came back negative. She was told that she had an allergic reaction to the vaccine. She added that she had no symptoms prior to the vaccine. The patient reported that she has to go back for the second Pfizer Covid 19 vaccine on 05Feb2021. The patient received treatment included prednisone, diphenhydramine (BENADRYL) and was given an epinephrine injection (EPIPEN) to bring home. She also was given acetaminophen (TYLENOL) for fever. She was given fluids to try to bring everything down. She added that she was given famotidine (PEPCID) for her stomach due to diarrhea on 15Jan2021 that she is still taking. The outcome of the events allergic reaction and felt funny were unknown, as for diarrhea was not recovered, for the event irritation in throat was recovered on 15Jan2021 while the outcome of the other events was recovered on 17Jan2021.
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| 54 | 2021-02-02 | impaired work ability |
Started with slight dizziness within minutes of receiving vaccine and progressed to severe dizziness...
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Started with slight dizziness within minutes of receiving vaccine and progressed to severe dizziness with quick turn of head by the afternoon. Progressed into that evening and night to "bed spins"and nausea. Persisted severe dizziness for the following day. Had to call off sick for work. By day three, dizziness had lessened and could return to work.
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| 54 | 2021-02-02 | sleep disorder |
On 1/28/2021, I woke from my sleep with legs cramps and muscle pain. I went to the toliet to urinat...
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On 1/28/2021, I woke from my sleep with legs cramps and muscle pain. I went to the toliet to urinate and began to have multiple bowel movement. I began to feel nauseated and very cold with shortness of breath and my heart racing. I cleaned up, washed my hands and proceeded to check my temperature it read 91.5, I continue to check it and it continue to read 91.5. I drank water and orange juice thinking it was my blood sugar. I began to feel dizzy but did not want to lay flat on my bed due to the shortness of breath. My heart rate was 120. I checked my blood pressure it was 180/120. I was fearful of shock. I continued to pace and warm up with blankets and a space heater. I took a warm bath and my temperature increased to 97.7. I continued to feel my pulse racing. I called Dr. office and got an appointment to see her 8:30 am 1/29/2021. She checked my vitals signs B/P - 143/87, P 80, T 98.1 O2Sat 99, heart and lungs. She did labs and urinalysis. She prescribed Clonidine 0.1mg TID take if BP greater 160/90 and Allergra 180 mg QD prn for itch and reaction. I will return to see her 2/5/2021.
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| 54 | 2021-02-03 | impaired work ability, feeling abnormal |
approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals: ...
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approx. 15 minutes after injection c/o chest tightness, slightly lightheaded, HR increase. Vitals: 112/78, HR 69, 16 RR,A/0x3, As time progressed c/o achiness when she turns head side to side. 7:12pm c/o head felt foggy, improved chest tightness, heaviness in abdomen, achiness in R) arm pitdenies SOB, BP:110/78, Hr 66, 7:25: felt HR flutter occasionally, heaviness in legs increased and cont. light headed. but ROM WNL, Denies numbness/tingling, denies SOB, no swallowing problems during entire time. Couldn't go back to work and went home with nursing instructions if heaviness were to increase or other symptoms worsen to call 911 or go to ER. Taken home by mother and brother. called next day and symptoms improved.
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| 54 | 2021-02-04 | feeling abnormal, loss of personal independence in daily activities |
she was useless; diarrhea; vomiting; low grade fever; sore arm; Stomach cramps; didn't feel good; Th...
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she was useless; diarrhea; vomiting; low grade fever; sore arm; Stomach cramps; didn't feel good; This is a spontaneous report from a contactable consumer (patient). The 54-years-old female patient (weight: 150lb-160lb) received first dose of bnt162b2 (BNT162B2, lot number: EL0142), via an unspecified route of administration in left arm on 14Jan2021 15:40 at SINGLE DOSE for covid-19 immunisation. Medical history included none. No Prior Vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID), omeprazole, calcium. On 20Jan2021 weds: "bad diarrhea", vomiting, low grade fever, sore arm (only the day after) and bad stomach cramps. Caller says, "if that's going to happen after 2nd dose- I wont take it". Caller referred to HCP for treatment of post vaccination side effects. She notes that at work on Wednesday she didn't feel good on 20Jan2021 and yesterday she was useless on 21Jan2021. She does feel better today thank goodness. No AE(s) require a visit to Emergency Room or Physician Office. The outcome of the events didn't feel good, she was useless, sore arm was unknown and was recovering for the rest events. No follow-up attempts possible. No further information expected.
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| 54 | 2021-02-04 | impaired work ability, sleep disorder, loss of personal independence in daily activities |
Patient reports with 1st shot had arm pain described as mild and not interfering with daily activiti...
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Patient reports with 1st shot had arm pain described as mild and not interfering with daily activities. Patient reports with second shot, within 5 hours had arm pain, malaise, headache, and nausea. At 7 hours symptoms increased in severity limiting activity. Also had chills and body aches. Unable to sleep overnight, felt feverish. On day 2 had difficulty working due to migraine headache, unrelieved by migraine medication. On day 3 migraine remained present but was less severe, modifications needed to continue working. On day 4 had worse migraine and nausea, unable to work. Developed itchy blisters, at least 12 to inner thighs, also on belly and back. Took OTC allergy medication, no worsening or additional spread of blisters following this.
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| 54 | 2021-02-04 | sensation of foreign body |
Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orall...
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Spike in BP, feeling of a lump in throat, pt feels hot and nauseous, 50 mg of generic Benadryl orally administered with water, pt went by ambulance to the hospital
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| 54 | 2021-02-07 | insomnia |
Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep...
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Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep and mind was racing; her mind was racing; Soreness at the injection site; Tension headache with pressure; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on left arm on 20Jan2021 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient received the vaccine on Wednesday, 20Jan2021. This was her first dose. She had the vaccine at 12:30 PM. Right after the vaccine she waited her 15-20 minutes and was fine. These things did not start till later. She was not sick prior to getting the vaccine. 8 hours after, around 8:30 PM she had a tension headache with pressure that went all through the night and let up around 21Jan2021 10 AM. Around 12 AM Thursday morning on 21Jan2021, she had chills, fever, and a racing heart. She ached from head to toe/body soreness. It was a flu like feeling. Then they all got better around the same time 21Jan2021 evening. The racing heart was not enough to need 911. It worried her but was not enough. She also could not sleep and her mind was racing. She thinks it was because what was going on with her racing heart. It was making her head pound. She finally was able to sleep last night on 21Jan2021 around 8:30 PM and slept until 4:30 AM this morning on 22Jan2021. The doctors said if she was not better by tomorrow they would work her in to see her. But she is much better today. She also had soreness at the injection site on 20Jan2021. She knew that was normal though. She is still sore but overall is better. It felt like there was an invasion in her body. She is a little scared now for the second dose. She is unsure if she wants to get it. She asks, do you recommend getting the second dose after she had all of these side effects? It worries her. The heart is the main thing. That worried her the most. Outcome of the event tension headache with pressure, chills, fever, heart racing, ached from head to toe/body soreness, flu like feeling was recovered on 21Jan2021, outcome of the event could not sleep and mind was racing was recovered on 22Jan2021, outcome of the event soreness at the injection site was not recovered.
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| 54 | 2021-02-11 | feeling abnormal |
headache, sensitive to light, eyes hurt, fatigue, body aches( felt like i was punched in various pla...
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headache, sensitive to light, eyes hurt, fatigue, body aches( felt like i was punched in various place on my body, mild dizziness(foggy feeling), left arm swelling and pain at injection site, stomach pain(mild nausea and achy empty feeling)
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| 54 | 2021-02-13 | excessive sleepiness |
AFTER 1ST 10 MINUTES, PAIN IN UPPER RIGHT THIGH. LACK OF APPETITE, CONSTANT SLEEPING, CONSTANT SLEEP...
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AFTER 1ST 10 MINUTES, PAIN IN UPPER RIGHT THIGH. LACK OF APPETITE, CONSTANT SLEEPING, CONSTANT SLEEPING, AND EXCRUCIATING HEADACHE THROUGHOUT THE WEEKEND ALONG WITH NAUSEA AND GOING TO BATHROOM..HEADACHE INTO MONDAY NOT LETTING UP NO MATTER WHAT..SEVERE MUSCLE PAINS IN LEGS AS WELL
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| 54 | 2021-02-14 | feeling abnormal |
1237 Pt complained she felt "off center" 1300 BP 140/80, )2 98%, HR 58, 1325 She felt better vs no...
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1237 Pt complained she felt "off center" 1300 BP 140/80, )2 98%, HR 58, 1325 She felt better vs no change. She ride home with her sister
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| 54 | 2021-02-15 | loss of personal independence in daily activities |
Nausea started around 11 am on day after vaccination, followed by fever and fatigue, with chills and...
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Nausea started around 11 am on day after vaccination, followed by fever and fatigue, with chills and loss of appetite. Mild-moderate headache as well. I slept the entire day, eating little. Fever continued throughout the day and night. Fever up to 103.3. Less fatigue on the next day (the 15th) and temp started at 99.8 but then increased to 100-101.8. Mild-moderate headache. Slept and rested most of the day, unable to perform normal routine. By the 16th no fever and felt well.
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| 54 | 2021-02-17 | anxiety |
Patient experienced dizziness after 1st dose of covid vaccine, BP was 153/68 and reported feeling an...
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Patient experienced dizziness after 1st dose of covid vaccine, BP was 153/68 and reported feeling anxious. Was taken to ED due to complaints of tongue and throat swelling wit some shortness of breath. No rash, abdominal pain, vomiting, or diarrhea. In the ED patient received diphenhydramine 50mg IV, epinephrine 0.3mg IM, famotidine 20mg IV, methylprednisolone 125mg IV, and 1000mL of normal saline. Discharged home with an EpiPen and 5mg prednisone daily for 5 days.
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| 54 | 2021-02-20 | feeling abnormal, disturbance in attention, mental impairment, memory impairment, impaired work ability |
Dense brain fog- slow thought processing, difficulty concentrating, unable to multi-task, word findi...
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Dense brain fog- slow thought processing, difficulty concentrating, unable to multi-task, word finding difficulties, difficulty remebering what the next task is at work, difficulty problem solving, problem perfoming routine tasks in proper squence. Problem started 3.5 hours after injection and continue with minimal improvement 26 days later.
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| 54 | 2021-02-21 | feeling abnormal |
This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I s...
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This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I stayed for 45 minutes after my vaccine due to my blood pressure was high. I also felt a little fuzzy. About an hour later I got nauseous, had chills and felt very fatigued. The next morning when I woke up, my left eye was crusted over. I did not think anything of it until I got the second vaccine and it crusted over with it as well. I was very fatigued for 2 1/2 days. Arm was a little sore.
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| 54 | 2021-02-21 | feeling abnormal |
Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the he...
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Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the head. Within an hour, I felt exhausted. I went to sleep until about 7pm and when I woke up I felt really nauseous and still very tired. I had a little broth and went back to sleep. on 02/19/2021 at 1am I woke up feeling really hot and had horrible body aches. Even my joints hurt. I took my temperature and it was only 99.2 but my temperature usually runs 97.4 or 97.6. I woke up on 02/20/2021 and my left eye was crusted over just like the first vaccine. My body aches and nausea lasted until 02/20/2021. In the evening of 02/20/2021 I noticed about 10 little red bumps in various places on my body. (2 on left arm, one on back neck in hairline, two on upper back, one on chest, two on left leg, one on lower back and one on left buttock. Today is 02/22/2021 and I am still feeling fatigued. It's not as bad as it was over the weekend but I am still tired. My arm was much sorer with this injection.
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| 54 | 2021-02-21 | memory impairment, disturbance in attention, feeling abnormal, mental impairment |
inability to multitask, difficultly with problem solving, significant reduction task completion; Slo...
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inability to multitask, difficultly with problem solving, significant reduction task completion; Slow mental processing; reduced concentration; significant reduction in memory; dense Brain fog set in; This combined with an increasing pressure at the center of my head pushing out.; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date: unknown), via an unspecified route of administration left arm on 26Jan2021 14:00 at a single dose for covid-19 immunization. Medical history included low back pain, and allergy to peanuts, gluten and nickel. Concomitant medication included vitamin b complex (VITAMIN B COMPLEX), egcg (EGCG), colecalciferol (VITAMIN D) and vitamin c [ascorbic acid] (VITAMIN C). The patient did not receive other vaccine in four weeks. The patient previously took ketorolac tromethamine (TORADOL) but had allergies. The patient recieved her most recent COVID-19 vaccine in her workplace clinic. On 26Jan2021 05:30 PM (reported as 3.5 hours after the vaccination), the patient had a dense brain fog set in, slow mental processing, reduced concentration, inability to multitask, difficultly with problem solving, significant reduction in memory and task completion. This has remained unchanged for 8 days. This combined with an increasing pressure at the center of her head pushing out. The patient reported that she received treatment for the adverse events and the events resulted in a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included covid-19 test with negative results on an unspecified date. The outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of mental impairment / mental disorders cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-02-22 | emotional distress |
PATIENT IN OBS AREA FOR 10 MIN WHE SHE BEGAN TO FEEL"PANICKY WITH HEART RACING. HR 144 BP 148/88. ...
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PATIENT IN OBS AREA FOR 10 MIN WHE SHE BEGAN TO FEEL"PANICKY WITH HEART RACING. HR 144 BP 148/88. REDIRECTION AND REFOCUS ATTEMPTED WITH GOOD EFFECT AS NOTED BY HR DECREASE TO 88-103 AND BP 130/88 100% PATIENT DENIED SOB AND CHEST PAIN. MARKED DECREASE IN SYMPTOMS WHEN CALM, HOWEVER, DIFFICULT TO KEEP HER CALM AND SHE WAS CONVINCED THE VACCINE WAS THE CAUSE OF THE SYMPTOMS. DECISION MADE TO TAKE PATIENT TO THE ER FOR EVALUATION. VS ON D/C 98- 138/73 100%; REPORT GIVEN TO RN ER CHARGE
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| 54 | 2021-02-23 | insomnia |
ABOUT AN HR AFTER RECEIVING MY 2ND DOSE OF THE PFIZER VACCINE I FELT COLD AND A SLIGHT HEADACHE AND ...
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ABOUT AN HR AFTER RECEIVING MY 2ND DOSE OF THE PFIZER VACCINE I FELT COLD AND A SLIGHT HEADACHE AND FATIGUED. LATER THAT EVENING AROUND 7PM THE SYMPTOMS I EXPERIENCED GOT WORSE, POUNDING HEADACHE, AND CHILLS, AND EXTREME MUSCLE ACHE,. INSOMNIA AS WELL. 7AM THE NEXT MORNING CHILLS WERE LESS BUT STILL THERE, BUT THE HEADACHE PERSISTED AND THE NAUSEA GOT WORSE. STILL UNABLE TO SLEEP. AROUND 3PM HEADACHE SLIGHT AND MILD NAUSEA. NO CHILLS. TODAY 2/24/2021 STILL HAVE SLIGHT NAUSEA AND HEADACHE. BUT MUCH BETTER.
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| 54 | 2021-02-23 | nervousness |
0825 Feeling Shaky skin little red, Pfizer 2nd dose. 0835 Cheeks feeling flushed. Benadryl 50mg give...
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0825 Feeling Shaky skin little red, Pfizer 2nd dose. 0835 Cheeks feeling flushed. Benadryl 50mg given orally. 0842 Cheeks feeling better arms, still flushed NO SOB,NO CP NO NAUSEA 854am Reports no worsening symptoms 910 Feeling better released to go home.
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| 54 | 2021-02-24 | anxiety |
Progress Notes by Family Medicine Nurse Practitioner COVID VACCINE CLINIC 2/19/2021 Patient is ...
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Progress Notes by Family Medicine Nurse Practitioner COVID VACCINE CLINIC 2/19/2021 Patient is a 54 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience mouth dryness. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH includes seasonal allergies (took zyrtec this am as routinely scheduled), htn, hld. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/19/21 1533 02/19/21 1536 02/19/21 1541 02/19/21 1600 BP: (!) 157/91 (!) 164/91 (!) 158/92 (!) 149/87 BP Location: Right arm Pulse: 88 SpO2: 99% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines and water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Pt stable and doing well. Pt agreeable to monitor symptoms. Aware of when to seek emergent care. Follow up with pcp otherwise. Pt given ride with one of her co-workers. Pt ambulatory out of the facility. Electronically Signed 2/19/2021 3:41 PM
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| 54 | 2021-02-26 | feeling abnormal | Tingling in head, dizziness, SOB, chest pain, palpitations, evaluated by EMS-cleared |
| 54 | 2021-02-28 | anxiety |
Developed sensation of increased heart rate about 10 minutes after injection along with anxiety. BP ...
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Developed sensation of increased heart rate about 10 minutes after injection along with anxiety. BP 144/88, p-93, O2sats- 99% on RA. Given water and symptoms resolved within 10 minutes. No chest pain, no shortness of breath, no sensation of tongue or lips swelling. Vitals rechecked 130/78, p-83 and O2sats- 99%. No further symptoms and patient expressed desire to leave.
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| 54 | 2021-02-28 | restlessness, sleep disorder, feeling abnormal |
Woke up twice not really feeling right. Restless sleep and woke up the second time with stomach ups...
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Woke up twice not really feeling right. Restless sleep and woke up the second time with stomach upset as if going to have diarrhea. minor lower stomach cramping. Did have a bowel movement within 2 hours that was soft with lower abdominal discomfort but wasn't diarhhea. Felt as if a headache was starting
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| 54 | 2021-03-01 | sleep disorder, insomnia |
Friday, Feb 26th 2021-About a hour after shot I had joint pain in my elbow and wrist. I took Tyleno...
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Friday, Feb 26th 2021-About a hour after shot I had joint pain in my elbow and wrist. I took Tylenol 1 hour prior to the shot and 6 hours afterwards. No redness or pain Friday evening. I had insomnia Friday night and did not fall to sleep until 5am. Saturday, Feb 27th, 2021- I woke up with joint pain to my elbow and wrist. Arm was extremely sore. I did not eat until 4pm and I took Tylenol then, Once I started moving my arm felt better and the joint pain went away. Trouble sleeping Saturday night. Fell asleep around 4am. Sunday, Feb 28th- Work up and arm wasn't as sore. Noticed around 1pm I had a red spot under the vaccine spot where I was injected. It was red and painful, about the size of 2 nickels put together. I took more Tylenol that evening and was ok. Monday, March 1st- I noticed the red spot had gotten bigger. It wasn't as itchy and was not bothering me. Around 8pm, I noticed the spot was bigger and itchy. I toke a Tylenol and Benadryl and about midnight put an ice pack on the redness for 15 min intervals. I did this 3 times. I outlined the red spot, which is now as big as a orange to see if it was spreading. Tuesday, March 2nd - Noticed no spread at 8:30am. Site beginning to itch. At 12 noon, taking a Benadryl and Tylenol after eating lunch.
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| 54 | 2021-03-02 | panic attack |
Pt states she recieved her first dose of the vaccine at 11:50 am.l Pt states after 40-50 minutes she...
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Pt states she recieved her first dose of the vaccine at 11:50 am.l Pt states after 40-50 minutes she started having tingling in her hands and face. Pt denies any rash, hives, or swelling. Crew determind the pt is having a panic attack and calmed her down. Pt's vitals are stable. Pt states she is feeling better and wants to leave. Pt didnt require transport to hospital.
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| 54 | 2021-03-04 | feeling abnormal |
She received vaccine at 3:20PM right deltoid. She felt numbness on the right side of her neck, ligh...
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She received vaccine at 3:20PM right deltoid. She felt numbness on the right side of her neck, lightheadedness, and sweaty profusely. She reports feeling foggy and dizzy . Vaccine center called Rapid Response Team.
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| 54 | 2021-03-06 | feeling abnormal |
Fever 100.3 all next day, head fog following days and severe stomach pain and diarrhea that continue...
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Fever 100.3 all next day, head fog following days and severe stomach pain and diarrhea that continues
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| 54 | 2021-03-09 | feeling abnormal |
Lightheaded, facial tingling, weird sensation in left hand. BPs 166/102 (pulse 84), 160/97 (pulse 77...
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Lightheaded, facial tingling, weird sensation in left hand. BPs 166/102 (pulse 84), 160/97 (pulse 77), O2 sats 100%.
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| 54 | 2021-03-09 | excessive sleepiness |
sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days l...
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sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days later; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included Known allergies to Possible latex, Diabetes, sleep apnea, PTSD (Post-traumatic stress disorder)/anxiety, herpes, vitamin d deficiency, environmental allergies, asthma. Concomitant medication was unspecified medication in two weeks. On 16Jan2021 08:00, The patient experienced sore arm, slept for 17 straight hours, chills, upset stomach, upper body flushing for up to 4 days later. Treatment received for the events included OTC medications. The patient was not pregnant. She had no COVID tested post vaccination. There was no other vaccine received in four weeks. The outcome of the events was recovered in 2021. information on the lot/batch number has been requested.
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| 54 | 2021-03-09 | loss of personal independence in daily activities |
hives all over the body 2 days after the vaccine, severe forearm pain bilateral from elbow down and ...
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hives all over the body 2 days after the vaccine, severe forearm pain bilateral from elbow down and was unable to write or lift anything for 3-4 days . pain has improved but still has hives very itchy
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| 54 | 2021-03-10 | disturbance in attention |
Approximately 8 minutes after vaccination, while seated in monitoring area, experienced sudden onset...
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Approximately 8 minutes after vaccination, while seated in monitoring area, experienced sudden onset of dizziness, profuse sweating, shakiness, difficulty speaking, stammering, difficulty sitting or standing without assistance, increased blood pressure, headache in right temple through back of head on right side. Nursing support response included taking me by wheel chair to isolated area, removing face covering, providing drinking water, monitoring pulse and blood oxygen rates and blood pressure. Began to feel better after several minutes, then symptoms returned but not as severe. Cycles of improvement and return of symptoms but diminished in severity occurred over the next 30 minutes. Tired feeling for approximately 4 hours following vaccine and low grade headache. Took 2 Tylenol regular strength approximately 1 hour following vaccine and again 4 hours later. 20 hours following vaccine, still feeling episodes of dizziness, headache, fatigue, difficulty with speech (stammering), shakiness, difficulty focusing/concentrating.
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| 54 | 2021-03-11 | feeling abnormal | Brain fog, headache, muscle aches, tightness in chest, nausea |
| 54 | 2021-03-11 | panic reaction, sleep disorder |
At the time of the injection, I had numbness in my left fingertips, and my tongue was bitter/burning...
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At the time of the injection, I had numbness in my left fingertips, and my tongue was bitter/burning for few minutes. The Doctor in place informed that it was a normal reaction. Everything was going well until I went to sleep. I woke up in panic due to not being able to breath. I felt like my brain, face, eyes, and nose were swelling. My chest was compressed. Then I remembered I didn't take any medication; therefore, I took two Advil. After and hour, I noticed that by sitting or walking , I began to feel better. I went back to sleep in a seated position around 4:30. Not sure if I want to take the 2nd dose. I'm frighten. Have an appointment with my Doctor on March 22nd.
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| 54 | 2021-03-11 | sleep disorder |
First I had chills and quite violent shaking. I then got a fever and felt muscle aches, joint pain a...
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First I had chills and quite violent shaking. I then got a fever and felt muscle aches, joint pain and my skin hurt. I also had a headache on and off. Sleep was almost impossible due to being uncomfortable, and I had thoughts racing through my head. I also had lack of appetite, but not nausea.
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| 54 | 2021-03-12 | insomnia |
Extreme ache at injection site started an hour after injection. Within a few hours my entire body s...
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Extreme ache at injection site started an hour after injection. Within a few hours my entire body started aching. The next day I could barely get out of bed and function. I also could not sleep. Aches lasted for two days.
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| 54 | 2021-03-13 | anxiety |
pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose ...
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pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose approx 1:20, at 1:28 said her arm was going numb and declined water and food. 1:33 continued tingling numbness of left arm and jawline, she again declined food and water. 1:43 hot, sweaty, ache in chest and rapid pulse feeling. called ems, gave water and crackers, 1:48 bp between 103/80 Pulse 94 to 127/79 pulse 86. 1:55 bp 156/113 pulse 88. said her arm was tingly and face going numb, feeling her heart flutter. when EMS arrived she said her blood glucose was 286 this am and she took Humalog then. normal bp 130s/80s pulse in 90s. Tx to hospital, FU 3/12&3/14 said she had throat closing and vax site numb and swollen
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| 54 | 2021-03-14 | confusional state |
Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, troubl...
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Hives and itchiness, dizziness and weakness, lip and tongue swelling, cough, throat swelling, trouble swallowing, difficulty breathing, confusion, chills, difficulty speaking.
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| 54 | 2021-03-14 | insomnia |
Exhaustion; muscle soreness; lack of sleep; This is a spontaneous report from a contactable consumer...
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Exhaustion; muscle soreness; lack of sleep; This is a spontaneous report from a contactable consumer (patient). This 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 08Feb2021 09:15 for COVID-19 immunisation. Medical history included allergy to Sulphur derived antibiotics. There were no concomitant medications. Previously the patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On 08Feb2021 19:00, the patient experienced exhaustion, muscle soreness, lack of sleep with outcome of recovered on an unspecified date in Feb2021. No treatment required. The vaccine was administered at Workplace clinic. Information on lot number/batch number has been requested.
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| 54 | 2021-03-15 | amnesia, disturbance in attention, insomnia |
Memory loss and difficulty concentrating, light vaginal bleeding, Shortness of breath and the chills...
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Memory loss and difficulty concentrating, light vaginal bleeding, Shortness of breath and the chills, Intense pain in both legs on the night, Insomnia 2 hours later after going to bed, Tiredness and sleepiness, Bruises on right leg.
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| 54 | 2021-03-15 | anxiety |
About 10 minutes (moments before they told me sage to leave) I began thinking I was having a hard ti...
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About 10 minutes (moments before they told me sage to leave) I began thinking I was having a hard time breathing but associated it to anxiousness about receiving the vaccine. Ran my errands in town and kept thinking I was having problems breathing. Again, thought I was imagining. For just a minute or so it felt like my throat was tight, but soon vanished so again thought I was imagining. Just didn?t feel ?right? rest of day but assumed I was dreaming it up. That evening when I laid down to go to sleep, I quickly realized I was having shortness of breath. Could barely breath. I checked my oxygen level & it was running 91-94. However, my heart rate (usually sits between 55-65 when resting) was running in high 70?s to mid-80?s. Called ER and asked if I could take Benadryl- they said yes. Took one adult Benadryl and felt a bit better soon after. An hour later took another along with a Pepcid. Eased up enough then I could go to sleep. Didn?t take any more meds, but it was another day & 1/2 before I felt ?normal? (I have CHF so I deal with some sob always).
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| 54 | 2021-03-15 | feeling abnormal, anxiety |
Post vaccine, patient reported feeling "strange", HR 170, BP elevated. Reported feeling "anxious". P...
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Post vaccine, patient reported feeling "strange", HR 170, BP elevated. Reported feeling "anxious". Patient stated she had not taken her blood pressure medicine today. Oxygen applied at 2 lpm for report of chest "pressure". Patient refused EMS transport to hospital for evaluation. Benadryl 50 mg given PO. Prior to discharge, HR in low 100's, BP remained elevated.
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| 54 | 2021-03-16 | disorientation |
I received the vaccine on 3/10/21 and felt fine until 3/16/21 in the AM. When I turned from my left...
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I received the vaccine on 3/10/21 and felt fine until 3/16/21 in the AM. When I turned from my left side to my right side I became extremely dizzy and disoriented. The room was spinning and I became nausea. It happened a few more times throughout the day on Tuesday. Same thing happened on Wednesday 3/17/21 while still lying in bed. I feel exhausted and neaseaus on an off during today and when I turn my head I become dizzy.
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| 54 | 2021-03-17 | restlessness |
approx. 5-6 hours after vaccine: rapid/racing/fluttering heartbeat, entire left side tingle sensati...
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approx. 5-6 hours after vaccine: rapid/racing/fluttering heartbeat, entire left side tingle sensation- restless ness
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| 54 | 2021-03-19 | anxiety |
Tongue tingling sensation. BP 154/93 (pulse 96), O2 sat 98%. F/U BP 135/83 (pulse 87). Patient felt ...
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Tongue tingling sensation. BP 154/93 (pulse 96), O2 sat 98%. F/U BP 135/83 (pulse 87). Patient felt like her reaction was more anxiety related.
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| 54 | 2021-03-21 | depression |
Two days after the shot, I've had severe depression. Difficult to think and get out of bed. Suicid...
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Two days after the shot, I've had severe depression. Difficult to think and get out of bed. Suicidal thoughts; Two days after the shot, I've had severe depression. Difficult to think and get out of bed. Suicidal thoughts; Two days after the shot, I've had severe depression. Difficult to think and get out of bed. Suicidal thoughts; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration, administered in left arm on 03Mar2021 17:45 as single dose for covid-19 immunisation at a Pharmacy/Drug Store. Medical history included anxiety and allergies to Penicillin and sulfar drugs. The patient had no Covid prior vaccination and was not tested for Covid post vaccination. Concomitant medication included buspirone hydrochloride (BUSPAR). The patient had no other vaccine in four weeks. On 05Mar2021 17:30, two days after the shot, the patient had severe depression, difficult to think and get out of bed and suicidal thoughts. The events were not treated. The outcome of the events was recovering. Information on the batch/lot number has been requested.
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| 54 | 2021-03-22 | impaired work ability |
Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued na...
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Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued nausea & migraine. Tuesday 3/9 went to ER with same symptoms. Was admitted to hospital on 3/9 with acute kidney injury, nausea & Migraine. Was discharged from hospital on 3/14. Followe up with primary doctor on 3/17. Primary DR requested more bloodwork. Had low potassium. Ended up back in ER 3/17 with nausea and vomiting. They pushed more fluids and sent me home. Will have follow up blood work on 3/26 and next Dr appointment on 4/19. Returned to work for 1/2 day on 3/22. Absent 3/23 for extreme fatigue.
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| 54 | 2021-03-23 | feeling abnormal | Chest pain, chest tightness, stomach upset, diarrhea , headache, arm soreness, brain fog |
| 54 | 2021-03-23 | insomnia | Dizziness; fatigue; sleeplessness; very sore at injection site |
| 54 | 2021-03-24 | delirium, excessive sleepiness, feeling abnormal |
delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills;...
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delirous as if I was hungover; delirous as if I was hungover; felt on the brink of fainting; chills; joint pain; pain at the injection site; lethargic; dry cough; severely nauseous; could not eat; serious fogginess; General malaise; fatigued; a debilitating headache; did not feel comfortable driving; weak; hurt in my chest; slept the whole day; This is a spontaneous report from a contactable consumer. A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 13:30 (Batch/Lot Number: EN6202) at 54-years-old as a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Medical history included hypertension, and acne from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications included hydrochlorothiazide, olmesartan medoxomil (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; isotretinoin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient previously took (ceftriaxone sodium) ANCEF, start and stop date were not reported, and experienced drug allergy. On 06Mar2021 at 04:00 (as reported), the patient experienced: delirious as if i was hungover (medically significant), felt on the brink of fainting (non-serious), chills (non-serious), joint pain (non-serious), pain at the injection site (non-serious), lethargic (non-serious), dry cough (non-serious), severely nauseous (non-serious), could not eat (non-serious), serious fogginess (non-serious), general malaise (non-serious), fatigued (non-serious), a debilitating headache (non-serious), did not feel comfortable driving (non-serious), weak (non-serious), hurt in my chest (non-serious), slept the whole day (non-serious); with no treatment received. The clinical course was reported as follows: The patient reported that on the first night (as reported) she had chills, joint pain and pain at the injection site. The next day (as reported) she was lethargic and was severely nauseous to the extent she could not eat. The patient also experienced serious fogginess, felt delirious as if she was hungover. The patient felt general malaise and a debilitating headache all day. The patient was fatigued to the extent she did not feel comfortable driving. The patient was so weak, that she felt on the brink of fainting. That evening, the patient slept the whole night through, except when she would awake with a dry cough that hurt in her chest. This cough was not as persistent and intense but was lasting even now. The patient slept the whole day and was just now beginning to feel as if she had recuperated from the vaccine four days later. The clinical outcome of the events was recovered with sequelae on an unspecified date (also reported as "recovered with lasting effects"). The patient was not tested for COVID post vaccination.
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| 54 | 2021-03-24 | feeling abnormal | Feeling "light" and tingling in hands and lips |
| 54 | 2021-03-24 | feeling abnormal |
The day after my second dose of the Pfizer vaccine, I experienced chills, severe body aches, stomac...
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The day after my second dose of the Pfizer vaccine, I experienced chills, severe body aches, stomach upset, vomiting. I had loss of sensitivity in my right thigh area that comes and goes. I also have brain fog, joint aches that overwhelming. Subsequently, I had Covid tests through my PCP which were negative but I had symptoms that mimicked Covid symptoms. My PCP recommended I go to the ER and I was admitted for two and a half days. They monitored my heart, did lab work, liver test. I continue with headaches that are more profound. I still have loss of strength in my right thigh, which is intermittent, comes and goes. I still have itchiness on my right thigh and leg with loss of sensation lasting from three to five hours. I will be seeing a neurologist next month.
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| 54 | 2021-03-24 | impaired work ability |
The first day I had chills and fatigue about 6 hours after the shot. The next morning I woke up and ...
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The first day I had chills and fatigue about 6 hours after the shot. The next morning I woke up and the room was spinning and I had severe muscle aches. I had to call off work. I went back to bed and slept 13 hours and then felt fine.
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| 54 | 2021-03-25 | confusional state, mental impairment, disturbance in attention |
Dizziness, confusion, nausea, night sweats, lack of concentration & inability to think clearly. Ext...
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Dizziness, confusion, nausea, night sweats, lack of concentration & inability to think clearly. Extreme fatigue & quickly becoming short of breath from walking. Rapid/racing heartbeat. Started evening of the vaccination & continued through the entire day on 3/24, the day after the vaccine. Went to bed at 5:30pm on the 24th and felt much better on the morning of the 26th.
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| 54 | 2021-03-25 | feeling abnormal |
Immediate runny nose and terrible headache. After about 8 minutes, lip feeling weird. After 25 min...
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Immediate runny nose and terrible headache. After about 8 minutes, lip feeling weird. After 25 minutes of receiving shot, numb chest, neck, lower fac3 - and swelling of throat and lower face. The numbness and swelling lasted for approximately 3 hours.
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| 54 | 2021-03-26 | confusional state |
Confusion, dizziness, tired, headache. I slept for 10 hours straight the first night. Body aches. Di...
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Confusion, dizziness, tired, headache. I slept for 10 hours straight the first night. Body aches. Diarrhea on day two. Slept for 10 hours again on 3/26/2021 and slept the majority of the day on 3/27/21. I had severe shortness of breath at 1pm on 3/27/21. I had to use my nebulizers and 4 puffs of the Combivent inhaler.
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| 54 | 2021-03-26 | disorientation |
DIZZINESS, NAUSEA, DIFFICULTY BREATHING, HIGH BLOOD PRESSURE (165/96), 11:20AM - 11:40AM, PT WAS CON...
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DIZZINESS, NAUSEA, DIFFICULTY BREATHING, HIGH BLOOD PRESSURE (165/96), 11:20AM - 11:40AM, PT WAS CONCIOUS AND DISORIENTED, WE CALLED AMBULANCE WHEN SHE STATED DIFFICULTY BREATHING.
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| 54 | 2021-03-26 | feeling abnormal |
Patient reports suddenly feeling tired and having "brain fog" and saying incorrect words. Instructed...
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Patient reports suddenly feeling tired and having "brain fog" and saying incorrect words. Instructed patient to lay down. VS at 1113 were BP 126/82, P 73, O2 100% on RA, and no pain. Patient reports having tiredness with her first dose. Patient denies any other symptoms. After 30 minutes patient reports feeling improved and no new symptoms. Instructed patient to arrange for a ride home and to rest. Instructed patient to seek medical help if symptoms worsen or new symptoms occur.
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| 54 | 2021-03-26 | sleep disorder |
Woke up from sound sleep at approximately 3:30AM on 3/ 27 /221 due to severe scalp burning and itch...
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Woke up from sound sleep at approximately 3:30AM on 3/ 27 /221 due to severe scalp burning and itching. Symptoms continued throughout the day. At 7pm n same day seen by Urgent Care practioner previously noted.
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| 54 | 2021-03-28 | disorientation |
heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immed...
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heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immediate overall body weakness; slurred speech; lips tingling; disoriented; lightheaded; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration, at the age of 54 years, on the left arm on 08Mar2021 15:00 at a single dose for COVID-19 immunisation. Medical history included fibromyalgia, musculoskeletal disorder, drug hypersensitivity to penicillin, other food sensitivities and gluten sensitivity; all from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); ascorbic acid (C 500 [ASCORBIC ACID]); colecalciferol (D3) and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient previously took progesterone, NP thyroid and lactose and experienced hypersensitivity. On 08Mar2021, the patient immediately felt the medications moving throughout her body. She felt immediate overall body weakness, slurred speech, lips tingling, disoriented, lightheaded, and heart discomforted. The medical staff took her blood pressure 30 minutes after the injection and it was 184/124. She stated she was not hypertensive. The final read before leaving the site was 149/90. No treatment was received for the events. The outcome of the events was recovering.
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| 54 | 2021-03-28 | feeling abnormal |
Worsening of existing light tinnitus. Prior to COVID vaccine, had only a small, barely noticeable r...
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Worsening of existing light tinnitus. Prior to COVID vaccine, had only a small, barely noticeable ringing in my ears. Now, the ringing is accompanied by a heaviness, throbbing. Not painful but distracting and makes me feel foggy.
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| 54 | 2021-03-28 | feeling abnormal | Fever, chills, headache, sore muscles sleepy, dizzy, brain fog increased |
| 54 | 2021-03-29 | insomnia |
12:30 AM - minor headache, body aches, trouble sleeping, pain at injection site 2:30 AM - freezing c...
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12:30 AM - minor headache, body aches, trouble sleeping, pain at injection site 2:30 AM - freezing cold hands, cold feet and body, minor headache, body aches, trouble sleeping, pain at injection site 6:30 AM - minor headache, body aches, trouble sleeping, fainting, pain at injection site
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| 54 | 2021-03-30 | anxiety |
The vaccine was given at a community Covid-19 drive-through vaccination outreach event. The patient...
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The vaccine was given at a community Covid-19 drive-through vaccination outreach event. The patient remained in her vehicle during the vaccination and while waiting in the post-vaccination observation parking area. I was summoned to the patient's vehicle at 10:28, the patient had a compliant of not feeling well after getting her shot. I remained with her for 15 additional minutes, she denied shortness of breath. I could hear audible wheezing, and she also began to cough. At 10:45 her cough increased, she appeared anxious, it appeared, that she was experiencing a mild bronchospasm. I requested the observation staff member to make a call to 911 to request an ambulance. At that time I concurrently administered a 0.3 mg epinephrine auto-injector into her right thigh. I continued to observe her until the ambulance arrived at 10:50. Her reparations were unlabored, a mild audible wheeze was still apparent. She ambulated to the ambulance was able to step up into the ambulance. The patient declined to be taken to an emergency department. I gave report to EMT tam, later they reported the initial VS as HR89, RR24, NC was placed, O2 sat was 98% on NC 2 LPM. She was discharge from their care approximately 20 minutes later, the VS were HR88, RR20 RA saturation was 94%. I made a call to the phone number on file in the patient's medical record, but the following message was received: the wireless customer you are calling is not available. Result or outcome of adverse event(s): EMT team called to observe the patient. I advised the patient to seek medical care at an emergency department, or call 911 if she had any additional concerns.
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| 54 | 2021-03-30 | feeling abnormal |
Client states feeling "a little loopy" after receiving the vaccine. Fire Rescue at the scene to ass...
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Client states feeling "a little loopy" after receiving the vaccine. Fire Rescue at the scene to assess client. All vitals + glucose stable. Symptoms resolved. Client cleared to leave at 11:52 am, per Fire Rescue no further evaluation needed.
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| 54 | 2021-03-31 | anxiety | anxiety, increased hearbeat |
| 54 | 2021-03-31 | confusional state, loss of personal independence in daily activities |
3/25/21- 6:30 pm vaccine shot 3/26/21 ~ 9:30- 10:00 am Chills, high fever reaching 103 (rising stead...
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3/25/21- 6:30 pm vaccine shot 3/26/21 ~ 9:30- 10:00 am Chills, high fever reaching 103 (rising steadily throughout the day after injection), fatigue, confusion, wiped out, couldn't move for 7-8 hours, unable to stay awake or focus/function on anything, Fever broke about 6 pm after taking Tylenol a couple hours earlier. Nausea, and weak 3/27/21- fatigue, body aches (lower back hurt, head hurt), night sweats 3/28/21 fatigue, body aches (lower back hurt, shoulders and neck hurt, stiff neck, body temperature dropped to 96
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| 54 | 2021-03-31 | feeling abnormal |
Day 7 -- still have EXTREME fatigue, nausea and brain fog Day 6 - fatigue, nausea and brain fog Day ...
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Day 7 -- still have EXTREME fatigue, nausea and brain fog Day 6 - fatigue, nausea and brain fog Day 5 - fatigue, nausea and brain fog Day 4 - Above + joint pain Day 3 - Above + fever of 101 (fever was higher on day 3 than day 2) Day 2 - Above + fever of 100 Day 1 - vaccine received
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| 54 | 2021-03-31 | insomnia, loss of personal independence in daily activities |
After 1st shot : arm soreness, raised red and hot to touch. Pain in hips as day went on, pain trave...
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After 1st shot : arm soreness, raised red and hot to touch. Pain in hips as day went on, pain traveling to lower extremities, then upper extremities. Lethargy and chills. After 2nd shot: Similar s/s but worse than 1st dose. Painful to move upper and lower extremities, extreme lethargy, slight temp, overall unwell feeling. My concerning issue is that arm soreness diminished after few days but then returned at approximately 3 weeks after 2nd dose . As of right now, I?m continually feeling pain, sometimes sharp and radiating pain above and below site. Seems to be covering more area of arm, armpit.I have hard time sleeping on left side, waking up from pain if on it too long, weakness in left arm, pain if lifting arm or turning it certain directions. If I press on injection site i can feel pain and tenderness. Affecting daily living. I?m also a nurse and it?s worrying me at this point.
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| 54 | 2021-04-02 | disorientation |
Achy muscles on the first day after the 2nd dose. The following day, sever chills, achy muscles (di...
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Achy muscles on the first day after the 2nd dose. The following day, sever chills, achy muscles (difficulty walking/climbing stairs) for about 3 days, bad headaches that lasted about 4 days off and on, and very disoriented.
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| 54 | 2021-04-02 | feeling abnormal, excessive sleepiness |
Chills and extreme arm soreness for a few hours prior to fever. fever ranging from 99- 102.7 degre...
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Chills and extreme arm soreness for a few hours prior to fever. fever ranging from 99- 102.7 degrees for about 30 hours.. Slept for nearly 36 hours and felt exhausted and foggy for an additional 6 hours. No appetite and minor stomach upset for duration of fever
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| 54 | 2021-04-02 | sleep disorder, fear |
After the first vaccine on 2/6/2021, I did not have any reaction except a sore arm until 2/10/2021 ...
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After the first vaccine on 2/6/2021, I did not have any reaction except a sore arm until 2/10/2021 when developed a bad headache causing me to leave work. When I awoke on 2/11/21 I felt worse as the day went on until I had complete flu like symptoms. On Friday, 2/12, I went to my primary care doctor and they did a COVID-19 test which was negative. Hence, I just waited for the reaction to go away, I was not better and able to resume normal activity until 2/15/21. I did decide to get the second shot as I was not entirely sure it was a result of the vaccine. On 2/27/2021, I received the second vaccination. Again, the immediate side effect was only a sore arm. On the following Monday (3/1/2021) see cont.I began to have what I thought was muscle aches and pains around the mid section on my body but they were manageable. On Tuesday and Wednesday (3/3/2021) the pain and area of the pain spread and intensified. I was unable to sleep or find a comfortable position and was losing strength and knew I needed medical attention as I was afraid it was a heart issue. My husband took me to the ER (3/4/2021). The ER doctor ran a CT scan with contrast and the result was a blood clot in my right lung and pneumonia in my left lung along with pleurisy. I was then admitted to Clinic on 3/4/2021. I remained in the hospital until 3/7/2021. There I was treated with IV antibiotics, warfarin, Lovenox (80mg), and pain medication for the pleurisy. I was also on a full time heart monitor and my heart was checked several times. Since returning home, I finished a dose of two antibiotics and am using an inhaler to help with breathing. I have also just finished a long dose of steriods. My INR is still not regulated to the therapeutic level. Prior to this reaction, I was in the therapeutic range and had been checked. As of 4/3/2021 I am at 1.8 not in the 2-3 range and have increased my dose from before the reaction at 7.5 mg to 9.0 mg daily.
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| 54 | 2021-04-03 | anxiety |
Flushing/sweating, dizziness, and increased anxiety. Initial BP 171/108 (pulse 82). F/u BP 124/65 (p...
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Flushing/sweating, dizziness, and increased anxiety. Initial BP 171/108 (pulse 82). F/u BP 124/65 (pulse 74). O2 sat 100%. Patient placed in supine position and stabilized.
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| 54 | 2021-04-03 | confusional state |
Dizziness; confusion; This is a spontaneous report from a non-contactable consumer(patient). A 54-y...
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Dizziness; confusion; This is a spontaneous report from a non-contactable consumer(patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on left arm on 24Mar2021 at 15:30 (at the age of 54-year-old) at a single dose for COVID-19 immunization. The patient was vaccinated at Pharmacy/Drug store. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination has not been tested for COVID-19. Medical history included Pencillin allergy. Concomitant medications included Multivitamin and Vitamin D. The patient experienced dizziness and confusion on 24Mar2021 at 15:45. The events were reported as non-serious. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 54 | 2021-04-03 | feeling abnormal |
Could not get out of bed the day following injection. Ran a fever as high as 104. Headache and flu s...
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Could not get out of bed the day following injection. Ran a fever as high as 104. Headache and flu symptoms. Still feeling foggy and running 100.4 temp second day after shot.
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| 54 | 2021-04-04 | feeling abnormal | Brain fog Dizziness Tiredness Ongoing for over 10 days now |
| 54 | 2021-04-04 | feeling abnormal |
Felt weird, dizzy, flushing/sweating, h/o multiple allergies. BPs 180/107 (pulse 126), 171/115. Give...
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Felt weird, dizzy, flushing/sweating, h/o multiple allergies. BPs 180/107 (pulse 126), 171/115. Given Benadryl 25 mg PO. Advised to go to ED, but patient refused.
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| 54 | 2021-04-04 | loss of personal independence in daily activities |
Possible SIRVA. Shoulder stiffness and pain, severe first day, continuing to lesser degree currentl...
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Possible SIRVA. Shoulder stiffness and pain, severe first day, continuing to lesser degree currently with use shot reported to be administered very high on shoulder; that afternoon patient developed a very painful, frozen shoulder. The weight of my arm itself was painful and patient reported sleeping in the shirt worn that day rather than attempt to pull my shirt over head. Steadily improving, but it is not gone yet. Arm was too weak to push the vacuum cleaner well. (reported on 4.1.21) Vaccine administered 3.30.21.
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| 54 | 2021-04-05 | feeling abnormal, sleep disorder |
Severe chills started 17 hours after shot. 20 hours after shot my heart started racing really bad a...
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Severe chills started 17 hours after shot. 20 hours after shot my heart started racing really bad and I was very breathless. I tried to sleep, but kept jolting awake and felt like I had quit breathing. I was lightheaded. Arm/neck/shoulders really sore. Chills went away after about 7 hours. The chills came back 5 hours later (April 1 at 10:00 pm). When I woke up on April 2, I felt better, but was extremely exhausted. I felt really "off" through April 4. (Off meaning: breath kept getting caught in my throat, bouts of lightheadedness, slight tightness in right side of chest)
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| 54 | 2021-04-05 | sleep disorder |
Woke up in the middle of the night, around 3 a.m., with all my joints feeling stiff, most pronounce...
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Woke up in the middle of the night, around 3 a.m., with all my joints feeling stiff, most pronounced in my hands. After getting up several hours later, around 7:30, and moving around the stiffness faded away.
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| 54 | 2021-04-06 | anxiety |
Systemic: Dizziness / Lightheadness-Medium, Systemic: anxiety due to shot. has anxiety disorder-Medi...
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Systemic: Dizziness / Lightheadness-Medium, Systemic: anxiety due to shot. has anxiety disorder-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
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| 54 | 2021-04-06 | confusional state | headache weakness no energy confusion very sore arm where shot was given Lasted 1 1/2 days |
| 54 | 2021-04-07 | feeling abnormal | patient reports she was mis-stepping and falling - states it felt "fuzzy" "sort of cloudy" |
| 54 | 2021-04-08 | feeling abnormal |
Patient recently left vaccine observation area and noted she was "I am feeling funny/weak and that s...
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Patient recently left vaccine observation area and noted she was "I am feeling funny/weak and that she had just obtained the COVID vaccine." with pre-syncopal episode. Patient taken to ED for evaluation. Given IV fluids and discharged from ED.
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| 54 | 2021-04-08 | impaired work ability |
After waiting the required 15 minutes after vaccine administration, patient states she felt nauseous...
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After waiting the required 15 minutes after vaccine administration, patient states she felt nauseous and light headed. She was placed in chair, blood pressure taken and questions answered regarding food/drink consumed today, medical history, etc. Co-workers notified, one of which was a nurse. Patient was advised to rest in her office w/supervision and at any time if she felt she needed to leave work, she was free to do so or assistance would be provided if needed. She voiced understanding and agreed. Later, hospital staff was notified that patient had arranged for a family member to pick her up and take her home for the remainder of her work day, as the symptoms had not yet resolved. Follow up call made at 1444. Patient reports mild nausea and fatigue. She was advised to continue to rest and hydrate. If symptoms worsen, chest pain develops, etc., she is to report to ED for eval.
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| 54 | 2021-04-08 | loss of personal independence in daily activities |
Severe pain in her upper left arm in the muscle around the injection site. She has to have help get...
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Severe pain in her upper left arm in the muscle around the injection site. She has to have help getting dressed. She cannot use this arm for anything and has to use her right arm to lift her left arm. She has been using rubbing alcohol and muscle rub for the pain. She contacted her PCP and she was recommended to get 2nd dose but was not given any medical advice.
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| 54 | 2021-04-08 | loss of personal independence in daily activities |
Shortly after the shot, felt extreme muscle/body aches - "very severe Flu like" , fatigue and some c...
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Shortly after the shot, felt extreme muscle/body aches - "very severe Flu like" , fatigue and some coughing. developed quickly into extreme muscle aches almost unbearable. Was unable to function. Stayed in bed. Only Ketoprofen helped dull them slightly. They lasted from Wednesday afternoon until Friday morning. Then woke up feeling completely normal.
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| 54 | 2021-04-09 | feeling abnormal, impaired work ability |
12 hours after the shot I got chills, then started running fever for 24 hours- highest being 102.1. ...
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12 hours after the shot I got chills, then started running fever for 24 hours- highest being 102.1. By 24 hour after the shot I had fever, chills, nauseated, dizzy, and bad headache. By 36 hour after the shot I felt fine other than a persistent headache that lasted 5 days. I also developed what I would call brain fog days 3 through 5 after the shot. I coukd not say the words I wanted to say or think clearly. 5 days after the shot everything was back to normal. I NEVER get sick, I have not missed a day of work in 9 years and had to call in sick the day after the shot because I was so dizzy and sick to my stomach.
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| 54 | 2021-04-09 | loss of personal independence in daily activities |
3 days after receiving 2nd dose many side effects presented causing several trips for medical care F...
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3 days after receiving 2nd dose many side effects presented causing several trips for medical care Fever, abdominal cramps much like a consistent runner's cramp, high BP, head ache, dry mouth feeling of burnung skin, heaviness/ tiredness in arms and legs, extreme tiredness ER dr confirmed adverse reaction to vaccine, Adverse symptoms are still present after 10 days Dr informed that symptoms may be present for weeks. I have been incapacitated by symptoms
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| 54 | 2021-04-11 | anxiety, feeling abnormal |
I felt strange immediately after getting the vaccine. But I thought it was anxiety. The next day I ...
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I felt strange immediately after getting the vaccine. But I thought it was anxiety. The next day I continued to feel strange, like I had run a long distance. It turn out that my resting heart rate was over 100. I went to an urgent care. They did an ekg and said it seemed ok but to be sure sent me to ER. There I was given another EKG a chest XRay and blood work. Labs came back normal. I was given IV fluids and released. The rapid heart rate continued for a week. Now I am finally feeling back to normal.
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| 54 | 2021-04-11 | excessive sleepiness, disturbance in attention, impaired work ability |
The day following the shot I slept excessively and despite taking extra strength Tylenol my headache...
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The day following the shot I slept excessively and despite taking extra strength Tylenol my headache never went away. My joints and muscles were very sore. No energy and difficulty concentrating. The second day was the same - sleeping most of the day with continuing headache and sore joints and muscles. The third day I did not go to work. Slight headache and body aches. New muscle pain across my chest when using my right arm (the arm of injection site).
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| 54 | 2021-04-12 | feeling abnormal |
Headache (80 hours), blurred vision (36 hours), brain fog (72 hours), fatigued (72 hours), chills (2...
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Headache (80 hours), blurred vision (36 hours), brain fog (72 hours), fatigued (72 hours), chills (24 hours).
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| 54 | 2021-04-12 | hallucination |
Hallucinations; Fever; Shaking chills; Headache; Bodyaches; Flu-like symptoms; Teeth chattering; Arm...
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Hallucinations; Fever; Shaking chills; Headache; Bodyaches; Flu-like symptoms; Teeth chattering; Arm soreness; Extreme nausea; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm, at age 54 years, on 26Mar2021 09:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Patient's medical history includes multiple sclerosis, hypothyroid, postconcussive syndrome and migraines from unspecified dates. The patient is not pregnant. Patient did not have other vaccine in four weeks. Patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. Patient previously took codeine for unspecified indication and had known allergies on an unspecified date, and other unspecified medications in two weeks. Patient historically took first dose of BNT162B2 (Product=COVID 19, Brand=Pfizer, administration time=05:00 PM, Vaccine location= Left arm) on 03Mar2021 at age 54 years for COVID-19 immunization. On 26Mar2021 20:00, 11 hours after vaccine administration, patient experienced fever, shaking chills, headache, hallucinations, body aches, flu-like symptoms, teeth chattering, arm soreness, extreme nausea. Therapeutic measures were taken as a result of these events which include paracetamol (TYLENOL). COVID was not tested post vaccination. Facility type of vaccine was at a public health clinic/veterans administration facility. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 54 | 2021-04-13 | anxiety |
No adverse events reported by patient to site staff. Pt reported a dry cough, tongue swelling sensat...
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No adverse events reported by patient to site staff. Pt reported a dry cough, tongue swelling sensation with mild dysphagia, anxiety and weakness 1 hour prior to ED presentation, roughly 1.5hours after shot provided, suggesting onset ~30 min after injection. Pt took chlorpheniramine with partial relief of symptoms.
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| 54 | 2021-04-13 | anxiety |
The patient got her 1st COVID vaccination shot 4/7/2021 and subsequently developed some symptoms of ...
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The patient got her 1st COVID vaccination shot 4/7/2021 and subsequently developed some symptoms of nausea, anxiety, short of breath. She took an EpiPen and subsequently felt some nausea and further anxiety. At the time of the emergency room physician's interview and exam she still reported some nausea and anxiety.
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| 54 | 2021-04-13 | feeling abnormal |
I developed several vertigo, dizziness and was diagnosed with BPPV by my doctor 5-6 days after my la...
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I developed several vertigo, dizziness and was diagnosed with BPPV by my doctor 5-6 days after my last vaccination. I am still having symptoms to this day as treatments and physical therapy have not worked.
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| 54 | 2021-04-13 | feeling abnormal |
Patient reported feeling ''weird''/lightheaded and seeing green dots. Patient was placed in a wheelc...
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Patient reported feeling ''weird''/lightheaded and seeing green dots. Patient was placed in a wheelchair and brought to a private observation area. On arrival patient was unresponsive and drooling. EMS was notified. Upon EMS arrival patient became arousable and was talking without difficulty. Vitals and telemetry wnl. Patient reported a similar syncopal episode with blood draw in the past. Patient was stable AAO x3. Patient agreed to have a friend drive her home, f/u with PCM if recurrent symptoms, and ER if new or worsening symptoms.
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| 54 | 2021-04-13 | feeling abnormal |
Within 24 hours low fever, sore arm. Still ongoing extreme fatigue, rash, headaches, dizziness, clou...
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Within 24 hours low fever, sore arm. Still ongoing extreme fatigue, rash, headaches, dizziness, cloudy thinking
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| 54 | 2021-04-13 | feeling drunk |
Patient reports dizzy, "sensation in chest", blurry vision, and "feeling drunk" and short of breath...
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Patient reports dizzy, "sensation in chest", blurry vision, and "feeling drunk" and short of breath occasionally about 20 mins after vaccine. blood glucose level checked -315, patient adjusted own insulin pump. Felt better at 1:06pm.
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| 54 | 2021-04-14 | feeling abnormal | Headache, fatigue, sleepiness, feeling blah |
| 54 | 2021-04-14 | hallucination, anxiety |
Patient was scheduled for 2nd dose of covid vaccine. Patient had a severe resp reaction to 1st vacci...
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Patient was scheduled for 2nd dose of covid vaccine. Patient had a severe resp reaction to 1st vaccine shot. Patient was ok to recevie seoncd dose per PCP documentation. Upon receving 2nd dose patient had severe allergic reaction to dose. Patient couldnt breathe, throat was swelling. EPI was administstered. EMS was called. Vitals were stable blood pressure148/85, heart rate 81 2liters 02 100%. Patient passed out for 10seconds at 2:08pm. Pt just had a flat affect. Patient abruptly woke up and started to hallucinate. 2:10pm ViItals at this time were blood pressure 168/98, heart rate 79, 2 liters 100%. At 2:15 patients throat was closing and pt was gasping for air. Patient was super anxious and a 2nd dose of EPI was given. EMS arrived at 2:24 BLood pressure 157/77 heart rate 87 2 liters 02 100%. EMs took patient to hospital to be further evaulated. Patients husband was at bedside with patient the whole time. Went to ER and was discharged 5 hours later to home.
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| 54 | 2021-04-14 | excessive sleepiness |
The next morning my arm was sore and I felt tired About 24 hours later my entire body ached terribl...
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The next morning my arm was sore and I felt tired About 24 hours later my entire body ached terribly and I needed to lay down. I slept 10 hours. today April 15, I feel better no aching not tired.
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| 54 | 2021-04-14 | impaired work ability |
Severe joint pain in lower body, fever 101.4 lasting 48 hours; visibly swollen and painful lymph nod...
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Severe joint pain in lower body, fever 101.4 lasting 48 hours; visibly swollen and painful lymph node above collar bone on right side; no appetite for 24 hours; slight cough, abdominal pain/cramping beginning after 48 hours; headache; malaise; sore arm at injection site. Unable to go to work for three days (and counting).
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| 54 | 2021-04-15 | disturbance in attention, insomnia, feeling abnormal |
Brain fog, difficulty sustaining thought -- began 72 hours after first Pfizer COVID shot and continu...
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Brain fog, difficulty sustaining thought -- began 72 hours after first Pfizer COVID shot and continuing to current day (2 weeks after first shot) Jelly legs -- began 72 hours after first shot; replaced by muscle spasms described below. Brain "shaking" -- began 96 hours after first shot and continuing to current day (2 weeks after first shot) Muscle spasms -- began 96 hours after first shot and continually worsening to current day (2 weeks after first shot). Began with slight head and shoulder jerks; progressed to also include leg, arm, ankle, and wrist spasms and numbness in toes. Extreme insomnia -- brain shaking and muscle spasms prevent sleep. Have slept a total of 22 hours in the last 240 hours.
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| 54 | 2021-04-15 | insomnia | Headache Hot and cold, with temp of 100 degrees Severe joint paint Could not sleep |
| 54 | 2021-04-16 | anxiety |
Attendee received dose at 4:04pm, reported symptoms of nausea, chest heaviness, dizziness, anxiety a...
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Attendee received dose at 4:04pm, reported symptoms of nausea, chest heaviness, dizziness, anxiety at 4:24pm, received benadryl for symptoms at 4:30pm with her daughter present for comfort, reported feeling better at 5pm
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| 54 | 2021-04-16 | feeling abnormal |
Patient felt like the right side of her face felt "weird" and tight. Received Benadryl 25mg po and s...
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Patient felt like the right side of her face felt "weird" and tight. Received Benadryl 25mg po and symptoms improved.
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| 54 | 2021-04-16 | impaired work ability, loss of personal independence in daily activities |
20 minutes after the vaccine my muscles started to become weak and painful. Throughout that day the ...
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20 minutes after the vaccine my muscles started to become weak and painful. Throughout that day the pain, muscle weakness, fatigue, lethargy increased then the next morning I was not able to function. This NEVER went away. The pain in every muscle and joint has been so severe and debilitating as well as the fatigue and lethargy. It has been 7 weeks and I am still suffering severely. I have been on high doses of Ibuprofen first(by my doctor) and then high doses of Prednisone by my doctor which I have not been able to come off of. The pain is in all four extremities, shoulders, low back, and hips and is a joint pain, muscle pain, and a severe burning pain. I continue to be lethargic and fatigued unable to get through my work day and needing to lie down often. I was a very fit, active person and now cannot do any activities due to the pain and lethargy. My joints will also give out when I walk including my hips, knees, and ankles. There is numbness and tingling in my extremities, but more in the right arm and right leg. It will feel like there is a tourniquet around them cutting off all circulation.
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| 54 | 2021-04-18 | feeling abnormal |
as soon as injection was made, it felt like liquid shooting up my neck. I had the usual arm pain, f...
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as soon as injection was made, it felt like liquid shooting up my neck. I had the usual arm pain, fatigue, fever, lasting about 24 hours. For next 11 days I was sick to stomach with very mild fever that would come and go, but nothing unbearable. On about day 13 after vaccination, I had a sharp, pulsating pain in the injection site. pulsated for about 5 min, then stopped. Over the next week, at random times, I feel pain in the injection site, not my whole arm, and feverish off and on. I have the stomach discomfort off and on as well. I have had many injections in my life and have never felt liquid run up my neck. Did it go into a vein? Is the vaccination as effective? Why am I continuing to have pain?
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| 54 | 2021-04-19 | confusional state |
I woke at midnight. I was all sweaty & felt like I couldn?t breathe, my heart was pounding. I ran do...
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I woke at midnight. I was all sweaty & felt like I couldn?t breathe, my heart was pounding. I ran downstairs and outside to get air and the earth felt like it was spinning under me and everything was moving. I felt nauseous and confused and had racing thoughts. I fell back and hit my head and got up and tried to come inside and ended up falling again and urinating while on the floor. I believe I lost consciousness. I couldn?t stand and vomited several times in the ER.
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| 54 | 2021-04-19 | feeling abnormal |
3/9/2021 After first vaccine I had brain fog, bowels hurts/stinging, headache, fatigue (just like th...
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3/9/2021 After first vaccine I had brain fog, bowels hurts/stinging, headache, fatigue (just like the illness), I felt better in about five days. About two weeks later I had an increased/altered sense of smell/taste to certain things such as banana?s, tequila, Baileys Irish Cream, certain sweet foods/fruit (but not ice cream). Other altered smells: Dawn dishwashing soap, Clothes washing detergents three brands (Tide, Arm& Hammer, and Gain). Belching caused the taste to be sensed. Most of the smell/taste had returned to normal in about four weeks (right before the second vaccine).
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| 54 | 2021-04-19 | excessive sleepiness, nervousness |
Fatigue set in about 11 hours after I was given the shot on Sunday, but it was bedtime so I didn't t...
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Fatigue set in about 11 hours after I was given the shot on Sunday, but it was bedtime so I didn't think much of it. At 1:15 am, I woke to violent shaking all over, and all-over achiness but no fever. I took one 500 mg Tylenol, and slept fitfully, I felt like I was aware that I was extremely uncomfortable, and I was either too cold or too hot. My temperature fluctuated from normal to about 100.8, on and off all the next day. It was an extreme effort and it was difficult to even shift my body position in bed, and my arm that was vaccinated could barely move and it hurt tremendously. My head ached, and my lower back ached the most, aside from my arm. I slept nearly all day yesterday (Monday), and I was very weak, with hardly any appetite. It took all effort to get out of bed to use the bathroom. I took a Tylenol 500 mg pill every 5-6 hours and those first couple hours felt the most pain relief. I counted down the time to get past 5 hours to take another one. Around 7 pm, after sleeping all day, I got out of bed to sit upright on the couch to relieve my back pain, and that helped. Symptoms started easing up later last night. I slept more than 9 hours again and today am feeling weak but no body aches or headache, only my arm is sore but not as bad as it was yesterday. I am less fatigued today but moving slowly, and my appetite is slowly returning. I have avoided taking more Tylenol since bedtime last night and feel like the worst is behind me. I hope.
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| 54 | 2021-04-20 | anxiety |
Pt had no issues the first Pfizer dose, but after this dose, she started experiencing her typical an...
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Pt had no issues the first Pfizer dose, but after this dose, she started experiencing her typical anxiety symptoms. EMS was called 182/101 84 18 97%. Pt c/o chest pressure 6/10, but she been having this discomfort for month, had an echo and saw a cardiologist 6 months ago. BP remained, pt waited almost an hour total until she felt comfortable enough to drive 40 min home
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| 54 | 2021-04-20 | feeling abnormal |
I did not see or feel the pharmacist insert a needle into my arm. What I saw was a square little box...
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I did not see or feel the pharmacist insert a needle into my arm. What I saw was a square little box pressed against my skin and then she said it was done. I felt absolutely nothing and was surprised that the injection had been administered. The day after I felt all right just a very sore arm. But the following day some side effects started occurring which still have not gone away after three weeks. Severe fatigue not able to function at normal level, exercise I can only do about a third what I usually do. Brain fog. Listlessness. All muscles and joints achy and burning all of the time, skin flaring up red, sensation of systemic inflammation. Tremendous water retention, picked up about 7 pounds without any dietary change. Urination is scant even though I drink about 64 ounces of water a day. Stool is a lot less than it used to be, and I?m usually very regular . I wake up very groggy and tired in the morning. Very heavy sensation in the body. What I should mention is that I was about 80 pounds overweight and tests showed heightened inflammation markers two years ago. Since then I lost about 30 pounds on a high-protein diet with 4 to 5 times a week exercising and strength training. The heightened inflammation disappeared as well as the chronic tinnitus in 2018. . Two days after I had the vaccine, all my inflammation symptoms tinnitus, water retention and weight gain returned, despite no change to my diet or exercise regime.
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| 54 | 2021-04-20 | impaired work ability |
pt says she got very woozy and waited 15 minutes before leaving after taking the vax. She ran erran...
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pt says she got very woozy and waited 15 minutes before leaving after taking the vax. She ran errands and then went home but still felt woozy. She took an aspirin and went to bed. She woke up with pain in her bones. She said the pain from her neck down to her feet. She had pain her her right arm, nauseated, head pressure, still neck, light headed, and cold. She took aspirin for her symptoms that lasted for 5 days. On the 6th day her neck was still stiff so she took aspirin and went back to work. Her symptoms have since subsided.
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| 54 | 2021-04-21 | confusional state |
Pfizer-BioNTech Covid-19 Vaccine EUA, 11:30 pm 4/20 thru 5am 4/22: shakes, chills, fever, body aches...
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Pfizer-BioNTech Covid-19 Vaccine EUA, 11:30 pm 4/20 thru 5am 4/22: shakes, chills, fever, body aches, joint pain, painful sensation on skin surface, confusion, need to sleep, no appetite.
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| 54 | 2021-04-21 | feeling abnormal |
Patient here for second dose COVID-19 Pfizer Vaccine. At the time of vaccination, patient reported e...
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Patient here for second dose COVID-19 Pfizer Vaccine. At the time of vaccination, patient reported experiencing nausea approximately two hours after first dose. Patient was advised to report symptoms to the observer in observation area. After approximately 20 minutes, patient stated that she was not feeling better. Nurse brought patient back to recovery room. Nurse took patient's vitals q15minX3. Patient stated that blood pressure was elevated from her baseline. Patient also stated that she felt warm and nurse gave her an ice pack. Patient reported that her husband was coming to transport her home. Patient advised of emergent symptoms and to report to Urgent Care or ED if symptoms worsened. Patient informed that an incident would be filed with VAERS and that she may be contacted.
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| 54 | 2021-04-21 | mental status changes | Patient vomited , hypertension and altered sensorium |
| 54 | 2021-04-22 | restlessness, sleep disorder |
12 hrs after injection experienced chills, muscle and joint pain, fever, inability to sleep comforta...
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12 hrs after injection experienced chills, muscle and joint pain, fever, inability to sleep comfortably, tired but restless, headache, stomach upset
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| 54 | 2021-04-24 | feeling abnormal, disorientation |
passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; so...
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passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; sores in her mouth and nose; sores in her mouth and nose; anal hemorrhoid sores; had difficulty speaking, with her words; has been dropping things, she has broken glass; her eye felt heavy and her eye was drooping; Dizzy; Fall; Slight fever; Fatigue; extreme pain through right side (right side means her shoulders, neck, torso, arm, and entire leg); first dose given 14Jan2021, and second dose given 07Mar2021; first dose given 14Jan2021, and second dose given 07Mar2021; Shortness of breath; severe nerve pain; Vomiting; had a feeling of urination, like she had to urinate when she didn't, that feeling of urination; Disorientated; eye pain like pins and needles; skin is burning and painful to the touch; Headache; joint and muscle pain; joint and muscle pain; Nausea; horrible lack of appetite/couldn't eat anything other than soup; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program called COVAX US Support. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunization. The patient's medical history included history of three spinal surgeries (takes no pain meds, she is not on pain meds, she has never been on or kept taking them); and has "neuropathy and nerve related issues" that were not this bad since ten years ago in 2011, clarified that what she has is not actually neuropathy, something with the peripheral nerve, she says she doesn't remember actual verbiage), since ten years ago in 2011, and the only difference was this vaccination, it was not this bad until this vaccination. She doesn't react well to pharmaceuticals anyway (unspecified). Her medications are that she takes the minimum amount of medications, very minimal (unspecified). There were no concomitant medications. There was no other products. Also, she has not had any other recent vaccinations or started any new medications. For past drug, she didn't take anything other than 5mg of zolpidem tartrate (AMBIEN) to sleep at night because of her spine. Patient previously also took pregabalin (LYRICA) and was off it, was also on gabapentin or neurontin (patient did not have those medications to provide NDC/LOT/EXP for either of them because she took them back to the pharmacy or turned them in to the police station because she doesn't keep medications in her house if she isn't taking them, and she couldn't take that medication). Historical vaccine included first dose of bnt162b2 on 14Jan2021 (at the age of 54-year-old; Lot Number: EN5318) in Arm Right for covid-19 immunization, and for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. She received both doses of vaccine. Her first dose was LOT: EN5318 and was given 14Jan2021, and her second dose was LOT: EN6204 given 07Mar2021. The patient was reporting for Pfizer COVID-19 vaccine, for she was having a horrible reaction to it "45 days" (as reported) after taking 2nd dose, and had been in the ER, and her temperature still hasn't gone back down to her normal, her oral temp is still raised and her rectal is raised even more. She was not feeling well, she felt very bad, she would never get a vaccine again, that is how bad it was. Since "45 days" later she was still having significant pain and trouble flexing her right hand open and closed. For events treatment, she took over the counter Tylenol for fever and pain, strength unknown. Patient said she had not had this kind of disabling symptoms or anything before this vaccination. She had a slight fever almost the whole "45 days". On 08Mar2021, her oral temp was over 98 degrees Fahrenheit when her norm temp being 97.2 or 97.3degrees Fahrenheit. Her rectal temp stayed at 100 degrees Fahrenheit. The next day, actually on the 09Mar2021 (which was two days after her second dose), she had the slight fever, fatigue, and extreme pain through her right side. She said her right side means her shoulders, neck, torso, arm, and entire leg. She also had shortness of breath, and severe nerve pain. She called her primary care provider who said to wait 5 days to be seen. On day 5, or actually the whole five days (reported as in Mar2021), she was in bed and didn't leave her apartment because she was in bed and she was vomiting. On day 2 or within 6 hours of vaccination, she had a feeling of urination, like she had to urinate when she didn't, that feeling of urination was equivalent of having contrast dye (NDC/LOT/EXP: Unknown) put in her IV which makes her feel like she is peeing her pants but she did not, and that feeling has not gone away. On day 5 (11Mar2021), she was dizzy and fell. In Mar2021, she was disorientated and vomiting, she couldn't eat anything other than soup. On day two (Mar2021) she had some kind of eye pain that is still there "45 days later", it feels like pins and needles. Her skin was burning and painful to the touch, she couldn't keep an IV in her when she was in the ER. She was not admitted to the hospital. She was having headaches, and joint and muscle pain. She had nausea and vomiting at different times. She continued to have shortness of breath. She had a horrible lack of appetite. She had sores in her mouth and nose. She had anal hemorrhoid sores. Last night (05Apr2021 )she had a headache that was severe like someone put a knife behind her right eye, and when she got up (06Apr2021) her eye felt heavy and her eye was drooping. She also had difficulty speaking, with her words. She says she had passed out, and had been dropping things, she had broken glass. She has been to a neurologist and a gastroenterologist. She clarified that all of these events were after her second dose, for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. None of her doctors know what to do, her gastro doctor was giving her an anti inflammatory suppository and was going to do some tests. She had blood done from neurologist and at the ER and no one knows what to do, they keep referring her to other doctors. She wished someone could explain to her, but no one know and they said it was uncharted territory, they didn't know what to do. She is now back on Lyrica which she was off of but the ER prescribed her 300mg three times a day. She wanted to know what the hell is going on with this vaccine, and that she doesn't think having these side effects "45 days" out is normal. She wanted to be transferred to speak with someone about what to do because her doctor's don't know anything. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 54 | 2021-04-24 | loss of personal independence in daily activities |
severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating ...
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severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating pain into the right arm and lymp nodes; blood pressure was through the rood; severe pain; cardiac issues; GI issues/GI malfunction of the pancreas and gallbladder; GI issues/GI malfunction of the pancreas and gallbladder; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 09:45 (Batch/Lot Number: Unknown reported as either EN6205 or EM6205) as SINGLE DOSE for COVID-19 immunization; azithromycin (ZITHROMAX), via an unspecified route of administration from 26Feb2021 until 02Mar2021, at unspecified dose and frequency for dental care; and corticosteroid (CORTICOSTEROID), via an unspecified route of administration from an unspecified date with last dose shot on 23Mar2021 at unknown dose, once or twice a year for a couple of years for knee pain and joint pain . Medical history included dental procedure on an unknown date. Concomitant medications were not reported. On 25Mar2021 (9 days later), she developed severe chest pain like severe heart burn attack radiating pain into the right arm and lymph nodes, blood pressure was through the roof and was in severe pain. She was unable to eat, was very weak and also cannot work or engage in daily activities noted in Mar2021. The patient required emergency room and physician office visit due the events (including cardiac issue and GI issues/malfunction of the pancreas and gallbladder). She was hospitalized on 03Apr2021 and was just released on 04Apr2021. During hospitalization, doctors have ruled out cardiac issue and GI issues/malfunction of the pancreas and gallbladder and they cannot find out the cause. The patient received famotidine (PEPCID), omeprazole (PRILOSEC), pantoprazole (PROTONIX), acetaminophen (TYLENOL) as treatment. While in the hospital they gave her dicycloverine (BENTYL) which she thought was for nausea noted in 2021.She stated a week after she got the vaccine she got a corticosteroid shot which she was wondering if it can impact one's immune system and cause an adverse reaction with the vaccine. She also stated that a month prior to vaccine she took an azithromycin. She also was wondering with the combination of all these three things being close together if it may have caused a disruption in her body organic system. The action taken in response with the adverse event for azithromycin was post therapy while unknown for corticosteroid shot. The patient did not recover from chest pain while outcome of the remaining events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021376222 Pfizer
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| 54 | 2021-04-26 | anxiety | Patient had anxiety. Released from vaccination site after significant improvement. |
| 54 | 2021-04-28 | impaired work ability, feeling abnormal |
I'll start at the first dose because it's all related, however the events from the 2nd dose have bee...
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I'll start at the first dose because it's all related, however the events from the 2nd dose have been more profound. 1st dose 3.27.21 Pfizer Left arm- within 30 seconds a metallic taste in my mouth lasting about 5 hours. Arm soreness that is it. 2nd dose: 4.17.21 Same arm for injection. within 30 seconds metallic taste in my mouth lasting 24 hours about an hour later my tongue felt like I had eaten 10 ghost peppers - this lasted another 24 hours, reappearing off and on for a few days -by Wednesday 4/21/21 the burning subsided. On 4/22/21, I started to feel off, but was able to work. At approximately 4:00pm, I turned away from a coworker to grab a pen - nothing unusual, no swift moves, when the world started spinning and the floor felt unstable, I grabbed the counter but that felt like it was moving. My coworker sat me down, within an hour I was better. I have had many dizzy spells since but nothing as epic as today where I was sent home. My session is running out so that's about all I can say.
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| 54 | 2021-04-29 | panic reaction |
Vaccine administration provided to left deltoid at 8:20a.m. While in recovering in the Obs area, pa...
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Vaccine administration provided to left deltoid at 8:20a.m. While in recovering in the Obs area, patient complained of left arm heaviness, left chest pressure and dizziness. The patient was positioned in a wheelchair; during transport to the on site medical tent, the patient started passing out. Prior to arriving at the Medical tent, the patient began flailing her arms, panicking and respiratory rate was observed to be a rate of about 60 breaths minute. She was soothed and was observed to slow down her breathing and was subsequently transferred to a supine position on a stretcher. She was provided water and a granola bar and EMS was summoned; Vital signs were 160/90, HR 76, SPo2 96% on room air. EMS requested. The patient refused transport to the hospital; EMS assessed; BP was 138/88. The patient stated that she felt better and refused transport to a local hospital. She was continued to be observed; approx 5 minutes later she complained of visual blurring, a headache, and was observed to have a facial droop and word slurring. Advised by EMS to be transported to hospital; she then agreed to transport to a local hospital.
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| 54 | 2021-04-30 | agitation |
high blood pressure; fast heart beat, fast blood stream; fast heart beat, fast blood stream; weak; s...
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high blood pressure; fast heart beat, fast blood stream; fast heart beat, fast blood stream; weak; shaking; very uncomfortable horrible feeling; very uncomfortable horrible feeling; faint; adrenaline rush; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 15Apr2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included low TSH and high blood pressure. Patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium; losartan potassium (LOSARTAN "AGP"); vitamin D3; cissus quadrangularis (CQL); all taken for unspecified indications, start and stop dates were not reported. On 15Apr2021, the patient had three times adrenaline rush at 16:10, 16:30 and 18:20. It came automatically at 16:15 (as reported) with high blood pressure, fast heart beat, fast blood stream, faint, weak, shaking, very uncomfortable horrible feeling. Usually, this feeling will come after something happen and impact the brain, but now it came just by itself. Patient has feeling that she might die. She wanted to know if this vaccine affected her nerve system and if she should take the second dose or not. No treatment received for the adverse events. The patient underwent lab tests and procedures which included on 08Jan2021, colonoscopy: none, nucleic: none and nasal swab: negative; on 08Apr2021, colonoscopy (received within 2 weeks of vaccination): unknown results; and on an unspecified date (since the vaccination, the patient been tested for COVID-19) nucleic acid test: unknown results. Outcome of events were recovered on an unspecified date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 54 | 2021-04-30 | feeling abnormal |
brain fog; Mild Headache; swelling in hands; fever; joint pain; Extreme Fatigue/ severe fatigue; Diz...
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brain fog; Mild Headache; swelling in hands; fever; joint pain; Extreme Fatigue/ severe fatigue; Dizziness; This is a spontaneous report received from a contactable consumer (patient). This 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 14:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, no known allergies to medications, food, or other products, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines within 4-weeks prior to the COVID vaccine. The patient had no concomitant medications. On 30Mar2021 at 19:00 the patient experienced extreme fatigue and dizziness four hours after vaccination; six hours post-vaccination the patient experienced mild headache, swelling in hands, fever, and joint pain. The patient further reported the next day she had mild hand swelling, severe fatigue, brain fog and mild joint pain. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of extreme fatigue, dizziness, mild headache, swelling in hands, fever, joint pain, and brain fog were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are needed. No further information is expected.
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| 54 | 2021-04-30 | excessive sleepiness |
I didn't feel well all night, achy and uncomfortable. In the morning, while getting ready to shower ...
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I didn't feel well all night, achy and uncomfortable. In the morning, while getting ready to shower for work, I got extremely hot and laid on the bathroom floor. Shortly thereafter, my left hand began to tingle and became numb and the numbness extended to my entire arm. My fingers locked into a claw and I couldn't move them. Then, my right hand and arm did the same although not as severe. My feet began to tingle too. It lasted probably a couple minutes and then all went away and I actually felt better than before. I showered, went to work but felt stiff, achy, headache and very tired. I left work at 12:30pm and went home and slept. The following day was much better, just slight headache and I now have a cough that I didn't have before.
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| 54 | 2021-05-12 | loss of personal independence in daily activities |
I had my first shot on Dec 22nd, 2020. I had my second shot on Jan 12th 2021. On May 7th, 2021 I st...
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I had my first shot on Dec 22nd, 2020. I had my second shot on Jan 12th 2021. On May 7th, 2021 I started a period 6 years or so menopaused. This is not normal. I am seeking treatment from my OB dr. 2 weeks after the 2nd shot, I noticed my shoulder was not getting much better, it was achy still. I started to have more shoulder pain. It has continued to get worse. I now have been diagnosed with bursitis at the place where they inserted the needle for the 2nd shot. It continues to alter my way of life, as It is hard to get ready in the morning, and also hard to use my arm to pick things up and bring back to me. So extending my arm out in front of me and brining it back, to drink a cup of coffee gives me much pain.
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| 54 | 2021-05-13 | panic attack |
bursts of energy; headache; Chills; Panic attack; Panic attack; Hyperventilation; seeing green; feel...
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bursts of energy; headache; Chills; Panic attack; Panic attack; Hyperventilation; seeing green; feeling faint / dizzy; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6206), via an unspecified route of administration in the right arm on 26Apr2021 at 08:45 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included ductal carcinoma in situ (DCIS), asthma from 5 years old, calcification of the breast, vitamin D deficiency, "keep immune system up", ongoing panic and anxiety disorder. Concomitant medications included ascorbic acid/calcium carbonate/calcium pantothenate/calcium phosphate/chromium/cyanocobalamin/folic acid/magnesium carbonate/ magnesium hydroxide/manganese gluconate/nicotinic acid/potassium bicarbonate/potassium carbonate/potassium phosphate dibasic/pyridoxine hydrochloride/quercetin/riboflavin sodium phosphate/sodium bicarbonate/sodium phosphate/thiamine hydrochloride/thioctic acid/zinc ascorbate (EMERGEN-C) to keep immune system up and colecalciferol (D3) for vitamin D deficiency. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 26Apr2021, right after the vaccination, the patient felt a little dizzy but proceeded to her car anyway, got about half a mile away and felt extreme panic. On 26Apr2021 at 09:35, the patient had a major panic attack (which the patient gets, "but it had to be something really big"). She began hyperventilating on 26Apr2021, felt like she was going to faint. She pulled over and started breathing in her hands until she felt almost normal; the anxiety didn't go away, but that was normal for her. Then the faintness came back, and she pulled over again; mentioned she was in heavy traffic and hurried up to pull over. Eventually she contacted her son and he came and took over the wheel. This happened three times on her 45-minute drive; at 15 minutes, then 10 minutes and then at 9 or 8 minutes. She stated she had nothing to eat or drink before the vaccine and they didn't advise her to get anything to eat or drink and that may have had something to do with it. She could see everything looking greenish and it was a sunny day outside. She had a bottle of water and started to drink, and it subsided for a little bit. She pulled over and sat for 15 minutes; there were trucks and cars going really fast; she was doing self-talk saying you can do this and get home; then she drove about 10 or 15 more minutes; she had stayed on the side so she could pull over; cars honked at her for going so slow and she pulled over again. It happened again after 20 minutes. She was feeling really funny. Her son took her for coffee and something to eat. Throughout the day she was having hyperventilation and anxiety feelings until about 19:30 it went away. She had a good night's rest. On 27Apr2021 in the evening, the patient experienced chills so she put on socks; and she had a headache (she never had headaches), so she went to bed. Then she woke up at midnight and felt really energetic, so she watched a little TV then went back to sleep. Now it was day three and she had a lot of bursts of energy. This morning, 28Apr2021, she had a burst of energy and felt renewed. The events did not require a visit to the physician office or emergency room. The clinical outcome of feeling faint and seeing green was resolved on 26Apr2021; of dizzy, headache, and chills was resolved on 27Apr2021; of panic attack and hyperventilation was not resolved; of bursts of energy was unknown. Information on batch number has been requested
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| 54 | 2021-05-18 | feeling abnormal, depression |
Dizziness, scratchy throat , headache - within 15 minutes: Benadryl 50 mg Day after: Dizziness, brai...
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Dizziness, scratchy throat , headache - within 15 minutes: Benadryl 50 mg Day after: Dizziness, brain fog, continued headache, fatigue (lasted about 24 hours) *** Moderate depression - started day after and still continuing 13 days later
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| 54 | 2021-05-18 | loss of personal independence in daily activities |
Extreme ongoing (10 weeks so far) nerve pain; muscle pain; joint pain; weakness in all 4 extremitie...
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Extreme ongoing (10 weeks so far) nerve pain; muscle pain; joint pain; weakness in all 4 extremities and hips and shoulders; numbness and tingling in all extremities with the right side being the worst; numbness and tingling in all extremities with the right side being the worst; I am unable to do activities that I used to do; This is spontaneous report from contactable nurse (patient). A 54-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EN6200 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 26Feb2021 13:00 (at the age of 54-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via an unspecified route of administration administered in right arm on 05Feb2021 13:00 as a single dose for covid-19 immunization. Medical history included asthma. The patient had known allergies with gluten, latex. Concomitant medication(s) received within 2 weeks of vaccination included vitamin d3; multi vitamin, b complex. The patient was not pregnant at the time of vaccination. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 13:15, the patient experienced extreme ongoing (10 weeks so far) nerve pain, muscle pain, joint pain and weakness in all 4 extremities and hips and shoulders with the right side being the worst. Also with numbness and tingling in all extremities with the right side being the worst. The pain and weakness are severe and debilitating. The patient unable to do activities that used to do and also had to cut down work hours as cannot tolerate the pain and adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with prednisone, labs, specialists, physiotherapy, acupuncture. The seriousness of the event was considered as disabling/incapacitating by reporter. Outcome of the events was not recovered. Device Date : 05May2021 Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 54 | 2021-05-19 | feeling abnormal |
right cheek numb, left cheek numb, front neck numbness. Right arm injection site, still has pain wit...
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right cheek numb, left cheek numb, front neck numbness. Right arm injection site, still has pain with movement. Right arm , mid spine and right leg intermittent paresthesias. Brain fog
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| 54 | 2021-05-23 | loss of personal independence in daily activities |
Numbness and tingling and left leg and foot approximately 6 hours after the vaccine. Joint pain in b...
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Numbness and tingling and left leg and foot approximately 6 hours after the vaccine. Joint pain in both knees approximately 12 hours after the vaccine making it difficult to descend stairs. Over the next several weeks joint pain increased to include both hands, wrist, elbows, shoulders, ankles and feet. The pain has increased, mobility and ability to do everyday tasks is greatly impaired.
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| 54 | 2021-05-24 | anxiety |
While sitting in observation post vax, at 4:15 PM, pt states that she felt anxious and took her own ...
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While sitting in observation post vax, at 4:15 PM, pt states that she felt anxious and took her own personal dose of ativan 1 mg. Pt had visual shakes and slight diaphoreses. Assessing RN gave 1 bottle of water. HR 119, 02 sat on RA 99 %. Pt remained anxious, husband at side. After a period of 15 min, pt requested RN to call 911. Charge Nurse notifiedn911 w/ current BP of 190/100 at 4:28 PM. Pt remained alert until arrival of EMS for transport to Medical Center. Husband remained w/ client for transport. Gave care to EMS at 4:45.
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| 54 | 2021-05-25 | anxiety |
1st Pfizer Vaccine, Lot#E0172. They put her on a cot for 30 minutes due to dizziness, anxiety and sl...
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1st Pfizer Vaccine, Lot#E0172. They put her on a cot for 30 minutes due to dizziness, anxiety and slight shortness of breath. Elevated legs and she started to feel better.
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| 54 | 2021-05-25 | loss of personal independence in daily activities, impaired work ability |
Pain and weakness in arm for almost 5 days. vertiginous migraine started within 12 hours, and laste...
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Pain and weakness in arm for almost 5 days. vertiginous migraine started within 12 hours, and lasted four weeks and three days, 24 hours a day, This is the longest vertigo episode I have had in my life ( longest was 3 weeks). Prior to this, I had not had a vertigo episode for over a year! It made me exhausted and I had a few headaches from the vertigo itself. There is no effective treatment for it. After two weeks, I decided to try an essential oil blend- topically and internally, which I made specifically to manage vertigo. Internally, I placed frankincense on the roof of my mouth and took Zendocrine blend supplements. This all helped significantly, yet this major vaccine side effect lasted incredibly long. I could not work, drive, or walk safely. I heard that for some people, the vaccine triggered underlying illnesses or "weak spots." I figured that's what happened to me. Last day of vertigo was May 14. It took another week to bounce back, still felt pretty tired until May 21. Finally think I am recuperated. For the first vaccine, I had a major migraine within 24 hours, arm pain for 3 days, and needed a nap in the middle of the day. It was very mild and easy compared to the second vaccine dose. Prior to vaccination, I called my PCP and MCS, and both Doctors told me I was cleared to take the vaccine, and did not think I would have any issues with it.
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| 54 | 2021-05-25 | sleep disorder |
I received my 2nd vaccine on Thursday, May 20th. Within hours after receiving my 2nd vaccine, my han...
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I received my 2nd vaccine on Thursday, May 20th. Within hours after receiving my 2nd vaccine, my hands began to shake, I was very hot with persistent sweating. I never ran a fever. I felt heart palpitations. I experienced extreme nausea, but did not vomit. I had 2 episodes of diarrhea. My head felt very "heavy". When I stood up to walk my gait was very unsteady and I could not walk straight. I was unable to sleep. I followed the advice of the nurse who administered the vaccine - she informed me that I may experience symptoms for 24-48 hours after the shot. For that length of time, I did nothing about the symptoms, assuming they would go away. However, the symptoms persisted (except for the diarrhea) without subsiding until Monday, May 24th. I contacted my primary healthcare provider via patient portal. She was concerned about the length of time I was experiencing such extreme nausea . She felt that I may have been dehydrated and told me to go to the ER. I was admitted to the ER. A chest x-ray was taken. Blood work was taken, urinalysis was conducted, IV fluids with anti-nausea medications and Benadryl were administered. I was discharged from the ER after several hours with minimal symptom relief
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| 54 | 2021-05-28 | disorientation |
The day following vaccination, I was doing doing light yard work, came in the house, got a drink and...
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The day following vaccination, I was doing doing light yard work, came in the house, got a drink and it got caught in my throat, I sat down in a chair and woke up on the floor( presuming I had passed out.) I was out for a few minutes. When I awoke I was disorientated and had suddenly a headache, nausea, sweaty and clammy skin.
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| 54 | 2021-05-28 | feeling abnormal |
wiped out; low grade fever ranging from 100-100.5°F; she had left arm injection site pain; chills; ...
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wiped out; low grade fever ranging from 100-100.5°F; she had left arm injection site pain; chills; knee and ankle pain; she felt wiped out the next day; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expiry Date: unknown), via unknown route of administration on 10Feb2021, as 1st dose, single for Covid-19 immunisation. Medical history included Covid-19 in the month of Aug2020 (minus loss of taste and smell). Concomitant medications were not reported. After vaccination, on an unspecified date, the patient had experienced left arm injection site pain, chills, low grade fever ranging from 100-100.5'F, knee and ankle pain, and she felt wiped out the next day. In Aug2020 she has tested positive for COVID antibodies and she has been donating convalescent plasma. She had underwent lab test which included SARS-CoV-2 antibody test: positive in Aug2020, body temperature: low grade fever ranging from 100-100.5'F on an unspecified date. The outcome of events was unknown. Information about lot/batch no has been requested. Follow-up attempts are completed. No further information is expected.
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| 54 | 2021-05-31 | loss of personal independence in daily activities, feeling abnormal |
- Teeth nerve pain - Extreem thirst - Swelling and warm hands and feet and aching - Ear pain and ti...
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- Teeth nerve pain - Extreem thirst - Swelling and warm hands and feet and aching - Ear pain and tinnitus and muffled sound (hearing loss) - Neck pain - Lower Back pain (4/19) - Middle back pain - Hiccups - Dry leathery skin (skin around fingernails and toenails peeled, hang nails (toes and fingers), lips cracked peeled overall skin looked dry wrinkled) no amount of oil or lotion helped. - Mouth painful blisters in the back that never popped just went away - Narcolepsy like tired episodes 35 minutes after vaccine 2x since - Dizzy when standing (evening of vaccine) - Knee patella dislocated and both knees seem unstable like they are going to dislocate entirely when leg is twisted like turning. - Tender to the touch and pain under left rib cage 4/13/21 one episode of narcolepsy weird tire episode that lasted a total of maybe 10 minutes with complete waking up just as I laid down to nap. Right arm hurt but not bad. Chills with a temperature of 97.1F and later was drenched in sweat with a temperature of 97.8F. Woke up super thirsty and was so thirsty for several days drinking 1.5 gallons of water and still being thirsty even when I tried some salt pills. 4/16/21 Really red, swollen and itchy eyes (allergies) with sinus headache 4/17/21 lower back went out slowly all day till I was stuck in bed with ice. Right arm tingling like pins and needles. Lips super dry cracking and peeling. 5/14/21 started prednisone
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| 54 | 2021-05-31 | panic attack |
Itching across chest from left to right arm (within 10-15 minutes of vaccine) moved down right arm, ...
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Itching across chest from left to right arm (within 10-15 minutes of vaccine) moved down right arm, around ankles, up the back of neck on the right all within about 20 minutes. Dizziness, inner ear itchiness, stabbing in right front chest to the back, hands ice cold and very pale all over within 30 minutes. No hives anywhere. Liquid Benadryl, double dose administered about 15 minutes in, held in mouth for about 20 seconds before swallowing. Of course panic set in, focused on slow, deep breaths, outer ear itchiness and neck all around my neck. Called ambulance while pharmacist observed me on the floor laying down. Ambulance assessed BP was high, oxygen was 100%, started feeling better, dizziness stopped and itching almost gone, within an hour of Benadryl dose. Family member drove me home. Released from ambulance, not taken to ER or Urgent care.
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| 54 | 2021-06-01 | feeling abnormal |
Saturday-monday severe brain fog, Tuesday severe brain fog and moderate headache, Wednesday moderate...
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Saturday-monday severe brain fog, Tuesday severe brain fog and moderate headache, Wednesday moderate brain fog with fever, chills and headache
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| 54 | 2021-06-02 | delirium, confusional state |
first dose is 10May2021 and the second dose was 15May2021; She had an 101 fever/probably like 100.5 ...
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first dose is 10May2021 and the second dose was 15May2021; She had an 101 fever/probably like 100.5 or close to 101; laryngitis; Short of breath/can't catch her breath; Her asthma has gotten worse; delirious/delirium; confused/confusion; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in upper left arm on 15May2021 13:45 (at the age of 54-years-old) (Lot Number: EW0169) as single dose for covid-19 immunization. Medical history included ongoing asthma and had been worse the past 2 days, ongoing panic attacks, ongoing anxiety, ongoing depression, ongoing pain, had 24 operations in the past 4 years, was in a motorcycle wreck and the muffler landed on her lower right leg and burned down to the fibula, she ended up getting staphylococcus from her wounds, had PICC (peripherally inserted central catheter) Iv's for 4 years and after that they went in and cut out 8 inches of her fibula and took muscle from her stomach and placed it down there because it was so shallow where they took the muscle out, because of the thin lining when she had a fall she ended up with a hernia it came through the fascia tissue, she ended up with an 8 pound hernia and had her gall bladder removed which they said was as big as a grapefruit. Concomitant medications included ongoing alprazolam (XANAX) taken for panic attacks and anxiety, had been taking for approximately 21 years; ongoing duloxetine hydrochloride (CYMBALTA) taken for depression and pain, had been taking for about 9 years. Historical vaccine included first dose of BNT162B2 on 10May2021 1:00 pm (at the age of 54-years-old) for covid-19 immunization. There was no Prior Vaccinations (within 4 weeks). There were no additional vaccines administered on same date of the pfizer suspect. The patient was calling regarding the Pfizer injection for Covid, clarified that she was referring to the Covid vaccine. Her voice was a little better right now. She had the second shot Monday and weird things have been happening. She received her second dose of the Pfizer BioNTech Covid 19 vaccine on 15May2021. She first provided a date of the 15May2021 for the second dose and then stated that the first dose was 10May2021. She provided lot number from the vaccine card of EW0169 and the date says 16Apr2021, she said that's the second dose. Attempted to clarify date of 10May2021 as it was 5 days apart from the date she provided for the second dose and she stated that they said it was ok. She provided again that first dose was 10May2021 and the second dose was 15May2021. She provided the only LOT number listed on the card. She did not see any other lot numbers. After receiving the vaccine she was pretty confused and delirious in 2021. People were not able to understand what she was saying until today. She had an 101 fever for two days as well as laryngitis. The morning after the vaccine she thought she was at the grocery store in a buggy and grabbing green beans off the shelf but she was really in bed. For the first 36-48 hours after the vaccine she was talking nonsense. Maybe the fever caused the delirium. She currently had no doctor. She asked if confusion and delirium are side effects of the vaccine. She can't find anywhere to read about the symptoms she had been having. She had been delirious all-day Tuesday and all night long in 2021. Everyone who talked to her told her she was talking out of her head. They couldn't understand anything she was saying, and everything was jumbled and mumbled. She had a fever that went along with it. Laryngitis had been so bad that people couldn't understand her. She was just going to weather her way through it and get to the other end. She had asked her mother where her fiance was and he lives in (city). Her niece, who lives with her was at school and she was asking where she was. When they told her she was at school, she was confused because she thought today was Saturday. She had been in total confusion. Her doctor literally walked out and left the practice and it turned into an urgent care. She was very delirious and confused on Tuesday. She was very delirious and everyone she knew that she had talked to was telling stories about her and their conversations with her. She had not gotten better. She just walked in and asked her mother where her fiance and niece were. For Fever, she did not take it but she was guessing it was around 101. Fever started that night of the vaccine on 15May2021. She asked her mother to feel her to see if she was hot and then stated she still had a fever, hadn't checked it but was probably like 100.5 or close to 101. She was treated with Ibuprofen and some Tylenol. She was surprised that Laryngitis had broken up today (unknown date). She was given Amoxicillin for dental implants that were prescribed by her dentist about a month and a half ago. She was prescribed 500mg capsules. She took 2 capsules yesterday and took 2 more capsules this morning. Her chest had seemed to clear up some. She thought that was working, she was not going to continue to take 1000 mg each time. She said the Amoxicillin was in a prescription bottle. She did not usually have bad asthma attacks but her asthma had gotten worse since she got the vaccine. Asthma symptoms had been worse the past 2 days in 2021. She had been very short of breath and can't catch her breath in 2021. She had not taken anything for the shortness of breath. She had just taken her regular medicine. The events did not require a visit to Emergency Room and Physician Office. She would have probably waited a few more days. The outcome of the events was unknown.
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| 54 | 2021-06-02 | feeling abnormal |
Within minutes of receiving the shot, I started getting a headache and just feeling generally off......
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Within minutes of receiving the shot, I started getting a headache and just feeling generally off...almost a feeling of an adrenaline rush. Felt a bit antsy and foggy for 1 hr. A couple of hours later, I got a small hive on the bottom of my right eye, followed by small hive in my left shoulder. My nose started to run a bit and I called my sister who brought me over some Benadryl. When she arrived, I felt the inside of my bottom lip begin to tingle and mildly swell. Stayed awake for a bit and then took the Benadryl before going to sleep. In the morning, the inside of my bottom lip felt like it had a series of small canker sores which resolved within 24 hours. I had a telemedicine visit with my doctor?s office, and they felt it was a local reaction, perhaps anxiety induced; they ok?d 2nd dose. Discussed with vaccination site coordinator, and they consulted with the County Health Department who will not administer a second dose due to CDC guidance regarding hives, etc.
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| 54 | 2021-06-03 | feeling abnormal |
Fatigue; Her "stomach feels like there's a knife",; She feels like she's "about to die", "I feel awf...
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Fatigue; Her "stomach feels like there's a knife",; She feels like she's "about to die", "I feel awful".; Wasn't feeling well; She "can't stand up straight", she's not been out of the house since Tuesday; Not eating; Vomiting; has Arm pain; Can't get up hardly; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (at the age of 54-year-old) (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on an unspecified date for covid-19 immunisation and she was sick pretty bad too. The patient reported that she received the second dose of the vaccine on Tuesday and she felt like she was "about to die" and felt awful in 2021. She was not transferred to Safety since she wasn't feeling well. She stated since the second dose, she cannot stand up straight, she had not been out of the house since Tuesday, she was not eating, was vomiting, fatigue, her stomach felt like there was a knife, has arm pain, and she can't get up hardly. She was referred to her healthcare provider. Outcome of events was unknown. Information about lot/batch number has been requested.
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| 54 | 2021-06-07 | anxiety |
Bright red rash starting at the wrists and extending up to forearm; Red rash was tender almost like ...
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Bright red rash starting at the wrists and extending up to forearm; Red rash was tender almost like a sunburn; Red rash was tender almost like a sunburn; Itching throat; Slight wheezing; Mucous causing cough; Mucous causing cough; Feeling of anxiousness; Arm was also sore enough that it hurt to lay on it; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER COVID-19 vaccine, Lot Number: GN6198), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 15:45 (at the age of 54 years old) as single dose for covid-19 immunization. Medical history included body mass index (BMI) more than 30, known allergies included: penicillin, latex sensitive, allergic to propylene glycol. The patient did not have COVID prior vaccination. The patient did not have any other vaccine in four weeks and did not pregnant at time of vaccination. Concomitant medication in two weeks included Vitamins. On 04Mar2021 at 01:00 AM, the patient Woke up from sleep with itching throat, slight wheezing, and mucous causing cough. It caused her to have a feeling of anxiousness because it happened so suddenly. After about 1 hour, it stopped just as suddenly as it all started. Arm was also sore enough that it hurt to lay on it. No swelling at injection site. This lasted for about 1 hour. On 09Mar21 noticed a bright red rash starting at the wrists and extending up to forearm. The red rash was tender almost like a sunburn. The patient had not been tested for COVID-19 post vaccination. No treatment for AEs. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 54 | 2021-06-07 | memory impairment, thinking abnormal, abnormal dreams |
Five hours after receiving the vaccine I developed a headache, nausea, I started to stutter and I co...
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Five hours after receiving the vaccine I developed a headache, nausea, I started to stutter and I couldn't think clearly. That evening I had really strange dreams. I could hear my husband talking on the phone out in the living room. I was dreaming, but I knew that I was awake. I just couldn't wake myself up. I had those dreams for 2-3 nights. I was screaming in my sleep. I was conscious about what was going on, but my body was in REM cycle, and I couldn't wake up. Around 03/15, I started vomiting, had chills, diarrhea and developed fevers. I couldn't stop vomiting and my doctor thought that I may have had COVID. I went into the ER on 03/15. I was put into an isolated room because they thought I had COVID. I received a couple COVID tests completed and the PCR came back negative. At this point, they thought I may have a secondary infection coming on. I was told I had a UTI, but then they thought it might have been a kidney stone that was stuck. They performed a CT scan and I had 7 kidney stones that were there. I was told that maybe my body was trying to pass a stone when I received the vaccine. The doctor gave me oxycodone, Zofran and I had 3 bags of IV's (one with antibiotics in it.) After I went home they changed my antibiotics to a much stronger one, Ciproslaxon, for 14 days. I recently had laser surgery and lithotripsy surgery to remove the kidney stones. They noticed that there were more kidney stones on the other side. I have to have a second surgery to remove them. I have to have a third surgery because they found a gall bladder stone. I have also noticed that I have been having problems with congestion. I have never had any allergies with pollen or having to take allergy medication. I am having difficulty swallowing and I am coughing more. I've noticed that my memory is foggy also.
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| 54 | 2021-06-07 | sensation of foreign body |
Patient came in for her second dose of the Covid-19 immunization. She stated that the arm had hurt s...
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Patient came in for her second dose of the Covid-19 immunization. She stated that the arm had hurt since her last shot, was swollen and she thought had a foreign body left inside the arm. She believed the needle had broken off in the arm. I reviewed her paperwork from the previous shot and no notes were made regarding the integrity of the vaccine administration. I examined her arm by touching and feeling the area of the vaccine but could not feel anything inside the arm. She was referred to the ER for evaluation, In the ER they performed an Xray but did not find anything inside the arm. She was diagnosed with cellulitis and was prescribed antibiotics.
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| 54 | 2021-06-08 | hallucination | Inflammation of joints substantially worse, migraine, hallucinations |
| 54 | 2021-06-08 | sleep disorder, disturbance in attention, loss of personal independence in daily activities |
Following administration of my 2nd Covid-19 vaccine, I experienced common effects such as fever, ext...
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Following administration of my 2nd Covid-19 vaccine, I experienced common effects such as fever, extreme fatigue, and warmth/redness/swelling at the injection site, all of which resolved completely within 72 hours. However, about a month after that vaccine, I started having terrible tinnitus, which I've never experienced before. I passed it off as a sinus related issue, but it continued. It severely interferes with sleep, focus, and concentration. I'm a wife, mom, & Registered Nurse and this is definitely having a negative impact on my daily activities.
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| 54 | 2021-06-09 | feeling abnormal |
Fever over 105 degrees, extreme shaking, hands and feet freezing for hours, hyper sensitive skin wit...
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Fever over 105 degrees, extreme shaking, hands and feet freezing for hours, hyper sensitive skin with pain everywhere. Took ibuprofen and acetaminophen to help with fever. It did very little to help with it. 24 hours later, and I'm feeling better, although still feel like crud.
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| 54 | 2021-06-10 | anxiety |
I received my first covid vaccine on 6/9/21 around 3:35 pm and around 30 minutes after shot, I sta...
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I received my first covid vaccine on 6/9/21 around 3:35 pm and around 30 minutes after shot, I started itching a little and noticed a rash on both forearms between wrists and elbows and both shoulders had a small rash. But the rash on my forearms were red and raised. I felt like I was getting the hives with feeling itchy and light headed so my son drove us home as I was having a hard time focusing. When I got home, I took a antihistamine and a Tylenol. A few minutes later I started feeling relief and by a couple hours later the rash was gone. I did feel my chest tighten while I was itchy but I wasn't sure if it was because I was worried/anxious. This morning (next day) everything seems normal, no symptoms.
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| 55 | 2021-01-01 | anxiety |
Employee developed some anxiety, heart racing and tingling in her lips. this resolved on its own af...
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Employee developed some anxiety, heart racing and tingling in her lips. this resolved on its own after 10 minutes.
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| 55 | 2021-01-03 | impaired work ability |
5 days after 1st vaccine, experienced sync opal event at home. .Arrived at work 12/28/2020 feeling s...
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5 days after 1st vaccine, experienced sync opal event at home. .Arrived at work 12/28/2020 feeling slightly lightheaded and tachy. went home.
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| 55 | 2021-01-03 | nervousness | Arm soreness Swelling Overall body feeling shaky |
| 55 | 2021-01-04 | agitation | Agitation, Sedation, Anaphylaxis, Rash & HYPOtension |
| 55 | 2021-01-04 | anxiety |
During her 15 minute waiting period after the injection, the patient began to experience dizziness, ...
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During her 15 minute waiting period after the injection, the patient began to experience dizziness, anxiety.; During her 15 minute waiting period after the injection, the patient began to experience dizziness, anxiety.; This is a spontaneous report from a non-contactable other health professional. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) dose number 1, intramuscularly on an unspecified date at single dose on left arm (left deltoid muscle) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She had no history of previous hypersensitivity reactions to immunizations. During her 15 minutes waiting period after the injection, the patient began to experience dizziness, anxiety. She denied rash, hives, difficulty breathing, difficulty swallowing, throat tightness, hoarseness, itching, facial swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, vomiting and abdominal pain. Planned action included: observation, serial examination. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was unknown. Assessment by reporter: transient anxiety associated with COVID vaccine administration. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-06 | impaired work ability |
Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall ...
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Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall weakness Narrative: Employee was unable to work second to symptoms, missing >1 days of work at time of this report.
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| 55 | 2021-01-07 | restlessness | By the evening pounding headache not relieved by Tylenol. Body hurts nausea still dizziness restless |
| 55 | 2021-01-07 | sleep disorder |
At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep around ...
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At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep around 530 am started running a fever of 100.3 and had a severe headache and body aches. Fever went down with tylenol, but had headache all day. Fever did come back later in the day resolved with Tylenol. Next day fine but did have cold sores inside mouth . Head ache on 1/8 no fever or anything.
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| 55 | 2021-01-10 | anxiety |
Patient experienced throat tightness, chest tightness, anxiety, and lightheadedness that did not sub...
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Patient experienced throat tightness, chest tightness, anxiety, and lightheadedness that did not subside after 30 minute observation. She was transferred to the ED for further evaluation.
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| 55 | 2021-01-10 | feeling abnormal, impaired work ability |
Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased B...
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Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased BP; blood pressure was up and down; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) via an unspecified route of administration in left arm on 29Dec2020 6 am at single dose for covid-19 immunisation. Co-suspected drug amoxicillin;clavulanic acid (AUGMENTIN, Batch/lot number: KN4291, Expiry Date: Mar2022) by mouth from Dec2020 to 28Dec2020 at 875mg, 1 tablet twice daily for pain or infection; MOXIFLOXACIN HYDROCHLORIDE (AVELOX, strength:400mg) by mouth from 29Dec2020 and ongoing at 400mg, 1 tablet once daily for infection; fluconazole (DIFLUCAN, strength:200mg) orally (by mouth) from unknown date and ongoing at 200mg, 1 tablet once daily for Infection.The patient's medical history was reported as ongoing high blood pressure, ongoing pains in her fingers and toes and they thought she had an infection from 02Dec2020, white count went down on 09Dec2020, ongoing pain was up and down. No other vaccines given at that time and none given 4 weeks prior. Had a Flu shot back in Oct2020, but no problems. None diagnosed allergies and family medical history relevant to adverse event. The concomitant medications included unspecified blood pressure medication by mouth daily for high blood pressure. She had also started 2 antibiotics around the same time that she received the vaccine. No further details provided Was on antibiotics at the time she was given the Pfizer COVID-19 vaccine. Patient experienced increased BP/ high blood pressure, pain in head, and leg numbness; all started 2 days (on 31Dec2020) after receiving the vaccine and persisted for 48 hours. First her blood pressure was up and they had to get it stable and had numbness in her head, face, and mouth for 48 hours. Her blood pressure was up and down and she has history of blood pressure and takes medicine. Was taken off work for a few hours and went to the emergency department on Fri night about 2am. Her blood pressure was 170/92 on 01Jan2021. Not sure if this was related to the vaccine, but the numbness in her head started from her upper neck to face to the right side of her check and she also had leg numbness. Wanting to know if this was related because she was worried about getting the second dose. Had a hard time for 48 hours. Weight was between 150-155 pounds. Stated everything improved after 48 hours. Her lip was also just a little bit numb, but it is feeling better. Patient was feeling bad from 01Jan2021, all Fri and Sat and much better by Sun. Events of increased BP/ blood pressure up and down, leg numbness, numbness in lips, head, face, mouth with emergency room visiting. Wanted to know if she should have the second dose. The action taken in response to Augmentin was permanently discontinued on 28Dec2020, for Avelox and Diflucan was dose not changed. The outcome of events was recovering.
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| 55 | 2021-01-11 | insomnia |
headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report fr...
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headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report from a contactable healthcare professional (patient herself). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history included Addison's disease, papaya allergy, and gluten intolerance. Concomitant medications included hydrocortisone and fludrocortisone acetate (FLORINEF ACETATE). The patient verbalized, "At first, on 29Dec2020, I experienced only mild side effects such as headache, dizziness and fatigue. Later, I woke up in the middle of the night with severe abdominal pain and couldn't sleep the pain was so bad. I had to take the following day off due to abdominal pain and fatigue." No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
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| 55 | 2021-01-12 | impaired work ability |
Tuesday, 1/12/21 around 8:00 am I noticed a Numbness, similar to when novocaine is wearing off. Loca...
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Tuesday, 1/12/21 around 8:00 am I noticed a Numbness, similar to when novocaine is wearing off. Location of numbness is in the area of the Right temple upper cheek bone easing toward ear. By 2:00 pm that day was experiencing a dull headache centering on my temple. I went home from work to lie down. The headache and numbness lasted into the next day. At the time of this report 8:57 pm on 1/13/21 the numbness is still there.
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| 55 | 2021-01-12 | insomnia |
12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck....
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12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck. 12/24/20 @ 0600 vomited x 2. Headache, runny nose, fatigue, general achiness---became worse as the day progress to include both hips and knees becoming painful. Shortness of breath with pulse ox levels of 91-97% on room air. Heart rate 104-124 bpm for 9 hours, Chest discomfort, cough, achy fingers, mild hand tremors, flushed face, nausea, decreased appetite, fatigue, chills . 12/25/20 @ 0120--severe muscle and joint pain---self medicated with 1000mg acetaminophen, stomach pain---used digestzen. tossed and turned until after 0428. 0920--increased area of painful lymph nodes: left arm axilla, breast and back of neck. Fatigue continues---although less than the day before 12/26/20 through 12/28/20 symptoms continue to decrease. 12/29/20----woke up feeling great. Took the stairs at work---no shortness of breath. At work received the mail out Covid test-----results were positive ( no symptoms of covid)
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| 55 | 2021-01-13 | feeling abnormal | fatigue, nausea, generalized feeling "junk" |
| 55 | 2021-01-13 | sleep disorder |
states she developed back pain unable to move, pain mid back shoulder blades and small headache inte...
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states she developed back pain unable to move, pain mid back shoulder blades and small headache intermittently; unable to sleep; feeling better at time of notification
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| 55 | 2021-01-14 | anxiety |
Patient became lightheaded at approximately 11:10 a.m. which was 9 minutes after administration of t...
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Patient became lightheaded at approximately 11:10 a.m. which was 9 minutes after administration of the vaccine. The patient had expressed some anxiety about receiving the vaccine but wanted to receive it. The patient complained of lightheadedness and we lowered her to the floor with feet elevated. Her blood pressure had lowered significantly (60/40 approximately). Patient began to feel better and sat back in her chair. She again began to complain of lightheadedness and was lowered to the floor with feet elevated once more. Patients stayed in this position for several minutes. When her blood pressure was rechecked, it had risen back to 118/78. Patient felt much better and also ate some crackers and drank some water. Patient's blood pressure was checked a final time in a seated position after approximately 20 minutes and her blood pressure was 118/82. Patient reported having an event like this 36 years ago after her first visit to an OB/GYN and was similarly nervous that day. Patient was counseled extensively on preventing future lightheadedness and signs of any vaccine related adverse event. After approximately 45 minutes of observation from the event, patient was driven home by her husband.
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| 55 | 2021-01-14 | feeling abnormal |
About 20 minutes after vaccination, felt tingling throughout body. Slight headache, followed by fee...
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About 20 minutes after vaccination, felt tingling throughout body. Slight headache, followed by feeling dizzy and wobbly. Must hold onto something to walk. Has some trouble focusing, "like a fog".
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| 55 | 2021-01-15 | confusional state, mental impairment |
Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At ...
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Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At around 2:30pm that day was complaining of chills and generalized malaise. Then at ~9:30pm when husband returned home from work found patient diaphoretic, confused (stating things like "not now, I want to go to lake"), and complaining of chills and weakness. Unable to provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to respond to verbal commands. Initial vitals notable for T102.6F (unclear other vitals). Patient is now AOx0 most concerning for encephalopathy.
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| 55 | 2021-01-15 | impaired work ability |
Fever up to 102 degrees pain at site headache chills muscle pain nausea felt unwell Took Tylenol fo...
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Fever up to 102 degrees pain at site headache chills muscle pain nausea felt unwell Took Tylenol for fever and aches
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| 55 | 2021-01-15 | nervousness, sleep disorder |
The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feelin...
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The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feeling shaky and short of breath- afternoon of injection Significant headache x 48 hours (note: still having intermittent HA associated with 1st dose.) Significant arm pain (injection site)- 2 days Feeling shaky in legs- evening of injection Low grade fever x 48 hours, ongoing intermittently Waking at night several times- this does not happen to me. Waking overnight last night (AM of 1/16/21) with right hand numbness that lasted for some time. Extreme, extreme fatigue- the worst lasted 48 hours post vaccination. Still continuing but not as severe as the first 48 hours. Body aches, particularly (but not only) right hip and knee that have arthritis- worst sx ~ 36 hours post vaccination. Ongoing intermittently. Heart palpitations but unable to determine if related to vaccination. Chest pain, mid-left sternal, intermittent, ongoing. More of a muscular pain/discomfort. Note: for 1st injection had some similar "side effects" but also some that were different.
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| 55 | 2021-01-16 | impaired work ability, sleep disorder |
I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such a...
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I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such as headache and fatigue and dizziness. That night I awake with severe stabbing abdominal pain. I couldn't sleep much of the night due to pain. The pain continued until the following day. I had to take the day off work due to fatigue and pan. I have a couple of autoimmune diseases and I surmised this is why the vaccine affected me in this way
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| 55 | 2021-01-17 | disorientation |
12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle ac...
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12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle aches, dizziness, headache, disorientation. 20 hours after injection: swelling of lips. Continued body aches, headache, 32 hours after injection: chest pain, continued body aches, headache, swelling of lips.
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| 55 | 2021-01-17 | feeling abnormal |
Day if injection Severe HA- that has not really let up 1 week later Facial numbness of injection sid...
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Day if injection Severe HA- that has not really let up 1 week later Facial numbness of injection side that spread to top of head, and down to chest and right arm- sensation of face being scaled on right side Day 2- Brain Fog, Generalized Weakness, Generalized pain Right ear remains numb Day 3 1/13- felt like my entire body received a tetanus vaccine Day 4 unchanged Day5- woke up in head to toe hives- was sent to ED Have been having intermittent rashes ( like dermatitis) pop up all over my body and random numbness typically on head/ neck Continue with headache on day 7
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| 55 | 2021-01-17 | feeling abnormal |
I had the vaccine on 12/20 and I started feeling cold couple of hours after the vaccine and chills o...
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I had the vaccine on 12/20 and I started feeling cold couple of hours after the vaccine and chills on 12/21/20. Mild body aches and soreness at site of injection and just feeling weird. This continued off and on 12/22, 12, 23 and etc. I thought it wasn?t a big deal as I had no respiratory symptoms and no fever. However, I just haven?t been well since then. I have ongoing nausea, head fog, severe weakness, very tired and just feeling unwell
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| 55 | 2021-01-17 | impaired work ability |
Pt. C/O blurred vision peripherally in both eyes. She denied Hx of migraines, did not have any heada...
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Pt. C/O blurred vision peripherally in both eyes. She denied Hx of migraines, did not have any headache. No other symptoms
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| 55 | 2021-01-18 | anxiety |
Anxious, tingling, heart racing, throat closing. Pt was given 25 mg IM. Pt started feeling within 15...
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Anxious, tingling, heart racing, throat closing. Pt was given 25 mg IM. Pt started feeling within 15 mins. PT vitals returned to normal within 10 mins. Pt discharged home with friend.
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| 55 | 2021-01-19 | anxiety |
on 1/12 started body aches and chills, took Tylenol and felt better, Wednesday felt short beat and i...
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on 1/12 started body aches and chills, took Tylenol and felt better, Wednesday felt short beat and irregular and heart beat not regular. checked pulse and it was irregular, that night 9-9:30 I went to ER close to house and pulse and heart rate abnormal after 2 hours went home and advised to contact cardiologist, he said to come in Thursday and the irregular beats were off and on atrial flutter, on Friday I came home and went back to hospital and got the shot cardio version or ablation to revert the rhythm and because the rhythm was back and forth I was observed until released on 1/19/21. Surgery was in 2017 and never had problems and they stated heart was compromised and maybe this is your reaction to the vaccine.
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| 55 | 2021-01-20 | impaired work ability | BODY ACHES, COLD CHILLS, STOMACH PAIN, BAD FATIGUE |
| 55 | 2021-01-21 | confusional state, excessive sleepiness |
High fever 102 started at 2:30AM on the 7th . I had riggers, my whole body was out of control shakin...
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High fever 102 started at 2:30AM on the 7th . I had riggers, my whole body was out of control shaking like a seizure. I was extremely confused I had a 8/10 headache. I had serve fatigue. This last about 24 hours then went away I finally got out of bed the next day about 4:30PM.
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| 55 | 2021-01-21 | insomnia | Muscle pain, tachycardia, headache, insomnia, nasal congestion |
| 55 | 2021-01-22 | feeling abnormal |
I received the first dose on 1/15/2021 around 3 pm. At around 8;30 PM, I felt an extreme shot of ad...
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I received the first dose on 1/15/2021 around 3 pm. At around 8;30 PM, I felt an extreme shot of adrenaline starting in toe,s that then traveled to my chest. I felt this wave come over my body and I knew something was wrong. I have HIGH BP, so i know what symptoms indicate another high BP event. . I measured my BP and it rocketed to 180/150. This event lasted less than five minutes. I ingested One Clonidine tablet and my pressure decreased. Outside of that ONE incident I had very little adverse events.
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| 55 | 2021-01-23 | impaired work ability |
1/11/21 6:00 pm low grade fever 99.5, body aches 1/12/21 same 1/13/21 morning, no fever, felt better...
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1/11/21 6:00 pm low grade fever 99.5, body aches 1/12/21 same 1/13/21 morning, no fever, felt better, went to work 1/13/21 12 noon started feeling poorly, headache, body aches 1/13/21 5 pm severe headache, 100.5 fever, chills, severe muscle and joint pain 1/13/21 5:15 began rotation of 800 mg Ibuprofen, 500 mg Tylenol every 2 hours, bed ridden 1/14/21 1:00 am fever of 101.5 on medication, severe aches and chills 1/14/21 2 pm no fever, severe headache and body aches, bed ridden 1/15/21 6 am severe headache , no fever mild body aches, started gastrointestinal symptoms diarrhea 1/16 & 1/17/21 severe headache and diarrhea 1/18/21 felt better, returned to work
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| 55 | 2021-01-24 | impaired work ability |
I had vaccine at 8:30 and 11 i started having palpitations and chest pressure and light headed and d...
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I had vaccine at 8:30 and 11 i started having palpitations and chest pressure and light headed and diaphoretic while i was at work. i continued to work and didn't go home until close to 4pm, i thought it would go away like the first time but it didn't, i went home and laid down and took a zanax and it didn't go away. the next morning i went to the ER and they put me on a telemetry monitor and i was having bigeminy and palpitations and i thought my heart was going to come out of my chest and was hurting they gave me 4mg of morphine, 2 hrs they gave me more morphine, i was nauseated they gave me Zofran then it finally subsided later but till had bigeminy and chest pressure, they admitted me and i stayed overnight. i had the PVC and bigeminy slowed down i had an echo and it was normal the potassium was low and they gave me kedar, i was still ight headed and nauseated they gave me Zofran prn it was 4-5 doses they gave me IV fluid, my fever with up to 100.4, i was not really eating that 24 hrs because i was afraid to throw up. the doctor gave me meds to take home to manage light symptoms . i went home and felt tired and had more palpitations when i move around too much and I'm still having issues today. i have not gone back to work since the vaccination and have an appointment with cardiologist 2:pm tomorrow and today I will see my PCP at 1pm. I have not recovered and still having issues and very tired.
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| 55 | 2021-01-24 | insomnia |
I had serve tenderness and redness at the site I had dizziness, headache, feeling, tired, I felt lik...
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I had serve tenderness and redness at the site I had dizziness, headache, feeling, tired, I felt like I had flu, chills, nausea, stomach cramps, muscle pain, joint pain. I had some insomnia. I had this for about 3-4 days after. I started feeling better on Saturday and got the vaccine on a Tuesday. I spoke to my Dr. about it and we decided to take Tylenol and a lot of baths.
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| 55 | 2021-01-25 | feeling drunk |
Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; ...
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Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Cold, chills, and felt like freezing to death; Cold, chills, and felt like freezing to death; Felt like drunk driving; Cold, chills, and felt like freezing to death; Severe headache; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 07Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. The patient experienced cold, chills, and felt like freezing to death, felt like drunk driving, severe headache and dizziness on 07Jan2021; swollen glands, neck, face, and ear on left side on 12Jan2021; tender on an unspecified date. The patient received COVID-19 Vaccine on 07Jan2021 at approximately 11:45. She felt like drunk driving: She waited the 15 minutes and was fine. Afterwards, she got into her truck and was literally weaving. Had to really concentrate to keep the truck in a straight line. She had severe headache: Did not go into work on Friday because headache was so bad. It was almost a migraine. She could still feel it, but it was not as severe. Patient known it's five days out, but yesterday (12Jan2021) she got up and glands on left side of neck were swollen. That side of her face and ear was swollen. It was very pronounced. She still swollen today (13Jan2021). Patient stated she worked with dementia and didn't know if she should go into work when she was still swollen and tender. The patient took Benadryl (Lot: P119936, Exp: Apr2023) as Equate Allergy Relief at 25mg, two capsules at night for the reaction. The patient had been taking it every night since she received the COVID-19 Vaccine. Headache was still there. This morning woke up with swollen glands, neck, ear, and face on the left side. The outcome of events "cold, chills, and felt like freezing to death" and dizziness was recovered on 10Jan2021; of event "Felt like drunk driving" was recovered on an unspecified date; of event severe headache was recovering; of event "Swollen glands, neck, face, and ear on left side" was not recovered; of event Tender was unknown. Information on Lot/Batch number has been requested.
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| 55 | 2021-01-25 | insomnia |
I couldn?t lift my arm above shoulder height or laterally without extreme pain for the first few day...
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I couldn?t lift my arm above shoulder height or laterally without extreme pain for the first few days. The pain lessened for a day or two and then came back, but not as severe. It is uncomfortable to lift it even after applying heat and taking Extra strength Tylenol and Ibuprofen. It is keeping me awake at night and limiting movement in the upper right shoulder/bicep area.
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| 55 | 2021-01-26 | nervousness |
dizzy; cold chills/chills; a little headache; nausea/nauseated/nauseous; vomiting/ vomited; This is ...
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dizzy; cold chills/chills; a little headache; nausea/nauseated/nauseous; vomiting/ vomited; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: Apr2021) via an unspecified route of administration on left deltoid on 12Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient stated she had a shingles vaccine, got dizzy and nauseous, thought this was about 3 years prior to the report. The patient received the first dose of the vaccine after working a night shift. She went home, went to bed and then woke up very dizzy, nauseated, vomited and experienced cold chills on and off. She also stated that about 10 hours after she got the shot, she got dizzy, nauseous, threw up a couple of times, got chills, and had a little headache on 12Jan2021. She stated she was a little nervous about getting the second vaccine. She also worked nights and that she got off her night shift and got the vaccine on 12Jan2021, didn't know if maybe she was a little dehydrated possibly. The events are reported as serious due to medically significant. The outcome of the events nausea/nauseated/nauseous and vomiting/ vomited was recovered on 13Jan2021, for the events dizzy, cold chills/chills and a little headache were recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-01-27 | loss of personal independence in daily activities |
The injection was unfortunately placed high up on my shoulder. It was much more painful going in th...
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The injection was unfortunately placed high up on my shoulder. It was much more painful going in than I have experienced in the past with any other injection. In addition, over the next few hours my shoulder became severely painful and I was no longer able to move my arm. 1/28/21 f/u: "The pain is still there but maybe slightly better. Still can?t take off my shirt without a lot of pain. "
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| 55 | 2021-01-28 | excessive sleepiness |
Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighi...
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Woke up 11 hours after vaccinated with chills and weakness/tiredness. Felt like sandbags were weighing me down. I also had a migraine, nausea, joint discomfort mostly in my shoulders hips, lower back and base of head. I slept most of the day into the next day and felt better approximately 46-48 hours after the vaccine administration. Slight headache continued and swollen lymph nodes in the armpit noticed day 2 and continue to this day. Alternated Tylenol 1000mg PO w/ Advil 400ng PO.
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| 55 | 2021-01-29 | feeling abnormal |
Felt flushed and tired by 8pm that night of injection,Jan 12. Woke the next morning with worst heada...
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Felt flushed and tired by 8pm that night of injection,Jan 12. Woke the next morning with worst headache I've ever had, in addition to horrible neck stiffness. Slept most of the day. Felt awful. 28 hours after vaccine started vomiting. Vomited for almost 24 hours. Had stomach pain the night of the 15th. Had a low grade temp the next day 16th and on the 17th my heart rate was elevated as high as the 150's. The whole time I was tired. I was Covid tested the 14th because symptoms were so severe but it was negative. I was abnormally tired but finally felt normal by January 19th.
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| 55 | 2021-01-30 | loss of personal independence in daily activities |
Fever 103.4, axillary lymph node size of an orange, symptoms beginning with slight headache proceede...
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Fever 103.4, axillary lymph node size of an orange, symptoms beginning with slight headache proceeded on to high temp for 24 hours and enlarged lymph node interfering with activities of daily living.
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| 55 | 2021-01-31 | impaired work ability |
Sever muscle aches, joint pain and headaches, along with some queasiness. The pain was debilitating....
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Sever muscle aches, joint pain and headaches, along with some queasiness. The pain was debilitating. This start the evening of the booster dose and lasted for about 2 days. I just stayed home from work that Friday and took over the counter pain relief medicine, Tylenol. I was doing better by Sunday morning. this could have been just a "fibro flare" brought on by the vaccine, but it was a bad one.
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| 55 | 2021-01-31 | nervousness |
The patient received the vaccine at 8:30 am. Reported no issues with first vaccine. The patient rep...
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The patient received the vaccine at 8:30 am. Reported no issues with first vaccine. The patient reported driving and feeling lightheaded and heart started racing. The patient pulled over sat and walked around and felt better. Then got back in the car and kept driving, heart was racing again, couldn't move fingers, blood was pounding, fingers appeared white and numb. The patient called 911 and volunteer firefighter came, ambulance arrived and could move fingers again. Blood pressure was 136/104. For 10-15 minutes fingers felt numb and tingly, light headedness, and heart racing all stopped. The patient drove home and was not taken to the hospital and felt weak and shaky for about an hour.
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| 55 | 2021-02-01 | feeling abnormal |
20 minutes after the shot my throat became itchy. I was given pepcid and benadryl. I felt real fogg...
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20 minutes after the shot my throat became itchy. I was given pepcid and benadryl. I felt real foggy for the first 30 minutes after the shot. 15 minutes after benadryl I felt better. One week later I started itching especially my head. I did not have anything on my skin but I would just itching for no reason. Also, I started experiencing heart palpations more than usual. I have some palpations at times but this was more than usual. I have experienced these reactions since then. That was Jan. 29 and today is Feb. 2. Today the itching is better but continue to have heart palpation. I am concerned about taking the 2nd dose of the COVID vaccine Feb. 12. I would like for someone to contact me by phone if any way possible.
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| 55 | 2021-02-01 | feeling abnormal |
Severe headache, mild arm pain, extreme fatigue, and brain fog. The headache subsided with advil aft...
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Severe headache, mild arm pain, extreme fatigue, and brain fog. The headache subsided with advil after 12 hours. Arm pain was 2 days, brain fog lasted around 65 hours, fatigue lasted 3 days.
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| 55 | 2021-02-01 | excessive sleepiness |
Cold chills for 16 hours, then sweats with temp, headache, terrible back pain, slept a lot. Shot at ...
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Cold chills for 16 hours, then sweats with temp, headache, terrible back pain, slept a lot. Shot at 10:30am on 1/27 - chills started at about 8pm til noon on 1/28. Everything else started during the night and I felt better about 3:00pm on 1/28.
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| 55 | 2021-02-02 | disturbance in attention |
36 hours after receiving the 1st dose of Pfizer vaccine I experienced extreme dizziness in the morni...
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36 hours after receiving the 1st dose of Pfizer vaccine I experienced extreme dizziness in the morning, nauseous, chills, hot flashes, racing heartbeat and was very weak. Had some lapses in thought process. I did not have a fever. These symptoms persisted for 5 days. On 2-2-21 I started to get a migraine, so took a prescription medication (Sumatriptan Succinate Tablet 50 mg) and this helped with the nauseousness. My symptoms seem to decrease around 3pm in the afternoon, but never completely go away. Each morning, the cycle repeats with dizziness, nauseousness and chills and some thought lapses. It's been one week since my first dose of the vaccine, and these symptoms are lessening but are still prevalent.
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| 55 | 2021-02-02 | impaired work ability |
Received 2nd vaccine on 1/14/21 on 1/15/21 was sick with flu like symptoms and pain in both legs for...
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Received 2nd vaccine on 1/14/21 on 1/15/21 was sick with flu like symptoms and pain in both legs for 5 days was seen by doctor who did covid test came back negative. After 5 days flu like symptoms some what resolved but leg pain continued. Hard to walk and painful. Seen doctors 2 more times when they finally did bloodwork and sent her for admission to hospital. They have done Bloodwork, MRI's and they are all coming back normal but still have leg pain, cant bend toes or touch leg. Been out of work since.
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| 55 | 2021-02-03 | disturbance in attention, mental impairment, sleep disorder, impaired work ability, feeling abnormal |
I got my first Covid19 shot (Pfizer) at noontime on Wednesday January 27, 2021 12 hours later, abou...
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I got my first Covid19 shot (Pfizer) at noontime on Wednesday January 27, 2021 12 hours later, about 12pm I start having side effect: Left Arm sore, hurt to lift (arm that was injected) Farting up a storm in my sleep Wednesday night, waking me up constantly, horrible weird smell, my poor husband, I moved to the couch and stunk up the first floor. Then diarrhea few hours later, about 4am, slight intestinal cramps, not bad. I was able to get ready and go to work for 6am. On Thursday January 28 Farting was over, thank goodness. As the morning went on I felt like I did when I originally had the Covid19 in May. I had to leave work at 10:30am due to: aches every where in body Especially neck hurt My left arm hard to lift or use (injection was in left arm), hard to think and concentrate (brain fog), chills Able to eat some soup Slept several hours at home, felt slightly better, than slept nine hours that night On Friday January 29th felt much better and arm hurt less to lift it. On Saturday January 30th Under my arm, glands are swollen and hurt to touch. All other symptoms have subsided Sunday January 31, glands under arm are better, much less sore Monday February 1st glands under arm, back to normal
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| 55 | 2021-02-03 | feeling abnormal |
CG received 2nd Covid Vaccine 1/11/2021; S/Sx Vertigo,,dizzy,,foggy feeling,generalized malaise on 1...
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CG received 2nd Covid Vaccine 1/11/2021; S/Sx Vertigo,,dizzy,,foggy feeling,generalized malaise on 1/12/21. on 1/13/21 felt near normal. Then 1/14/21 ,almost passed out on way to work,foggy feeling,vertigo,dizzy & therefore called in sick for today,1/14/21. . Vertigo, loss of balance, extreme malaise, near syncopal episodes. . I continued to have neurological symptoms both days. Vertigo, loss of balance, extreme malaise, near syncopal episodes. . 1/20: I continued to have neurological symptoms both days. Vertigo, loss of balance, extreme malaise, near syncopal episodes on 1/15.
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| 55 | 2021-02-03 | feeling abnormal |
Pt received 2nd dose of Covid vaccine on 1/31/21. presented to clinic with worsening back pain, chi...
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Pt received 2nd dose of Covid vaccine on 1/31/21. presented to clinic with worsening back pain, chills, fatigue, headache and body aches. and overall complaint of "I feel awful" tested negative for covid
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| 55 | 2021-02-04 | depression |
nausea; body aches; headache; fatigue; tingling in both hands (and fingers); crushing depression; Th...
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nausea; body aches; headache; fatigue; tingling in both hands (and fingers); crushing depression; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the left arm on 19Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included osteoarthritis, restless legs syndrome, rubber sensitivity (latex allergies), and COVID-19. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included ropinirole. On 19Jan2021 14:15, the patient experienced nausea, body aches, headache, fatigue, tingling in both hands (and fingers) and crushing depression. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 55 | 2021-02-04 | excessive sleepiness, feeling abnormal |
Felt crummy; Felt funny and started to get hot and chills at the same time; Felt funny and started t...
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Felt crummy; Felt funny and started to get hot and chills at the same time; Felt funny and started to get hot and chills at the same time; Tired; Had increase temperature; Hot and flushed and bright red in face; Hot and flushed and bright red in face; immunocompromised; Slept 14 hours; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3248), intramuscularly in right arm on 15Jan2021 14:27 at single dose for covid-19 immunisation. Medical history included Lupus may make her immunocompromised which diagnosed in 2011, Raynaud's, hypertension which was completely managed, irritable bowel and reflux. All were diagnosed prior to the vaccine. Family medical history was none. There were no additional vaccines administered on same date of the Pfizer suspect. Concomitant medication included hydroxychloroquine for Lupus for many years, tadalafil (CIALIS) took for years for secondary reynauds associated with lupus, amlodipine from Jan2019 for blood pressure abnormal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient only had the first vaccine and at the time she received it, she got hot and flushed and went bright red in the face. That lasted 2 hours. She was literally bright red on her face. She got it Friday at 2:27 pm on 15Jan2021. Friday night, she slept 14 hours, which was unusual. She only got out of bed to walk her dogs. Saturday (16Jan2021), she felt funny and she started to get hot and chills at the same time. She took her temperature and temperature started in mid 99 degrees Fahrenheit and popped up to 100 degrees Fahrenheit. Then same thing again Saturday night. She slept 14 hours, which was unusual. Sunday (17Jan2021), she felt crummy. Her temperature spikes to 100.3 on Sunday. She contacted her manager who advised her to contact Employee Health the next morning and employee health told her that if her temperature spiked again on Monday to get a COVID test. She said it never went above 99 degrees Fahrenheit. Today (21Jan2021) was the first day she did not feel crummy. The sleepiness improved but only because she had to go to work. She was still tired. Feeling funny lasted 2-3 days. Her temperature on Saturday (16Jan2021) was 100 degrees Fahrenheit and on Sunday (17Jan2021) was 100.3 degrees Fahrenheit. She never took her temperature on 15Jan2021. The temperature had improved, but it was still hanging out around 99.4 and 99.6. Feeling crummy persisted through yesterday (20Jan2021). Today (21Jan2021) was the first day she felt normal again. She felt crappy all week. She took a fair amount of medication and did not know if it was relevant or not. She had other medications and had been on them for a long time. No ER or physician's office required. She contacted with employee health but had not seen a provider. She planned to discuss with her provider because she wanted recommendation if she should receive vaccine 2. She realized it was a judgment call because she was only 50% covered after having the first dose. She was not sure if she will have a worse reaction with the second. Most people she talked to have no reaction but a significant reaction to the second one. She did not have any information on any of those that had a significant reaction. Details and time of onset provided as: Hot and flushed and bright red in face 14:28, Slept 14 hours 21:00-23:00, tired - she felt it the day before and said it started at 10:00 on Saturday morning, Felt funny and started to get hot and chills at the same time: 12:00, had increase temperature shortly after 12:00, because that was when she checked her temperature, felt crummy 10:00. The outcome of event hot and flushed and bright red in face, felt funny and started to get hot and chills at the same time, felt crummy was recovering. The outcome of event slept 14 hours, tired, increase temperature was not recovered.
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| 55 | 2021-02-07 | feeling abnormal |
nauseous/sick to my stomach; Weird headache; slight ache in my hip; Slight dizziness; fogginess/didn...
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nauseous/sick to my stomach; Weird headache; slight ache in my hip; Slight dizziness; fogginess/didn't feel right; I got hot/got very over heated; This is a spontaneous report from a contactable other hcp (patient). A 55-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL3246), intramuscular at left arm, on 20Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included possibly ibs occasionally from an unknown date. The patient's concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No Known allergies. Approximately 20 hours after, on 21Jan2021 14:15, slight dizziness/ fogginess, she got hot, just didn't feel right lasted about 5 minutes. Around 1030 am on 22Jan. She got very nauseous, sick to her stomach, dizziness/ fogginess again, got very over heated. Weird headache. No fever, slight ache in her hip. After about 10 minutes it passed and she feels fine. No treatment AE. No COVID tested post vaccination. The outcome of the events slight dizziness/ fogginess, she got hot, just didn't feel right on 21Jan2021 14:15 were recovered on 21Jan2021 14:20 (reported as lasted about 5 minutes), of events nauseous, sick to her stomach, dizziness/ fogginess again, got very over heated, Weird headache, slight ache in her hip on 22Jan2021 10:30 were recovered on 22Jan2021 10:40 (reported as passes after about 10 minutes).
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| 55 | 2021-02-09 | insomnia |
stress; not sleeping very well; sore arm; slight headache; This is a spontaneous report from a conta...
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stress; not sleeping very well; sore arm; slight headache; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the first of three reports. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) via unspecified route of administration on 19Jan2021 at single dose in left arm for COVID-19 immunization. The patient's medical history included occupational exposure to COVID-19 (adult foster care, direct line caring for people). The patient's concomitant medications were reported as no. The patient experienced sore arm on 19Jan2021, slight headache on 19Jan2021. Sore arm went away between 20Jan2021 and 21Jan2021. She has recovered completely from sore arm. She is unsure if the headache was from the vaccine or stress, or several different things, such as not sleeping very well. Headache went away, she is not 100% positive, but maybe by the 22Jan2021, and she had recovered completely. The patient asked if she can take paracetamol (TYLENOL) or ibuprofen for side effects if have to. The outcome of sore arm and slight headache was resolved. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092693 same reporter/drug, different patient/ event;US-PFIZER INC-2021092694 same reporter/drug, different patient/ event
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| 55 | 2021-02-10 | insomnia, anxiety |
chills; fever of 101 f; went to bed with an uneasy feeling; had a hard time sleeping; intermittent b...
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chills; fever of 101 f; went to bed with an uneasy feeling; had a hard time sleeping; intermittent body aches; fatigue; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek9231 and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 11:00 at a single dose for COVID-19 immunization. The first dose was received on 04Jan2021 11:00 (lot number: Ek5730) on the left arm. Medical history included epilepsy. Patient was not pregnant at the time of vaccination. Concomitant medication included lamotrigine (LAMICTAL), and levetiracetam (KEPPRA) and unspecified multivitamin. There were no other vaccines received within 4 weeks prior to COVID vaccination. The patient previously took DILANTIN and experienced allergy. Patient went to bed with an uneasy feeling and had a hard time sleeping and had intermittent body aches on 25Jan2021 22:00. He woke up at 2am on 26Jan2021 with chills and a fever of 101 F. Patient took Acetaminophen and Iborprophin. The medications did get rid of the fever and body aches. Patient woke up at 4 feeling a little better but the body aches and fatigue on Jan2021 was still there. Patient called in sick to work on 26Jan2021. Outcome of the events was recovering. Case was considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 55 | 2021-02-12 | impaired work ability |
On 1/7 (post-vaccination day 1) patient awoke with malaise, febrile with generalized weakness and ch...
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On 1/7 (post-vaccination day 1) patient awoke with malaise, febrile with generalized weakness and chills. Slept most of the day, peak temperature 102.5F. Consulted employee health, advised to get COVID tested - which was negative. On 1/8 (post-vaccination day 2) patient felt somewhat better with improved energy, still febrile to 101.5. Symptoms were treated with acetaminophen 650mg q6h PRN. Pt was able to return to work on post-vaccine day 3, continued to take acetaminophen PRN until post-vaccine day 6. She continued to have some generalized malaise, which resolved by post-vaccine day 14. ---- Of note, the patient has dermatomyositis, for which she normally takes azathioprine 150mg daily. This was held starting on 12/18/2020 on advice of her rheumatologist, with the thinking being to optimize the immune response for COVID vaccination. First dose of Pfizer was on 12/18. So the patient was off her immunosuppression, when she received the second dose and experienced the adverse event.
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| 55 | 2021-02-14 | loss of personal independence in daily activities |
At 725 pm was extremely tired. Went to bed. Woke up at 1030 pm with out of control shaking and fev...
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At 725 pm was extremely tired. Went to bed. Woke up at 1030 pm with out of control shaking and fever of 102. Body aches and pains. Had to put on extra clothes and blankets. Went to work in am but had to leave early due to ongoing body pains and fever of 101. Also, inflamed lymph node in axilla of shot arm- very painful. Felt better by Sat late morning. Please note I am strawberry blonde as is coworker who had same response. Other individuals with us with very mild symptoms.
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| 55 | 2021-02-14 | restlessness |
Severe chills on 2/12/21; overnight on 2/12/21 restless sleep; 2/13/21 - headache, stomachache, diar...
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Severe chills on 2/12/21; overnight on 2/12/21 restless sleep; 2/13/21 - headache, stomachache, diarrhea, vomiting, chills, temperature of 95.6
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| 55 | 2021-02-16 | disturbance in attention |
1/22pm: Sore throat, muscle aches, chills, temperature 102 F, nausea and vomiting, diarrhea, fatigue...
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1/22pm: Sore throat, muscle aches, chills, temperature 102 F, nausea and vomiting, diarrhea, fatigue, couldn't focus at work. 1/28: Was seen in the Emergency room and treated with amoxicillin
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| 55 | 2021-02-16 | sleep disorder, feeling abnormal, mental impairment |
About 20 hours after injection, in addition to sore arm, my brain felt foggy. I work on the compute...
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About 20 hours after injection, in addition to sore arm, my brain felt foggy. I work on the computer could not remember what to do next as I searched for needed files. At the end of the day, I signed off my computer but needed to think about how to turn off the monitor. The next day was better, but by the 3rd day out I became very sensitive to sound. On the 4th morning the brain fog got much worse, my head hurt and I felt like I was moving through life in slow motion. This continued for two whole days and I could not sleep at night due to the intensity of my headache. All of this could have been a migraine which I had in the past, but never to this extent. Past migraines were visual in nature and only lasted about an hour. By the 5th day, I started to feel normal, with the occasional headache or wave of nausea.
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| 55 | 2021-02-18 | anxiety |
Patient experienced an episode of vertigo, sudden increase in blood pressure, and feeling anxious. P...
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Patient experienced an episode of vertigo, sudden increase in blood pressure, and feeling anxious. Patient had similar episodes at prior vaccinations.
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| 55 | 2021-02-18 | insomnia, disturbance in attention |
About 48-hours after second COVID vax, I had serious body aches, headache, trouble focusing, feeling...
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About 48-hours after second COVID vax, I had serious body aches, headache, trouble focusing, feeling dizzy/ready to faint, unable to sleep, extreme exhaustion, general over all weakness lasting about 6-days.
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| 55 | 2021-02-20 | mental impairment |
Severe headache and flu like symptoms for 5 days. On the sixth day 1-11-21, I was left with a slight...
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Severe headache and flu like symptoms for 5 days. On the sixth day 1-11-21, I was left with a slight headache and dizziness (from 1-10 about a 3) 24 hours a day. On 2-17-21 around noon, I felt i was going to pass out. speaking, thinking were difficult. A nurse took my blood pressure it was 180 over 90. I couldn't stand and was taken to the hospital via ambulance. from noon to nine pm, (my time in the er) i felt was was going to loss all conscientiousness eleven times. I now have an appt to see a neurologist Thursday 2-25-21. I have not felt like i was going to pass out since 2-17-21. I am still left with a headache and dizziness 24 hours a day. i have had 3 appointments with a doctor to address my headache and dizziness along with my emergency room visit via ambulance.
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| 55 | 2021-02-21 | feeling abnormal | 2) "Stoned" From 8:15pm 2/5 thru 12:00 pm 2/7 1) Sporadic vibration of entire body 3) Constipation |
| 55 | 2021-02-24 | anxiety | Shaky, felt closed in, patient believes it was anxiety, waited 15 minutes, cleared by EMS. |
| 55 | 2021-02-25 | feeling abnormal, disturbance in attention, excessive sleepiness |
Reaction to 2nd Dose Pfizer covid19 vaccine I had second dose of the experimental Pfizer vacine Feb...
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Reaction to 2nd Dose Pfizer covid19 vaccine I had second dose of the experimental Pfizer vacine February 17, 2021. 1st dose was on January 27, 2021 I had reactions both times. I already reported on this site, on my 1/27/2021 reaction Received through a pharmacy clinic set up at my work. Lot#. EL9263 Received dose #2 about 10:30am on Wednesday 2/17/2021 during my work hours. (7-4pm) Paid closer attention to how I felt during the day, I could feel, I was going to be foggy in my head again. I was getting tried quickly. My left arm was not sore this time. Got home about 4pm (left a little early). Very tired, went to bed by 5:30pm. Slept, woke up to heat soup and eat. 7pm: Back to sleep. Very exhausted, my eyes were hurting (a sign I have a fever) I did not care enough to take my temp. Seemed to hard to try and find the thermometer. 7:30pm: Back to bed. Sleep. I'm very warm in my bed, sweating under arms and chest, I don't care, I can sleep thru that. Smells funny (sweat has a distinct oder) 11pm: wake up. I want to go pee, but I'm too cold to leave my warm covers. as soon as I uncover to get up, I have violent chills. I don't have chills if I stay covered. This was the exact same symtom I had on May 11, 2021 when I had the covid19 and came home sick from work. Violent chills, barely able to stand and walk alone. After midnight: I wait for someone to come upstairs to help me get up, with a blanket ready to throw over me and help me to toilet. I was too weak to call for him or to care, I just slept and waited for him to check on me. someone helped me to to tiolet, chills are under control if I have a blanket on me. The house is not cold, someone has the wood stove cranking that night, it's 70 in my bedroom. I sleep all night Wednesday. 6:30am: Thursday My eyes still hurt, I'm still hot. I don't care what my temp is. No more chills. I'm smelly from sweating all night. I'm motivated to shower, I think maybe I can do stuff today, I try to plan some things for the day. I shower and eat some oatmeal. I'm exhausted from doing those two things. My lower back/hips and neck are and shoulders are tight and sore, aches all over, especially neck. It's hard to think, brain fog, finding the right words. The injection site is not really sore though (last time it was). I have to just go back to bed. I sleep all day Thursday. Get up late afternoon to eat a little bit (soup and crackers) I try to watch TV. I can't focus on the show. I go back to bed by 5:30pm. I look at dumb funny videos on FB. Asleep by 6pm on Thursday evening. Sleep all night and wake up Friday 5am. I'm able to function and do most of my usual activities on Friday, but not very motivated to exercise or go for with dogs like I normally would do. Still stiff muscles. I do play in snow Friday night with dogs. By Saturday most of the stiffness is much better, I'm moving, walking dogs outside, moving furniture, doing my usual activities. I care about things again.
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| 55 | 2021-02-28 | impaired work ability |
Headache Throwing up Stomach upset, only ate toast Sore arm Overall feeling lousy Could not go to...
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Headache Throwing up Stomach upset, only ate toast Sore arm Overall feeling lousy Could not go to work
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| 55 | 2021-03-01 | impaired work ability |
Pt woke up that night w/ nausea, body aches, chills, fever, fatigue, and swelling/redness/soreness a...
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Pt woke up that night w/ nausea, body aches, chills, fever, fatigue, and swelling/redness/soreness at injection site that spread up left neck; s/s continued for 2 days. Pt unable to complete work day and left early on 2nd day of symptoms.
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| 55 | 2021-03-01 | nervousness | shaky, jittery. Waited 15 mins extra. Evaluated by EMS-Cleared |
| 55 | 2021-03-03 | impaired work ability |
pt stated that almost a week after she got the vax she could not move, her body was stiff and her p...
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pt stated that almost a week after she got the vax she could not move, her body was stiff and her pain level was at a 12. She was not able to work that day but the pain was still bad but she was able to go to work. Pt had a virtual appt w/ PCP where she was told it was a reaction to taking the vax. She was ordered blood work on 2/22/2021 and told if she does not here from them that means everything should be ok. She later had an appt w/ her Neurologist which confirmed the symptoms were related to taking the vax. Pt no longer has this pain.
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| 55 | 2021-03-03 | panic reaction, hallucination |
I was fine during the day .. at about 11 o?clock pm i started feeling like i was falling off the ear...
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I was fine during the day .. at about 11 o?clock pm i started feeling like i was falling off the earth .. spinning .. that i was going to jump out my window ... etc !! Like my whole body was out of control. I could not breathe ... i couldn?t realize at the time i was hallucinating terribly !! Like the worst bad acid trip gone wrong .. i am panicked now !!!
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| 55 | 2021-03-05 | feeling abnormal |
Foggy brain, hand tremors, chills, fever, feet throbbing, muscle aches, joint pain , nasal congesti...
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Foggy brain, hand tremors, chills, fever, feet throbbing, muscle aches, joint pain , nasal congestion, headache, earache
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| 55 | 2021-03-07 | insomnia |
1st Dose: No problem; just a bit of fatigue 1 day following inoculation. 2nd Dose: My shot was sch...
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1st Dose: No problem; just a bit of fatigue 1 day following inoculation. 2nd Dose: My shot was scheduled for 3:40 PM, but probably didn't receive until 4:20 PM. At night, I had insomnia. The next morning, my fever went up to 101.2, I had swelling of the neck, my arm @ injection site, swollen lymph nodes in my left armpit, body aches, occasional stabbing pains in random places (back, arm, leg, etc.), extreme fatigue, it lasted for 1.5 days and then the fever dropped to 99. By the second day the fever was gone, body aches gone & only thing left on day 2 is swollen lymph nodes in arm pit, arm soreness at inoculation site, and fatigue. Day 3 slight fatigue, a bit of soreness in arm and armpit.
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| 55 | 2021-03-10 | impaired work ability |
Had swelling at site and lips swelled up from first dose symmetrically but did not affect airway, h...
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Had swelling at site and lips swelled up from first dose symmetrically but did not affect airway, had chills , and malaise , 2nd dose had more chills fatigue , GI upset , nausea , swelling at site of injection , arm pain couple of small hives on arm no lip swelling with second dose and migranous headache . Was not as bad as prior reactions to flu vaccine but enough to not feel well enough to go in to work Monday . Was able to go to work Tues though after Sat appt .
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| 55 | 2021-03-11 | feeling abnormal, impaired work ability |
Chills, weakness Shoulder and arm pain Joint pain Fatigue Fever 100.1-100.2 Brain fog Tinnitis Felt...
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Chills, weakness Shoulder and arm pain Joint pain Fatigue Fever 100.1-100.2 Brain fog Tinnitis Felt like the Flu, and would not describe as mild. Symtoms began the evening after the shot. Fever gone but still unusually tired as of 3/12/2021 at 4:00 pm. Missed 3 days of work.
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| 55 | 2021-03-12 | thinking abnormal |
Diarrhea Stomach ache nausea Headache Chills Fever Severe fatigue Unfocused thought process Sore arm...
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Diarrhea Stomach ache nausea Headache Chills Fever Severe fatigue Unfocused thought process Sore arm at injection site
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| 55 | 2021-03-14 | feeling abnormal |
Feeling weak and tired/achy about 12 hours after shot; woke up in the morning and went to work but c...
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Feeling weak and tired/achy about 12 hours after shot; woke up in the morning and went to work but couldn't get warm - cold & chilled all day, headache, muscle & joint achiness; took Tylenol for achiness and headache, felt better about 48 hours after shot, but still feel a bit "off" 4 days after shot
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| 55 | 2021-03-15 | feeling abnormal, abnormal dreams |
Sleeping 1 full day after vaccine tiredness, Back Pain and spasms for 4 days, Headache for 1 day, ...
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Sleeping 1 full day after vaccine tiredness, Back Pain and spasms for 4 days, Headache for 1 day, Vivid Dreams, feeling out of it, increased pulse 110, increased blood pressure 160/80 not a hypertensive patient, dizziness and light headedness. Increase vitals day 2 Back pain started late in the 2nd day and ended on 3/16.
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| 55 | 2021-03-15 | excessive sleepiness |
Body chills, low grade fever, headache, nausea, light headed, joint and muscle aches, couldn?t sleep...
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Body chills, low grade fever, headache, nausea, light headed, joint and muscle aches, couldn?t sleep due to headache, vomited twice, fatigue. Started about 11 hours after shot, and lasted until about 9 am the next morning then slept the entire day and evening.
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| 55 | 2021-03-16 | feeling abnormal |
After sitting for the required 15 minutes, stood up and felt light headed and fuzzy. Waited for it t...
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After sitting for the required 15 minutes, stood up and felt light headed and fuzzy. Waited for it to pass and walked to car. Sat in car for a few minutes, drank some water and had a few bites of a protein bar. Felt hot, flushed, broke out in an all over sweat. Waited about 5 minutes, continued to sip water and nibble on protein bar. It eventually passed. On and off headache for next couple of hours. Only some injection sight tenderness since then.
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| 55 | 2021-03-17 | disturbance in attention |
right arm felt like needles and sensitive to the touch; all joints hurt more than usual; difficult t...
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right arm felt like needles and sensitive to the touch; all joints hurt more than usual; difficult to concentrate; The right arm felt a little dormant with a little tiredness and pain; The right arm felt a little dormant with a little tiredness and pain; This is a spontaneous report from a contactable female consumer reported for herself. A 55-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EN5318) in left arm 14:15 on 17Feb2021 for Covid-19 immunization. The patient had her first injection (lot number EN5318) in left arm 2:15PM on 27Jan2021. The patient had a history of some age related arthritis and had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had not received other medications within 2 weeks of vaccination. The vaccine was applied in the left arm, close to shoulder. About one hour later, the right arm felt a little dormant with a little tiredness and pain. 18 hours later the right arm felt like needles and sensitive to the touch. Additionally, all joints hurt more than usual and it was difficult to concentrate. No headache nor fever. After 48 hours patient felt normal. No Tylenol was taken. No treatment was received for the events. The patient had recovered from the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter considered all events were non-serious.
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| 55 | 2021-03-18 | nervousness |
Pt received vaccine and reported feeling flush and shaky. Pt was escorted via wheelchair from a vacc...
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Pt received vaccine and reported feeling flush and shaky. Pt was escorted via wheelchair from a vaccination pod to an observation unit where she was observed and monitored for +30 minutes. Vitals were 114/74, O2 94%, HR 80. Pt reported using albuterol as a rescue inhaler and G Breo regularly. Pt verified symptoms had subsided and was escorted via wheelchair from the premise.
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| 55 | 2021-03-18 | sensation of foreign body | Pt with cough, lump in throat, scratchy throat. Headache severity 5 of 10. Strong cough present. |
| 55 | 2021-03-21 | anxiety |
Presented w/ c/o feeling lightheaded and chest tightness, hands sweaty. B/P 126/67, HR 104, O2 sat ...
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Presented w/ c/o feeling lightheaded and chest tightness, hands sweaty. B/P 126/67, HR 104, O2 sat 99%. 5:09 pm B/P 122/71, HR 106, ECG strip NSR. 5:25 pm Palms dry HR decreased to 98, stated lightheadedness subsided. States she gets anxious and just wanted to be checked. Advised if symptoms returned, pull over safety and call 911. Said she was going home to relax w. hot bath and sit on patio.
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| 55 | 2021-03-23 | feeling abnormal |
The first 3 days I could not get out of bed without crawling, extreme muscle weakness and pain dizzi...
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The first 3 days I could not get out of bed without crawling, extreme muscle weakness and pain dizziness extreme mental fog, malaize, low cognitive functioning drowsy, slept day and night the first 3 days symptoms still evident to lesser degrees 18 days post inoculation
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| 55 | 2021-03-24 | anxiety |
Hotness in chest area and stomach, nausea, and headache, and anxiety feeling. Which lasted about 2 ...
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Hotness in chest area and stomach, nausea, and headache, and anxiety feeling. Which lasted about 2 hours but headache lasted until next day.
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| 55 | 2021-03-24 | anxiety |
Pt c/o numbness/tingling in arm. Assessment showed speech not slurred, equal grip bilaterally. Hig...
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Pt c/o numbness/tingling in arm. Assessment showed speech not slurred, equal grip bilaterally. High BP is abnormal for patient, but pt stated anxiety due to shot. Pt refused transport, advised to contact PCP if HTN, symptoms occurs
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| 55 | 2021-03-24 | confusional state |
Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensat...
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Patient is been complaining of swollen arms, breast, face and neck. she's also having burning sensation all over body, especially breast area. Patient has also blue spots on upper Thigh. Patient also complaining of weakness, body aches, and abdominal pain sometimes. Patient also today is complaining about head ache and feeling confused.
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| 55 | 2021-03-24 | disorientation |
1024: received injection and came into observation area. I spoke to patient personally and discussed...
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1024: received injection and came into observation area. I spoke to patient personally and discussed her allergies, she was feeling well at the time. Sometime since then, patient then began feeling unwell, complained of nausea and sore throat, and vehicle was pulled aside. 1040: upon evaluation of the patient, she appeared in mild-moderate respiratory distress, tachypneic and diaphoretic. She was mildly disoriented and upon inspection of airway, there was oropharyngeal swelling. There was no audible stridor or wheezing. No rash visible on neck or upper chest. 1041: rapid response called for medical team, EMS was called. BP 190/100, P 106, O2 98% 1042: Epinephrine given IM in right thigh. Patient continued to be tachypneic, no wheezing on auscultation. 1044: pulse 102, O2 95% 1045: oropharyngeal swelling worsened upon inspection. second Epinephrine given IM in left thigh. BP 196/110, P 93, O2 98% 1046: pulse 83, O2 97% 1048: pulse 95, O2 98% 1049: BP 170/102, pulse 73, O2 94% 1051: BP 176/100, pulse 77, O2 98% 1053: EMS arrived and evaluated patient, transported to ED.
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| 55 | 2021-03-25 | feeling abnormal |
pt stated that she felt a little funny and lightheaded after taking the covid vax. Her skin started...
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pt stated that she felt a little funny and lightheaded after taking the covid vax. Her skin started feeling a little prickly and she developed rash on her extremities and upper chest. She started having trouble speaking, her voice got hoarse and she started coughing. She had an intense headache, fatigue and could barely speak. She was taken to the UrgentCare . She was given EPI pen and steroids injections. Paramedics were called and she was taken to a hospital, where she was monitored after getting those injections and given Pepcid and IV fluids. She was diagnosed w/ Anaphylaxis from adverse reaction to vaccine. She discharged and sent home to FU w/PCP. Her appt w/ her PCP on 3/25/2021 she was taken next door by wheelchair to all allergist Dr. She noticed that her respiratory symptoms were improving while she was there as her Pepcid medication was wearing off. Pt is convinced that she is allergic to the ingredient Polyethylene Glycol. She is still taking prednisone medication and continuing to improve.
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| 55 | 2021-03-27 | feeling abnormal |
My reaction to the vaccine is the same way I felt when I had Covid back in December but with a new s...
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My reaction to the vaccine is the same way I felt when I had Covid back in December but with a new symptom. I am experiencing bad head aches, severe body aches, fever, nauseous,. This time with the vaccine I'm having severe spasms on my leg, arms and back to the point that I can't even touch it . I feel worse than I did when I was going through Covid. This is my 2nd day and I'm still feeling terrible.
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| 55 | 2021-03-27 | sleep disorder |
3/27 Awoke at 1 am with muscle ache & cramps in legs. Shoulder was stiff., could not sleep due to p...
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3/27 Awoke at 1 am with muscle ache & cramps in legs. Shoulder was stiff., could not sleep due to pain. Around 5 am 101 fever, body aches, sick to stomach, migraine headache. 3/28 fever is gone , muscle pain gone, migraine more like a bad headache now..
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| 55 | 2021-03-29 | anxiety |
C/o numbness, tingling in both arms ,face and feels warm all over. No swelling rash redness, flushin...
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C/o numbness, tingling in both arms ,face and feels warm all over. No swelling rash redness, flushing, SOB, chest pain or nausea. Pat feels nervous/ anxious. v/s HR 79, 119/77, 97% O2 RA. Pt felt s/s resolve and reported 126/79. No tingling after assessment . Refused transport.
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| 55 | 2021-03-29 | feeling abnormal |
Light headed and dizzy , headache, body aches, chills, pain radiating from left shoulder to bottom o...
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Light headed and dizzy , headache, body aches, chills, pain radiating from left shoulder to bottom of left leg. Severe muscle aches. Fatigue, sleepy and foggy.
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| 55 | 2021-03-29 | feeling abnormal |
Since having the shot, I have noticed a great amount of swelling in my neck, even making it hard for...
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Since having the shot, I have noticed a great amount of swelling in my neck, even making it hard for me to breath at night when laying down to sleep. I also feel heart palpatations, even when laying down and it feels like irregular or racing heart rate, to the extent that I have to sit up and focus my mind on calming my heart rate. I also feel easily out of breath even in doing small activities. I have a lack of energy and I am sleeping a lot and still always feeling tired, I also have brain fog unless I drink a ton of coffee. I have no mental clarity for much of the day. I wonder if I will ever regain my full health prior to getting the shot. I also got really sick about 2 weeks after the shot with a really sore throat and chills and I didn't get better even when taking antibiotics. It's been a few weeks, and I am still not feeling normal.
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| 55 | 2021-03-30 | depression, feeling abnormal |
Impulsive suicidal thoughts; depression; Brain fog; fatigue; This is a spontaneous report from a con...
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Impulsive suicidal thoughts; depression; Brain fog; fatigue; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided) via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunisation. Medical history included Diabetes, depression and high Cholesterol. The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine but took other unspecified medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Jan2021, the patient experienced impulsive suicidal thoughts, depression, Brain fog and fatigue. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received in response to the events included psychotherapy. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581) on 13Feb2021. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.
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| 55 | 2021-03-30 | feeling abnormal |
Patient became lightheaded and stated she felt ?weird.? Nurse offered Gatorade, which did not help,...
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Patient became lightheaded and stated she felt ?weird.? Nurse offered Gatorade, which did not help, so nurse initiated a code green-request for paramedics.
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| 55 | 2021-03-30 | sleep disorder | Chills, fatigue, nausea and vomiting, headaches, non sleep |
| 55 | 2021-03-31 | anxiety |
Client received to post vaccination observation with hx of anaphylaxis with influenza and pneumonia ...
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Client received to post vaccination observation with hx of anaphylaxis with influenza and pneumonia vaccination when administered together. Guest accompanied by husband. Husband states he is a medic with the fire department. Client has brought Epi-Pen with her today given her previous experiences. Client is seated in observation area with complaint of dry mouth. Pt given water. Client is visibly anxious and it was decided to take a set of vitals to help reassure and calm the client. VSS. Client was visibly relieved when given vitals were normal. Client continued to wait 30 min observation time without incident. Client discharged with her husband.
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| 55 | 2021-03-31 | anxiety |
"Complained of ""splotches"" to anterior chest wall, denied itching, SOB, facial swelling. Admits to...
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"Complained of ""splotches"" to anterior chest wall, denied itching, SOB, facial swelling. Admits to feeling anxious. Had only yogurt today prior to vaccine, no full meals. No hx of vaccine reaction or HTN. Escorted from monitoring area to rapid response area. VS performed and monitored for 40 minutes. Rash began to improve independently within moments. Husband at bedside reports hx of becoming flushed and red when anxious. Remained asymptomatic throughout the entire encounter. VS 1 pm: 212/113 pulse 108 resp 18 sp02 97% VS 115 pm 192/110 pulse 105 resp 18 sp02 98% seated in chair, no redness to chest or back, husband at bedside, asymptomatic VS 130 pm 198/118 pulse 102 resp 18 sp02 98% reports feeling 100%, asking to go home Consulted with medical director on site. Husband will transport home. Red flags reviewed. Agrees to eat and remain well hydrated. Incident appears related to underlying anxiety and not vaccine adverse reaction. There was also Flushing and Tachycardia reported! Pt was monitored and was ok! Was also scheduled for 2nd dose "
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| 55 | 2021-03-31 | anxiety |
4/1/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination scr...
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4/1/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness. Assessment : Time of assessment 0915. Alert and oriented and Anxious.Complains of feeling light headed. Actions taken: Vitals sign taken VAERS form completed BP- 154/96, P- 61, SPO2- 98%, water and snack given Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/1/2021 9:28 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc
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| 55 | 2021-03-31 | anxiety |
Patient presented at Altec for her first covid vaccine shot. Patient stated she has had a reaction t...
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Patient presented at Altec for her first covid vaccine shot. Patient stated she has had a reaction to a previous immunization. Patient was counseled about possible side effects and reactions and was counseled to stay in observation area for a minimum of 30 minutes. Vaccine given at 1008. At 1019 patient appeared to be anxious and stated that she felt her heart was racing, eyes started watering and a tightness in her neck. C/O headache. 25mg PO Benadryl given. Pulse 80 BPM. Patient continued to appear anxious and redness noted on neck like hives. 911 called to evaluate patient. Patient declined the need to go to the emergency room. Patient was reported by human resources at Altec that she was able to return to work and they have been keeping a close eye on her.
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| 55 | 2021-03-31 | disorientation |
After vaccination, while waiting the recommended 15 minutes post vaccination, around 10 minutes, pat...
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After vaccination, while waiting the recommended 15 minutes post vaccination, around 10 minutes, patient fainted and eyes rolled back, patient was limb and could not stand. Patient was breathing and talking, however was disoriented, did not know where she was.
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| 55 | 2021-04-01 | anxiety |
Patient had left the covid vaccine clinic after being observed for 15 minutes. She came back in bre...
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Patient had left the covid vaccine clinic after being observed for 15 minutes. She came back in breathing quickly and hyperventilating. Complaining of "throat feeling funny". Patient was brought into a private room and sat down. She was responsive and coherent at that time. VS obtained and stable. She appeared anxious. Patient continued to complain of her throat feeling tight so a dose of Epi was given and 911 called. After 10 minutes she became more anxious and breathing increased. Another dose of epi was given due to pt still feeling like throat was tight. EMS here at that time and they intervened. Patient transferred to the ER.
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| 55 | 2021-04-01 | disorientation |
Dizziness after the shot, feelings of disorientation but felt better later. The night of the injecti...
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Dizziness after the shot, feelings of disorientation but felt better later. The night of the injection - profuse sweating, extreme body aches, fever, headache, extreme thirst - these were all symptoms I had when I believe I had COVID last Feb 2020. Very similar symptoms except not the dry cough/pneumonia, etc. Most symptoms dissipated after about 2 1/2 days but I didn't feel completely recovered for about 5 days.
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| 55 | 2021-04-03 | insomnia |
On sunday she developed a rash on her shoulder that looks like poison ivy; itchiness on her wrist; w...
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On sunday she developed a rash on her shoulder that looks like poison ivy; itchiness on her wrist; wake her up last night; This is a spontaneous report from a contactable consumer (patient's husband). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "Husband, calling on behalf of wife, cold transfer, received first dose of the Pfizer BioNTech Covid on Thursday. On Sunday she developed a rash on her shoulder that looked like poison ivy. The rash had since spread to her elbow and wrist. It had been getting better since treating with poison ivy cream, although the itchiness on her wrist did wake her up last night (23Mar2021)". Reported asked that "was this normal; could she get the second dose; and was it a good idea to treat with poison ivy cream, how could they treat it. Outcome of the event rash was recovering whereas other events was unknown. Information on the lot/batch number has been requested.
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| 55 | 2021-04-04 | anxiety |
4-3-21 APROX 11:15AM PT SHAKING, VERY ANXIOUS WITH REDNESS AND ITCHING ALL OVER - PT PLACED IN WHEEL...
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4-3-21 APROX 11:15AM PT SHAKING, VERY ANXIOUS WITH REDNESS AND ITCHING ALL OVER - PT PLACED IN WHEELCHAIR AND TAKEN TO MEDIC TENT PER, RN. PT STATES SHE HAD A RASH LAST TIME SO SHE TOOK BENADRYL AT 6:30AM AND 10:30AM TODAY (PT TOOK 2 MORE OF HER OWN BENADRYL AT 11:15AM). RAPID BREATHING, 'BAD HEADACHE'. SQUAD CALLED FOR TRANSPORT. PT W/D. HUSBAND AT HER SIDE. COMFORT GIVEN. 11:27AM TO ER PER SQUAD, HUSBAND TO FOLLOW IN AUTO. 4-5-21 11:23AM TC: PT STATES SHE HAD A 'GRAND MAL SEIZURE IN THE SQUAD'. THEY TOLD HER SHE HAD LACTIC ACIDOSIS, ELEVATED POTASSIUM AND WAS DEHYDRATED. 'CT WAS NEG.' STATES HIVES/RASH IS GONE TODAY.
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| 55 | 2021-04-04 | feeling abnormal |
On Day 2 following the first dose, I started to feel light-headed and dizzy. I also have had a heada...
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On Day 2 following the first dose, I started to feel light-headed and dizzy. I also have had a headache for the two weeks since the first dose. I feel brain fognot fully sharp at work and at other tasks. I'm also quite fatigued. I noticed that a glass of wine with dinner considerably magnifies the dizziness. I've tried eliminating wine for a few days, which seems to help. But when I had a glass of wine again, the symptoms returned the following morning. I have tried vestibular exercises, which seemed to help for a few hours. But overall, the symptoms persist.
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| 55 | 2021-04-04 | feeling abnormal | Brain fog. Fatigue |
| 55 | 2021-04-04 | sleep disorder |
starting about 12 hours after the second Covid-19 vaccine injection in left arm: fever, body aches...
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starting about 12 hours after the second Covid-19 vaccine injection in left arm: fever, body aches, strong headache, general "flu like symptoms" about 24 hours afterr injection: cotinued fever, continued body aches, continued headache, red rash on arm at injection site, swollen lymph nodes on left side of body, unable to sleep 36 hours after injection: slight fever, continued body aches, continued red rash at injection site, continued swollen lymph nodes, unable to sleep comfortably
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| 55 | 2021-04-05 | anxiety, panic attack |
4/6/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination s...
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4/6/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: Anxiety and panic attack. Assessment : Time of assessment 1010 Alert and oriented and Anxious. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. 1010 : bp-127/65, p- 80, O2- 92%, 1038- bp- 133/71, p- 72, o2- 98% Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/6/2021 10:01 AM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8729
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| 55 | 2021-04-05 | feeling abnormal | hot flashes, tightness on left arm, headache, funny feeling, resolved. |
| 55 | 2021-04-05 | loss of personal independence in daily activities, insomnia |
I have a very strong muscle back pain on both sides. Can not bend at all. Very strong muscle pain on...
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I have a very strong muscle back pain on both sides. Can not bend at all. Very strong muscle pain on the shoulder not able to put dresses or everything on me needs to use help. I had two days headache which I don't have any more. But the pain on the low back are very strong .Difficult to sleep. Difficult to move the shoulder and the hand. I never had this pain before in my Life. I'm very healthy person and now you and your vaccine make me feel half person. If something bad will happen with me and I died I give permit ion for my daughter to sue .
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| 55 | 2021-04-05 | sleep disorder |
Enlarged and painful lymph nodes under arm / in left arm pit for approximately 5 days following the ...
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Enlarged and painful lymph nodes under arm / in left arm pit for approximately 5 days following the vaccine. Significant enough that it was uncomfortable for arm to hang at side when standing and would awaken me from sleep if arms was not held out from side.
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| 55 | 2021-04-06 | anxiety |
Driving home from receiving first dose of Pfizer vaccine for Covid 19, So about 40 minutes after rec...
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Driving home from receiving first dose of Pfizer vaccine for Covid 19, So about 40 minutes after receiving the shot, I started to experience lip tingling and burning, heart palpitations/racing and a headache that started from out of no where. The burning and tingling would come and go, so I pulled over and took a Benadryl. I made it home and took some Advil. That evening, the heart racing continued with pressure, it would come and go. I also developed a hive/sore on the inside of my upper lip that burned. I felt very tired but simultaneously I had a feeling of anxiousness at the same time. I took more Advil before bed. Day after the shot, I felt better, the hive on the inside of my lip was almost gone and I took Advil and Tylenol during the day when I started feeling not well.
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| 55 | 2021-04-06 | sleep disorder |
INITIALLY FEVER, ACHES, HEADACHES,HOT FLUSHES, NAUSEA, DIARRHEA, AND UPPER ABDOMINAL STOMACH PAIN WI...
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INITIALLY FEVER, ACHES, HEADACHES,HOT FLUSHES, NAUSEA, DIARRHEA, AND UPPER ABDOMINAL STOMACH PAIN WITH DIGESTIVE COMPACITIY DIMINISHED. LASTED ABOUT 1 WEEK, THEN FOR ADDITIONAL 10 DAYS AND STILL CONTINUING, I HAVE HAD HOT FLASHES, TINGINLING IN MY HEAD WITH TIGHTNESS, INCREASE HEART RATE, AND BLOOD PRESSURE, AND WAKING UP EVERY NIGHT AT 3 AM IN THE MORNING WITH BAD NIGHT SWEATS MOST OF THE TIME. NONE OF THIS EXISTED BEFORE THE SECOND PFIZER VACCINE. I AM 55 AND IN MENOPAUSE , BUT WAS TOTALLY CONTROLLED WITH NATURAL PROGESTERONE SUPPLEMENTATION. THE WORST IS THE RACY HEART, AND JITTERINESS , WITH HEADACHES.
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| 55 | 2021-04-07 | anxiety |
Shakey and cold, reports having anxiety. 1:15 PSO2 98% pulse 70 Respirations even and unlabored. N...
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Shakey and cold, reports having anxiety. 1:15 PSO2 98% pulse 70 Respirations even and unlabored. No sign or symptom of ditress. Continued to monitor. 1:26 Pso2 99% pusle 65 continued to monitor. 1:38 client decided she was okay to leave still cold and shakey. Informed she could stay longer to be monitored. Decided she would leave and try to warm up in her car. Was informed to seek medical attention if any other problems. Given V-safe information for follow up.
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| 55 | 2021-04-07 | anxiety |
Pt states that she was experiencing anxiety and tongue tingling on her way out of the clinic. Had pa...
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Pt states that she was experiencing anxiety and tongue tingling on her way out of the clinic. Had patient wait in clinic another 15 min and took her vitals. B/P- 130/80, P-72, R-20, SPO2-98% room air.
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| 55 | 2021-04-07 | disorientation |
Systemic: Dizziness / Lightheadness-Severe, Systemic: DIZZINES AND DISORIENTED-Severe, Systemic: Hyp...
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Systemic: Dizziness / Lightheadness-Severe, Systemic: DIZZINES AND DISORIENTED-Severe, Systemic: Hypertension-Severe
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| 55 | 2021-04-07 | feeling abnormal |
3/28/21, 9:35 a.m. received Pfizer shot. 28 mins after receiving shot in my right arm, my forehead ...
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3/28/21, 9:35 a.m. received Pfizer shot. 28 mins after receiving shot in my right arm, my forehead and cheek bones started to feel numb. Shortly after, my whole left arm (opposite arm where I had shot) all the way to my fingertips, extending to my left part of my chest, had a very strong sensation, numbing. I told the EMT's on site and was watched. That lasted 12 mins. Once it subsided, we left ,thinking it was done. Throughout the rest of the day, I felt waves of a "spacey" feeling, walked with a wide gait feeling "out of wack", and this would occur every 10-15 mins. 3/28/21 4:00 p.m.went emergency room when my left arm again, went numb. It extended from my left elbow down and worked its way up my arm after extending to the left side of my upper back. This occurrence was a little less intense than the first, but very worrisome. Also, my right arm had the same reaction this time, only on a lesser intensity than my left arm. After it resolved, both thumbs remained tingling. Went to ER.
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| 55 | 2021-04-08 | loss of personal independence in daily activities, disturbance in attention, impaired work ability |
Vice-like headache, shooting pain in neck and upper back, sensitivity to light, exhaustion, tinnitus...
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Vice-like headache, shooting pain in neck and upper back, sensitivity to light, exhaustion, tinnitus, low appetite, back pain shifted to sacrum and hamstrings second day, painful to sit, stand, walk, put on socks, difficult to concentrate, unable to work for nearly 2 weeks, still extremely low energy.
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| 55 | 2021-04-08 | loss of personal independence in daily activities |
On 3/19/20 approx 2:30 pm Pfizer COVID vaccination. Felt fine, no obvious side effects On 3/20/21, ...
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On 3/19/20 approx 2:30 pm Pfizer COVID vaccination. Felt fine, no obvious side effects On 3/20/21, late afternoon, the following adverse reactions occurred: Back pain & spasms Right knee swollen and sore Shoulder, clavicle, trapezius pain Shoulder/Clavicle Pain: Sharp pain started in left shoulder joint, then moved a little further in to settle underneath my clavicle. Pain exactly like after abdominal surgery when they insufflate you with Co2 and your body develops that horrible, sharp pain under your collar bone and in your shoulder joint as you off-gas. From 3/20 to 3/27, the shoulder joint/clavicle pain was mild to moderate, becoming more intense when I lay down. It kept moving up and down specific spots in my shoulder area, from the shoulder joint to the base of my neck and back again, not spread out through the whole shoulder area. Shoulder pain level 1-4, so nothing compared to the level 8 of my back. The shoulder pain was the least of my worries in comparison at the time. It seemed to be getting milder as my back pain subsided At 12:30 am on 3/28, I woke with excruciating stabbing pain in the middle of my left shoulder area, specifically halfway between my neck and my shoulder joint. Pain level 8. The pain gets worse when I inhale. The pain moves from the middle of my shoulder/clavicle area to the base of my neck, and back to the shoulder joint. It continues to travel up and down my shoulder area and makes it very hard to breathe as it?s so painful to inhale at 7:30 am on 3/28, the pain started snaking down the front of my chest towards my heart and up my neck into the left side of my head. I now have a mild pulsing headache on the left and sharp stabbing pain in my heart area and down the ribs on that side, as well as the sharp pain in the middle of my shoulder/trapezius area. The left side of my head feels heavy Using my left arm and lifting my head from the pillow intensifies the pain. Inhaling, Leaning forward to put on socks, leaning forward to clean the litter box, hiccuping, burping, going to the bathroom??..anything that requires abdominal pressure or pressure to the top of my body, like leaning over, intensifies the pain incredibly. . 9:30 3/28 ? pain has settled in mid clavicle region and has dropped to pain level 6 3/29 ? pain pretty much the same as on 3/28. I was able to get some sleep by sitting up in my recliner?.lying down increases the pressure in my shoulder/clavicle region, thus intensifying the pain incredibly so I can?t inhale without intense pain and can?t sleep. Cleaning the litter box, putting on shoes or socks, going #2, hiccuping, taking a deep breath?..all cause incredible sharp pain at mid clavicle?.level 8. Lying down brings the pain to the front of the clavicle, sitting upright or standing moves the pain more towards my trapezius. I want to make clear this is not a muscle pain?.I haven?t strained or sprained any muscle and this is not that. I?m not sure what this is?..possibly a nerve pain? Feels exactly like off-gassing from Co2 insufflation, only more intense. Something to do with my abdomen? 3/30 ? pain seems to be a little less intense. Still had to sleep with my upper body elevated last night, but I was able to sleep. 3/30 ? 10:15 pain is less?.I?m able to inhale at level 5 instead of 8. 3/31 ? Pain much less, level 3 overall and staying put at center clavicle 4/1 ? 10:15 Sudden, Sharp, stabbing pain moved from center clavicle to shoulder joint and then moved down my left side and over into my abdomen below my ribcage. Worse on left side, but reaching across mid abdomen and mildly into the right side. Level 6 11:15 pain in abdomen subsiding, shoulder joint pain level 3 4/2-4/7 ? clavicle/shoulder pain improved each day, fluctuating between pain level 1-3. 4/8 ? clavicle/shoulder pain has almost resolved itself. Pain level 0-1 Back Pain: On 3/20 - lower back sudden excruciating pain, radiated to right hip on Sunday, then switched to left hip on Monday and Tuesday. Also right groin painful. Pain level 7 Tuesday night 3-23 ? pain moved from lower back to mid back with bad spasms. Pain level 8. Fever 99.9. pain also in left groin & lower abdomen today. Weds morning 3-24 ? pain has lessened in mid back somewhat, but is much worse on right side center back. Still having spasms. Pain level 7, 8 when I engage back muscles at all. Leaning forward, sitting, standing, and wiping extremely painful. It?s slightly better when lying down or in anti-gravity chair. Fever 99.9. pain has also moved to under my ribs on right front and more into my abdominals. Thursday morning 3-25 ? pain has lessened somewhat overall, but has spread more fully across my mid back, so both sides of my mid back are painful. Sharp pain in right side isn?t as bad, but now I have a sharp pain snaking down from mid back toward lower along the right side spine. Fever has broken. Pain level 6-7. Groin and abdominal pain much less 3/25 ? Saw my Spine Dr. She agrees that this is an adverse reaction to the Covid vaccination. Prescribed muscle relaxers to help with spasms. Evening 3/25 ? pain horrible across my mid back, wrapping around my rib cage, snaking down along my spine. Pain Level 8 3/26 ? pain and spasms bad upon awaking, but began to subside mid morning. Pain level reduced from 8 to 5 over the course of the day. By evening, pain level reduced to 4 and stabbing pains almost gone when moving and breathing. 3/27 ? mid back, ribcage, groin and abdominal pain almost gone, pain level 3. Lumbar region pain my ?normal? 3-4 pain level. Lumbar pain improves with rest. By evening, all pain except lumbar down to level 1-2. Lumbar level 3 3/28 - mid back, ribcage, groin and abdominal pain almost gone, pain level 1-2. Lumbar region pain my ?normal? 3 pain level. Lumbar pain improves with rest. 3/29 ? shoulder/ clavicle/trap pain level 8 starting at 12:30 am Knee Pain: Right knee swelled up and painful Knee stays moderately swollen, stiff and painful throughout this ordeal from 3/20-3/28 so far. Pain level 3 My knee replacement recovery was going great prior to this. I had minimal swelling and pain until 3/20 3/30 ? knee still stiff, but not as swollen. Pain 3 3/31 ? 4/8 ? knee swelling and pain still present, but has been slowly improving each day. I?m continuing to do my knee rehab exercises and ride my recumbent bike.
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| 55 | 2021-04-08 | sleep disorder |
About an hour after receiving the first dose of the vaccine I began having ringing/hissing noise in ...
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About an hour after receiving the first dose of the vaccine I began having ringing/hissing noise in both ears. It has not gone away. A week after it started, I saw my primary care physician. There is not much to be done. Suggested taking allergy meds. It has not cleared up. - two weeks after the first dose. It is difficult to sleep as it seems to be worse at night.
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| 55 | 2021-04-12 | anxiety |
Pt developed facial tingling, throat tightness and anxiety. She mentioned that she may be having anx...
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Pt developed facial tingling, throat tightness and anxiety. She mentioned that she may be having anxiety issues. BP 200/120, HR 80 and SP02 98%. 911/EMS evaluation and transport to ER recommended. Pt declined and is aware of the risks of leaving AMA. She improved without intervention. Family picked her up and she departed at 735pm.
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| 55 | 2021-04-12 | feeling abnormal |
Brain fog and drowsiness 5 minutes after receiving vaccine, slight headache, fatigued later. Within ...
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Brain fog and drowsiness 5 minutes after receiving vaccine, slight headache, fatigued later. Within the week, neck out of alignment (went to chiropractor), felt neck/head pulsing, felt like a muscle contraction, vascular issues, hard to breathe, hypoxia. For the first two weeks, legs felt like they had blocks on them, had to get a massage from massage therapist. Lacks energy
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| 55 | 2021-04-12 | sleep disorder, loss of personal independence in daily activities |
After receiving my 2nd Pfizer COVID vaccine, I have been experiencing severe neck pain and tingling ...
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After receiving my 2nd Pfizer COVID vaccine, I have been experiencing severe neck pain and tingling in my arm, shoulder, and neck on the side where I was given the vaccine. I have been taking Aleve muscle and back pain twice a day every day since March 29, 2021, and that really is not helping. The pain seems to be lessening, but it is beyond difficult to sleep, and being able to concentrate through the pain while working is difficult as well.
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| 55 | 2021-04-13 | anxiety |
1-WEEK AFTER RECEIVING THE VACCINE I DEVELOPED SPOTS AND LIGHT FLASHES IN MY RIGHT EYE. I WENT TO T...
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1-WEEK AFTER RECEIVING THE VACCINE I DEVELOPED SPOTS AND LIGHT FLASHES IN MY RIGHT EYE. I WENT TO THE HOSPITAL AND HAD A ULTRASOUND OF THE EYE TO CHECK FOR HEMORAGE BEHIND EYE. IT WAS CLEAR. FOLLOWED UP WITH EYE SPECIALIST THE NEXT DAY AND WAS DIAGNOISED WITH Posterior Vitreous Detachment. I HAVE NOW SEVERAL LARGE FLOATERS IN THE EYE.
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| 55 | 2021-04-13 | feeling abnormal, sleep disorder, nervousness |
Severe headache woke me up in the night after vaccine -resolved after putting ice pack on neck and h...
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Severe headache woke me up in the night after vaccine -resolved after putting ice pack on neck and head, night 2 woke again in the night with severe headache repeated ice pack felt better but I felt like something was wrong so made apt with my PCP that morning. BP was very high, was shaky and had low grade pain in back neck/ spine. BP slowly came down. Day 3 had 2 episodes of chest pain in am had an ekg later that day and it came out ok. No events detected. Going into week after vaccine (days 5-8) ongoing pain mid back/ spine and developed a cold sore ( had not had one in over a year) 4/12 woke with Head and neck pain but not as severe as first couple days. Still don?t feel ?quite right? but functioning ok.
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| 55 | 2021-04-13 | impaired work ability |
Red, swollen, extremely sore at the injection site after both shots One day following both vaccinati...
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Red, swollen, extremely sore at the injection site after both shots One day following both vaccinations, I experienced exhaustion, body aches, and slight fever. As a result of these side effects, I missed a total of 3 days of work.
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| 55 | 2021-04-13 | loss of personal independence in daily activities |
Extreme fatigue, low energy, unable to complete physical tasks as I was able too prior to receiving ...
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Extreme fatigue, low energy, unable to complete physical tasks as I was able too prior to receiving the COVID19 shot.
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| 55 | 2021-04-14 | confusional state, memory impairment, anxiety, panic reaction, panic attack, nervousness |
I need to talk about my pfizer experience. I'm 56. January 15 I received my first dose. I had zero s...
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I need to talk about my pfizer experience. I'm 56. January 15 I received my first dose. I had zero side effects. The night after that initial dose. I began having what I'd term as cognitive issues. Trouble focusing. Blurred vision. Confusion. My synapsis weren't synapping. My brain and mouth didn't work. I felt like inside my body was shaking. But visibly, outside, was nothing. At that time, I was managing diabetes and I figured it was related to victoza being stopped since I'm not a diabetic now. And it continued about 7 days. Then, dwindled for a few, but it returned. I then began getting panicked about it and having panic attacks. I'm afraid of dementia, and remembering was an issue. It continued 4 days off 4 days on. Oddly enough. The 3rd week, it went away about 3 days in. I had about 7 days of bliss, but on the 4th day I got vaccination number 2. At this point, troubleshooting, I quit all my medications. I thought the issue was meditation related. I got shot number two and 3 days later, it hit and stayed again. 4 days on. 4 days off. By this time, I figured it is not my medications. So I went to my Dr. We did an MRI. Carotid workup. We did every test known to man, inluding heavy metals and found no anomalies except I was dehydrated. So I increased water and raised kidney functions. Weeks went by like this. Off and on. Dr finally told me I had toxic metabolic encephalopathy and I could have died. All testing rules out everything except vaccination reactions. He said my body didn't recognize the vaccine and that my brain attacked the toxins and swellee and caused the TME because of that. I want others to know. TMEs can be deadly. Your brain can swell, and you can die. Fortunately I'm on the upswing. But I still worry about memory. I forget appointments. I still am for the vaccinations. But we never know how our own bodies will react. My physicians diagnosis is a TME caused by Pfizer vaccine. He has ruled everything else out. I advocate this vaccinaction. Do it. I think what I went through is rare. But interestingly enough, online, it states 23 percent of covid victims get TME. I didn't have Covid. I've tested negative. This is also not dementia or anything of that nature. I've been thoroughly examined.
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| 55 | 2021-04-14 | feeling abnormal |
On April 12, 2021 experienced extreme dizziness at about 1 pm while standing. Immediately sat down a...
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On April 12, 2021 experienced extreme dizziness at about 1 pm while standing. Immediately sat down and put my head lower than my heart. Extreme dizziness lasted about half hour and continued to be dizzy for another hour or so. Slept about 1.5 hours and felt ok upon wakening. Light Dizziness/fogginess April 13, 14, & 15 mid-day. Lasts off and on for a few hours.
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| 55 | 2021-04-14 | impaired work ability |
Had a reaction 25 minutes after receiving the vaccine. swelling tongue, hands and feet. Dizzy, nause...
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Had a reaction 25 minutes after receiving the vaccine. swelling tongue, hands and feet. Dizzy, nausea, felt like I was going to throw up. Cold sweat. Lasted for about 25 minutes. Felt okay the next two days, then starting Friday 4/9 the dizzy and nausea came back. Tightness in chest and so dizzy having trouble working a full day at work. Some times it would go away and I would feel fine, then it would come back. I haven't had one day where I have felt good the whole day since.
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| 55 | 2021-04-14 | sensation of foreign body |
Started with dizziness, then nausea, tingling sensation, lump in throat. Then racing heart and heart...
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Started with dizziness, then nausea, tingling sensation, lump in throat. Then racing heart and heart palpitations. Blood pressure dangerously high. Then extreme tiredness and passed out. Then ambulance was called
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| 55 | 2021-04-14 | sleep disorder |
When I woke up the day after receiving the vaccine my armpit on the left (side I received the vaccin...
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When I woke up the day after receiving the vaccine my armpit on the left (side I received the vaccine) and the underside of my arm heading towards my elbow (but not all the way to the elbow) was in excruciating pain. The pain kept me up til 5am the following day and this continued for 5 nights. I treated it with frozen vegetable packs under my arm. Very very painful. I have had surgical procedures and take ZERO painkillers......have a high threshold for pain, and I'm telling you this was bad....very uncomfortable.
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| 55 | 2021-04-15 | disorientation |
fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial ...
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fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial tingling/bilateral hand and foot tingling; double vision; disorientation; joint pain; orthostatic hypotension; chills; photophobic/photophobia; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left deltoid on 26Jan2021 15:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The first dose was received on 05Jan2021 15:00 (lot number: EL1284) on the left arm. Medical history included herpes simplex virus (HSV), Superior Oblique Myokymia, and Lyme Disease; from an unspecified date and unknown if ongoing. Patient was not pregnant. Concomitant medications included calcium citrate, magnesium citrate (CAL/MAG CITRATE), ergocalciferol (VIT D), fish oil (OMEGA 3), and paracetamol (TYLENOL). The patient previously took VICODIN and flu vaccine as a child, and experienced allergies. The patient experienced headache, nausea, dizziness, facial tingling, double vision, disorientation, joint pain, orthostatic hypotension, chills, photophobic from 27Jan2021 05:00. On 02Feb2021, she experienced dizziness, headache, nausea, photophobia, facial tingling, bilateral hand and foot tingling, GFR 47 all other CBC, cmp normal. There was headache, nausea, photophobia, facial tingling on 07Feb2021 and on 10Feb2021, tingling and fatigue from waist to feet posteriorly and bilaterally. She had lab test drawn and blood work done when she was sick and her GFR came back as 47, so everything else was normal, and her GFR was 47 which was out of range. On 03Feb2021 was the first test and it was 2 weeks that she had to repeat test just to make sure it was back in normal range which it was. Thee patient was still experiencing the events but 'not as bad', and stated she can still function. Her side effects were improving but she still have a daily headache and paresthesia. The events resulted in physician/ healthcare professional visit. Patient was recovering from the events. ZOFRAN was given as treatment for the events. Patient stated she takes Tylenol but her doctor want her not to take medication for a while but she had to take Tylenol. Patient had no covid prior to vaccination and has been tested (nasal swab) post vaccination on 29Jan2021 with negative results.
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| 55 | 2021-04-16 | anxiety |
4/17/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation...
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4/17/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: difficulty breathing and dizziness, chest pain. Assessment : Time of assessment 150pm Alert and oriented, Anxious and hypertensive.Patient reports that she did not take her hypertensive medication today. Actions taken: Vitals sign taken EMS called at 215pm. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 215pm. At 150pm BP - 139/103, P- 96, O2- 99%, recheck at 202pm- BP- 144/88, P- 94, O2- 97%, water given x1 Medications administered: ASA 81 mg x 4 tabs given by EMS at 225pm Disposition:Patient evaluated and transferred to the hospital for further evaluation and care. Time of transport: 0218pm. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/17/2021 1:30 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: EW0164 NDC: 59267-1000-2
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| 55 | 2021-04-16 | insomnia |
Vaccine at 1115a. Hydrated after the vaccine a lot. Was fine most of the day and evening, except f...
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Vaccine at 1115a. Hydrated after the vaccine a lot. Was fine most of the day and evening, except for increasing soreness of arm at injection site. Woke up at 2a with headache, then sleepless most of the night. Sore arm. Headache and general feeling of nausea thru mid afternoon, 2p. Sensitive skin, occasional slight chills. Headache turned very severe mid afternoon. Fever of 101. Took 2 Excedrin around 530p, used ice pack on head and neck. Felt slightly better around 7p and was able to eat some food. Noticed swelling under my arms that evening, particularly left arm. Headache mostly gone by 930p. Slept 9 1/2 hours. Seem recovered, except for sore arm and continued lymph node swelling.
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| 55 | 2021-04-17 | disorientation, feeling abnormal |
visual hallucinations; psychosis; derealization/ depersonalization; fuzzy brain, brain fog, brain fe...
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visual hallucinations; psychosis; derealization/ depersonalization; fuzzy brain, brain fog, brain feels as though it is stuffed with cotton; severe dizziness; disorientation; This is a spontaneous report from a contactable other health professional (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 25Mar2021 at 10:45 (at the age of 55 years) at a single dose in the right arm for COVID-19 immunization. Medical history included depression and post-traumatic stress disorder (PTSD). Concomitant medications included paliperidone palmitate (INVEGA SUSTENNA); vortioxetine hydrobromide (TRINTELLIX); cariprazine hydrochloride (VRAYLAR); levothyroxine sodium (SYNTHROID); clonazepam (KLONOPIN); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); methylphenidate hydrochloride (RITALIN). The patient previously took NSAID, MAOI'S and synthetic progesterone and experienced allergy; and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, on 04Mar2021 at 01:45 pm in the right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 25Mar2021 at 18:30, the patient experienced visual hallucinations, psychosis, derealization/ depersonalization, fuzzy brain, brain fog, brain feels as though it is stuffed with cotton, severe dizziness, and disorientation. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.; Sender's Comments: based on the information available, the contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), to reported events is possible.
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| 55 | 2021-04-17 | feeling abnormal |
Adverse event was lower heart rate at around 61 at rest. Normal at rest rate is approximately 75. No...
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Adverse event was lower heart rate at around 61 at rest. Normal at rest rate is approximately 75. Normal rate while walking is around 110. Previously had 200 rate lasting 60 minutes in November. Adverse event was 4/1/21 and 4/2/21. Slight swooning feeling, uncomfortable feeling, difficulty finding pulse.
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| 55 | 2021-04-19 | impaired work ability |
Lot # unknown. On 4/7/21 very tired for 24 hours. But on 4/11/21 experienced extreme fatigue with so...
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Lot # unknown. On 4/7/21 very tired for 24 hours. But on 4/11/21 experienced extreme fatigue with sore body by late evening temp had risen to 100.5. Temp continued ranging from 99.9 to 101, also experienced body aches, headache, eyes burned, decreased appetite, sweating and chills all continued to 4/15/21. 4/15/21 temp normal but fatigue remained and cough started. Hard cough both dry and productive at times. An ache in the middle of my chest. Had doc appointment on 4/16/21. Temp normal but doc stated my labs were at the levels of someone who had covid but I was covid neg. The doctor suggested my illness was related to the vaccine. I missed a week of work and although I have returned to work I am still experiencing a lingering hard cough.
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| 55 | 2021-04-19 | insomnia |
Approximately 10-12 hours after vaccine body aches & headache began, 12-24hrs added chills, sweating...
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Approximately 10-12 hours after vaccine body aches & headache began, 12-24hrs added chills, sweating, sleeplessness, 24-36 very bad headache w/sensitivity to noise & light, added low fever, muscle aches, dizziness, light headed when sitting up, getting up to walk. 36-48 hours continued body aches lessened, headache lessened, nausea & dizzy w/lightheadedness. 60-72 hours diarrhea for 12 hours & stiff sore muscles, but headache lowered in pain, as with body aches, chills & sweating.
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| 55 | 2021-04-20 | feeling abnormal |
Nausea, exhaustion, dizziness, headache, tinnitus the day after the vaccine. Rested all day. Day 2 a...
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Nausea, exhaustion, dizziness, headache, tinnitus the day after the vaccine. Rested all day. Day 2 after the shot, feeling better but intermittent dizziness and tinnitus have continued. 2 weeks after shot, full day of being very dizzy, brain fog, and tinnitus. Tinnitus not overbearing but bothersome as I have never had this before.
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| 55 | 2021-04-20 | loss of personal independence in daily activities, disorientation |
1st injection - 25 minutes afterwards I experienced a slightly heavy sensation - like a drop in pre...
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1st injection - 25 minutes afterwards I experienced a slightly heavy sensation - like a drop in pressure in the head, chest, and stomach. 5 minutes later, I experienced multiple tiny sharp pains in left calve and foot and same in right side of head, They were mildly painful, pins and needles and it was scary with regard to wondering if it was a stroke. Then 15 minutes later, I experienced random skin itching in different spots. The neurological attacks continued and came on randomly in short attacks in mostly the extremities, but sometimes the face. The facial skin seemed also to have swollen and aged very rapidly after 1st shot, Also, blurred vision. 2nd injection, 4 weeks later, no immediate response but 11 hours later neuro and vascular symptoms began to come on. in left foot and right arm. pins and needles and neuropathic itch in left foot. 8 hours following, full on fever and weakness and severe flu symptoms, Weak and disoriented and sweats and chills with fever in mornings of 102 or greater. Heavy chest and head congestion, dizziness, rigidity, inability to function - quite sick for days.
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| 55 | 2021-04-20 | nightmare |
Extreme symptoms for a full week after 1st Pfizer vaccine. Extremely painful muscle aches everywhere...
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Extreme symptoms for a full week after 1st Pfizer vaccine. Extremely painful muscle aches everywhere but worse in my legs. Constant nausea, could not taste or smell food, watery diarrhea, profound weakness, extreme fatigue, nightmares.
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| 55 | 2021-04-21 | feeling abnormal | Extreme nausea Unbearable migraine Foggy brain |
| 55 | 2021-04-22 | anxiety |
reports symptoms of feeling warm, anxious, heart pounding, felt a "whoosh" come over her. Patient...
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reports symptoms of feeling warm, anxious, heart pounding, felt a "whoosh" come over her. Patient states she has anxiety. At 0800 this morning she had labs drawn, and at 0930 she took her prescribed Synthroid. She stated she has PTSD since her husband passed away from anaphylactic shock. Treatment/intervention : Vitals taken, patient placed in trendelenburg: 15:40 180/80 HR38 R16 98% RA 1540: 180/80 HR30 R20 98% 1550: 112/70 HR 97 R20 98% 1555: 148/90 HR 90 R20 97% 1600: 170/90 HR 90 R18 97% 1605: 160/98 HR 118 R20 97% Patient stated she felt better, vitals had improved, then patient stated she did not feel well, elevated HR, feeling "shivery." 1605 EMS contacted.
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| 55 | 2021-04-22 | loss of personal independence in daily activities, insomnia, disorientation |
2 days after vaccine around 3pm i felt heart palpitations. went for a walk to see if it would subsid...
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2 days after vaccine around 3pm i felt heart palpitations. went for a walk to see if it would subside. as i was walking my left leg buckled a bit, within a few seconds of that happening my entire body went limp. the person i was walking with grabbed me, i could not stand. i looked up and i could not see, it did not go black, all i can see were wavy lines. that lasted about 10 min until i came to . since that day i feel the nausea coming up and my head pushing down, as if it is in a vice. i feel tired and disoriented (loopy) It has been difficult to funtion. It is now almost 1 week since 2nd dose and I still have the same symtoms.
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| 55 | 2021-04-22 | sleep disorder |
I have had the WORST body aches ever. My Joints hurt, even my nuckles in my hand. The pain was so ba...
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I have had the WORST body aches ever. My Joints hurt, even my nuckles in my hand. The pain was so bad I could not rest well. I had a hard time moving around and am still having problems. Lost my appitie for a couple of days and then feel rough.
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| 55 | 2021-04-24 | anxiety |
5 minutes after having vaccine I felt lightheaded. Paramedics checked vitals 30 minutes after vaccin...
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5 minutes after having vaccine I felt lightheaded. Paramedics checked vitals 30 minutes after vaccine and felt it was anxiety. This is day 5 after having vaccine and every day I feel lightheadedness and feel as if I am going to faint. I have called my primary doctor to report this daily and went to Urgent care once. Vitals at urgent care was fine. Not sure why I keep being lightheaded 5 days after first Pfizer dose. This happens once per twice each day and lingers for about 10 minutes.
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| 55 | 2021-04-24 | anxiety |
Diarrhea, rapid heart rate, tremors, anxiety, sweating, intolerance to warm weather. diagnosis of hy...
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Diarrhea, rapid heart rate, tremors, anxiety, sweating, intolerance to warm weather. diagnosis of hyperthyroidism.
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| 55 | 2021-04-24 | impaired work ability |
Woke up Monday (3/29) with clogged ears that would not pop. I felt like I was in a a tunnel, couldn?...
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Woke up Monday (3/29) with clogged ears that would not pop. I felt like I was in a a tunnel, couldn?t hear myself talk and couldn?t really hear others. I was also dizzy, my head was spinning. It was usually tolerable but it got progressively worse to the point where I had to call off work a few days later. When I would look down I would get dizzier.
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| 55 | 2021-04-24 | insomnia, restlessness |
It is not comfortable. It goes under arm all the way under her boob and down her side. It is not com...
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It is not comfortable. It goes under arm all the way under her boob and down her side. It is not comfortable and cannot rest; It is not comfortable and cannot rest; Pain and Soreness in left shoulder; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Right arm swollen/arm was swelling/right arm is swollen underneath and on top; her arm was swelling and really hurting; has not been able to sleep in about 2 days because of this; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0150) intramuscularly in left arm on 01Apr2021 10:00 at single dose for COVID-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: diabetes diagnosed 3-4 years ago, blood pressure abnormal, and hiatal hernia. She has to take Prilosec for a hiatal hernia but has been taking it for years. Concomitant medications included omeprazole magnesium (PRILOSEC) for hiatal hernia, and blood pressure medication and diabetes medication. She previously received the first dose of BNT162B2 on 04Mar2021 (Lot EN6202) in right arm in the muscle for COVID-19 immunisation. She took the second one on Thursday and it was not bothering her until Friday night until Saturday morning. On 03Apr2021 05:00, it woke her up and it felt like it went in the muscle under her arm. It was real sore like lymph nodes are sore and she cannot lift her arm. She got the second shot on Thursday morning and that is what caused it. Sometime toward daybreak on Saturday morning is when she first felt that her arm was swelling and really hurting on 03Apr2021 05:00. Her right arm is swollen underneath and on top. On 04Apr2021 08:00, pain in left shoulder is like when old people say they have pleurisy in the back. She has not been able to sleep in about 2 days (Apr2021) because of this. No ER or physician's office required. She felt like going but did not took Ibuprofen. She thought it was going to be great because she did not have any symptoms, but this has whooped her. It is not comfortable. It goes under arm all the way under her boob and down her side. It is not comfortable and cannot rest. She read over the paperwork and saw that there were Lymph nodes and she wanted to know if there was anything she can do for it. She is just taking blood pressure medication and diabetes medication and has been on them for several years. Event outcome of not comfortable and cannot rest, insomnia was unknown, while for others was not recovered.
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| 55 | 2021-04-25 | feeling abnormal | dizzyness, bilateral ear redness, spinal pain, foggy, |
| 55 | 2021-04-25 | insomnia |
Patient received first dose of COVID-19 vaccine (Pfizer) on 4/16/21 on left arm. On day 2 after vacc...
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Patient received first dose of COVID-19 vaccine (Pfizer) on 4/16/21 on left arm. On day 2 after vaccination, +fatigue, headaches (though she had some headaches on and off even before the vaccination), some raspiness when talking (but no pain in the throat with swallowing). On day 3, patient had subjective fever (did not check temperature that day). Fatigue has still continued on until today. She is still having headaches on and off. Raspiness in throat is still present. Patient has had some difficulty falling asleep on about 5-6 nights since the vaccination. She has had this issue in the past as well on and off. Patient has also been taking more naps during the day due to the fatigue.
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| 55 | 2021-04-28 | sleep disorder |
weakness in her left arm; pain is increasing; Total hysterectomy; pain is up to her shoulder and dow...
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weakness in her left arm; pain is increasing; Total hysterectomy; pain is up to her shoulder and down to her elbow; waking her up at night; soreness in her left arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No. EL3246; Expiration Date: unknown) via an unspecified route of administration in left arm on 30-DEC-2020 09:15 at single dose (age at vaccination: 55-year-old) for COVID-19 immunization and patient had second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No. EL9251; Expiration Date: unknown) via an unspecified route of administration in left arm on 20Jan2021 1:30 PM at single dose for COVID-19 immunization. The patient medical history included high blood pressure (From: Unspecified To: Ongoing). The patient concomitant medications included losartan: (Start: Unspecified Stop: Ongoing), taken for 7 years, amlodipine: (Start: Unspecified Stop: Ongoing) taken for 7 years. It was reported that, she has had both vaccines. First vaccine on 30Dec2020 and the second vaccine on 20Jan2021 and she is having pain. She wasn't having pain, just soreness in her left arm. But that soreness has gotten worse now. She also reports that when she got her first Covid 19 vaccine, the person who gave the injection went straight into her arm with the needle and when she got the second vaccine the person who gave the injection went more towards the back of her arm with the needle. The first injection where the needle went straight on has bothered her since 30Dec2020. She also has weakness in that left arm and it's waking her up at night. She is an administrator and was in the first phase of people who received the Covid 19 vaccine. she did tell the attendant giving her the second Covid 19 vaccine that she was still having soreness in her left arm. That person told her soreness in her arm was normal. She reports she had a total hysterectomy on 18Feb2021 and had preop labs done at that time. Her primary care doctor has not ordered any labs related to her issue with her left arm. On an unknown date in Apr2021, the pain is increasing, and the arm is getting weak. The attendant giving her second vaccine did ask her if she wanted the injection in the right arm, her other arm and she said no. She is right hand dominant, and she needed one working arm. On an unknown date 2021, that soreness, that pain is up to her shoulder and down to her elbow. She reports her doctor did reflex testing and asked the caller to squeeze the doctor's hands and push down on her hands like a strength test to see if there was equal strength. The doctor told her she had less strength in her left arm than her right arm. She had gone to the doctor for a blood pressure check and while she was there, she mentioned to her doctor the problem with her arm. She had gone to the doctor for a blood pressure check and while she was there, she mentioned to her doctor the problem with her arm. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event hysterectomy was unknown, for rest of the events it is not recovered. No follow-up attempts possible. No further information expected.
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| 55 | 2021-05-05 | confusional state |
Passed out on the road while on a walk with friends . Unable to standup w balance and weakness. Wen...
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Passed out on the road while on a walk with friends . Unable to standup w balance and weakness. Went to ER and was a TIA code. Full work up MRI, TC scan, chest X-ray, blood work, heart monitor COVID test. All were negative. Symptoms seem to have worsen (tired, weak, no appetite, diarrhea, confusion while talking). My fall was on my left side never hit my head and my hands have no cuts, that would show I braced my fall.
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| 55 | 2021-05-07 | anxiety |
Amlodipine and Lisinopril also taken dailyWithin 30 seconds, it got tachycardia and high blood press...
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Amlodipine and Lisinopril also taken dailyWithin 30 seconds, it got tachycardia and high blood pressure. Pulse was 160, Blood pressure around 182/111. Ambulance came and took me to a local hospital; I felt I like I was going to faint; I felt light headed; I feel anxiety; My breathing was like shallow; I had to take deep breath to prevent myself; Amlodipine and Lisinopril also taken dailyWithin 30 seconds, it got tachycardia and high blood pressure. Pulse was 160, Blood pressure around 182/111. Ambulance came and took me to a local hospital; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0161), single dose, dose 2 via an unspecified route of administration, administered in the right arm on 24Apr2021 at 15:00 (at the age of 55 years-old) for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing, type 2 diabetes mellitus from an unknown date and unknown if ongoing Type II diabetes, drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Ciprofloxacin , food allergy from an unknown date and unknown if ongoing known allergies: tomatoes , rubber sensitivity from an unknown date and unknown if ongoing known allergies: latex. The patient was not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8730), dose 1 in the right arm on 31Mar2021 at 3:00 PM. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin 2,000 mg daily taken for an unspecified indication, start and stop date were not reported; dulaglutide (TRULICITY) .75 mg /0.5 ml taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported and doxycycline taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient experienced amlodipine and lisinopril also taken daily within 30 seconds, I got tachycardia, my heart started beating quite fast, faster my pulse and it was 160 beat per minute and high blood pressure, pulse was 160, blood pressure around 182/111. The ambulance came and took me to a local hospital (tachycardia) (hospitalization) on 24Apr2021 at 15:00. I felt I like I was going to faint; I felt light headed on an unspecified date, I feel anxiety on an unspecified date, my breathing was like shallow; I had to take deep breath to prevent myself on an unspecified date. An emergency room visit was required for tachycardia, high blood pressure, faint and light headed, breathing shallow and anxiety. The patient underwent lab tests and procedures which included blood pressure measurement: 182/111 mmhg on 24Apr2021, heart rate: 160 on 24Apr2021. The patient had blood work done a few weeks ago, albumin, thyroid stimulating hormone (TSH), Vitamin-D, cholesterol and complete blood count (CBC) (Further not clarified). Therapeutic measures were taken as a result of amlodipine and lisinopril also taken daily within 30 seconds, it got tachycardia and high blood pressure, pulse was 160, blood pressure around 182/111, ambulance came and took me to a local hospital (tachycardia and hypertension), felt I like I was going to faint; I felt light headed (dizziness), I feel anxiety (anxiety), my breathing was like shallow and I had to take deep breath to prevent myself (hypopnoea) and included intravenous (IV) hydration and blood pressure medication. The clinical outcome of tachycardia and high blood pressure was recovering and unknown for faint and light headed, breathing shallowand anxiety. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on Lot/Batch number is available; further information has been requested.
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| 55 | 2021-05-07 | feeling abnormal |
Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/...
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Shingles; bad back pain; felt like something was not right; checked my temperature and it was 102.1/fever broke; but I had body aches; My ear my neck my nose my mouth and underneath my chin the lymph node was swollen; Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side; my mouth was horrible much difficulty eating and pain was pretty intense; my mouth was horrible much difficulty eating and pain was pretty intense; This is a spontaneous report from a contactable consumer. This patient reported for 2 patients. A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 10:30 at the age of 55 years-old(Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included High Blood Pressure , Vertigo, Meniere"s Disease, Gallbladder removed, Cluster of Calcifications and Nodules removed in left breast (benign) , Plaque Psoriasis ( had it very bad on hands and feet) Methotrexate (7 tablets I take on Saturdays)Methotrexate ( 7 tablets i take on Saturdays), also lots of enviromental allergies I was tested few years ago, possibly Augmentin and Clindamycin The patient's concomitant medications were not reported. The patient reported that on 13Mar2021, I was awoken up with bad back pain and I felt like something was not right . I checked my temperature and it was 102.1 . The fever broke but I had body aches etc And the left side of my face wasn't feeling right . My ear my neck my nose my mouth and underneath my chin the lymph node was swollen. Then I had these lesions / sores starting to appear on my face, my nose , my lips and in my mouth all on the left side, my mouth was horrible much difficulty eating and pain was pretty intense. Immediately scheduled appointments with my medical doctor and my dermatologist. The dermatologist biopsy and came back as Shingles . He immediately put me anti viral drug and my medical doctor put me on amoxicillin, Acyclovir, Gabapentin. I was out of work for 4 weeks cause I work in a Supermarket ( Deli). The patient did not have COVID prior to vaccination nor tested positive after vaccination. The outcome of the events was recovered with sequelae. No follow-up attempts are needed. No further information is expected.
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| 55 | 2021-05-18 | feeling abnormal |
Loss of taste and mild numbness on right side of the tongue. Noticed it the morning after my first ...
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Loss of taste and mild numbness on right side of the tongue. Noticed it the morning after my first dose of vaccine. After I brushed my teeth, I proceeded to brush my tongue and could not feel the right side. weird sensation like when the anesthesia is starting to wear off after a dental procedure. Later that morning, I couldn't taste a cinnamon gum i put in my mouth, except on the left side. Anything I eat, I cannot taste it on my right side. Only on the left side. Neither the taste or feeling has returned to this date (5/18/21 - almost two months)
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| 55 | 2021-05-18 | loss of personal independence in daily activities |
Absent minded; Doing things that are not my normal routine. Reading messages incorrectly, taking wr...
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Absent minded; Doing things that are not my normal routine. Reading messages incorrectly, taking wrong turns when I know the streets so well. I am a school bus driver, I know my route and made a few odd mistakes today. I am not distracted, I am not forgetful, I am just doing things that make no sense.
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| 55 | 2021-05-19 | disorientation, disturbance in attention |
racing heart; dizziness; disorientation; blurred vision; forearm muscle pain/lower leg muscle pain; ...
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racing heart; dizziness; disorientation; blurred vision; forearm muscle pain/lower leg muscle pain; fatigue; loss of strength and coordination in fingers and arms/ residual arm & leg weakness; loss of coordination.; right lower lip became numb; difficulty with concentration; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the right arm on 26Apr2021 at 02:30 AM as single dose for COVID-19 immunisation. Medical history included lumbar disc degeneration, spinal surgeries x2, stem cell injection (lumbar disc) a little over a year ago, allergies to shellfish. Concomitant medications reported as none. No other vaccine in four weeks. None other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 26Apr2021 at 14:30 PM, (reported as after approx 15 min), racing heart, dizziness, disorientation, blurred vision (inability to focus), forearm muscle pain, fatigue affecting ability to perform my job, loss of strength and coordination in fingers and arms, right lower lip became numb, lower leg muscle pain and loss of coordination. Symptoms that continued to persist after 10 days were right lower lip numbness, difficulty with concentration and fatigue that was affecting my ability to perform my job, and some residual arm & leg weakness and coordination. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Unknown if treatment received for events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-05-24 | loss of personal independence in daily activities |
About 2 hours after receiving the vaccine, patient reports having experienced swelling and pain of t...
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About 2 hours after receiving the vaccine, patient reports having experienced swelling and pain of the right wrist, left arm, and left hand, making use of her arms difficult. She also experienced a headache. The following morning 5/25, she woke up with these symptoms still occurring, only "worse" and states it is hard to/painful to hold the phone. Patient does not plan to seek medical attention at this point, she plans to wait and see if the swelling/pain/headache get better over the course of the day.
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| 55 | 2021-05-25 | feeling abnormal |
Received vaccine and the following day she had severe left arm pain (vaccine site) lasting 1 week, E...
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Received vaccine and the following day she had severe left arm pain (vaccine site) lasting 1 week, Extreme exhaustion lasting 1 week, and brain fogginess lasting 2 days.
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| 55 | 2021-05-25 | feeling abnormal |
My mother described feeling "off" from the moment after the second vaccination of COVID19 (Pfizer-Bi...
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My mother described feeling "off" from the moment after the second vaccination of COVID19 (Pfizer-BioNTech). She Continued to feel strange weeks after the vaccine. My mother passed away at age 55 completely healthy and had a check-up with her primary care physician prior to any vaccinations. My mother did not die of natural causes at the time of her age and health.
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| 55 | 2021-05-25 | feeling abnormal |
Dose 1 - 12/19/20 - Exactly 12 hrs later, I started vomiting every 15 to 20 min, for 5 1/2 hours. Ar...
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Dose 1 - 12/19/20 - Exactly 12 hrs later, I started vomiting every 15 to 20 min, for 5 1/2 hours. Around 9 am, I had a fever of 102.4, a bad headache and body aches--flu like symptoms. I called the Occupational Health Doctor at my job and was told that I needed to get rehydrated. I took some Zofran that I had on hand and was then able to drink some Gatorade. I stopped vomiting, but was nauseous for the next 5 days. I didn't feel like myself until around 8 days later. Dose 2 - 1/9/21 - I took Phenergan and Tylenol about 4 hours after I received my vaccine. On the following Monday, I had a fever of 100.4, so I took more Tylenol. I was fine after that. Nothing like my experience with the first dose.
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| 55 | 2021-05-26 | feeling abnormal |
her hormones were over the top; soreness in her back/ It hurt and at times felt numb; No period in m...
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her hormones were over the top; soreness in her back/ It hurt and at times felt numb; No period in months. 2 days after the vaccine she ovulated; Soreness in back; Arm hurt really bad; Sensation of not feeling right; Skin feels like it's burning; body felt like it's vibrating; Ache in injection site; Pre-menstruation symptoms of sore breasts; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration, administered in right arm on 13Mar2021 at 14:00 (at 55-year-old) at dose 1, single dose for COVID-19 immunisation. Medical history included ongoing peri-menopause, she had off and on been having peri-menopause for at least 3 years. Patient reported that it has been this past year since she hasn't had a period and she thought she was done; ongoing hypertension, she was controlling her hypertension with food, specifically no salt. Patient reported that it makes her feel better when avoids salt. Patient reported that she was diagnosed with hypertension probably 4 years ago in 2017; ongoing asthma, she felt like sometimes she had asthma but it's seasonal; ongoing congenital heart defect, diagnosed when she was a baby; when patient got a period, she got anemic. She's high-risk; COVID-19 vaccine was recommended to her. None family medical history relevant to the events. There were no concomitant medications. The patient previously received flu shot in 1991 (reported as 30 years ago) and experienced that her arm got swollen and red and that the doctor had her come back in to look at her and stated that it looked like she was having an allergy to the egg in the vaccine. No Prior vaccinations within 4 weeks. The patient had no period in months. 2 days after the vaccine on 15Mar2021 she ovulated. She also reported having pre-menstruation symptoms of sore breasts in Mar2021. She was concerned about getting a period, as it made her anemic. Patient reported that she has been experiencing peri-menopause for the last year and hasn't had a period in 10 months. Patient reported that the Covid-19 vaccine has triggered her period and that her hormones were over the top. Patient reported that she was scheduled to get her next dose of the Covid-19 vaccine on 02Apr2021 and because she was having all those hormone experiences, she was unsure how to navigate this next shot. Her doctor was aware of what she was experiencing and that she didn't know what her physician can do. Patient reported that she has not yet had a period, but that it's coming, definitely coming even though she hasn't gotten it yet. Patient reported that if she does have her period she needs to go in to see her physician. Patient reported that while she hasn't had her period yet she has all of the symptoms that her period brings. Patient reported that she hasn't had these symptoms in 10 months. Patient reported that her boobs hurt and that she can't even touch them because they hurt so bad. Patient reported that she has had some weird things and that she was going back and forth with her doctor. Patient reported that she hasn't been to the doctor in a year and a half. Patient reported that she was afraid to go to the doctor and that her doctor was trying to evaluate her symptoms over the phone. Patient reported that she was getting frustrated as she didn't want to get the Covid-19 virus going to the doctor's office. The patient experienced arm hurt really bad on 13Mar2021. Patient reported that immediately after receiving the first dose of the Covid-19 vaccine, her arm hurt really bad. The patient experienced soreness in back on 15Mar2021. Patient reported that the pain from her arm the next day went into her back. Patient reported that she was having back pain for probably a good week after. Patient reported that her back pain has calmed down. Patient reported that she then started having a sensation of not feeling right in Mar2021. Then she was having pre-menopausal things that started probably 3 days after vaccine on 13Mar2021. She still had a sensation in her arm, that every once in a while her arm will ache. Patient reported that she had the pain in her arm for 2 days and that the pain then went into her back in between her shoulder blades. The back pain felt like someone was punching her in the back and she felt most winded. The sensation in her arm was like a dull ache in that spot, the injection site, and that she wanted to rub or put heat on it. Patient reported the soreness in her back was like pressure in her back. It hurt and at times felt numb. It hurt to the point where it felt like it was knocking the wind out of her. It was like the pain from her arm moved to her back. The back pain was not as bad, that it's calmed down a little bit. Her boobs hurt so bad but she didn't know if that's correlated to the Covid-19 vaccine. The breast tenderness started about a week ago, maybe 20Mar2021. The breast pain was ongoing but that it comes and goes. There are times where the breast pain has gotten worse and times where it's gotten better. When she woke in the morning the breast pain was worse. Once she started moving around the breast pain kind of went away but later in evening got really bad. She felt like her body was fighting the hormones to have a period and that she would feel a hundred times better if she got her period. Apparently her physician doesn't want her to get a period. The patient experienced sensation of not feeling right in Mar2021. Patient reported that the sensation of not feeling right started like a week ago, that there was week in between getting the Covid-19 vaccine and when she started experiencing weird things. She has talked to some people that have reported they have not had any side effects following the Covid-19 vaccine. Patient explained that the vaccine has just triggered so much in her, she was just frightened because everybody said the second dose was the worse. Patient reported that her doctor kept saying to give the side effects some time, maybe they'll settle down, but they haven't. All of her symptoms kind of gradually came a few days to a week after receiving the Covid-19 vaccine. The patient experienced skin feels like it's burning in Mar2021. Patient reported that she never felt like she was going to jump out of her skin, but the skin burning was an annoying feeling, like a sunburn. The patient experienced body felt like it's vibrating in Mar2021. Patient reported that she developed this symptom a week to a few days after receiving the Covid-19 vaccine. It was not a constant thing but when she was sitting still she felt it. The patient experienced ache in injection site in Mar2021. Patient reported that her right side, which was the same side that she received the first dose of the Covid-19 vaccine, was the side she was having back pain and that she had more pain in her right breast. Her doctor recommended that she get the second dose in the other side, her left arm. She did not take any medications. Patient reported that she has not had any relevant tests done but that she didn't know if she should or not. She doesn't know if how she is feeling now will impact if she should get the second dose of the Covid-19 vaccine. If she didn't feel a thing, she would go ahead and get that second dose, but because she has so many things going on, she's wondering how it is going to effect her. She was not sure if she should push out the date for the appointment for her second dose of the Covid-19 vaccine. For her, if she pushes out the second dose of the Covid-19 vaccine for a week, it might help her recover from the first dose. She definitely wanted to complete the series of vaccines for Covid-19, but she didn't want to die from this shot either. Patient reported that her second dose of the Covid-19 vaccine was originally scheduled for the 01Apr2021 and that she rescheduled the appointment to hopefully get the second dose Saturday, 03Apr2021. The events did not require a visit to emergency room or physician office. The outcome of events pre-menstruation symptoms of sore breasts, sensation of not feeling right, skin feels like it's burning, ache in injection site, body felt like it's vibrating was not recovered; outcome of event arm hurt really bad was recovered on 15Mar2021; outcome of event soreness in back was recovering. The outcome of the other events was unknown.
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| 55 | 2021-05-27 | feeling abnormal |
Severe itching in arms, chest and head for two days. Within an hour felt like my brain and my body ...
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Severe itching in arms, chest and head for two days. Within an hour felt like my brain and my body were not in sync, that lasted for 4 days, extreme exhaustion, increased heart rate.
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| 55 | 2021-05-31 | disturbance in attention |
The day after receiving the 1st dose of Pfizer vaccine on 5/19, my heart beat increased to 95-103 b...
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The day after receiving the 1st dose of Pfizer vaccine on 5/19, my heart beat increased to 95-103 beats per minute for the entire 24 hours. I was very tired and could not focus. I also had muscle aches. Then, on 5/20, my heart beat decreased to 85 without any treatment and I felt much better.
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| 55 | 2021-06-01 | feeling abnormal |
day after: tired; felt a little "off" 2 days later: rash all over trunk and both arms. Swollen, sore...
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day after: tired; felt a little "off" 2 days later: rash all over trunk and both arms. Swollen, sore and itchy at site/general area of injection, little headache.
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| 55 | 2021-06-01 | panic attack, anxiety, irritability |
Elevated blood pressure; heart rate was 125; thyroid is low; very sick; panic attack; chest is tight...
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Elevated blood pressure; heart rate was 125; thyroid is low; very sick; panic attack; chest is tight; irritable and having mood swings; anxiety or panic attack; irritable and having mood swings; pounding head; nausea; horrible body aches; Cramps; Shaking; shivering; gets violently hot; sweating profusely; arm turned dark red, went numb and tingly; arm turned dark red, went numb and tingly; arm turned dark red, went numb and tingly; blood in the urine; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 (Batch/Lot Number: ER8736) as 2nd dose, single for covid-19 immunisation. Medical history includes post-menopausal. The patient has a family history of low thyroid (mother). Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA-D 12HR) taken for an unspecified indication and paracetamol (TYLENOL EXTRA STRENGTH) taken for pain, start and stop date were not reported. The patient previously received first dose of Bnt162b2 on 13Apr2021 (lot number: ER8729) in the left arm for Covid-19 immunization. After she got the second dose in May2021, she did get very sick for about 48 hours, with a pounding head, nausea, and horrible body aches, cramps and shaking. She clarifies these symptoms lasted for about 24-48 hours. She has been much, much, much worse now since the second dose. It looks like some things were thrown off in the blood tests and stuff that were done in the ER. It's even showing that her thyroid is low and they immediately put her on Synthroid thyroid medication which made her a little nervous. She is not sure that what is showing up is something that is systemic with her or if this is something effecting what is systemic with her or if she is having some reaction. She is a little terrified right now to have her heart rate and blood pressure be up so much all the time. The level it was on Friday (209/100) scared her to death. Last Friday, after she took a shower, she was feeling like she was going to die. She does not know how else to explain it. She does have a blood pressure cuff and she decided to take her blood pressure. Her blood pressure was 209/100 and her heart rate was 125. Her blood pressure has been hovering around the 160s and 170's for the top number. She explains she and her doctors cannot get her to calm down. She called her doctor and she was sent to the Emergency Room. Some of the heart palpitation stuff and other things is coming in waves, it's not like its constant. But the blood pressure being elevated is constant. Also, when she has these waves, she also has perfused sweating. The waves last for about 5 minutes and the perfuse sweating takes a long time to stop. Her body is wet and she is instantly drenched. She is post-menopausal for like 2 years, it's not like hot flashes or anything weird showing up at the same time. She feels like she is in the middle of some sort of panic or anxiety attack 24 hours a day. She is also experiencing a lot of shaking and shivering. All of sudden, she gets violently hot and starts sweating profusely until she is drenched. She wakes up drenched in the middle of the night with her heart beating and high blood pressure, it wakes her up violently in the middle of the night. These symptoms have been continuing the entire time and she thinks it is getting worse. Friday was the highest her blood pressure has ever been. When she tried to use blood pressure cuff, her arm turned dark red, went numb and tingly, and she had tons of pain. She thought her arm was going to explode. She has never had that happen. She thinks the blood pressure was so high that the cuff caused that to happen. This made her think her blood pressure was close to heart attack level. Her blood pressure was 209/100 and her heart rate was 125. Her arm had never done that before. She clarifies she only went to the emergency room and she was never admitted into the hospital. She tried to get them to admit her because this has been going on so long and it's not correcting itself but they did not want to admit her. Clarified she went to the ER on Friday 14May2021. Several things were showing up weird in her blood tests. One of the things that showed up was that her thyroid was slightly low. She clarifies the TSH level was elevated, which meant hypothyroidism (thyroid is low). She was immediately put on Synthroid even though she was telling the doctors she was not so sure if what was happening to her was systemic and that it may be something that is exacerbated by or caused by the vaccine. She had to call into an endocrinologist because wanted her to see the endocrinologist immediately. In the hospital, her heart rate was okay while she was there, this kind of goes in waves. A wave of her heart beat going really, really hard and really, really fast. She states "you can see it through my clothes". The sweating starts at the same time. However, on the regular, like at the time of report, she has been shaking and she can tell her blood pressure is elevated. She has taken her blood pressure twice this morning and it was in the 180s over 90s range and then in the 160/80's range. Constantly, she feels like her heart is racing around and her blood pressure is racing all day long. It feels like what an anxiety attack would feel like. It's like she just can't get her body to calm down. Her heart rate calms down a little bit, she is constantly hearing the pounding in her ears when her heart beats. She is just riled up all of the time and her chest is tight. It's not like a breathing issue, her body is just tight, it feels like when she is scared or alarmed. She also has become very irritable and having mood swings. She thinks that is more coming from her body feeling like her body is on high alert or overly sensitive. It feels like every little thing is gigantic. She has never felt that before. She is normally a fully high functioning person. Because her blood pressure is so high and this isn't stopping. She is literally debilitated and cannot function. The patient underwent lab tests and procedures on 14May2021 which included albumin globulin ratio: 1.1, lowest of recommended low, anion gap: 5, slightly low, blood glucose: 111, elevated, potassium: 3.4, slightly low, blood pressure measurement: 209/100, blood thyroid stimulating hormone: 3.820, slightly elevated (low thyroid), globulin: 3.9, slightly elevated, heart rate: 125, platelet count: 448, slightly elevated, protein total: 8.2 (right at recommended normal high level), blood UA positive 1+ and blood pressure measurement: 171/101; heart rate: 109 both on 17May2021. The patient added that her endocrinologist ran all of her tests last Sept2020 and her thyroid was not even an issue. Some traces of blood in the urine was found in blood UA. Nothing that should be causing that because there is no menstrual cycle or anything else they know is going on. The outcome of event chest tightness was not recovered; all other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 55 | 2021-06-03 | insomnia |
This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old female pat...
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This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0168, NDC number and Expiry Date are Unknown), via an unspecified route of administration, administered in Left arm deltoid on 21May2021 around 13 to 13:30 (at the age of 55-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included chronic sinus infections, caffeine addict. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0169, NDC number and Expiry Date are Unknown) administered in Left arm deltoid on 15Apr2021 at 11:00 or 12:00 for COVID-19 immunization and experienced, doesn't have the heart fluttering anymore, excessive sleep, feels younger after her vaccine, more frequent hot flashes than she would normally feel, hasn't had a period since her shots. On an unspecified date in 1999, at the age of 33 years, the patient received historical Vaccine, Pneumovax vaccine and she had high fever, she was really sick, she thinks the nurse put the bolus really close to the bone in her Deltoid, she had a black bruise. Caller states the reason she did have that vaccine at such a young age is because she was having chronic sinus infections and the ears, nose, and throat doctor suggested she had it and it helped quite a bit. The patient also received historical vaccine, Flu Vaccine (Onset Age: yearly) on an unspecified date and states she tends to get pretty sick from a flu vaccine, so she tends to avoid them. Caller states but she did get a flu vaccine this year and she didn't seem to have too much of a side effect. Patients medical History including any illness at time of vaccination was none. Vaccines administered on same date with the Pfizer vaccine considered as suspect were none. Family Medical History Relevant to adverse events was not provided. Concomitant medication included amoxicillin (AMOXICILLIN) taken for an unspecified indication, on an unspecified date for two weeks and she heard she can get infections in the lining of her heart or whatever, but she has sinus infections frequently and she's been on antibiotics many times, so she doesn't relate antibiotics to this getting better because she's been on antibiotics for many years. Caller states time time actually, she has a dog that's on Clindamycin, but she's on Amoxicillin, which is the typical thing they give her so it's very interesting. Caller states she will see if it lasts or will come back at some point. Caller states she is definitely correlating it with her shots. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Caller states she's not sure if her side effect is adverse. Caller states she always had, she thinks its related perhaps to menopause, she always had like a flutter of her heart that she would feel nearly everyday, every other day. Caller states she would get a little tightness and she doesn't know some kind of a syncope would happen. Caller states she never had her heart checked with the doctor. Caller states since she got her shot 15Apr2021 and her second shot was delayed, she doesn't have the fluttering anymore, isn't that interesting? Caller states her second shot was delayed because a week after the first dose, she caught a sinus infection and had to have antibiotics so she got her second shot this last Friday. Caller states she wanted to call she knows this kind of information is important. Caller states everybody wants to bash companies, like the whole thing with Accutane, she said they totally helped her. Caller states there are so many disclosures, they shouldn't have taken it if they were concerned. Caller states maybe Pfizer has discovered a solution to murmurs or whatever. Caller states she feels younger after her vaccine. It was reported that she doesn't have the heart fluttering anymore and states it was just this flutter she would get, she was very conscious of it every time it happened. Caller stated, it's been going on for a couple of years, she read something that it happens to women if their estrogen drops. Caller states her menopause came late and since she's had her shots, it hasn't happened for sure because she's just so conscious every time it happens. Caller stated, prior to the second shot is when the fluttering stooped, she would say in the first week or two after the first shot. Caller stated, she thought oh my gosh it was gone, so she felt like that before her second shot. Caller states she got her first Pfizer shot on 15Apr2021, she was supposed to get her second dose the first week of May but she was on antibiotics still so she waited a few days past her antibiotics and time and for it to be convenient so she got it last Friday so she could convalesce, her dog had a dental thing. Caller stated she's gotten hot and can't tell if its a hot flash or the vaccine. Caller states she has had more frequent hot flashes than she would normally feel and she had a headache on Sunday on 23May2021 and now its gone. Caller states but that could have also been a lack of caffeine because she is a caffeine addict. Caller states she didn't have her morning coffee until really late that day, so it could be caffeine withdrawal. Caller states she drank water and then she went out to the pet store and she got a coffee and then she felt okay within the hours. Caller confirms she has recovered completely from the headache. Caller states caffeine always helps a headache. Caller states she never gets headaches, it was really weird. Caller states her cure for a headache is caffeine. Caller states she went for 10 years without drinking coffee and she rarely gets headaches. Caller stated, she felt a little bit sick on Saturday on 22May2021. So she watched movies with her dog, but that was it. Caller stated, they are saying women are getting heavier periods, it could be a hormonal effect, she imagines it will eventually come back. Caller states she has a degree. Caller states she was working and is reading a lot of science, she read tons about this whole thing and she doesn't relate it directly to the shot, it's some effect on the hormone system, maybe its not all bad. Caller stated, she was going to tell Pfizer, the first shot, the only side effect was excessive sleep. Caller states she was sleeping 12 hours the first day, the first night. Caller she slept for 14 hours the next night, and the next night it was 12 hours, the next night was 14 hours, slept again a ridiculous amount of time, 12 or 15 hours. Caller states she got it on Friday, she's a planner, she slept so deeply and it was really great. caller confirms it began at 20:00 at night the night of her vaccine 15Apr2021. Caller states she went home and she was in bed at 20:30 and didn't get up the next day until 1130, she doesn't know if she fell asleep immediately, she thinks she slept 14 hours, it was great and she loved it. Caller stated that she didn't get that much sleep on an unspecified date in May2021 with the second vaccine, she was a little disappointed. Caller stated she doesn't really consider these adverse effects, just side effects. Caller states they don't seem too negative to her, she will see if her hormones will adjust and if her fluttering comes back. Caller stated that she hasn't had a period at all since her shot too on an unspecified date in May2021. Caller states she had gotten to where she was weaning. Caller states she had regular periods until the age of 55 and she had a bunch of candied hibiscus and its known to really suppress estrogen and she sort of put herself into menopause and so she was having less frequent periods, but since she's had her shot, she hasn't had any. Caller states she doesn't know how related that is or not. Caller states she doesn't know if its ever coming back, that will be alright though. Caller she doesn't know if the weaning of it is related to the shot or not. Caller stated thanks for getting the shot out there. Caller states there has to be some special honor for these development teams. Caller states presidents have those medals and awards they can give. Caller states the scientific teams at these science companies she thinks they basically saved the world. Caller states she doesn't know, it could wipe out the globe, it's a nasty little bugger. Caller states anyway she's writing and encouraging others to do the same. Caller states she's writing the white house and her federal representatives saying and especially these developmental scientists, one of them immigrated from an # but these are teams of people that pull this off and she thinks it would be absolutely appropriate to get to the other side of this. Caller states she thinks we have a year to go, she will not be taking her mask off. Caller states they really deserve a high honor. Caller stated that honestly she did not want to take the vaccine until 9 months had gone by to see other people's side effects but because she has a science background, she knows the more the virus spreads, the more it will mutate, so she felt it was a societal obligation. Caller states she has a friend whos an emergency room doctor and they had a talk and the doctor is basically like she's got to get it, everybody's got to get it, and the caller's like okay, she's going to get it. Caller states she just thinks that she is obligated to get it or this is gonna go on and on and she thinks this virus came out of the lab, it seems very engineered to her. Caller states it's the most dangerous virus the globe has really seen. Caller stated that she hasn't had any problems. Caller states her doctor is her age and she doesn't want to expose her or her staff unnecessarily. Caller states she hasn't tried to see her in the past year and a half unless she actually has to. Caller states she's avoiding the doctor, she loves her doctor, she doesn't want her to get sick. Caller states when she did go see her, she got a COVID test and quarantined for five days before, she doesn't want to expose her to anything, she wants to make sure she's safe, she doesn't plan to see her doctor unless it's really absolutely necessary. The time of onset (24-hour clock) of adverse Events was not provided. It was reported that adverse events did not require a visit to: Emergency Room, Physician Office. There were no Investigation assessments and relevant Tests were none. The outcome of the event, headache was recovered on 23May2021 and for other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 55 | 2021-06-05 | confusional state |
fever of 102.6 by 1 AM. Muscle ache, headache, fatigue, diarrhea and mental confusion continued for ...
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fever of 102.6 by 1 AM. Muscle ache, headache, fatigue, diarrhea and mental confusion continued for up to a month. Arm where injection was became red, swollen and hot to the touch. About 50% of my upper arm was red. The redness finally went away by 04/19/2021 but the other symptoms lingered until approximately 05/28/2021.
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| 55 | 2021-06-06 | feeling abnormal |
Approximately 12 hours after vaccine I got an excruciating headache that lasted for 8 hours. (I've ...
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Approximately 12 hours after vaccine I got an excruciating headache that lasted for 8 hours. (I've had Meningitis in the past and this was worse). Once the headache went away I developed Vertigo that lasted approximately 14 days along with a feeling of brain fog. Approximately 2 1/2 weeks after vaccine I developed another excruciating headache with pain that radiated down the back of my throat (not sore throat pain). The pain of the headache was also in the back of my throat. This lasted approximately 12 hours.
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| 55 | 2021-06-06 | memory impairment | CLOUDY MEMORY, HEADACHES, SLUGGISH |
| 55 | 2021-06-07 | disorientation |
This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant fe...
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This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6203, expiration date not provided), 2nd dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 at age of 55 years old as a single dose for COVID-19 immunisation; mepivacaine hcl (manufacture unknown), via an unspecified route, date, dose for an unspecified indication. Medical history included Shingles. Concomitant medication included enalapril maleate (VASOTEC) taken for blood pressure. The patient previously took morphine and experienced allergies, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9265, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 11Feb2021 as a single dose for COVID-19 immunisation. The patient experienced guillane-barre syndrome, tingling and numbness in the legs, arms and lower face, severe headache, imbalance, disorientation, muscle spasms, diarrhea, all on 16May2021. The action taken in response to the events for mepivacaine hcl was unknown. The outcome of the events was not recovered. No treatment received for the events. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Pfizer is a marketing authorization holder of [mepivacaine hcl] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [mepivacaine hcl] has submitted the same report to the regulatory authorities.
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| 55 | 2021-06-07 | loss of personal independence in daily activities, confusional state |
VAERS ID from previous report 1036950 Headache and confusion that started 20 hours after 1st dose of...
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VAERS ID from previous report 1036950 Headache and confusion that started 20 hours after 1st dose of the Pfizer vaccine. Hearing sensitivity by day 3. In ER for high blood pressure on day 8 with no explanation. Nursing Staff at my place of employment informed me I needed to be in the ER that day due to BP of 187/120. I had an MRI of my brain showing migraine-like activity. It is almost 4 months from the date I received the vaccine and I have had only 9 days with no migraine. I'm tired of all the headaches that are completely new since the vaccine. Thankfully my doctor instructed me not to get another dose. I'm tired of feeling like this and feel I have no one to turn to for help. The migraines are affecting my daily activities and my work.
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| 55 | 2021-06-07 | sensation of foreign body |
Big pimples on right side cheeks/Pimples on end of tongue; Lump in right side of throat; Chills; Wea...
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Big pimples on right side cheeks/Pimples on end of tongue; Lump in right side of throat; Chills; Weak; Dizziness; This is a spontaneous report received from a contactable consumer (Patient). A 55-year-old female patient received second dose of BNT162B2(PFIZER BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 18May2021 (at the age of 55 years) (Batch/Lot Number: EW0176) as second dose, single dose for covid-19 immunisation. Medical history included ongoing asthma Diagnosed about 2 years ago. The patient's concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Lot Number: EW0162) received on 23Apr2021 (at the age of 55 years). Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient denied any family medical History Relevant to adverse event. On an unspecified date in May2021, the patient experienced big pimples on right side cheeks/pimples on end of tongue, lump in right side of throat, chills, weak and dizziness. She stated that she had the Covid Pfizer Vaccine, second dose, on 18May2021. She then travelled on 24May2021. She was having side effects and wanted to report them. She was currently out of the country. Stated that the symptoms started after the second dose of the vaccine; but before she travelled out of the country. She developed big pimples on the right side of her cheeks. then a lump in the right side of her throat. She thought these were going away, so she went ahead and travelled. She stated now they've gotten bigger. She also had pimples on the end of her tongue. States she also experienced chills, being weak, and dizziness but that was okay now. Now everyday she noticed something new. She would like to know if she should continue this way if symptoms persist. Should she go back and receive treatment, or she should wait. She called her healthcare provider, but she isn't working on Fridays. She denied any medications, labs, testing, or treatments relevant to events. She was not visited to either emergency room or physician's office. Relevant teste was reported as none. The outcome of event Big pimples on right side cheeks/Pimples on end of tongue was unknown, Lump in right side of throat was worsened and not recovered and chills, weakness and dizziness were recovered on an unspecified date in May2021.
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| 55 | 2021-06-09 | impaired work ability, loss of personal independence in daily activities, feeling abnormal |
Had tolerable off and on body aches, fatigue and tachycardia for months before the vaccine. I coul...
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Had tolerable off and on body aches, fatigue and tachycardia for months before the vaccine. I could go a month or more without symptoms. vaccine 3/15 Fatigue, body aches and tachycardia got much worse and intolerable after vaccine 3/15 8 days later at physical doctor gave me thorough exam and I become much sicker which escalated (I couldn?t do anything including work) Got to the point I was in constant horrible pain Severe body aches and fatigue Increased HR especially when upright Very dizzy SOB Some Headaches Nauseas almost always when I am upright Terrible Brain fog Body ache Symptoms improved some with prednisone but have gotten worse again since being off prednisone Struggling to function / work Left / middle Chest pain Tingling lips, finger tips and toes Weak Shaky
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| 55 | 2021-06-09 | impaired work ability |
After the second dose, I started feeling like I had the flu for 24 hours, I missed a day of work. Th...
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After the second dose, I started feeling like I had the flu for 24 hours, I missed a day of work. Then I noticed my heart racing continuously. Starting in the beginning of May 2021, I started having chest pain. I went to my primary care Dr. office on May 12,2021 . She performed an EKG and suggested I see a Cardiologist. The next day I was in the Emergency room at Hospital. There I was Diagnosed with Pericarditis. I was referred to Dr. Cardiology. He performed a Echocardiogram at hospital. He confirmed and diagnosed me with Pericarditis. The time course was Started in May 2021 and I an still under treatment for this condition as of this day. I am feeling better but I have missed a some time from work and I have incurred Medical bills. I feel this may caused by the Vaccine , I tested negative for covid.
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| 55 | 2021-06-10 | feeling abnormal, nervousness |
The rash is coming and going on her chest, arm where she had the shot, and to her elbow and part of ...
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The rash is coming and going on her chest, arm where she had the shot, and to her elbow and part of her back.; it was making her nervous and was not a good feeling; it was making her nervous and was not a good feeling; This is a spontaneous report from a contactable consumer A 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Apr2021 01:00 as single dose for covid-19 immunisation. Medical history included allergies and allergy to plants (she was just allergic to everything - grass and flowers, so she took Zyrtec every night.Sometimes, she needed one in the morning and one at night because her allergies were very bad). The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies as 5 mg, 120 mg something like that. The patient previously took dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021, as single dose for covid-19 immunisation. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that since she had the second dose, she had been having a rash and it was bothering her. This started when she had the second rash, she was not sure the date. She was taking Benadryl and it was coming and going, it was making her nervous and was not a good feeling. The rash was coming and going on her chest, arm where she had the shot and to her elbow and part of her back. It was on her chest and the other side, just like one line from the elbow like a rectangle to the the other arm. The reporter stated that she carried her EpiPen with her in case that happened. She stated that what she was facing was uncomfortable. The reporter stated that they would have told her that she would have this side effect and then she could have made the decision to get the vaccine, she inquired if she had to go to the physician. Therapeutic measures were taken as a result of the event rash is coming and going on her chest, arm where she had the shot, and to her elbow and part of her back. The outcome of the event was unknown. Information on the lot/batch number has been requested.
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| 55 | 2021-06-10 | feeling abnormal |
On 02/25/2021 I experienced a fever, headache, arm and back pain, nausea, brain fog, COVID tongue, d...
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On 02/25/2021 I experienced a fever, headache, arm and back pain, nausea, brain fog, COVID tongue, dizziness. On 02/26/2021 I was very tired, high heart rate and shortness of breathe. On 02/27/2021 I was tired with a headache but better. On 02/28/2021 Less tired and headache was better. On 03/01/2021 I was less tired and back to 80%. On 03/10/2021 I went to the doctor because it was difficult to walk due to high heart rate and shortness of breathe with chest pain.
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| 55 | 2021-06-10 | feeling abnormal |
Within 30-40 min of vaccination on the way home (around 7 pm) , friend developed sudden headache; fe...
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Within 30-40 min of vaccination on the way home (around 7 pm) , friend developed sudden headache; felt tingling around the nose and face; felt dizzy; had dry mouth; She was trembling; had rash around the collar for about 45 min to 1 hour; swollen right arm (injection site but no redness, vaccination arm); floating sensation; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old non-pregnant female patient received bnt162b2 (Lot Number: EN6202), via an unspecified route of administration on 12Mar2021 at 18:15 (at the age of 55 years old) as single dose for covid-19 immunization. Medical history included breast cancer left, cholecystectomy for stones, deep vein thrombosis (DVT) during pregnancy, oophorectomy. The patient's known allergies included chocolate-since 1997 received epinephrine and additional food allergy: banana, orange, almonds, fresh tomato, avocado and strawberries (burning of moth and tingling around the nose). The patient's concomitant medications were not reported. It was unknown that patient had other vaccine in four weeks. Within 30-40 min of vaccination on the way home (around 7 pm), friend developed sudden headache, felt tingling around the nose and face, felt dizzy and had dry mouth. Her husband was driving the car. They drove to (Name withheld) Emergency Room/Urgent Care in (Name withheld) where she was admitted for care and observation. Additional details: She was trembling and was brought in on the wheelchair, had rash around the collar for about 45 min to 1 hour. She was dizzy, felt like "floating". Eventually improved overtime. She stated that her vitals were stable, oxygenation was 98%. Per her report, she did not receive epinephrine. Diphenhydramine hydrochloride (BENADRYL) was suggested but she did not want to take it as she had "bad headache" post diphenhydramine hydrochloride. She remained in ER for about 5 hours and eventually was discharged home. She was improving on the 13Mar2021, but continued to have headache and dizziness/floating sensation throughout the day. Also reported swollen right arm (injection site but no redness, vaccination arm). All events occurred on 12Mar2021 at 06:15 PM. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. Treatment for events included paracetamol (TYLENOL). The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-06-10 | loss of personal independence in daily activities |
Within 24 hours after the second does of the Pfizer COVID-19 vaccination, I had increasing pain in m...
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Within 24 hours after the second does of the Pfizer COVID-19 vaccination, I had increasing pain in my right low back and right hip. Within two days after the vaccination, I could not undress, sit down on the toilet without assistance, lift my leg to tie my shoe, put on socks, etc.
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| 56 | 2020-12-31 | anxiety |
Dizziness immediately after injection, anxiety, questionable tongue thickening. Then canker sores o...
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Dizziness immediately after injection, anxiety, questionable tongue thickening. Then canker sores on tongue, lips swollen later in day and next day. No breathing issues.
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| 56 | 2021-01-03 | insomnia |
Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appe...
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Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appetite I had a hard time sleeping. I just took Tylenol.
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| 56 | 2021-01-04 | feeling abnormal |
Patient stated after vaccination felt lightheaded and numbness on left side. She sat down and had he...
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Patient stated after vaccination felt lightheaded and numbness on left side. She sat down and had her blood pressure taken. It was 171/105. Stated that she had not taken her morning blood pressure medications (lisinopril 10mg and atenolol 50mg). The nurse at the facility gave her a dose of lisinopril 10mg. Patient then stated prickly, numb feeling and foggy-headed. The facility then gave her 2 doses of diphenhydramine 25mg. At approximately 11am, patient was still not improving and felt like she was getting worse. The facility then called for an ambulance to take her to the ER for assessment.
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| 56 | 2021-01-04 | loss of personal independence in daily activities, insomnia |
Deep muscle soreness developed within 2 hours. Soreness restricted movement prevented normal activi...
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Deep muscle soreness developed within 2 hours. Soreness restricted movement prevented normal activities and work for 12 hours. Temperature 99 at 12 hours following injection. Insomnia 12/15. Fatigue x 2 days. No redness or swelling at injection site.
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| 56 | 2021-01-05 | impaired work ability, excessive sleepiness |
Headache, Myalgia, Tachycardia, Significant chills also reported. Required employee to be away from ...
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Headache, Myalgia, Tachycardia, Significant chills also reported. Required employee to be away from work, reported greater than 16 hours of sleep second to the overwhelming fatigue
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| 56 | 2021-01-05 | loss of personal independence in daily activities |
Patient reports vertigo and it comes and goes since vaccine. She says the room is spinning and was u...
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Patient reports vertigo and it comes and goes since vaccine. She says the room is spinning and was unable to drive and not able to care for patients.
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| 56 | 2021-01-06 | impaired work ability |
2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; ...
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2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; 3-4 hours later took 3 ibuprofen due to the headache. Feeling light headedness. Next morning, sore arm was heavy, headache, body aches, temp 99, and nausea; felt unwell; took 3 ibuprofen. Time off from work to just lay flat and rest for the day.
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| 56 | 2021-01-06 | sensation of foreign body | Globus sensation in throat, was better the next day and gone on the day after |
| 56 | 2021-01-07 | nervousness |
Patient reported feeling shaky and presented with increased HR and BP five minutes after injection. ...
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Patient reported feeling shaky and presented with increased HR and BP five minutes after injection. O2 100% RA. Patient provided with snacks and water. Status monitored during observation of 30 mins. All symptoms resolved at discharge from vaccine clinic.
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| 56 | 2021-01-08 | impaired work ability | Severe vertigo, vomiting for 12 hours. Vertigo for 5 days. Out of work for 5 days. |
| 56 | 2021-01-10 | nightmare |
Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports...
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Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports on 01/11/2021 to this RN that she had a couple nightmares after the first injection. Pt reports that she had two nightmares after the first dose. Since her second dose was received on January 8, 2021 she reports having disturbing night mares and requested reporting of the events. Pt declined evaluation at the clinic after notification of the event. Pt voiced she will follow-up with her PCP if the nightmares continue. Other side effects she reported with the second dose is nausea, tiredness, fatigue, headache, chills and some weakness. Those symptoms have since improved.
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| 56 | 2021-01-10 | nightmare |
Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the P...
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Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the Pfizer vaccine (COVID-10) that she had had disturbing nightmares. Pt reports that she had two night-mares after the 1st dose, but said the second dose she started having nightmares this morning. Pt declined evaluation at the clinic after reporting of the events. Other S/S she had experienced are headache, nausea, chills, weakness, feeling tired but symptoms have improved.
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| 56 | 2021-01-11 | feeling abnormal |
full day of full body aches; chills; headache; miserable; This is a spontaneous report from a contac...
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full day of full body aches; chills; headache; miserable; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration at left arm on 04Jan2021 14:45 at single dose for COVID-19 immunization at a workplace clinic. The patient's medical history was reported as none, no known allergies to medications, food, or other products and no other medical history. Concomitant medication in two weeks included progesterone, testosterone, colecalciferol (D3), calcium, "C", "E", and "Ty". No other vaccine within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. On 04Jan2021 the patient received the injection. And on 05Jan2021, the patient experienced full day of full body aches, chills, headache, and miserable. No fever. The events started on 05Jan2021 05:00. On 06Jan2020, the patient felt great. No treatment was received for the events. The outcome of the events was recovered on 06Jan2021.
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| 56 | 2021-01-11 | impaired work ability |
Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tirednes...
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Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tiredness. Approximately 2.5hrs later developed generalized muscle aches, tired, chills. Next morning muscle aches were less, new headache and dizziness. took Tylenol which helped, about 5 hrs later symptoms worsened, improved with sleep and Tylenol. Awoke this morning with some chest pain similar to initial response, some headache and dizziness, improved with Tylenol, now returning (noon). occasionally feels like I need to take a deep breath. I believe its mostly muscular pain gets a little worse with deep breathing. Sent home from work day of vaccine, worked partial days next 2 days
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| 56 | 2021-01-11 | sleep disorder |
Patient was given first dose of Pfizer COVID vaccine and had no immediate pain on injection. She sta...
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Patient was given first dose of Pfizer COVID vaccine and had no immediate pain on injection. She stated she developed increased pain in her right shoulder joint and was unable to sleep the night of the injection on 12/22/20. She stated the pain continued to increase and was unable to sleep on that shoulder. She was seen by her primary care provider on 1/8/21 for continued pain and decreased range of motion in her R shoulder, she is unable to raise it above shoulder height. She continues to have pain and decreased range of motion despite rest and ibuprofen.
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| 56 | 2021-01-12 | impaired work ability |
20 minutes of fever, chills, headache, fatigue, back ache. Repeated at 8:00 PM. Called out of work S...
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20 minutes of fever, chills, headache, fatigue, back ache. Repeated at 8:00 PM. Called out of work Saturday 1/9/2021
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| 56 | 2021-01-12 | impaired work ability |
1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain towar...
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1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain toward the kidney, stomach area. Felt like she would pass out. Dizzy, nausea. Seeing a patient she had to leave the room and go sit on the floor. Blood pressure was very low, couldn't stand up. Painful to have clothes touching the skin all over. Felt like she need more air, panting. Didn't sleep 8-10 hours. Started with sever H/A and muscle pain. Sensitive to light and sound. Fatigue. Out of work 1/12-1/13. Skin sensitivity is gone. Talk big dose of ibuprofen. Still fatigue. H/A is better.
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| 56 | 2021-01-12 | insomnia, disorientation |
Mild arm soreness started within 6 hrs of administration of vaccine. Within 12-16 hours of adminis...
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Mild arm soreness started within 6 hrs of administration of vaccine. Within 12-16 hours of administration patient developed intermittent chills, fever 101.4 to 102.2 F , moderate to severe tension headache, mild muscle ache/joint pain, insomnia, severe fatigue, and mild nauseau. Fever lasted for approximately 48 hours. Other signs and symptoms resolved by 72 hours following vaccination. Patient also noticed mild fatigue as well as slight disorientation and slight loss of balance until 1/11/21. Patient was normal by 1/12/21. No specific treatments administered.
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| 56 | 2021-01-13 | anxiety |
The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling ...
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The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling like her heart was racing and short of breath. She was diaphoretic, had a notable tremor and reported anxiety as well. Patient was transported to the Emergency Department where the patient was monitored. Ultimately, patient felt better, with a normal EKG. Patients states this reaction felt similar to anxiety attacks she has had in the past. ED Physician felt this was likely an anxiety attack. Patient remained stable throughout ED course and was discharged from the ED in stable condition.
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| 56 | 2021-01-13 | anxiety |
56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine....
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56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine. She reports feeling weakness and dizziness. She states she fellt sensation to her neck immediately after she got the vaccine. Pt appears very anxious. Provided cold pack behind her neck and vital signs taken 152/90 with HR 98 O2 SAT 98%. Pt then taken to the gurney to lay down. Pt continued to feel weak with short of breath, tingling finger tips. 100% NR mask provided, Dr notified and arrived immediately. vital signs taken every 5-10 min with b/p trending down within 20 minutes. Pt states felt better around 1150. Attempted to sit up but states felt weak again. Pt felt anxious and wanted to speak to her husband, Medic, called husband and was able to speak to him. Pt continues to feel weak. Continue to monitor and comfort provided. Discussed with medical team that patient need to be sent to the ER for further observation. 911 called at 1215 and arrived within few minutes, report given to EMS. Patient transferred to ER at 1230 via gurney. 1117: 152/90,HR 103, O2 sat 98% 1121: 144/72, HR 89, O2 SAT 99%-applied O2 100% non rebreather mask 1126: 153/88, HR 80 1142: 160/92, HR 85, O2 SAT 100% 1147: 147/85, HR 77, O2 SAT 100% 1152: 136/85, HR 70, 02 SAT 100% 1202: 133/81, HR 68, 02 SAT 99%
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| 56 | 2021-01-13 | confusional state |
approximately 20 hours after vaccine woke with generalized myalgia. Throughout the day began to fee...
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approximately 20 hours after vaccine woke with generalized myalgia. Throughout the day began to feel weaker and getting confused. C/O legs weighing 500 pounds and leg weakness with difficulty walking. Intermittent chills.
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| 56 | 2021-01-13 | feeling abnormal |
Vaccine administered at 10:41. Monitored in vaccine clinic before returning to work area in PACU. ...
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Vaccine administered at 10:41. Monitored in vaccine clinic before returning to work area in PACU. Upon return to PACU at 10:57, felt foggy and didn't feel right. Employee sat down. Left upper lip started to tingle, patient experienced palpitations and difficulty breathing, requiring surgical mask to be removed. Code EMA (code for non-patient called). Employee taken to emergency department for evaluation.
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| 56 | 2021-01-14 | feeling abnormal, confusional state | Mental confusion,shakes, foggy brain , things did not make sense to me, driving confusion |
| 56 | 2021-01-14 | insomnia |
Chills; Insomnia; soreness at injection site; This is a spontaneous report from a contactable health...
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Chills; Insomnia; soreness at injection site; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 09Jan2021 12:15 in left arm at single dose for COVID-19 immunization. Medical history included chronic sinusitis from an unknown date and unknown if ongoing. There were no concomitant medications. On 09Jan2021 12:45, the patient experienced chills, insomnia and soreness at injection site. No treatment was given to the patient for the events. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 56 | 2021-01-17 | feeling abnormal |
A few days after the vaccine I began to have a cough about mid morning which changed to SOB. Covid ...
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A few days after the vaccine I began to have a cough about mid morning which changed to SOB. Covid test on 12/27 which was neg. I went to work on 12/28 but woke up 12/29 with a low grade fever and felt like my throat was on fire. so on the 29th I went and got a Strep and flu test which were negative. I was feeling so bad so on the 6th of Jan do I went to the stand alone ER and got a chest xray and CT scan which revealed I did have pnemonia. I went back home but was feeling worse and was taken to and admitted in hospital for 2 days. Initially I was admitted into the COVID unit but never was diagnosed COVID positive so I was moved off the COVID unit. I was given albuterol pills to try to help with the symptoms but didnt work causing me to have to be admitted and was given several doses of steorid and other antibioics and had to use O2 at night because my stats kept falling.
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| 56 | 2021-01-18 | disturbance in attention |
1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes ma...
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1st vaccine: spontaneous tachycardia (HR 110 initially) and elevated BP (160/100) at 10 minutes mark which subsequently resolved spontaneously at 30 mins (closely monitored by MD, NP) 2nd vaccine: spontaneous tachycardia, and elevated BP (160/100) at 10 minutes mark (monitored by MD and NP), normalized after 1 hour of observation. On 1/8/2020 I developed severe fatigue, fever, numbness on lower lip, bitter taste in my mouth, fever, chills, headache until Sunday 1/10/2021. Went to work on 1/11/2021 with worsening symptoms. Ended up in ER on 1/12/2021 due to weakness, high BP, numbness on lower lip, difficulty focusing. BP is normalizing as of 1/19/2021 but still have weakness, equilibrium is off and difficulty in focusing
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| 56 | 2021-01-18 | insomnia |
10 minutes after the time of the injection I developed metal taste in mouth this lasted about 1 hour...
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10 minutes after the time of the injection I developed metal taste in mouth this lasted about 1 hour went away and came back later in the day. 13 hours after the vaccine injection I developed extreme rigors lasting atleast 60 minutes followed by very hot body temperature to touch unable to sleep body not comfortable cold then hot and very bad headache. Next day rested all day terrible headache, body aches and chills on and off. The next night did sleep for 5 hours then woke up soaked hair night garments had to change still had headache and just felt achy and tired all day mild headache arm was sore warm at inj site and very itchy. Third day headache was gone just felt extreme fatigue and today tired but feel more like myself.
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| 56 | 2021-01-18 | insomnia |
woke several times during the night with fever and chills in morning fever was 101.4 and strong head...
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woke several times during the night with fever and chills in morning fever was 101.4 and strong headache, hips and back ache, fatigue
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| 56 | 2021-01-19 | feeling drunk |
At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling naus...
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At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling nauseated almost threw up, also felt drunk (balance, lack of clear thinking, a little weak, etc). That lasted from about 8 hours after the shot (when it started) to 20 hours after the shot was administered.
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| 56 | 2021-01-19 | impaired work ability |
I received my 1st vaccine dose 12.22.20 The next morning, I awoke with EXTREME fatigue. By the time ...
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I received my 1st vaccine dose 12.22.20 The next morning, I awoke with EXTREME fatigue. By the time I arrived to work, my temperature was greater than 101 degrees Fahrenheit and I was told to go home. By the time I arrived home (40 minutes later), extreme chills and body aches. I have never experienced anything like it. The fever, chills, and body aches persisted throughout the day despite Tylenol. Fever broke around 2AM on 12.24.20, slept and felt perfectly fine later that morning.
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| 56 | 2021-01-19 | sensation of foreign body |
Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", ...
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Globus feeling - feeling like "something caught in her throat", tingling lips, tongue felt "weird", tingling in legs. Patient was monitored for approximate one hour total in the clinic. Patient vital signs were stable at the beginning and continued to be stable. No other signs or symptoms of an allergic reaction.
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| 56 | 2021-01-21 | impaired work ability |
Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ea...
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Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ear ache, nausea for one day, headache, and shortness of breath with coughing and stairs. She had a telemedicine appointment with her MD office and they recommended her not to work and to use her inhaler and some cough medicine.
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| 56 | 2021-01-24 | anxiety, emotional distress, feeling abnormal |
significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness;...
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significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness; muscle weakness/lower leg feel shaky and weak and tingly; depersonalization; shakey/lower leg feel shaky and weak and tingly; mild nausea; arm pain; The caller would touch her hand but couldn't feel her hands, it was like they weren't hers; lower leg feel shaky and weak and tingly; hand on that same side was painful, but not unbearable, just uncomfortable; emotional; tearful; felt completely overwhelmed; This is a spontaneous report from a contactable consumer. A 56-Year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 12Jan2021 about 9:15am at single dose for COVID-19 immunization. Vaccination facility type was hospital. Medical history and concomitant drugs were not reported. Weight: 175-180 lbs. No additional vaccines administered on same date of the Pfizer suspect vaccine. No prior vaccinations within 4 weeks. Past drug included rivaroxaban (XARELTO) been using the product more than 10 years and never had a problem with it, she didn't think that was related to her experience. Patient received first vaccine yesterday 12Jan2021. 45 minutes after receiving vaccine (12Jan2021 10 AM), she developed hot flashes in sternum (flushing sensation in her sternum or upper chest area. It was like when she had a dye injected), anxiety, dizziness/ light headedness, muscle weakness, significant dissociation, depersonalization, shakey, mild nausea, arm pain. The patient explained that this was why she was in the MRI scanner (Jan2021). This came a couple of times yesterday and had not been experienced this today (13Jan2021). It (dizziness) was ongoing and sporadic and had happened couple times yesterday and today. There were a few hours yesterday 12Jan2021 where she felt like herself but then it all started again last night. The patient reported feeling disassociated from her body, this was within about 20 minutes of the flushing and went in and out of being more or less alarming. She stated she felt disconnecting from where she was and space she was in, mentally. She knew where she was but could feel no connection to where she was or her body. The patient would touch her hand but couldn't feel her hands, it was like they weren't hers. This was during the half hour of the events occurring. She had mild nausea, this started not long after the flushing and it came and went a little bit but it was not too troublesome. The patient felt disconnect from her body and had shakiness like her lower leg feel shaky and weak and tingly. This happened on and off since the episodes started. The patient reported she slept great and had a few hours yesterday where she felt good. Her arm was tender, this might have been yesterday but she thought it was this morning and was only tender to touch. The hand on that same side was painful, but not unbearable, just uncomfortable. The patient apologized for being emotional and tearful. She felt completely overwhelmed. She couldn't believe that she put herself in this position and she was perfectly fine before the shot. She did contact her doctor. No AE required a visit to emergency room/ physician office. There had been no treatment, she didn't know what to do. She remarked she was not going back for the second dose. Outcome of event dizziness was not recovered, and the rest of events was unknown.
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| 56 | 2021-01-24 | feeling abnormal | Tachycardia pulse 130's, palpation, lymph node swelling, brain fog ( difficulties concentration) |
| 56 | 2021-01-25 | feeling abnormal |
FATIGUE ON DAY OF VACCINE. SYMPTOMS SET IN AROUND 9:30 PM ON 1/19 - CHILLS, SWELLING, MILD HEADACHE,...
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FATIGUE ON DAY OF VACCINE. SYMPTOMS SET IN AROUND 9:30 PM ON 1/19 - CHILLS, SWELLING, MILD HEADACHE, EXTREME FATIGUE; FOGGINESS AND FEVERISH. SYMPTOMS BECAME MILDER AOUND 8PM ON 1/20 - TEHN OVERHEATED BUT CLEARERE. GRADUALLY GETTING BACK TO NORMAL TODAY 1/21. VERY DEHYDRATED. TOOK ADVIL. DRANK LOTS OF FLUIDS
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| 56 | 2021-01-26 | loss of personal independence in daily activities |
High fever, malaise, sore throat, went from independent to help with assistance in feeding, red sor...
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High fever, malaise, sore throat, went from independent to help with assistance in feeding, red sore arm, ROM affected.
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| 56 | 2021-01-26 | sleep disorder |
headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision ...
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headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Jan2021 15:00 at a single dose in the left arm for COVID-19 immunization. The patient received the vaccine in a skilled nursing facility or long term care facility. The patient received no other vaccinations recently. Medical history included attention deficit disorder diagnosed at least 5 years ago for which the patient was taking Ritalin; hypothyroidism diagnosed a long time ago, probably 10 years and depression diagnosed a long time ago, probably at least 25 year, she takes a cocktail of anti-depressants for this (no further details provided about her anti-depressants). The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus before when her doctor put her on an antibiotic (unspecified). The patient was also very overweight. Concomitant medications included methylphenidate hydrochloride (RITALIN; lot: unknown, expiry: 28Jul2021) for attention deficit disorder and the patient takes a cocktail of anti-depressants (unspecified) for her depression. The patient received the first dose of the covid vaccine on 11Jan2021 at 3 PM and by 5PM she was experiencing bad headache, fever, L arm (injection site) pain that was severe. Later that evening she had blurred double vision and couldn't function. She also got a fever of about 100 degrees Fahrenheit, was dizzy and her eyes could not focus and were almost like double vision but not quite, it was hard to explain. She just remembered that she had a similar reaction with her eyes before, when her doctor put her on an antibiotic. She cannot recall what antibiotic that was. The patient also experienced dizziness on 11Jan2021. The patient treated her side effects with ibuprofen and most of these improved. The injection was given in her left arm, her non-dominate one. She says that the pain was so bad it woke her up, and she doesn't take any pain meds, but that was really bad. She says that she took some Ibuprofen (lot: P113671, exp: Jan2022), about a total of 800mg over a few hours. Her fever had started pretty fast, by 05:00PM on the 11th, and it was better after taking the Ibuprofen, as was her arm pain, and headache. She says that the dizziness went away probably around 02:00AM the following day (12Jan2021). She says her eyes can focus again as well. The patient thinks that these effects are medically significant, mostly that her eyes were not able to focus, it was very scary. The patient stated that the purpose of this call is to have this documented, and possibly find out if there are recommendations that she should not get the second dose, since she had to call out of work because she couldn't function. The outcome of the event "blurred double vision and couldn't function; eyes wouldn't focus, couldn't function" was recovered on an unspecified date and dizziness recovered on 12Jan2021 at 02:00. The outcome of the event "she had to call out of work because she couldn't function" was unknown while the other events were recovering. Information on the lot/batch number has been requested.; Sender's Comments: The 56-year-old female patient had medical history included attention deficit disorder; hypothyroidism and depression and she takes a cocktail of anti-depressants for this. The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus. Based on information reported, the reported double vision and difficulty focusing eyes were more likely due to pre-existing condition (s); and less likely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The rest events fever, headache, vaccination site pain and dizziness were likely causally related to the use of vaccine due to plausible temporal relationship and known safety profile of this product. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-01-27 | insomnia |
Sore arm after dose 1 (mild, ,resolved); Mild-Moderate side effects after dose 2 (headache, fatigue,...
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Sore arm after dose 1 (mild, ,resolved); Mild-Moderate side effects after dose 2 (headache, fatigue, muscle aches, dizziness, chills, sleeplessness) persisting past 48 hours and ongoing but fluctuating; At 72 hours: Injection site is red, with raised welt around 2 inches in diameter, with itching and warm to touch; ongoing.
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| 56 | 2021-01-27 | mental status changes |
On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point ...
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On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point vomit was dark in appearance. Patient receives home dialysis when nurse came to home on Monday, 1/18, saw condition of patient and sent them to the hospital. At the hospital it was noted she had redness throughout body, no hives or blisters. Patient was lethargic, received antiemetic and medication for rash, does not know what medications were. On Tuesday, 1/19, she received 2 liter transfusion, discharged on Thursday, 1/21. Today, Thursday 1/28 patient still feels lethargic and states rash is peeling.
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| 56 | 2021-01-27 | sleep disorder |
Severe low back and hip pain; Severe low back and hip pain; malaise; woke up soaking wet in the midd...
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Severe low back and hip pain; Severe low back and hip pain; malaise; woke up soaking wet in the middle of the night with chills; Extremely tired; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscularly on 07Jan2021 10:30 at a single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history included hypothyroidism, hypertension, known allergies: penicillin. The patient previously took first dose of bnt162b2 (lot number: EK5730) via intramuscular on 18Dec2020 13:30 at a single dose in left arm for COVID-19 immunization. There was no other vaccine administrated in four weeks. Concomitant medication included losartan, bupropion hydrochloride (WELLBUTRIN), levothyroxine, colecalciferol (VITAMIN D 3), estradiol (ESTROGEN), and progesterone. On 09Jan2021 15:45, the patient experienced severe low back and hip pain along with general malaise, woke up soaking wet in the middle of the night with chills, and extremely tired. No fever. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No treatment received for adverse event. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021.
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| 56 | 2021-01-29 | impaired work ability, feeling abnormal, sleep disorder |
18 hours after the second shot, I started feeling feverish with uncontrollable chills. My extremiti...
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18 hours after the second shot, I started feeling feverish with uncontrollable chills. My extremities were ice cold and for about an hour I couldn't feel my right thumb. I experienced waves of fever and chills for about 6 more hours with extreme body aches, headache, joint pain, and a foggy head. I was able to go to sleep that night but woke often. I was unable to work the next day due to extreme fatigue and slept most of the day. On the 13th, I was back to normal.
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| 56 | 2021-02-01 | anxiety |
short of breath; had a high heart rate afterwards; anxiety; This is a spontaneous report from a cont...
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short of breath; had a high heart rate afterwards; anxiety; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686; expiration date: Mar2021), via an unspecified route of administration left upper arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. Medical history included ongoing blood pressure high, ongoing hyperthyroidism reported as hyperthyroid, historically tachycardia from time to time resting, wears glasses, stressed and ongoing thyroid (thyroid disorder). Ongoing concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid and losartan for blood pressure high. She did not received other vaccination within 4 weeks. The patient stated that she first dose of the Covid vaccine and became short of breath and had a high heart rate afterwards after she got her vaccine. She mentioned that she had a high heart rate and shortness of breath on 31Dec2020 immediately after getting the vaccine. She received it at her workplace (in the hospital conference room) and was taken to the ER to be checked out. It was like soon as she sat down after getting the vaccine, she immediately started to have the high heart rate and shortness of breath. She wasn't sure if it was anxiety or a true adverse reaction. She further added that at first, she was thinking it was anxiety because she was stressed when first went there. However, she was reading the paperwork and it said high heart rate and shortness of breath could occur. After reading that she realized it may not be anxiety. When she was taken the Emergency Room and her heart rate then was 115-120 [units unspecified], she felt like it could have been higher before it was checked. She was kept in the Emergency Room for like 30 minutes or so for further observation. As a whole, the high heart rate and shortness of breath probably lasted no more than ten minutes. She confirmed she has recovered completely from the high heart rate and shortness of breath as she has not had any other episodes. She added, she gets tachycardia historically from time to time resting. However, she has never had shortness of breath and that is why she was concerned. She wants to know if she should get the second dose. The patient underwent lab tests and procedures which included EKG (electrocardiogram) and troponin were normal on 31Dec2020. The outcome of the events was recovered on 31Dec2020.
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| 56 | 2021-02-01 | feeling abnormal |
Employee noted adverse effects began 1/15/21, the day after vaccination. She experienced chills (00:...
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Employee noted adverse effects began 1/15/21, the day after vaccination. She experienced chills (00:00 - 04:30), frequent urination, diaphoresis (09:00-12:30), and "brain fog" (09:00-13:30). She also reported loss of appetite (00:00-16:00). All events occurred on 1/15/2021. She took acetaminophen 500 mg twice (10:00, 12:30). She reported resolution of symptoms around 15:00, 1/15/21.
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| 56 | 2021-02-01 | excessive sleepiness, impaired work ability |
sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; se...
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sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; severe abdominal pain; Nausea; Injection site pain; This is a spontaneous report from contactable other hcps (including patient herself). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid19, lot number EL3248) , via an unspecified route of administration 08Jan2021 17:30 at single dose on left deltoid for covid-19 immunisation. Medical history included covid-19 the first time in Oct2020 to an unknown date , then from 16Nov2020 to an unknown date and experienced "every symptom except for vomiting". The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 18Dec2020 for covid-19 immunisation and experienced neck hurting, Shingrix Vaccine on 04Dec2020 for immunization and experienced no adverse effect. The patient experienced severe abdominal pain, nausea, Injection site pain on 12Jan2021, headache, fatigue, feeling of total lack of energy on 13Jan2021, fever on 16Jan2021. She had severe abdominal pain and nausea for three days (as reported). The caller stated she took Zofran for her nausea. The caller stated she had a rapid COVID-19 Virus test that was negative, but continued to feel queasy. She stated she had 100.5-101.8 degree fevers over the weekend, and has been sleeping a lot. Reported she woke at 4:00AM on Tuesday, 12Jan2021, with severe abdominal pain. She said the abdominal pain is better but not completely gone. Abdominal Pain Treatment: Declined any. Reported she hasn't discussed with her doctor the adverse events she has been experiencing since receiving the second COVID-19 Vaccine dose. She stated she had injection site pain for 2-3 days after receiving the second COVID-19 Vaccine dose. She said she didn't have any injection site soreness with the first COVID-19 Vaccine dose. She said she thought she was good after receiving the second COVID-19 Vaccine dose, but then on Tuesday, 12Jan2021, she woke at 4:00AM with severe abdominal pain. She said the abdominal pain came in waves. She described the abdominal pain as an 8 out of 10, clarifying the abdominal pain would be sharp and then fade away, and then the abdominal pain would cycle back around. She said she found herself standing over her toilet a few times because the abdominal pain was so severe, she thought she was going to throw-up. She clarified she had nausea and took and old prescription of Zofran she had received for vertigo years ago. She stated she did not have the Zofran NDC, Lot, and Expiration Date. Reported her abdominal pain and nausea went away by Thursday, 14Jan2021, saying the abdominal pain and nausea was less and less each day. She clarified the abdominal pain and nausea were intermittent, saying all of a sudden she would not feel good. She said her nausea has been better for the past 2-3 days. She clarified she called off work on Tuesday, 12Jan2021, and on Wednesday, 13Jan2021, she had a Rapid COVID-19 Virus Test before she started work that day (13Jan2021) to make sure that she wasn't positive for the COVID-19 Virus. She said she had a headache, no energy, and felt fatigued at work on Wednesday (13Jan2021), and Thursday (14Jan2021), but didn't take her temperature during that time. She said she didn't work on Friday (15Jan2021), but continued to have the headache, fatigue, and feeling like she had no energy. She said she didn't check her temperature until Saturday, 16Jan2021. She said she woke up Saturday (16Jan2021) at 9:40AM and went back to sleep until 11:30AM. She said she woke back up at 1:42PM and her husband told her she felt hot to the touch. She said she checked her temperature and it was 101.8 degrees. She said she checked her temperature first thing this morning (18Jan2021) because she could tell she sweated overnight, and her temperature was 100.3. She said she just checked her temperature again, and her temperature was now 99.3 degrees. She said by this afternoon, her temperature will be in the 101 range. Headache & Fever Treatment: Reported she took Naproxen (clarified as a prescription Naproxen 500mg tablet), and Tylenol (clarified as Equate brand Acetaminophen 500mg tablet) for her headache and fever on Saturday (16Jan2021). She said she took the Naproxen and Acetaminophen 500mg once in the morning, and again at night, before bed. She stated she did not take any Naproxen or Acetaminophen on Sunday, 17Jan2021. Acetaminophen 500mg tablet (Equate Brand): UPC Number: Unknown, Lot Number: 0HV1335, Expiration Date: May2022 Naproxen 500mg tablet (Prescription dispensed in round, pharmacy bottle): No NDC, Lot, or Expiration Date Reported she had another COVID-19 Virus test performed on Sunday, 17Jan2021, at 11:40AM at a drive-thru test site at Pharmacy. She clarified it was a "send-out" PCR COVID-19 Virus test, and she had not received her test results yet. She said her belly doesn't hurt anymore. She said she doesn't have a gallbladder and appendix. She said if she had the flu, the flu lasts for 3-5 days, and she is not coughing. She said she feels like now, what she felt like when she had the COVID-19 Virus the first time in Oct2020. She said she had a 12 days of severe fatigue when she had COVID-19 in Oct2020. She said her COVID-19 Virus symptoms started on 14Oct2020 with nasal congestion, and by 16Oct2020 she couldn't taste her yogurt. She said she got tested later in the day on 16Oct2020 for the COVID-19 Virus. She clarified she definitely had no sense of smell or taste on Friday, 16Oct2020. She said on Thursday, 15Oct2020, she kept falling asleep in the evening, saying that never happens. She said on Friday, 16Oct2020, she had a fever of 100.3, as well. The outcome of the events severe abdominal pain, nausea was resolved on 14Jan2021, of Injection site pain was resolved on an unspecified date, of sleeping a lot and she sweated overnight was unknown, of other events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of abdominal pain, nausea and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-02-02 | impaired work ability |
Loss my sense of smell and taste; three days got sick with cold - still have stuffy nose; three days...
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Loss my sense of smell and taste; three days got sick with cold - still have stuffy nose; three days I felt dizzy and I wake up to go to the restroom and I feel like I will fall. I treat with fluids .And I have an antiobiotics from appt with doctor. I had a little cough but not a bad one. My head hurts a little but not that much. COVID test on the 13th or so of January. Results on 16th - positive. They told me not to go to work. On the 30th I went to work.
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| 56 | 2021-02-03 | anxiety |
56 year old female presents with complaint of tingling and numbness that she noticed to her lower le...
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56 year old female presents with complaint of tingling and numbness that she noticed to her lower left jaw. It occurred yesterday around 3 PM after she received her Covid vaccination. She states that then started to move up to her left cheek but has now gone back down just to the lower left jaw. It is in a specific region of that area. She states also that she is having a fever today and generalized body aches that are moderate in nature. She also notes some urinary frequency without dysuria or hematuria. Patient took Tylenol this morning around 6 AM. She initially tried to swallow the pill and felt like she was going to choke on it and spit the pill up. She then sat down for a few minutes and was then able to take the pill. She denies any actual stridor or wheezing. No focal weakness or numbness of one arm or leg. No change in speech. Differential diagnoses include but are not limited to: CVA, TIA, anxiety reaction, paresthesia, metabolic process, bleed, vaccine reaction. 56-year-old female with paresthesia to the left chin. Otherwise normal neurologic examination. The TPA window given symptoms started yesterday. I will get a head CT but I do not feel the patient needs an MRI. Given the fact the patient does have autoimmune disorder, blood cultures and lactic acid obtained. I suspect that her fever is in response to her Covid vaccine yesterday. Covid test negative. Urinalysis no evidence of UTI. Chest x-ray is clear. Head CT negative. On reevaluation after Motrin patient feels much improved. At this time I think she is stable for discharge to home. I do not think this is Bell's I am finding no facial weakness on my examination. Follow-up and return precautions discussed patient understood
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| 56 | 2021-02-03 | poor quality sleep |
wakes up at night because of the headache; headaches were intermittent; This is a spontaneous report...
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wakes up at night because of the headache; headaches were intermittent; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date: 30Apr2021), via an unspecified route of administration on 07Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included allergy to trees and grass; and asthma. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), and oxymetazoline hydrochloride (CLARITIN ALLERGIC). The patient experienced headaches on 07Jan2021. She sometimes wakes up at night because of the headache. The headaches were not as terrible as before and they were on and off. She took Tylenol for it. She was concerned about the 2nd dose side effects as it may be worse. She got the vaccine on a Thursday, and she laughingly states that she didn't feel human till Tuesday, it was a rough few days. The headaches were intermittent but the headache was to the point that they make her have to lay down. The intensity of the headache has gotten better, her pain was at 7 before but now max pain is a 5. The frequency varies, it could be 3-4 hours but then might only get it for 1 hour or so then go away. Her 2nd dose is scheduled for 29Jan2021. She has not had labs for like 6 months. She has had no positive test for COVID. She does work with COVID patients but has had no symptoms like cold or nothing. She has had no antibody test. She has had no issues with vaccine in the past. The patient is recovering from headaches. Outcome of the event "wakes up at night because of the headache" was unknown.
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| 56 | 2021-02-07 | feeling abnormal |
Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - w...
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Post vaccine day 1 (after 2nd dose) Was at work, began feeling very poorly in the late afternoon - went home & went to bed, slept through night and had sweats on and off. Post vaccine day 2- Fatigue, abdominal discomfort and pressure, constipated. Nausea and vomiting developed, with dehydration. Constipated, symptoms consistent with Crohn's flare. Went to ER but due to long wait was not seen by physician. Gradually improved, saw GI specialist day 4, felt much better by day 6. Bowels not quite back to normal 2 weeks later
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| 56 | 2021-02-09 | feeling drunk |
diarrhea; I still don't feel quite well; i felt almost like a mild fever; light headed; little nause...
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diarrhea; I still don't feel quite well; i felt almost like a mild fever; light headed; little nauseated; quite chilled; had nausea that worsened when lying down and felt like i was drunk (balance/coordination, clarity of thought); had nausea that worsened when lying down and felt like i was drunk (balance/coordination, clarity of thought); This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3246/expiration date: unknown), via unknown route of administration, on 19Jan2021 03:30 PM (at the age of 56 years old) as a single dose on left arm for COVID-19 immunisation for COVID-19 immunisation at a hospital. Relevant medical history included hypothyroid, hypertension, celiac, chronic dermatitis. The patient allergic to statins, gluten-intolerant (celiac). The patient was not pregnant at time of vaccination. Relevant concomitant medications included Levothyroxine, Irbesartin, Vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that on 19Jan2021 10:30 PM, about 7 hours after the shot and for the next 12 hours, she was quite chilled, had nausea that worsened when lying down and felt like she was drunk (balance/coordination, clarity of thought). After 12 hours of those symptoms, the drunk feeling and nausea were gone but she has since then struggled with diarrhea if she eats anything not completely bland, including today (4 days later). She stated "I still don't feel quite well and if I am very active (like she was packing boxes last night), I felt almost like a mild fever, light headed and a little nauseated." The outcome of the events chills, nausea, feeling drunk was recovered after 12 hrs later. The outcome of events diarrhea, don't feel quite well, fever, light headed and nauseated was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.
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| 56 | 2021-02-11 | excessive sleepiness, amnesia, confusional state, feeling abnormal, impaired work ability |
I received my vaccine at 6:55am on 12/30/2020. I waited about 20minutes in the observation area. I f...
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I received my vaccine at 6:55am on 12/30/2020. I waited about 20minutes in the observation area. I felt fine and went to work. It was a normal day of rooming patients, I had lunch of yogurt and blueberries about 2 pm I started feeling very hot and "off". I went to the front of the office and checked my temp which was normal. As I walked down the hall to the back of the office I started feeling very nauseous, dizzy and my legs felt like jello. I sat down in my chair and got more dizzy so I put my head in my hands. The other MAs were asking me if I was ok but I couldn't think of the words and then I couldn't get the words out for about 10 seconds. When I did arouse again I was told I was slow to answer questions after
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| 56 | 2021-02-14 | feeling abnormal |
1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels res...
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1/21/2021- First Dose- Following day mild muscle soreness at site, ongoing fatigue, never feels rested or wants/needs to sleep, a lot. Noticed abdominal pain, but did not connect the two. 2/11/2021- 2nd dose- Two hours later (approx) moderate pain at site, my head/mind felt "off", out of sync like one side of brain slower, affected balance. It was strange, and unpleasant. 2/12/2021- Groggy, face/eyes swollen, did not feel well, but not so bad I could not go to work. It was a 50 mile drive, and as I drove the same feeling of not thinking straight did not want to drive. The feeling of being unwell escalated quickly. Congestion, muscle aches throughout, sore throat, chills, and a need to catch my breath caused dizziness. I pulled over, called work, and made my way home where I went directly to bed. My head ached, abdominal (sharp) pains, especially after ingesting fluids. or food similar to gall bladder pain, but not close to its worse intensity still, continues. 2/15/2021- Update- Nearly 96 hrs. passed: What remains is: Feeling exhausted, need to sleep, more frequent and intensifying abdominal pains, headaches, pain in left lung/easily winded, and site pain expansion. Injection arm (left) pins & needles, and fingers ice cold, neck pain (stiffness).
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| 56 | 2021-02-14 | impaired work ability |
15 hours after receiving the vaccine I started having severe body aches all over and in my bones, mo...
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15 hours after receiving the vaccine I started having severe body aches all over and in my bones, moderate headache, fatigue, dizziness. Then 21 hours after receiving the vaccine I developed a temperature of 100.5. I treated the fever and pain with ibuprofen 600 mg orally every 6 hours. I was ill and not able to work or get out of bed for a total of 1 1/2 days.
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| 56 | 2021-02-14 | insomnia |
After first dose severe headache for two days with some dizziness. After second dose sleepless that...
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After first dose severe headache for two days with some dizziness. After second dose sleepless that night then around 4AM chills and hot flashes with sweating, got up to walk around and had shortness of breath, teeth chattering, slept most of Friday had aches, headache, nausea.. had to concentrate on not vomiting, heightened sense of smell, had 101.7. Saturday initially felt ok the terrible headache and nausea, achey and still 101.7 temp. Sunday initially felt good and then with the headache, nausea, shortness of breath, achey, 101.7 temp. Monday felt ok all day until around 5pm and then chest hurt and shortness of breath.
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| 56 | 2021-02-14 | loss of personal independence in daily activities |
I went from couch watching a movie to my husband helping me walk to the bedroom. My body was locked...
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I went from couch watching a movie to my husband helping me walk to the bedroom. My body was locked i could barely move. I went into a cold hypothermia chill, I could get warm. ( teeth chattering) My husband said I burning up hot on my body . I didn't think to take my temperature. I was so scared. I've never had the flu ,or anything like this before in my entire life. I called into work the next day , because my job is physical.
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| 56 | 2021-02-14 | loss of personal independence in daily activities |
She developed fatigue, malaise, body aches, fever the day after receiving vaccine, joint pains worse...
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She developed fatigue, malaise, body aches, fever the day after receiving vaccine, joint pains worsened limiting ability to walk; Treatment: rest, Tylenol, Aleve; Fever resolved; Has been unable to return to work due to persistent joint pain, body aches, and fatigue, no significant improvement, despite rest, analgesics
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| 56 | 2021-02-14 | nervousness |
24 hours Chills/body aches fever 102.5 Next 24 hours chills/body aches fever 101.5 Headache/ injecti...
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24 hours Chills/body aches fever 102.5 Next 24 hours chills/body aches fever 101.5 Headache/ injection site itchiness for 3 days lethargic and shaky Total recovery time 36 hours
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| 56 | 2021-02-14 | sensation of foreign body | Numbness lower face; swelling lower face and tongue; lump in throat (throat closing); extreme thirst |
| 56 | 2021-02-15 | anxiety |
patient reported to observers feelings of anxiety, jitteriness, shaky hands, and chest itchiness. As...
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patient reported to observers feelings of anxiety, jitteriness, shaky hands, and chest itchiness. Assessment performed respirations counted and were within normal limits, clear respiratory sounds. had patient sit near the door for cooler air, symptoms continued and Benadryl was given. Paramedics arrived and further assessment was completed and she refused to received further treatment in the ambulance and was allowed to go home. LVN and RN assessed further and patient stated symptoms no longer present 20 minutes after Benadryl was given.
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| 56 | 2021-02-15 | feeling abnormal |
1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt...
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1/7/21 arm soreness overnight, 10 AM 1/8/21 next morning pt noticed pulse was about 135 resting, pt went to work and felt out of it, overall unwell feeling, went to walk in clinic, blood pressure was high even after meds, EKG showed tachycardia but normal rhythm, pt went home went to bed at 2 PM slept until next morning, 1/9/21 fatigue, swollen lymph node under left arm, small lymph node in neck also swollen, headaches, flushed/grey looking, as of 2/16/21 pt is feeling much better
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| 56 | 2021-02-21 | feeling abnormal | I have been dizzy and my head feels cloudy and I can't stand up well without falling over. |
| 56 | 2021-02-21 | impaired work ability |
After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water o...
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After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water only since the night before and no food. I stayed about 1/2 hour, no one could say if this happens, About 12:30 or 1pm I wanted to sleep and slept 4 hours. The next dayi experience sensitivity to light sound headache nausea dizzy and ringing in the ears. I had to take off work at 12:30 and every since then I have had a headache after trying to work only a few hours. I couldn't keep my head set on, cant talk or train because the headaches are too bad. My doctor prescribed Imitrex. The Imitrex didn't even tough the headache, it just made me tired.
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| 56 | 2021-02-23 | anxiety |
Prior to receiving vaccine, vaccinator stated patient had increased ?anxiety? making statements such...
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Prior to receiving vaccine, vaccinator stated patient had increased ?anxiety? making statements such as ?I?m going to die! This vaccine is going to kill me!? Immediately after receiving vaccine (less than 3 seconds) patient slumped down in chair, writer to the patient, patient stating ?I can?t breathe, its going dark, I?m going to die! What about my daughter!? Writer and vaccinator attempted to talk patient down, ineffective. Patient V/S 100/60, 66-HR, 98%-O2, 22-Resp. Patient became limp in chair, unresponsive, episode of urinary incontinence, EMS activated. ~90 seconds into episode patient regained consciousness, A&Ox4, stating ?I?m back. I?m back.? Patient reports this last happened to her ?in college?. Patient also states ?my doctor told me not to get the vaccine, to wait until August since I have Lyme Disease.? Patient to ED with EMS.
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| 56 | 2021-02-23 | insomnia |
severe soreness at the injection site; soreness at the injection site was so severe that she was una...
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severe soreness at the injection site; soreness at the injection site was so severe that she was unable to sleep or lift her arm; soreness at the injection site was so severe that she was unable to sleep or lift her arm; Chills; mild headache; Nausea; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EC324U), via an unspecified route of administration on 11Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included penicillin allergy. Concomitant medications included unspecified daily vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via intramuscular on an unspecified date at 12:00 pm at 56- years of age on the left arm for COVID-19 immunization and had only mild muscle soreness at injection site. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Jan2021, at eight hours post injection, the patient experienced severe soreness at the injection site. The patient stated that the soreness at the injection site was so severe that she was unable to sleep or lift her arm. On the same day, the patient also had chills, mild headache and nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event mild headache was not recovered while the other events was recovered on an unspecified date in Jan2021.
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| 56 | 2021-02-23 | nervousness |
Patient felt dizzy and nervous prior to receiving vaccination. After vaccination, patient reports h...
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Patient felt dizzy and nervous prior to receiving vaccination. After vaccination, patient reports her heart was racing and still feeling dizzy. EMS onsite and pulse was 90, BP of 170/88, patient was taken to hospital for further evaluation.
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| 56 | 2021-02-25 | anxiety |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Pt called for follow up s/p covid-19...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Pt called for follow up s/p covid-19 vaccine done on 02/24/21. She was sent to the ED from here for further evaluation of chest pain. She states her bp continued to be elevated but they gave her an anti-inflammatory shot for her chest pain. States it helped a little but not much. States last night was "rough" but got better through the night and "honestly I didn't feel better until noon today." Took her bp today and it was 148/98. She has not contacted her pcp for follow up. She was reminded to continue to track her bp and record. It was also recommended that she contact her pcp tomorrow to get in sometime next week to be further evaluated and f/up on bp. She is aware of when to return to ED for worsening or new symptoms discussed today. Pt voiced appreciation for the phone call/follow up. Denies any other questions or concerns. Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Attempt to call patient for follow up via phone. No answer. Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Date: 2/24/2021 Subjective Pt is a 56 y.o. female who was seen at clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience chest tightness. She denied rash, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, hypotension, rapid progression of symptoms, respiratory distress and tongue swelling. PMH: DM and HTN. She was taken off Actos here in the last couple of weeks and switched over to Glipizide. She also takes 10 mg of Lisinopril at night time. She also takes Morphine BID for chronic pain. ALLERGY REVIEW OF SYSTEMS: Patient complains of chest tightness and dizziness Patient denies chills, fever, malaise/fatigue, sore throat, frequent throat clearing, cough, shortness of breath, wheezing, rash, hives, eczema, itching of skin, abdominal pain, muscle aches and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 0915 02/24/21 0928 02/24/21 0939 02/24/21 0945 BP: (!) 155/82 (!) 159/93 (!) 154/79 (!) 156/88 BP Location: Left arm Left arm Left arm Left arm Patient Position: Sitting Sitting Sitting Sitting Pulse: 87 SpO2: 99% Blood Sugar 185 collected at 0915 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is obese. She is not ill-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Right lower leg: No edema. Left lower leg: No edema. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines and water Follow up response to treatment: fair. Patient discharge: Transported to ED by POV. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) During her stay she was monitored. After zyrtec was administered and she was laying down. She reported to feel a little better. Upon ambulation to evaluate, she reported lightheaded and chest tightness worsening slightly. She states she has her husband out front who is "angry with me for even being here." We discussed reasons for further evaluation as I am limited here. She declines Ambulance and states her husband won't take her but she would take herself or find a friend. Pt stable. Taken out in wheelchair. Pt ambulates without assistance. 2/24/2021 11:11 AM
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| 56 | 2021-02-25 | loss of personal independence in daily activities |
To whom it May concern: I want to report that after the first dose of Pfizer's COVID-19 vaccine I su...
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To whom it May concern: I want to report that after the first dose of Pfizer's COVID-19 vaccine I suffered from peripheral facial paralysis and it affected my mouth. My right upper lip does not rise and I have trouble eating, drinking, and washing my mouth. This is the first time something like this has happened to me. Thanks for your attention.
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| 56 | 2021-02-25 | mental impairment |
mental fog; Headache; fatigue; pain in armpit; This is a spontaneous report from a contactable consu...
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mental fog; Headache; fatigue; pain in armpit; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 05Feb2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and patient's concomitant medications were not reported. Patient is not pregnant. Patient has no covid prior vaccination. It was unknown if patient got tested post vaccination. It was unknown if patient had vaccine in four weeks and unknown if other medications in two weeks. The patient experienced mental fog (medically significant); headache, fatigue, and pain in armpit. All the events occurred on 06Feb2021. It was reported that the events were continuing after 6 days. No treatment was provided for the events. Facility type vaccine was nursing home. Outcome of the events was not recovered. Information about lot/batch number has been requested.
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| 56 | 2021-02-27 | insomnia | Horrible headache, chills, body aches, and unable to sleep |
| 56 | 2021-02-28 | impaired work ability |
I started running a fever couple a hours,dizziness, nausea that lasted to around 12:00 pm. I missed ...
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I started running a fever couple a hours,dizziness, nausea that lasted to around 12:00 pm. I missed a day of work dint feel safe driving.
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| 56 | 2021-02-28 | mental status changes |
Pt described a difficulty swallowing, slight swelling, and a brief time of altered mental status abo...
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Pt described a difficulty swallowing, slight swelling, and a brief time of altered mental status about 30 minutes after vaccine administration. Pt was able to calm down and described a slight alleviation in symptoms. Pt denied hx of anaphylaxis. Medics were dispatched to the location to transport. No medications given by health department or EMS on scene.
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| 56 | 2021-03-01 | feeling abnormal |
Within 12 hours I had extreme fatigue, extreme muscle/body ache, chills, brain fog. This lasted for ...
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Within 12 hours I had extreme fatigue, extreme muscle/body ache, chills, brain fog. This lasted for about 48 hours. After 48 hours the rash started on top on both ankles. That lasted probably 8 days and didn't get better with cream. The muscle aches started in my neck and upper body and about 11days ago decided to settle in my knee (right). I though I maybe slipped or fell but didn't because of the pain. The pain is cross between a cramping muscle and shin pain. I've been walking with a limp. I got in yesterday with my PCP and sending me for an ultrasound to rule out a blood cot. He doesn't believe it is because it moves, I don't have any swelling or redness. I have just been really fatigue. I had BP done to make sure my Thyroid is ok and it is. The past 3 nights it has stopped waking me up at night. I've been doing epsilon salt baths, I can't put weight on it and still walk with a limp. I go for ultrasound tomorrow.
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| 56 | 2021-03-01 | sleep disorder |
abdominal pain; mild muscle soreness at site; Fatigue; never feels rested or wants/needs to sleep; T...
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abdominal pain; mild muscle soreness at site; Fatigue; never feels rested or wants/needs to sleep; This is a spontaneous report from a contactable Consumer (patient). A 56-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 56-year-old) on 21Jan2021 as a single dose for COVID-19 immunisation, lot number: EL8982. Medical history included gall bladder, liver disease (diagnosed in 2008, 2017 exam fully functional), Umbilical (umb) hernia and ulcer. Patient had allergy-severe hives caused by plasma transfusion. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Other medications within two weeks prior to the vaccination was reported as not applicable (N/A). On 21Jan2021 patient received the first dose, following day (22Jan2021) mild muscle soreness at site, ongoing fatigue, never felt rested or wanted/needed to sleep, a lot. Noticed abdominal pain, did not connect the two. All events considered serious due to disability or permanent damage. No treatments received for the events. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was not tested for Covid post vaccination. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the event fatigue and recovered with sequel (recovered with lasting effects) from the other mentioned events.
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| 56 | 2021-03-02 | feeling abnormal |
About 12 hours later, I had fever, severe body aches, shortness of breath, headache, thought I was g...
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About 12 hours later, I had fever, severe body aches, shortness of breath, headache, thought I was going to die! I felt bad. I was extremely tired. It lasted for 72 hours and then the symptoms were gone. I took Tylenol the first day. The second and third day, I took Ibuprofen. I called the Dr on the second day - he told me it had to run its course. I still have residual shortness of breath - I had COVID at the end of July and had severe scarring in my lungs from the lung.
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| 56 | 2021-03-07 | loss of personal independence in daily activities |
Immediately following injection felt fine with only minor soreness in arm. 24 hours post injection, ...
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Immediately following injection felt fine with only minor soreness in arm. 24 hours post injection, chills, fatigue, headache, neckache, backache, nausea, throbbing pain in arm. Symptoms persisted 5:00 PM through 3:00 PM following day. Symptoms kept me in bed unable to function.
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| 56 | 2021-03-10 | anxiety |
The first vaccine my side effect was that my sinuses opened up. That could've been due to the anxie...
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The first vaccine my side effect was that my sinuses opened up. That could've been due to the anxiety and then relief of receiving the vaccination causing that effect. I had dry mouth and I was thirsty. The second vaccine EN 6201 I had a headache the next day. Throbbing headache. I read not to take Advil or anything right after. February 09= vaccine February 10=headache February 11= headache didn't go away. I took Advil in the evening. February 12=headache worsened. I took Advil in the afternoon. February 13=I woke up and couldn't see out of my left eye. There was a fog in central vision. About an hour later there was a strange aura. A tornado like tunnel in the central vision started and then shot out from the corner of my left eye. The aura lasted seconds and then the foggy center dissipated throughout the day. The headache throbbed and throbbed. I took Advil around the clock every four hours instead of just one a day. February 14= Full head-ache was gone but sinus throbbed above both eyes. February 16= Eye doctor visit. Know clue if the vaccine caused the ocular migraine or not. I've never had one before and it is super scary. My vision hasn't been clear since then and my dry stable MD turned into wet which I don't think has anything to do with the vaccine. Maybe the headache and the Ocular Migraine was caused by the vaccine. Who knows. I just thought I would report it in case other people have the same. Collecting data is a good thing.
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| 56 | 2021-03-10 | anxiety |
Progress NotesFamily Medicine Cosigned/8/2021 10:39 AM COVID VACCINE CLINIC a 56 y.o. female wh...
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Progress NotesFamily Medicine Cosigned/8/2021 10:39 AM COVID VACCINE CLINIC a 56 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience tingling/shaking, short of breath. She denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and respiratory distress. PMH: depression, takes Abilify and Cymbalta. GERD on Protonix. Lipitor for cholesterol. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills ("shaky") and shortness of breath Patient denies fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, wheezing, rash, hives, eczema, itching of skin, abdominal pain, muscle aches, joint pain, dizziness and headaches tingling in hands.: Previous Reactions: none Objective Vitals Vitals: 03/08/21 0833 03/08/21 0851 BP: 133/78 123/71 BP Location: Left arm Patient Position: Sitting Pulse: 95 81 SpO2: 99% 98% Blood Sugar 117 collected at 0839 Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: intially hyperventilating but improved after removal of mask. Eupnea at discharge. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Comments: Hyperventilating upon arrival to bay. Mask taken off to assist with this along with instructions on deep breathing. Assessment/Plan Treatment included: water, snacks and pepcid Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Pt observed in the bay for approx. 15 minutes. Pt greatly improved with treatments above. Pt encouraged to eat 30 minutes prior to next vaccine. She reports that she is appreciative of her care today. F/up with pcp as needed.
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| 56 | 2021-03-11 | anxiety | anxious, SOB, dizzy. Evaluated by EMS-Cleared |
| 56 | 2021-03-11 | fear, feeling abnormal, excessive sleepiness, disorientation, disturbance in attention |
45 minutes after receiving the vaccine I felt like I was helping by getting my vaccine. After 45 min...
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45 minutes after receiving the vaccine I felt like I was helping by getting my vaccine. After 45 minutes I started to get weird symptoms. I started to have a hot flushing sensation in my left chest and became mentally dissociated from the situation. I felt separated from the conversation and tried to touch my hands together and couldn't feel them it was like a part of me. I was still trying to function for days and the feeling of being unable to think continued. I remember muscle weakness and dizziness. It was hard to focus. I had body tremors and some nausea and fatigue, headaches, body aches. The dissociation came and went and I felt really wobbly. I tried driving on day four and was unable to function in traffic. I started having abdominal pain which has lasted for five weeks. The flushing was still there in my chest and started to move up into my neck. Extreme dizziness on day 6 and I slept for much of the day, brain fog. I reached out to many doctors for help but no one had advice. I felt really scared and overwhelmed. Day 8 I had severe nausea and abdominal pain muscle pain in legs and dizziness. I thought I wasn't going to wake up after sleeping on many days. My muscles hurt so bad that I thought it wouldn't end. I had many days of day long headaches and the flushing sensation with shortness of breath. All of my symptoms continued with different levels of severity for five weeks. On the fifth week I had a few days that I thought I was not going to live. I had a band of pain and abdominal fluid that felt hard to touch. I had no appetite and I still had severe muscle pain. I was still disoriented and dizzy. Over this time I reached out through telehealth and several medical professional that had no advice. My symptoms seemed to lessen from the five week point with more periods of feeling more normal. I have only felt a little normal for three weeks.
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| 56 | 2021-03-11 | feeling abnormal |
Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I h...
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Within seconds tingling and chills surged through my body. As I sat, lips started to tingle, and I had chills. Moved to the clinic area. While under observation, symptoms increased. Tongue was reported to be swelling on right side. In retrospect, believe this was lymph nodes.Administered 2 doses together of Benadryl. Oxygen level and blood pressure remained strong. Hands turned bright red and itched. Left at 2:30. Took Benadryl and Tylenol at 3:00. Rashes and itchy throat continued for 48 hours as well as chills and aches. Overall outcome, positive health returned. Lack of energy. Bit of brain fog still remain.
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| 56 | 2021-03-11 | impaired work ability |
Day 2 after the shot I began to feel chills and fatigue. My temperature was 102.2 when I checked it....
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Day 2 after the shot I began to feel chills and fatigue. My temperature was 102.2 when I checked it. Later that same day it had gone up to 102.4. I had no appetite and extreme fatigue. Took Tylenol which lowered the fever. Day 3 my temperature stayed at 102.4 and I had painful, swollen glands along my left clavicle, as well as fatigue. Also, the injection site became hot and swollen. Day 4, my temperature has gone down but I have a terrible headache, swollen clavicle glands and a chain of swollen nodes (?) from the base of my skull down the back of my neck on the right side. My left arm is still hot and swollen at the injection site. I've had to miss two days of work.
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| 56 | 2021-03-13 | anxiety |
Patient felt anxious and said she was experiencing tightness and pressure in her upper chest. Denied...
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Patient felt anxious and said she was experiencing tightness and pressure in her upper chest. Denied any difficulty breathing and did not seem to be in any immediate distress. No swelling or difficulty breathing was obsereved. Patient sat in observation area for at least 30 minutes and was given a small bottle of water. Vitals were taken after that time. Heart rate was 87 bpm, blood pressure was taken on a machine and results were 187/90. Oxygen saturation was 97%. Patient was given option to be taken over to ER to be evaluated and she said "yes". Told later by ER doctor that patient claimed syptoms had resolved and left AMA before any other diagnostic tests were preformed.
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| 56 | 2021-03-13 | feeling abnormal |
started out as feeling kind of like I was getting sick. It progressed to feeling achy, low grade fe...
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started out as feeling kind of like I was getting sick. It progressed to feeling achy, low grade fever and overall feeling bad. As the evening progressed so did the intensity and I began to have chills and my whole body hurt. I would have almost like a spasm throughout my body that happened a few times. I could not move without it hurting or feeling awful. The chills and fever finally broke early the morning of 03/14/2021. I had a confirmed case COVID in December of 2020. I never felt like this when I actually had COVID.
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| 56 | 2021-03-15 | feeling abnormal |
2/22/2021 1st Dose: Within 2 hours: severe pain from neck to fingertips on L arm. Lasted approximate...
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2/22/2021 1st Dose: Within 2 hours: severe pain from neck to fingertips on L arm. Lasted approximately 4 days. Within 4 hours: severe headache, took 2 500mg Tylenol about 3-4 times over the course of 48 hours. Headache subsided on 3rd day. 3/15/2021 2nd Dose: Within 1 hour: weakness, pain from neck thru fingertips in L arm, throat swelling, came home took 2 Tylenol 500mg gel caps at 4:00pm. Napped until 7:00pm. Temperature was 97.5. Thought I was feeling better. Went to bed at 11:00pm. By 2:30am I was awaking, restless sleep, pain all over body, every joint. Finally got out of bed at 11:30am today. Nerves and joints feel as tho on fire. Both arms and hands very swollen. Toes swollen. Nauseous. No appetite. Hurts to move, sit or lay down. Have rested all day. 6:40pm temperature is 99.8. Feel awful. Shooting pain like electricity down both arms into hands extremely sensitive to cold - feels like fire.
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| 56 | 2021-03-16 | sleep disorder |
Never been pregnant I received the injection in my right arm. On the next day around 12 pm, I began ...
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Never been pregnant I received the injection in my right arm. On the next day around 12 pm, I began to feel a dull ache in the left breast. The pain grew sharper and deeper to the point where I could not lift my left arm, it was that painful making it hard to sleep. The next day the pain started diminishing. On the 3rd day after the vaccine, the pain had mostly resolved.
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| 56 | 2021-03-17 | feeling abnormal |
headache, nausea, muscle pain - neck & upper back, joint pain - left shoulder and both hips, feel un...
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headache, nausea, muscle pain - neck & upper back, joint pain - left shoulder and both hips, feel unwell, brain fog
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| 56 | 2021-03-17 | sleep disorder |
About 3 days after the vaccine I started feeling arm pain (right below the shoulder, not exactly at ...
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About 3 days after the vaccine I started feeling arm pain (right below the shoulder, not exactly at the injection site, a little back), in the evening, around suppertime. In the morning it got much worse. I had a little trip the next morning (3 hours each way) and when I returned home the pain was really severe. Used Ibuprofen at home and it solved the problem at first (for the weekend), it would take off that edge. But by Tuesday, I noticed that it was not getting any better just would ease off while taking Tylenol and Ibuprofen. Decided to go see my PCP. Initially PCP thought it was a case of tendinitis and was treated with Voltaren and Tramadol for night time in case it was too hard to sleep. Took Voltaren for a couple of days but did not see any real improvement so decided to go back to the Ibuprofen. The next Monday or Tuesday (about a week later) it was really really bad, and PCP gave me a shot of cortisone into that shoulder because at that time I was feelings numbness on my fingers and horrible pain in the shoulder. About 48/72hrs after the shot the pain subsided but the numbness and the tingling on my pointer finger and thumb were still present. The pain went away in about a week. Then PCP decided to refer me to see a neurologist. By the time I had my appt the numbness and tingling were much better and I had some tests done and they came back normal. Never lost strength in my arm. Neurologist said the numbness and tingling should go away on its own. Now, 2 months later he numbness and tingling are really mild, I am a stomach sleeper and I can't because if I do it will make my arm tingling again. Nowadays I feel it maybe once or twice a day an not extreme.
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| 56 | 2021-03-20 | nervousness |
Pins and needles feeling in my feet, legs, hands and arms. Started out off and on, but is now almost...
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Pins and needles feeling in my feet, legs, hands and arms. Started out off and on, but is now almost constant. It's been 13 days since I was vaccinated and is not going away yet. Very prevalent shaky, buzzy type feeling. I am concerned about getting the second vaccine. Do I still get it? It is scheduled for Apr 1st. Hopefully this will have subsided by then. If not, and I don't get the second dose, am I still protected against Covid?
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| 56 | 2021-03-23 | feeling abnormal |
Patient 56 y.o. year old Date of incident: 03/24/21 Time of incident: 1013 am Location of ...
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Patient 56 y.o. year old Date of incident: 03/24/21 Time of incident: 1013 am Location of incident: vaccine hub triage area Pertinent patient history: History of severe anaphylactic reaction to gabapentin in 2018. Patient had discussed with PCP and allergist who agreed that patient should receive her COVID-19 vaccine. Description of incident: Patient was brought back to the triage area for vaccinator to administer the vaccine near emergency equipment and patient had her own epi pen with her (this was not used). Patient agreed and consented to receive the COVID-19 vaccine. Patient received the COVID-19 vaccine at 1013. At 1023 patient started feeling "off" BP was 177/105, pulse 96 and oxygen 97% Dr. was notified and was present in the triage area and 1st dose of epinephrine was administered in patients right thigh. Patient was coughing and feeling like her throat was closing. Patients BP at 10:25 was 197/109 and 10:26 pulse ox 95% and pulse 64. Patient continued to cough and experience shakiness and unable to catch her breath oxygen was applied at 6 L/minute per VORB from Dr. Patient received 2nd dose of epinephrine at 1026 per VORB from Dr. Patient received 125 mg of IM solumedrol in left deltoid VORB from Dr. at 1032. No benadryl was given due to allergies. EMS arrived at 1035 and administered a 3rd dose of epinephrine. IV started by EMS. EMS transported patient to ED. Patients wife was present during event and drove to meet patient at ED. Orders initiated per RN protocol: EpiPen administered per protocol Additional verbal order for 6 L oxygen by nasal cannula, 2nd dose of epinephrine & 125 mg of solumedrol given by Dr. - read back by RN Patient outcome: Transported via EMS to ED Patient left vaccine clinic via Patient Transport: Ambulance: EMS Called at 1023 arrived at approximately 1033. Other notes: Other RN's involved in this event were RN, RN, RN, Dr., and Dr. RN .................... 3/24/2021 11:04 AM
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| 56 | 2021-03-24 | feeling abnormal |
Severe arm pain all night. Woke up around midnight with my entire left arm and hand numb and tingli...
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Severe arm pain all night. Woke up around midnight with my entire left arm and hand numb and tingling like it had fallen asleep but I was not laying on it. I moved it around until it finally stopped. Pain continued all not. On 3/24/21 was very tired and foggy. On 3/25/21 have a headache and slight nausea. I had an ophthalmic event where I saw lighting flashes in my right eye so it could be this causing instead of the vaccine. I am fine just thought I should report these occurred. Thanks!
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| 56 | 2021-03-24 | loss of personal independence in daily activities |
Woke up at 3am with shooting pains in my arm back and neck. Had a bad headache and was nauseous. I ...
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Woke up at 3am with shooting pains in my arm back and neck. Had a bad headache and was nauseous. I got up and took a Tylenol, went back to bed and woke up 2 hrs. later with the same side effects. I could not eat, tried to drink as much as possible and continued to have extreme cramping all over my body as well as chills, sweats, nausea and light headedness. I did not run a fever, but was unable to get off the couch and do normal activities until the next morning. I continued to take Tylenol for 3 days but had a low grade headache and backache for a number of days. I have not been this sick for years. Glad the severity only lasted a day and a half. Im still struggling with back pain 3 days later.
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| 56 | 2021-03-24 | sleep disorder |
severe arm pain on arm of injection - limited movement and difficulty sleeping due to pain. Sever fo...
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severe arm pain on arm of injection - limited movement and difficulty sleeping due to pain. Sever for 2 days, then just sore. After 9 days severe pain returned for 2 days. Now at 14 days am still sore but most range of motion is returning. Have treated with ice and advil but concerned that I won't be healed before vaccine #2.
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| 56 | 2021-03-24 | sleep disorder |
Experienced strong symptoms of usually well-controlled major depressive disorder, including feelings...
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Experienced strong symptoms of usually well-controlled major depressive disorder, including feelings of worthlessness/helplessness/hopelessness and intrusive thoughts. Experience began while in bed awaiting sleep, ca. 11:00 p.m. Used CBT and DBT distress tolerance techniques to calm down enough to go to sleep by 1:30 a.m. Mood still unsettled in the morning, but severe distress has passed.
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| 56 | 2021-03-24 | sleep disorder |
1. Mild headache 2. Moderate itchiness all over (I am on my 4th round of antihistamine) 3. On the l...
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1. Mild headache 2. Moderate itchiness all over (I am on my 4th round of antihistamine) 3. On the location of the shot (left upper arm) muscles are very tender. It hurts when I put pressure. Unable to sleeping on my left side. 4. Mild stomach pain - typical feeling when I am having an allergic reaction.
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| 56 | 2021-03-26 | feeling abnormal |
March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the ch...
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March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the chest and palpitations. I was given anti-nausea medication. I found the longer that I spoke the tighter and more sore my throat felt. Symptoms of lightheadedness, headaches, brain fog, pain in throat, ear pressure, nausea, diarrhea, body aches and pain, chills, fever of 102 at 6am on March 27th, neuropathy was exacerbated, palpitations and sore left arm. I feel a sharp pain in my right arm, deltoid muscle, when I try to lift it, I can barely move it. It feels as if I had the shot there but I know it was in the left arm for both doses. March 27th all symptoms continue and my temp is fluctuating between 99.5 and 100.5 so far today. March 5th 2021- Dose 1 Within 10 minutes I started to feel the vaccine. I felt a few pangs, brain fog, and exhaustion. The first night I had terrible nightmares. The first three days I experienced dizziness, light headed and off-balance, headaches, brain fog, pain in throat, ear pain, tinnitus and pressure, nausea, diarrhea, body aches and pain, difficulty breathing, chills, fever of 99.5, neuropathy was exacerbated, heart racing and palpitations and sore arm. On the fourth day, I felt normal but was very tired. On the fifth day (March 9th) I again felt exhaustion, brain fog, throat and ear pain, loose stools, body aches and pain, sharp chest pain and neuropathy.
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| 56 | 2021-03-26 | feeling abnormal |
Approximately 5 minutes after vaccination, pt resting in car as advised, noted some lightheadedness,...
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Approximately 5 minutes after vaccination, pt resting in car as advised, noted some lightheadedness, mild hedache, and throat "feeling funny. " No respiratory difficulty, alert, no apparent distress. No medications or treatment given. After about 20 minutes of observation, pt reported feeling well again and allowed to leave, with precautions to report to ED if symptoms recurred or worsened.
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| 56 | 2021-03-27 | feeling abnormal |
almost immediate crushing pain in forearm, hand went numb and fingers tingling. sensation of back in...
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almost immediate crushing pain in forearm, hand went numb and fingers tingling. sensation of back into neck and head. black out feeling.. headache left temple. flashing orange in eyes. lasted for up to 90 minutes.
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| 56 | 2021-03-27 | mental impairment, confusional state |
blacked out or fell asleep while driving to work the next morning which resulted in a car accident; ...
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blacked out or fell asleep while driving to work the next morning which resulted in a car accident; no recall of driving; extreme confusion during the day. Heaviness in head for several days; fatigue for several days
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| 56 | 2021-03-28 | confusional state |
Initially just a sore arm in area of injection. Then I was ok for the first 5 days after the injecti...
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Initially just a sore arm in area of injection. Then I was ok for the first 5 days after the injection. On day 6 I went downhill fast, feeling overwhelming exhaustion, headache, dizziness, confusion. I just needed to sleep, and did so for much of the day. Day 7 was the same, as were days 8 and 9. The days start out sort of ok, but the same symptoms gradually resume towards noon, early afternoon, and I have to go back to bed.
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| 56 | 2021-03-29 | restlessness, depressed mood, feeling abnormal |
Immediately could taste the vaccine in the middle of my tongue, started to feel jittery, hands grew ...
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Immediately could taste the vaccine in the middle of my tongue, started to feel jittery, hands grew cold after 4 minutes, felt spacey, felt numbness in the tips of middle fingers of right hand, face started to feel slightly numb from right to left, tongue started to swell on the left side, lips felt thick. This was a progression of 15 minutes. Vitals taken by EMT - all in normal range. I could walk cautiously. It was a matter of drinking water, eating oyster crackers without salt, and waiting. Left the facility about 11:30am and went for Benadryl. Benadryl helped some (taken about 11:45am) This also affects my serotonin levels making me sad and edgy. Restless afternoon, initial event subsided. Right arm hurt. Needed more Benadryl (1 tablet again) the next day. Added 2 ibuprofen in evening. Spacey, unsettled, fatigued. No fever. Monday: Brain fog most of day. Tuesday: brain fog lifting, but pain occurring in left hand in knuckles and fingers.
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| 56 | 2021-03-29 | sensation of foreign body |
two hours after vaccination I experienced injection site felt like it was hit with a bat, tired, diz...
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two hours after vaccination I experienced injection site felt like it was hit with a bat, tired, dizzy, headache, muscles and joint pain every where like I had the flu, chills, nausea, face and throat swollen and knots on throat, my mouth had sores on my gums, I had a cough and had to take medication for that, sore throat, my fever was up and down.
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| 56 | 2021-03-30 | depression, crying |
having thoughts of suicide; I Instantly became very emotional, I thought it was relief but my emotio...
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having thoughts of suicide; I Instantly became very emotional, I thought it was relief but my emotions have been off the chart for two weeks.; I had an abundance of energy the first week into to try to get rid of some of the energy I went for a very long walk.; I've been very argumentative; have been crying a lot; high depression; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205), via an unspecified route of administration administered in arm left on 01Mar2021 11:45 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medications included lisinopril; pseudoephedrine; chloramphenicol (UNISON). There was no other vaccine in four weeks. The patient previously took codeine and experienced reaction to codeine. The patient instantly became very emotional, she thought it was relief but her emotions had been off the chart for two weeks. She had an abundance of energy the first week into to try to get rid of some of the energy she went for a very long walk. Since then been very argumentative, having thoughts of suicide, and had been crying a lot. Before the vaccine she did not have thoughts of suicide or high depression. Adverse event start date was 01Mar2021 at time of 11:45 am. No treatment received. No Covid prior vaccination. Covid was not tested post vaccination. The outcome of events was not recovered.
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| 56 | 2021-03-30 | disturbance in attention, insomnia |
I did not have a reaction to the vaccine per se, but developed symptoms of Covid 19 on December 30, ...
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I did not have a reaction to the vaccine per se, but developed symptoms of Covid 19 on December 30, 2020 and tested positive the following day. I had a known exposure to covid 19 several days after my shot (my son had it and we didn't know it yet). I think I had not yet had enough time to develop immunity. The vaccine safe person who called me said to report that on this website. Of interest, I was a bit of a long-hauler with persistent fatigue, inability to concentrate, sleeplessness, and shortness of breath despite not having even had a cough with my covid. I got my second shot on 1 March 2021. I had a pretty strong immune reaction (o.k., I might have taken to my bed for three days over it) but two weeks later, I noticed a sudden change in my long-haul symptoms. I have much improved and although I can't definitely tie it to the vaccine, there is a temporal relationship. Thank you for reading all of this.
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| 56 | 2021-03-30 | feeling abnormal |
emotional support; vaque c/o "not feeling right" - mask removed " tickle in throat throat feeling m...
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emotional support; vaque c/o "not feeling right" - mask removed " tickle in throat throat feeling mucousy" RR 16/min, unlabored, no rash; no dysphagia; no tongue swelling; drank water; symptom subsided. waited in observation lot x 15 mins. total.
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| 56 | 2021-03-30 | feeling abnormal |
Joint aches for 48 hours; Fever & chills followed by severe headache beginning 8 hours post injectio...
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Joint aches for 48 hours; Fever & chills followed by severe headache beginning 8 hours post injection and continuing all night and next morning. Terrible. Truly painful and worse than a flu. Followed by intense Fatigue fir an additional 24 hours. And brain fog. Hungry but eating food made me nauseous. Total duration 48-72 hours scariest part was racing heart fir 8-12 hours, incredible thirst but water added to nausea.
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| 56 | 2021-03-30 | insomnia |
Severe headache, low fever diarrhea, severe muscle and joint pain and weakness, chills, first insomn...
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Severe headache, low fever diarrhea, severe muscle and joint pain and weakness, chills, first insomnia,, then extreme fatigue. Symptoms persisted until Tues. 3/30/21.
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| 56 | 2021-03-31 | anxiety |
VR received first dose and was observed for 15 minutes and departed the vaccination site. Approx. 5...
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VR received first dose and was observed for 15 minutes and departed the vaccination site. Approx. 5 minutes after departing she returned saying she was having difficulty swallowing. No other symptoms reported but did indicate she had some anxiety. EMS was called to the site and was transported to the nearest facility.
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| 56 | 2021-03-31 | anxiety |
she wakes herself up with anxiety; Heart racing; felt like she was clunked over the head; she was ti...
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she wakes herself up with anxiety; Heart racing; felt like she was clunked over the head; she was tired and sleepy; she was tired and sleepy; right thigh area in the muscle feels throbbing and pain; Fluttering Heart Beat; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 18Mar2021 at 08:15 (batch/lot number: ER2613) as a single dose for COVID-19 immunisation (also reported as "preventing COVID-19 virus"). Medical history included ongoing rheumatoid arthritis diagnosed 15 years ago, type 2 diabetes from Jun2019 and ongoing, and ongoing high blood pressure diagnosed about 25 years ago. Concomitant medications included adalimumab (HUMIRA) taken for rheumatoid arthritis from 2020 (started it a year ago) and ongoing; insulin detemir (LEVEMIR) taken for type 2 diabetes from 2019 and ongoing; insulin aspart (NOVOLOG) taken for type 2 diabetes from 2019 and ongoing. The patient previously took tofacitinib citrate (XELJANZ) prior to adalimumab. The patient stated that she has a question. She received her first dose today at the in (City name). Stated they gave out a fact sheet upon leaving after vaccine. She stated the sheet stated that she should mention if she was immunocompromised or on medication that compromises the immune system. Asked should she be expecting something different. Stated no one asked her or told her before she got the vaccine. On 18Mar2021, she stated that she felt a fluttering heart beat that lasted for a half hour. She stated that she got the vaccine at 08:15, and about a half hour after (08:45) that she had a racing heart. She stated that she felt like she was clunked over the head, she was tired and sleepy but that has passed. She stated that her brother mentioned he had this too after his vaccine but resolved. Stated her right thigh area in the muscle feels throbbing and pain, nothing excruciating. Stated it was nothing to notice, her brother said he felt the same thing after his vaccination 2 days ago. For the event fluttering heart beat, stated that she had to sit down because she didn't know what was happening but it went away. For the event right thigh area in muscle throbbing and pain, stated it could be muscle of thigh, pain throbbing, not injection site. For the event tired and sleepy, stated that when she got home she first wanted to lay down and take a nap but thought she needed to stay awake. Stated sometimes she wakes herself up with anxiety or maybe it was side effects but she felt like she was starting to come around. She stated that she only has 10 minutes before she needed to walk out the door for an appointment. She still wanted to speak with Medical Information so she wanted to be transferred since she doesn't have much time before she needs to go. The outcome was recovered on 18Mar2021 for the events "fluttering heart beat" and "heart racing", and recovering for the rest of the events.; Sender's Comments: Linked Report(s) : PFIZER INC-2021307886 same reporter/drug/events, different patient
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| 56 | 2021-03-31 | sleep disorder, impaired work ability |
I felt fine after the vaccine. However, twelve hours later (around 12:30am), I awoke from a deep sle...
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I felt fine after the vaccine. However, twelve hours later (around 12:30am), I awoke from a deep sleep with severe vomiting. This lasted for a little over two hours. In the morning, my right arm was sore surrounding the area of the injection. Had to call in sick for the work day due to slight nausea and feeling very tired and run down.
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| 56 | 2021-03-31 | sleep disorder |
About 12 hours after initial injection I had the chills. While sleeping that evening, I kept on rep...
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About 12 hours after initial injection I had the chills. While sleeping that evening, I kept on repeatedly waking up because I had a slight fever (about 1 degree F higher than usual). After having breakfast the next morning I felt fine.
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| 56 | 2021-04-02 | anxiety |
chest tightness/ chest tightness worsening slightly; lightheaded; vaccine-related axiety; chest pain...
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chest tightness/ chest tightness worsening slightly; lightheaded; vaccine-related axiety; chest pain; shortness of breath; nausea; vomiting; diarrhea; This is a spontaneous report from a non-contactable health care practitioner (other HCP). A 56-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: EN6205; Expiry date was not reported) via an unspecified route of administration on an unspecified date (at the age of 56-years-old) at a single dose for covid-19 immunization. Medical history included chronic pain from an unknown date and ongoing. Concomitant medications included glipizide and lisinopril 10mg (taken at night) which were taken for an unspecified indication; and morphine taken two times a day for chronic pain. The start and stop dates of these medications were not reported. The patient previously took pioglitazone hydrochloride (ACTOS) and was taken off in the last couple of weeks and switched over to Glipizide. On an unspecified date during the patient's 15-minute waiting period after the vaccination, the patient began to experience chest tightness. The patient was transported to emergency department (ED). The patient also experienced lightheadedness and chest tightness worsening slightly while she was being monitored after the treatment was given. The events were reported as non-serious. Differential Diagnosis: Vaccine- Related Anxiety (include misc mental health, unspecified) and Red flag symptoms (CP (Chest pain), SOB (Shortness of breath), NVD (Nausea, vomiting, diarrhea), and unspecified Visual/Neuro concerns. Treatment included antihistamine, Cetirizine (Zyrtec), and water for the event chest tightness. The outcome of event chest tightness was not recovered (reported as worsening); while other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-04-02 | sleep disorder |
Severe arm pain that prevented sleeping on both left or right side, difficulty getting dressed and u...
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Severe arm pain that prevented sleeping on both left or right side, difficulty getting dressed and undressed the next day. Arm pain resolved after 40 hrs. Extreme fatigue beginning hours after injection and continuing through present. Routine long walks now result in need to rest for the remainder of the day. Fatigue examples: too tired to walk the dog, too tired to do daily chores, too tired to cook.
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| 56 | 2021-04-03 | feeling abnormal |
Extreme nausea could not keep nothing down for 2 days , headaches, sweats, Lightheaded, this is da...
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Extreme nausea could not keep nothing down for 2 days , headaches, sweats, Lightheaded, this is day 6 starting to feel a lot better but still not myself
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| 56 | 2021-04-03 | memory impairment, feeling abnormal |
Very sore arm for several days after shot. On day 9 I started to get a low grade fever, body aches,...
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Very sore arm for several days after shot. On day 9 I started to get a low grade fever, body aches, headache, upset stomach and extreme fatigue. Day 10 I was having severe memory issues. I struggled with putting words together and forgetting things like passwords and even how to turn off my computer. My husband was very alarmed and thought I was having a stroke. He took me to the ER.
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| 56 | 2021-04-03 | thinking abnormal, depression |
Day1- fingers hurt Day 2- dizziness, fatigue, not thinking clearly Day 3- arm burning hot and swoll...
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Day1- fingers hurt Day 2- dizziness, fatigue, not thinking clearly Day 3- arm burning hot and swollen at injection site. Worsening Fatigue, headache. Day 4- fatigue, headache, depression, arm still burning hot
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| 56 | 2021-04-04 | anxiety, sensation of foreign body |
Patient was wheeled to observation area at 1415. States she started to feel a lump in her throat. VS...
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Patient was wheeled to observation area at 1415. States she started to feel a lump in her throat. VS at 1418 168/102 100% O2 Sat HR 80 bpm. 20 RR. Denies SOB, chest pain, and or difficulty breathing. Lung sounds are clear. States she took her own 25 mg Benadryl prior to coming in due to typically feeling in lump of throat after vaccines. VS at 1425 156/102, 98% O2 sat, HR 68, RR 18. Patient decides to take an additional 25 mg of Benadryl while in observation. Patient states she is having mild anxiety. Talks in full complete sentences. 10 mins after 2md dose of Benadryl patient states the lump is going away and feels much better. Pt was advised to seek medical care if she starts having SOB, difficulty breathing or throat swelling to seek medical care.
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| 56 | 2021-04-04 | anxiety | Anxiety, dizziness, respiratory distress. BP 194/94 (pulse 96), 162/95 (pulse 74). |
| 56 | 2021-04-05 | sleep disorder |
Severe soreness within in hours of the injection and continued pain in the right shoulder joint, elb...
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Severe soreness within in hours of the injection and continued pain in the right shoulder joint, elbow joint, wrist joint and what feels like deep in the bones of the right arm. This pain has been severe enough to disrupt my sleep continuously through last night.
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| 56 | 2021-04-06 | disorientation |
Immediately dizzy when I walked out of room and within a few moments felt disoriented. I sat in my c...
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Immediately dizzy when I walked out of room and within a few moments felt disoriented. I sat in my car for 20 min and felt ok enough to drive home but was overwhelmed with fatigue. It is 3 hours since vaccine and lethargy is same and am unsteady when walking
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| 56 | 2021-04-06 | insomnia |
Beginning 5 days after injection on March 16, I started experiencing back pain. The next day, the 17...
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Beginning 5 days after injection on March 16, I started experiencing back pain. The next day, the 17th, a small red rash started near my navel with itching and started with headache and malaise. Later that same day I looked on my abdomen and right torso and notice an additional red rash on my right torso, under my arm, leading from my navel. Itching became intense and the pain started. Vesicles stared on the 18th and I was unable to get an appointment until the 19 the where the MD confirmed Shingles. I was started on Valtrex (generic) 1 tab bid for 7 days. The pain was so intense, I was unable to have any clothing, bedding touch the area. I had a fever, chills, intense pain, with inability to raise right arm due to pain. There was also a lymph node that was tender and swollen under my right arm. Treatments included Calamine lotion and OTC Lidocaine applied topically and the fever and headache were managed with Tylenol 500 mg every 3-4 hours until it became unbearable and I requested additional pain meds. The MD gave me Oxycodone which helped some. The lymph node were no longer tender and sore by day the 28th or so. The lesions/vesicles started to dry up by 04/02/21 but the itching persisted and remained very painful. The back pain persisted throughout with difficulty sleeping due to the pain. By the 4th of April, the lesions had dried completly and all the scabs had fallen off. Some of the nerve pain persisted but clothing was more bearable by this time. As of today, there is some itching that remains and some back pain with some tenderness on my right torso.
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| 56 | 2021-04-06 | sleep disorder |
On Saturday 4/3, about 6 hours after shot, I began to have cold chills. Within 2 hours later I was ...
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On Saturday 4/3, about 6 hours after shot, I began to have cold chills. Within 2 hours later I was so tired that I went to bed. I have never shook so much from cold chills. Fever reached 103.8 during the night. I did feel nauseous a couple of times, but no vomiting. Drank lots of water but no appetite. On Sunday 4/4, stayed in bed and slept - waking every 2-3 hours. On Monday 4/5, feel better - just really tired. Still unable to sleep more than 2-3 hours at a time. Still no appetite but forced myself to eat a little. On Tuesday 4/6, feel better than day before. Still really tired. No energy. Still sleeping 2-3 hours at a time. Appetite coming back slowly.
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| 56 | 2021-04-07 | feeling abnormal, sensation of foreign body |
4/7/21 at 7pm Felt faint a little breathing off. Sore throat 8pm and started to feel uncomfortable a...
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4/7/21 at 7pm Felt faint a little breathing off. Sore throat 8pm and started to feel uncomfortable and trouble swallowing a little bit.. 10pm felt like lump in throat. 11pm more trouble swallowing and tongue swollen and throat felt swollen. 6am under chin tongue still felt swollen. 2:45pm 4/8 trouble swallowing and felt odd in mouth/throat. Soft palate and uvula swollen and throat felt swollen. 7pm felt faint and breathing off a little. 9:45pm Mouth still swollen. All of this with Benadryl and Motrin in me.
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| 56 | 2021-04-07 | feeling abnormal |
I have reported this event previously. I want to report this event because I am continuing to be sym...
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I have reported this event previously. I want to report this event because I am continuing to be symptomatic. After my first covid vaccine on March 5th 2021, I was sick for 4 days, then the following day I was ok, and then the next day I was sick for the day. The second covid vaccine, March 26th 2021, I was sick for six days then I felt ok for three days, and on April 5th I became symptomatic again and it has continued through today April 8th. Tired/exhausted dizziness headaches brain fog nausea body aches and pain fever 99-102 neuropathy difficulty breathing palpitations
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| 56 | 2021-04-07 | feeling abnormal |
She said she felt poorly, and then developed diffuse itching about 10-15 minutes after receiving the...
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She said she felt poorly, and then developed diffuse itching about 10-15 minutes after receiving the vaccine. She then developed a few hives on trunk and arms. She was given Claritin and Pepcid PO. Symptoms improved in about an hour.
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| 56 | 2021-04-07 | sleep disorder |
I woke up in the middle of the night following the shot with leg cramps, body aches, headache and fa...
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I woke up in the middle of the night following the shot with leg cramps, body aches, headache and fatigue. I contracted Covid back in January and I felt just like I did while infected, except for the chest heaviness. This lasted about 36 hours and completely went away.
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| 56 | 2021-04-08 | confusional state |
Fatigue, lethargy, confusion, started on day 8 after the vaccine. The confusion got worse on day 9....
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Fatigue, lethargy, confusion, started on day 8 after the vaccine. The confusion got worse on day 9. All symptoms present but subsiding on day 10 after the vaccine.
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| 56 | 2021-04-08 | confusional state |
57 y/o with Past Medical History of Rheumatoid Arthritis on Methotrexate and a biologic medication ...
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57 y/o with Past Medical History of Rheumatoid Arthritis on Methotrexate and a biologic medication completed her 15 minute observation period post administration of her 2nd Pfizer COVID vaccination. As she walked out and she began listing to the right side. She sat down, confused, and complaining of chest pain. She also noted pruritus over her face and scalp. No c/o Shortness of Breath, wheezing or nausea. She was immediately evaluated by me and EMT's . Vital signs demonstrated a HR of 74 in sinus rhythm, O2 Sat of 98% and BP was 192/104. She did not have a rash but was scratching at pruritic areas on scalp and face. See continuation page...
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| 56 | 2021-04-09 | feeling abnormal |
Feeling of dizziness, lightheadedness, in a fog, off balance - all started on 3/6/21 at 9:30 am whil...
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Feeling of dizziness, lightheadedness, in a fog, off balance - all started on 3/6/21 at 9:30 am while doing floor exercise at home. I couldn't get up without listing to the right. My husband who is a firefighter had me get on all 4's until I was able to get up. It happened several times over the weekend ie: lying down watching tv, reading a book on the sofa I was and still am experiencing it every day since then. Each "episode" lasts for approximately 30 seconds.
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| 56 | 2021-04-09 | sleep disorder |
At 2 a.m., Patient began getting very sick. She has a fever. She reports her whole body feels it is ...
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At 2 a.m., Patient began getting very sick. She has a fever. She reports her whole body feels it is on fire. She can not sleep.
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| 56 | 2021-04-10 | feeling abnormal, irritability |
Lightheaded, metal fog, fatigue, irritable, felt drugged, continued for over 72 hours. Heartburn a...
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Lightheaded, metal fog, fatigue, irritable, felt drugged, continued for over 72 hours. Heartburn after that (may or may not be related) but not going away with usual methods.
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| 56 | 2021-04-10 | excessive sleepiness | Chills, burning up , legs weak , barely able to walk , slept for 18 hours straight |
| 56 | 2021-04-10 | sleep disorder, excessive sleepiness |
I awoke to pain all over my body, and was either too hot or too cold, and could not sleep because of...
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I awoke to pain all over my body, and was either too hot or too cold, and could not sleep because of the discomfort. At 2p on 04/10/2021, the pain and chills stopped. I slept from then until 7a today (04/11/2021). Today I feel good, but feel like I had a really hard workout yesterday.
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| 56 | 2021-04-11 | anxiety |
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient experienced anxiety and palpitations post v...
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Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient experienced anxiety and palpitations post vaccination. Patient was transferred to the emergency department. She was in the ED from 10:25 AM to 11:26 AM.
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| 56 | 2021-04-11 | feeling abnormal |
Patient reported side effects - Onset: 45 minutes after getting vaccine; Severity: moderate; Symp...
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Patient reported side effects - Onset: 45 minutes after getting vaccine; Severity: moderate; Symptoms: Dizziness for 2 hours, can't think clearly. Second Pfizer vaccine -- Got shot at 8:20 AM and started to feel warm at 9 AM, and got dizzy with vertigo. Feels foggy, needs to hold onto furniture to walk. No fever. (With 2nd shingles shot -- next morning achy, exhausted, low grade fever. Only time has ever reacted before). Other symptoms = Ringing ears, fogginess in thought. HISTORY OF PRESENT ILLNESS A 56 y.o. female who presents regarding a potential concern for an adverse reaction to the COVID-19 vaccine. Second Dose in Series: Vaccine was obtained from the following clinic/location: on the date of: 4/9 and approximate time of 8:15 AM Vaccine was administered to patient's: Left Deltoid Vaccine manufacture was: Pfizer Past Reaction to other immunizations- yes: symptoms: second dose of shingles causing flu like symptoms Known COVID Exposure since receiving vaccination?: No Patient notes the following symptoms: disiens, tight throat, scratchy voice, ringing ears. Modifying Factors or additional details: by the time got home after vaccine today - dizzy, ears ringing and symptoms haven't improved. Denies lightheadedness or feeling like she is going to pass out. Voice sounds scratchy, feeling unbalanced. Denies history of vertigo. Throat feels tighter but denies difficulty breathing. Denies tongue or lip swelling. Did take atarax one hour after without relief. Dramamine as needed -Benadryl at night - may make you sleepy -Daily antihistamine (e.g Claritin) -Increase rest and fluids Signs and symptoms that require an Emergency Room Evaluation-rapid breathing, using accessory muscles to breathe, difficulty breathing, severe wheezing, tongue/lip/airway swelling, altered mental status, weakness, visual changes, lightheadedness, not eating or drinking, severe headache, chest pain, neck pain or stiffness, the development of high fevers/chills/overall feeling unwell despite medications, or any new concerning symptom. -Follow up with PCP if no improvement over the next three days
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| 56 | 2021-04-11 | feeling abnormal | Brain fog for a total of 2 days after receiving vaccination, starting on day 1 post-vaccination |
| 56 | 2021-04-11 | sleep disorder |
Dizziness, fatigue started around 11am, pressure headache including jaw started 6pm. Slept on and o...
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Dizziness, fatigue started around 11am, pressure headache including jaw started 6pm. Slept on and off, dizziness continued until next morning. I don?t know if this was related to shot because I do have back issues but my entire spine had a burning pain. Next morning everything was fine, including back pain.
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| 56 | 2021-04-12 | sensation of foreign body |
Chest pressure at 09:37. Patient given 25 mg Benadryl. At 10:10 patient reported chest pressure and ...
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Chest pressure at 09:37. Patient given 25 mg Benadryl. At 10:10 patient reported chest pressure and lump in throat. Patient treated with another 25 mg Benadryl.
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| 56 | 2021-04-12 | sleep disorder |
elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; s...
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elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; smell altered on and off; taste altered on and off; muscle pain; headache; all over pain first 36 hours preventing sleep; a little bleeding from bowel at 24 hrs and nose at 36 hrs; Burning like fire at injection site; Hair follicle pain; a little bleeding from bowel at 24 hrs and nose at 36 hrs; extreme armpit pain like torn muscles; no use of arm first two days; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ER 8733) via an unspecified route of administration at left arm on 27Mar2021 15:15 at a single dose for Covid-19 immunization. Medical history of patient was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamin, calcium and fish oil (other medications the patient received within 2 weeks of vaccination). Patient stated as injected arm went numb within 15 minutes and stayed that way 48 hrs, extreme armpit pain like torn muscles began at 48hrs, bad stomach cramps first 24 hours, a little bleeding from bowel at 24 hrs and nose at 36 hrs, no use of arm first two days could not even put a robe on, fever that climbed to 101.7 until breaking first 48 hrs, smell and taste altered on and off. Burning like fire at injection site 12 hours later that came and went in waves for another 36 hrs. Hair follicle paint at 12 hrs when headache started, headache lasting 72 hours, all over pain first 36 hours preventing sleep, nausea began within first hour lasting about 40 hours, muscle pain first 48 hrs, fatigue begins at 36 hrs and continues, elevated resting heart rate since first night, dizziness and light headedness from 1st hour. The patient underwent lab tests and procedures which included body temperature was 101.7 and heart rate was elevated (elevated resting heart rate since first night) on 27Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The outcome of event was recovering.
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| 56 | 2021-04-12 | sleep disorder |
I was woken up to inability to straightening my left leg and strong left leg pain around the knee. I...
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I was woken up to inability to straightening my left leg and strong left leg pain around the knee. I had trouble walking and pain while walking. This lasted 12 hours and then stopped
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| 56 | 2021-04-13 | anxiety | Anxiety and dizziness |
| 56 | 2021-04-13 | anxiety |
Patient had throat swelling, anxiety, & chest pain. Patient was given 25mg Benadryl. Patient decline...
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Patient had throat swelling, anxiety, & chest pain. Patient was given 25mg Benadryl. Patient declined transport.
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| 56 | 2021-04-14 | feeling abnormal |
Had a flush/rush in chest like water running through me about 5 minutes after receiving the vaccine....
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Had a flush/rush in chest like water running through me about 5 minutes after receiving the vaccine. Then started to feel dizzy/weakness as if I was going to faint. I didn't tell the nurse on hand until 25 minutes later as I thought these were normal so I was asked to stay another 30 minutes after they took my pulse and BP. All was normal. But still felt weak. Stayed an hour then left. Felt odd, not myself., out of sorts....went home, felt ok for an hour, then started feeling tired and fatigued...fell asleep and had diarrhea at night. Yesterday slept in, had one episode where I felt off and felt like I couldn't breath which lasted for a couple minutes. Feel ok today.
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| 56 | 2021-04-16 | depressed mood, feeling abnormal |
Within 5 minutes after the injection I felt drugged, foggy headed, down in mood, a hum, buzz, tingli...
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Within 5 minutes after the injection I felt drugged, foggy headed, down in mood, a hum, buzz, tingling type feeling through out my body, slowed down reactions and reflex?s, glad to know my husband was with me to drive me home. I didn?t feel confident after the injection to trust my reactions with driving. Which was totally unexpected to happen so soon. Later that evening had the usual chills and achiness. It?s now 2 days later and I?m still foggy headed and tired. None of this is life threatening but it could have been if I tried to drive. Which is my point in filling this out. No one mentioned this could happen so quickly.
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| 56 | 2021-04-16 | feeling abnormal |
Pain all over, very fatigue, foggy, chest tiredness, exhaustion with ambulation, plum size swelling,...
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Pain all over, very fatigue, foggy, chest tiredness, exhaustion with ambulation, plum size swelling, pain and redness under right armpit, slight sore throat, ear ache, and stuffy nose gradually got worse since 23 April
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| 56 | 2021-04-16 | impaired work ability |
It hurt more than 1st shot at time of shot. It was higher up on the arm, an inch from my shoulder. T...
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It hurt more than 1st shot at time of shot. It was higher up on the arm, an inch from my shoulder. Throughout the day, the pain mildly increased. By 5pm, I couldn't lift my left arm, pull up my pants, extend my arm. The pain radiated up my shoulder and is excruciating. I had fun plans for today that I had to cancel. That is not me. I suffer through. I can't carry a light blanket with left arm at this time.
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| 56 | 2021-04-17 | feeling abnormal |
left ear began to itch, and then the inside of both ears felt a little 'funny"; left ear began to it...
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left ear began to itch, and then the inside of both ears felt a little 'funny"; left ear began to itch, and then the inside of both ears felt a little 'funny"; experienced intermittent tinnitus in both ears.; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (pregnant: no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 23Mar2021 at single dose for COVID-19 immunization. The relevant medical history included ovarian cancer and allergy: Penicillin, from unspecified date. Concomitant medications included colecalciferol (VITAMIN D 3). On 23Mar2021, within about 10 min of receiving the vaccine, her left ear began to itch, and then the inside of both ears felt a little "funny". Since having the vaccine, she had experienced intermittent tinnitus in both ears. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures included 1 tablet of Benadryl were taken as a result of the events. The outcome of the event was recovered with sequel on an unspecified date. Information on the lot/batch number has been requested.
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| 56 | 2021-04-17 | memory impairment |
bleeding on the brain; she had a stroke; couldn't hardly remember anything; smile was stuck; she's w...
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bleeding on the brain; she had a stroke; couldn't hardly remember anything; smile was stuck; she's walking, but her right leg is hard to lift up; still in a lot of pain; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:30 (at 56-year-old) as single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Vaccination Facility Type: Hospital. Concomitant medication included lisinopril (LISINOPRIL) taken for high blood pressure from an unspecified start date and ongoing. Caller states he is calling for his fiance, she's in the hospital. Caller states she had this vaccine done on the 22MAR2021 and had some side effects. Caller states she had a stroke (27Mar2021, hospitalized) and when he went online, he googled it about the shots, it actually said that COVID, the medicine, can cause the stroke, he actually watched a video about it. Caller states patient did good for two days then after two days, she woke up and couldn't remember hardly anything (25Mar2021, hospitalized) and he was questioning her like what month it was. Caller states he thought patient was playing with him, he waited a day and then her smile was stuck (25Mar2021, hospitalized) and when he got to the hospital, the doctor told him what happened. Caller states they actually want to keep her in a facility for therapy or rehab but she doesn't want to stay in the hospital and so they are seeing about getting therapy to come to the house. Caller states he works as a security officer. Prescribing Healthcare Professional: Caller states the healthcare she has is (state). Caller states he set up an appointment for her that she will be going. Caller states the patient hasn't gone there yet, she will be a new patient, on the 06 or 07. Caller states they are still at the hospital right now and all the information is at home. That doctor will be her new family physician. Caller states patient had the vaccine 22Mar2021 and she did good. Caller states then the next days she was not herself. He later clarified it was 25Mar2021 where she couldn't hardly remember anything, she was talking real funny. Caller states he's been around someone with strokes and he just wasn't sure so he told her he was going to take her to the hospital if she didn't get no better. Caller states she didn't get any better so she had bleeding on the brain (27Mar2021, hospitalized) and a stoke. Caller states the doctors told us what was going on and she was fine until she got the shot. Caller states it was about three days out from the shot. Caller states he would say she's not improving. Caller states the speech therapist came in, and wanted her to have therapy, they are really wanting to admit her. Caller states they told her she would have to get better. Caller states they talked to them about 40 minutes ago and he told them she didn't want to agree to that and they were trying to set it up where someone can come to the house for speech therapy and for her walking, she's walking but her right leg is still hard to lift up and just her memory, she doesn't remember her age. Caller states they said it could be up to six months before it gets better and if it don't, it's not gonna get better. Caller states on 27Mar2021, that's when they went to the ER and they did the CAT scan, that is when found out had a stroke and bleeding on the brain. Caller states he doesn't have the card she was given when she was received the shot, caller states that's at home. Outcome of stroke, bleeding on the brain, cannot remember anything : Caller states she has improved a little but everything is really about the same. Caller states she is still in a lot of pain and her memory's just not the same. Caller states they come in and they do tests on her, a word test, spelling test, she gets it right, she just has problems remembering her what her age is, what the month is, and what year it is. Caller states patient is supposed to get the second shot next week sometime, caller is unsure of the exact date. He mentioned he sees second dose it is within 2-3 weeks. No additional details provided. Caller states she was tested, they tested her there at the hospital, she just decided she wanted to get it. Caller states she didn't have the COVID any time. Caller states she had a CAT scan that showed bleeding on the brain and a stroke. Caller also reports she had a X-ray of the Chest, not sure of the results from that. Caller also states she had blood work done but doesn't know what it was or the results. Caller states he has to catch one of those doctors when they came in, but there was a lot of callers before him and they missed them. Time of Onset (24-hour clock) of Adverse Event was in the morning. Caller states they always get up, gets coffee started, 3-11 he does security. Caller states it was that morning, say around, she got up about 9:15AM (unspecified). It was also reported that she had Emergency Room visit. The outcome of the events she had a stroke, couldn't hardly remember anything, and bleeding on the brain was recovering; while for other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 56 | 2021-04-18 | confusional state, feeling abnormal |
Headache, chills, nausea, dizziness, confusion, exhaustion for 2 days, then dizziness, confusion and...
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Headache, chills, nausea, dizziness, confusion, exhaustion for 2 days, then dizziness, confusion and exhaustion for 3+ additional days. I am on the 4 day after the vaccine and completely exhausted, dizzy, and foggy headed still.
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| 56 | 2021-04-18 | disturbance in attention, memory impairment |
I am reporting these symptoms in the hopes it helps others. Injection site pain and swelling start...
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I am reporting these symptoms in the hopes it helps others. Injection site pain and swelling started 3 hours after injection and lasted 4 days, minor pain now if press on muscle. Beginning 4/11 until present tiredness, no energy, minor difficulty concentrating and remembering how to say things. I thought at first needed good night sleep, it gets worse towards end of the day. Beginning 4/14 muscle pain began on my lower back and began to move up as the day progressed, became uncomfortable to sit for more than 1 hour. Over weekend extended to legs and neck. On 4/19, Monday night 6:30pm muscle pain over all body, slight headache that comes and goes more annoying then anything, feeling a little warmer than usual, no fever. There is no muscle pain if I do not move. I'm resting, in bed, drinking water, appetite not affected. I am scheduled for the second dose on 4/30 . May this information be helpful. Thanks!
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| 56 | 2021-04-18 | feeling abnormal, sleep disorder |
pretty severe headache within three hours fatigue within three hours next morning headache, dirrehea...
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pretty severe headache within three hours fatigue within three hours next morning headache, dirrehea and nausea symptoms gone about 30 hrs after injection several days later developed mental fog felt out of sorts. lasted a couple of days Had exactly the same side affects on the second shot given 3/25/21 at the same facility. symptoms less severe in nature but lasted a little long. Severe arm pain not necessarily at the injection site but same arm.. Woke me up with pain if I accidently moved or touched it while sleeping. All resolved in 48 hours of vaccine.
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| 56 | 2021-04-18 | feeling abnormal |
Received vaccine at 12:30 p.m. on Thurs., 4/15. By bedtime, I was experiencing body aches quickly fo...
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Received vaccine at 12:30 p.m. on Thurs., 4/15. By bedtime, I was experiencing body aches quickly followed by severe chills and a splitting headache. Was awful. Lasted all evening. At 9:10 a.m. on Fri, 4/16, I had a seizure that I believe was caused by the vaccine since I haven't had a seizure for over a year (and the last one was triggered by a med change). After the seizure, my symptoms increased to include vomiting and nausea along with a severe headache. The vomiting stopped around noon. My headache lasted until Saturday morning. I felt okay Saturday, just a slight headache.
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| 56 | 2021-04-18 | feeling abnormal |
I?m a healthcare worker who has worked in Neurology and Behavioral Health for 10 years. I have never...
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I?m a healthcare worker who has worked in Neurology and Behavioral Health for 10 years. I have never had an abnormal EEG due to my history of migraines. I was in bed when I felt severe lightheadedness and an urgent needed to defacate. My husband lowered the bed to help with the lightheadedness however the need to defacate remained and I went into the bathroom had LOC, hit my head on the door jam, fell to the floor. No tonic/clinic movement was noted by husband. No bowel or bladder incontinence. The LOC remained for 15 seconds. I regained consciousness and was aware of my surroundings but was not clear headed. I crawled to the toilet but was not able to hoist myself onto the toilet. I leaned over the bathtub (Still on my knees) and nearly had another LOC. My husband helped me onto the toilet and I was able to relieve myself and a couple of minutes later while still lightheaded I was able to get back to the bed on my own while holding onto the wall. I texted Dr and made him aware of this incident. He advised me to schedule EEG, carotid ultrasound and CT head on the upcoming Monday. Carotid ultrasound was within normal limits.
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| 56 | 2021-04-18 | loss of personal independence in daily activities, feeling abnormal |
12 minutes after the injection, I felt very dizzy, nauseous, a few minutes later, I totally blacked ...
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12 minutes after the injection, I felt very dizzy, nauseous, a few minutes later, I totally blacked out, they took me into the emergency room and took my blood pressure, which was very low and my heart was racing. I came to about 7-10 minutes later with very dizzy feeling, a itchy throat and was feeling very dizzy. The hospital staff gave me water and took a EKG - I was told to just rest. I got the chills and felt waves of dizzy/nauseous for a while. After about an hour, I felt strong enough to go home. I went home and was very tired and still dizzy. I was tired and was too tired to do anything other than stay in bed for three days. I lost my appetite, had weird metal taste in my mouth and had a few dizzy episodes the next day where I couldn't walk to the bathroom without help. I am usually a very healthy person, never have passed out before and now three days later, I can only work a few hours a day without getting tired and my brain feels foggy - hard to focus.
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| 56 | 2021-04-19 | feeling abnormal |
I was dizzy and rapid heartbeat after the injection but not bad enough for care. That receded after ...
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I was dizzy and rapid heartbeat after the injection but not bad enough for care. That receded after an hour or so, but then I had the worst herpes nerve pain down my legs that I've ever had. Took the acyclovir and mostly avoided the breakout, but felt bad for a few days. No fever. A week after the vaccination I started to feel dizzy on and off then 10 days or so later started having weird heart palpitations and pressure in my chest. I ended up in the ER. They said I wasn't having a heart attack but the condition has continued on and off as well as the dizziness. I also got a period 3 weeks after the shot having not had one for almost 2 years. I'm still not feeling well 4 weeks after the 1st shot with fatigue, intermittent dizziness and heart issues. I've been advised to hold off on the second shot. The dizziness was diagnosed as vertigo.
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| 56 | 2021-04-19 | loss of personal independence in daily activities |
Pain started in my upper and lower abdomen for the first three days. The following days the pain gr...
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Pain started in my upper and lower abdomen for the first three days. The following days the pain grew to an excruciating stabbing pain radiating throughout my stomach to my lower abdomen. The excruciating and debilitating pain has left me without the ability to walk or maintain my home.
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| 56 | 2021-04-19 | sleep disorder |
Woke up at 2am (approx 14 hrs after vaccine) with bad chills/shaking/sweating, fell asleep for a few...
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Woke up at 2am (approx 14 hrs after vaccine) with bad chills/shaking/sweating, fell asleep for a few hours then woke up feverish, bad headache, major bodyaches, nauseous with throwing up throughout the day, fatigue, weakness and sore arm at injection site so I slept most of the day in general, in between sickness. 2nd day after vaccine, April 15th I woke up with still a bad headache, bodyaches, nauseous, and sore arm. Headache subsided that night. April 16th I still was nauseous most of day and sore arm. Took extra strength tylenol a couple times on April 13th, 14th and 15th.
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| 56 | 2021-04-20 | feeling abnormal, amnesia |
This was my second vaccine. After the first I had normal side effects - tired and run down for 24 ho...
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This was my second vaccine. After the first I had normal side effects - tired and run down for 24 hours. After the second dose, there was a delay, but now, over a week later, I am still struggling with fatigue, memory loss, foggy brain, and overall malaise. I had Covid last spring (late March - May). I now feel like I did as I was recovering from actual Covid once the fever and cough were gone. I have done some searching online and I don't see any cases of taking this long to recover from the vaccine so I thought I should report it. Mornings are the worst.
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| 56 | 2021-04-20 | loss of personal independence in daily activities |
Started ringing in the left ear. Got much worse after the 2nd shot on April 1, 2021. It is now extre...
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Started ringing in the left ear. Got much worse after the 2nd shot on April 1, 2021. It is now extremely loud and interfering with my quality of life, work, being able to hear.
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| 56 | 2021-04-21 | nervousness, anxiety |
55 y/o female, with no past medical history, who presents with Right arm tingling post vaccination. ...
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55 y/o female, with no past medical history, who presents with Right arm tingling post vaccination. Patient states that this is her first dose in the two-dose series. Patient denies previous vaccination reactions. Patient received her vaccination to the Right arm. Patient states that she also feels anxious and nervous. Patient denies sore throat, difficulty swallowing, chest pain or difficulty breathing. NP and Paramedics at patient side. Patient provided with a bottle of water and legs were elevated. Within 3 minutes patient stated that tingling resolved. Patient noted to be hypertensive (172/104) with all other vital signs normal. Patient denies medical history of hypertension. Patient moved to the partitioned off area and placed on cot. Patient vitals monitored every 5 mins for 1 hour. Patient became normotensive and stated that symptoms had resolved. Patient discharged home in stable condition.
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| 56 | 2021-04-21 | panic attack |
Patient reported that three previous times after receiving season flu vaccine, she developed acceler...
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Patient reported that three previous times after receiving season flu vaccine, she developed accelerated heartrate and shortness of breath, but that it had been four years since that last happened. We instructed to remain her for 30 minutes after the shot rather than 15. About 10 minutes after receiving the COVID injection, she developed increased hearth rate and shortness of breath. She reported she also felt nauseous. We removed her face mask and had her lie on her side on the floor. We called 911 and remained with her until the ambulance left. She looked less pale and was feeling somewhat better by the time the ambulance arrived, but Patient returned later in the morning, looking and feeling fine. She told us that the ER assessment was that it was not an allergic reaction to the vaccine, but rather something in the vaccine that triggers her increased heartrate. She told us that when this happens, it compounds her anxiety, and she attributes what happened to being as much a panic attack as a physical reaction. She also told us that due to her agoraphobia, she feels anxious in unfamiliar surroundings. She had never been to our pharmacy before.
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| 56 | 2021-04-22 | anxiety |
Post vaccine patient became dizzy, sweaty, anxious and experienced nausea . Pt. was given water in v...
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Post vaccine patient became dizzy, sweaty, anxious and experienced nausea . Pt. was given water in vaccination area. Patient had eaten approx. 1 hour prior to vaccination. Pt. transferred to med obs. via w/c. After lying down for several minutes pt. felt better. Husband arrived to area and pt. felt less anxious. Pt. released at 1352 with husband. Vital signs- 1315 LYING BP 155/80 HR77 RR24 SpO2 97% 1322 LYING BP 154/85 HR77 RR20 SpO2 97% 1331 LYING BP 154/85 HR75 RR20 SpO2 96% 1335 SITTING BP 157/93 HR78 RR20 SpO2 95% 1345 SITTING BP 148/98 HR79 RR20 SpO2 96% 1350 STANDING BP 144/90 HR 83 RR20 SpO2 97%
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| 56 | 2021-04-22 | loss of personal independence in daily activities, depression, impaired work ability |
Injection in left arm on Sunday, 3/28 - 4PM. By Tuesday, 3/30 - I stared feeling unusually / more t...
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Injection in left arm on Sunday, 3/28 - 4PM. By Tuesday, 3/30 - I stared feeling unusually / more than normal tired. By Thursday, April 1, 2021, symptoms of headache, body aches, extreme tiredness where all I wanted to do is sleep, depression, a bit of nausea continued and by 4/1 I had to go home from work. My lower calves (both legs) and ankles and feet were swollen, throbbing and felt like there were pin pricks / tingly sensation in my legs. I stayed home from work on that Friday, April 2, slept and slept. I tried to do minimal tasks that exhausted me - like wash dishes. I took aspirin - drank a ton of water and had lay with both legs elevated. By Sunday I was fine.
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| 56 | 2021-04-22 | sensation of foreign body |
Date and time adverse event started: 3/10/2021 at approx. 12:30pm, a few moments after rcvding the v...
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Date and time adverse event started: 3/10/2021 at approx. 12:30pm, a few moments after rcvding the vaccine. Pt reported that a few moments of rcvding the vaccine she felt pressure in her whole head, ears were clogged up, and had lumps in her throat; these symptoms lessen as the days goes by and she felt better by day 3. On day 4 (3/13/2021), pt reported she felt like she had a bad cold which turned into bronchitis and that lasted for 2 weeks that was accompanied by symptoms of stuffy head, stuffed up sinus and drainage, had low grade fever, and coughed up phlegm). Pt reported that she have history of tinnitus and post-nasal drips, the ringing in her left ear and the post-nasal drip was still ongoing prior to rcvding the COVID vaccine and these symptoms seems to have been exacerbated after she got the vaccine because she felt like it has gotten worse. Pt reported that she took otc Mucinex and Claritin on the 5th or 6th day from rcvding the vaccine. She went to see her PCP and got a chest x-ray (results: negative for any infections). Pt also reported she got tested twice for COVID-19 on 3/17/2021 & 3/23/2021 (results on both dates: negative). Pt reported that her PCP had advised her against getting the second dose. Advised pt that per her ADEs these are not a contraindication to getting the 2nd dose per CDC guidelines and per consulted Dr. The decision to get the second dose is up to her and her PCP. Advised pt that there is not knowing if the 2nd dose will make her tinnitus worse or if she will experience any ADEs. Also advised per CDC guidelines, "if it is not feasible to adhere to the recommended interval, the second dose of BioNTech COVID-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose. There are currently limited data on efficacy of mRNA COVID-19 vaccines administered beyond this window. If the second dose is administered beyond these intervals, there is no need to restart the series". 4/18-Patient feeling much better, symptoms have resolved with the exception of weakness and fatigue. Patient has taken Advil to help alleviate migraine. No longer has migraines. Caller called back to adv that she is still having tinnitus and post nasal drip from the 1st shot.
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| 56 | 2021-04-24 | feeling drunk |
This is a spontaneous report from a contactable consumer reported for self. This 56-year-old female ...
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This is a spontaneous report from a contactable consumer reported for self. This 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient received her 1st dose of the Pfizer COVID vaccine earlier this morning. She mentioned that she had no allergic reaction but had experienced heavy dizziness, really bad weakness and tiredness, and muscle pains in the shoulders and arm the same day. She was feeling unwell and really tired to point of feeling like she's drunk. She drove 10 miles in her car on her way home from the vaccination facility and was struggling because of her symptoms, particularly the drunken feeling. She was asking if she needed to go to the emergency room. Patient was referred to HCP if symptoms persisted or if the patient felt the need to do so. The outcome of events was unknown. No follow-up attempts are needed. Information about lot/batch number can be obtained.
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| 56 | 2021-04-25 | anxiety, feeling abnormal |
One hour after receiving the vaccine, the patient started feeling poorly with some anxiety and what ...
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One hour after receiving the vaccine, the patient started feeling poorly with some anxiety and what appears to her to be some involuntary body movements she has no history of ms/neuro issues.
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| 56 | 2021-04-26 | anxiety |
Patient Received her second dose Pfizer (LOT#: EW0172 EXP: 8/2021) at 1224 on 4/23/21. Patient had b...
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Patient Received her second dose Pfizer (LOT#: EW0172 EXP: 8/2021) at 1224 on 4/23/21. Patient had bad anxiety attack during her first dose. PHN decided to stay with patient for a little. Patient requested husband to stay with her. 5 minutes into observation patient started exhibiting similar signs to her last anxiety attack. Patient used coping mechanisms to relax. PHN offered patient some juice. patient accepted the juice. PHN also stayed with patient to make sure she was alert and oriented. EMT took vital signs and vital signs were normal. Patient finished 30 minute observation. Patient walked out of vaccination area with a steady gait with her husband.
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| 56 | 2021-04-26 | sensation of foreign body |
Prior to administering vaccine, nurse discussed anaphylactic reactions to mango and bee stings. Not...
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Prior to administering vaccine, nurse discussed anaphylactic reactions to mango and bee stings. Not a component in vaccine but will monitor for 30 minutes after. discussed risk vs benefit. Answered pt questions and administered vaccine. 11:23am pt reported to nurse tingling sensation around mouth and lump in back of throat. breathing WNL. Administered benadryl at 11:23am with consent of pt. Continued to monitor. 11:45am pulse 85, BP 168/98, respirations 16. Denies SOB. Pt feels sensation in back of neck going up to head. Tightness in throat and compares it to her previous anaphylactic reactions. Notices vision changes. 11:50am pulse 82, strong and steady, BP 158/90. respirations WNL. Discussed epinephrine with pt. pt agreed. administered 0.3 mg 11:52am, called EMS. Continued to monitor pt. 11:59am pulse 88, BP 160/100, respirations WNL denies SOB. Normal pallor. Responding appropriately. Pt stated feeling tired and wants to just close her eyes, "feeling my body react". Continues to complain of lump in throat, itchy eyes. 12:03pm discussed, consented and administered second dose of Epinephrine 0.3mg. EMS arrived, pt still responding appropriately. Pt left via stretcher to ER.
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| 56 | 2021-04-27 | feeling abnormal |
Felt like she was floating. Patient refused transport. Patient stated that she is feeling better. ...
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Felt like she was floating. Patient refused transport. Patient stated that she is feeling better. Patient advised if not feeling well to call 911 or primary doctor. Verbalized understanding. B/S 189, BP 146/90, HR 80, O2Sat 100.
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| 56 | 2021-04-27 | loss of personal independence in daily activities |
Patient tells me 2 days prior to vaccine on 3/3 (Pfizer) she had mild hives?not unusual for her in ...
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Patient tells me 2 days prior to vaccine on 3/3 (Pfizer) she had mild hives?not unusual for her in the spring. They typically occur along with seasonal allergies and she thinks the hives are unrelated to current rash. She went ahead and had the 1st Pfizer vaccine on 3/3. She developed a new circular rash at the injection site on the left arm and new rash over the left side of her back described as ?on fire?. she was seen for a telemedicine clinic visit diagnosed with possible shingles and was prescribed treatment. Did not improve significantly. She went ahead and had the second Pfizer jab on 3/24. She developed extreme tenderness at injection site. the rash that was on her back got much worse and spread. The rash occurs any place she scratches, has blood drawn or gets a band-aid placement. After that second shot she also noticed that her hip joints feel ?weak and unhinged". . Has also had similar symptoms of weakness in bilateral shoulders. Feels like her leg muscles are weak (points specifically to quadriceps). She has trouble repositioning herself and doing normal activities that she had been doing without difficulty just a few weeks ago. Her RN notes that she can get out of bed and walk to bathroom but is unsteady and shuffles. Has also noticed facial and periorbital swelling with purple discoloration and darkness around eyes. Had a faint pink rash extending from eyelids up over brows that has now decreased. Feels her legs are puffy and swollen.
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| 56 | 2021-04-28 | confusional state, mental impairment |
Client complained of throat closing minutes after getting to observation tent. Then she c/o right si...
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Client complained of throat closing minutes after getting to observation tent. Then she c/o right side abdominal pain, "hot and tight." Then "weird taste in my mouth." I spoke with client and she seemed not clear and a little confused.
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| 56 | 2021-04-28 | fear |
I was awaken by a fast heart beat, that made me completely fearful and then I developed diarrhea. I...
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I was awaken by a fast heart beat, that made me completely fearful and then I developed diarrhea. I took 2 (two) Bayer aspirins, waited 2 hours and took 2 more aspirins. Later, I took Tylenol for pain. I'm still experiencing a little tightness.
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| 56 | 2021-04-28 | feeling abnormal | Dizziness, lathergy/no energy, spacy feeling, sleeping a lot. |
| 56 | 2021-04-28 | insomnia |
it was not liquid coming out of my rectum but a grey/taupe very soft stool; gassy; my stomach and ba...
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it was not liquid coming out of my rectum but a grey/taupe very soft stool; gassy; my stomach and back side were very pain full; sour belches; vomited; having dark liquid diarrhea pouring out of my rectum; I could not sleep; my entire stomach area was swollen and in extreme pain just to touch; my entire stomach area was swollen and in extreme pain just to touch; my back side was raw and bleeding; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 08Apr2021 18:45 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included blood pressure (BP), sleeping, cholesterol. Patient had no covid prior vaccination. Concomitant medications included calcium and unspecified Multi Vitamin. No other vaccine in four weeks. The patient previously took erythromycin (EMYCIN) and experienced allergies, hydrocodone bitartrate/paracetamol (VICODIN) and experienced allergies. The patient experienced her back side was raw and bleeding on 12Apr2021, sour belches on 12Apr2021 08:00, vomited on 12Apr2021 08:00, having dark liquid diarrhea pouring out of her rectum on 12Apr2021 08:00, could not sleep on 12Apr2021, her entire stomach area was swollen and in extreme pain just to touch on 12Apr2021, her stomach and back side were very pain full on 13Apr2021, it was not liquid coming out of her rectum but a grey/taupe very soft stool on 14Apr2021, gassy on 14Apr2021. No treatment received. No covid tested post vaccination. Clinical course: She received the first Pfizer vaccine on 08Apr2021 evening, she thought it was easy, no problems. 12Apr2021 morning driving to work she started having sour belches, she got to work and ran to the bathroom, she vomited #6 times while having dark liquid diarrhea pouring out of her rectum, it finally stopped, 3 hours later it started again, she vomited 4 more times with more dark liquid pouring out of her rectum. Her boss sent me home. At home she was running back and forth to the bathroom the rest of the day with dark liquid diarrhea and another vomiting session throwing up #5 more times for a total of #15 Times. She could not sleep as her entire stomach area was swollen and in extreme pain just to touch and her back side was raw and bleeding. 13Apr2021 morning she vomited 3 times along with still having dark liquid diarrhea pouring out of her rectum and her stomach and back side were very pain full. 14Apr2021 she could not go to work again, she had no vomiting but continued with the on going dark liquid until 3:00 PM, she went to the bathroom and it was not liquid coming out of her rectum but a grey/taupe very soft stool. Her stomach area continued to hurt, she was still gassy. She only ate a banana, toast and Gatorade per the Dr. This was such a horrible experience. After the first shot she was praising the Pfizer Shot, now she would not. She did no really want the second shot after this experience. She was a new widow struggling, she had no one to help her, she had no phone as she had thrown up on her new phone and ruined it. This was such a terrible experience. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 56 | 2021-04-28 | memory impairment, feeling abnormal, amnesia |
shaking, muscle spasms, eyeball spasms, fatigue, tightness in thigh and arms, come and go rash on ba...
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shaking, muscle spasms, eyeball spasms, fatigue, tightness in thigh and arms, come and go rash on back of arm, headache, fuzzy-headed, ringing in ears that sometimes sounds like an ambulance siren, had menstrual cycle 1 week after shot and haven't had one in two years. intermittent chills, cold and sweat at same time, takes longer to find words, brain seems slower - something I've been doing for years I have to look up because I can't remember. severe shakes from waist up I think it's called convulsions but only once so far, chest tight and shallow breathing, forgetfulness
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| 56 | 2021-04-29 | nervousness |
severe body aches, joint aches, for two days, followed by vomiting , severe head pain, head spins, n...
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severe body aches, joint aches, for two days, followed by vomiting , severe head pain, head spins, nervousness stomach, diarrhea and despair for a few weeks. I cancelled the second shot, I don't feel strong enough to do the second shot, was not expecting severe reactions with the first shot.
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| 56 | 2021-04-29 | sleep disorder |
Onset of sx started several hours after first Covid vaccine. Started with severe injection site pain...
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Onset of sx started several hours after first Covid vaccine. Started with severe injection site pain, diffuse pruritis, body aches, fever 101.7 axillary, chills/sweats, and severe HA. Took acetaminophe, alternated w ibubrofen every 4 hours overnight. Next AM woke w T 99.7 axillary, HA, weakness, severe body aches, fatigue, sore throat and dry throat. Injection site swollen to ~7 mm diam with bruised appearance, extremely tender, unable to lie on L side. Able to sip sports drink; warm, clear liquids (soup) without appetite. Continued w Ibuprofen HA formula. Sleep difficult due to chills/sweating. Also frequent cough, SOB with ADLs. Recd Dose #2 Pfiz 4/5/21 - s/sx worsened significantly and CONTINUE.
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| 56 | 2021-04-30 | abnormal dreams, sleep disorder |
About 24 hours after my second COVID vaccine I was asleep and started having strange dreams. Woke my...
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About 24 hours after my second COVID vaccine I was asleep and started having strange dreams. Woke myself up several times talking in my sleep. I woke up to chills, fever, vertigo, muscle weakness and pain, shin sensitivity on back only. A lot of pan on vaccination site. Pressure behind my eyes, fatigue.
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| 56 | 2021-04-30 | confusional state |
Woke up with chest pains diagnosed as blood clots in both lungs.; Mental confusion; This is a sponta...
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Woke up with chest pains diagnosed as blood clots in both lungs.; Mental confusion; This is a spontaneous report from a contactable consumer reporting for herself. A 56-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left Arm on 31Mar2021 13:00 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation . Medical history included sleep apnoea syndrome , depression , drug hypersensitivity to penicillin. Concomitant medications included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported; meloxicam (MELOXICAM) taken for an unspecified indication, start and stop date were not reported. The patient previously took Biaxin and experienced drug hypersensitivity, first dose of bnt162b2 for covid-19 immunisation on 10Mar2021. The patient woke up with chest pains diagnosed as blood clots in both lungs on 10Apr2021 08:30 with outcome of recovering , mental confusion on 10Apr2021 08:30 with outcome of recovering. The patient was hospitalized for 3 days because of the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Apr2021 . The patient is receiving apixaban (ELIQUIS) as treatment of the reported events. Follow up information has been requested. Lot number already received.
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| 56 | 2021-04-30 | feeling abnormal |
I felt tingling in the feet hands and mouth; After a lot of sleep; second day strong pains began in ...
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I felt tingling in the feet hands and mouth; After a lot of sleep; second day strong pains began in the back; Inflammation in the ganglia; shortness of breath; High or slow heart rate; I began to feel strong pain in my spine, legs and joints; I feel uncoordinated to speak; I began to feel strong pain in my spine, legs and joints; It is a horrible feeling.; This is a spontaneous report from a contactable consumer (patient herself). A 56-years-old non-pregnant female patient started therapy with bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162), via an unknown route on 16Apr2021 at 1:00 pm in the arm left as a single dose for COVID-19 immunization. The patient's medical history included hypertension and a liver problem. Patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient 2 weeks prior to the COVID vaccine included Bisoprolol (5mg). Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient did not have allergies to medications, food or other products. On 17Apr2021 at 14:30, the patient felt tingling in her feet, hands and mouth and became very sleepy. On the second day after vaccination, patient felt strong pain in her spine, legs and joints and neck. The patient also reported neck lymph nodes inflammation and shortness of breath. Patient reported that high or low heart rate and she felt uncoordinated to speak. Patient described that it as a horrible feeling. The outcome of the events was not resolved. It was unknown if the patient taken any treatment due to AE. No follow-up attempts are needed. No further information is expected.
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| 56 | 2021-05-10 | nervousness, anxiety, feeling abnormal |
she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; ...
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she thinks may be blood clot or a muscle but not really sure; passed out; very anxious and nervous; her heart is beating fast and she is nervous.; burning sensation in her ear; tiredness; headache; heaviness on her back and chest on the left side; heaviness on her back and chest on the left side; no appetite; nauseous; diarrhea; throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh she could feel crushing and throbbing; her heart is beating fast and she is nervous.; sharp pain in her thigh/pinching sensation on inner thigh; sick; throbbing; muscle pain; weird sensation; throbbing sensation to the left side of her belly button/It was like at her stomach; fever of 100.3F; had a feeling of heat on her neck, face, and ears; redness and itchiness at the injection site; redness and itchiness at the injection site; the injection was large, red, hot, and itchy; the injection was large/ the swelling went down; dizzy; This is a spontaneous report from a contactable consumer reported herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included disability, obese, covid-19 when she was sick with COVID last year, she has never been that sick. she thinks she made it through because she owns a nebulizer and can say her lungs have never felt like they were full of fluid. If anything, they felt heavy. It was heavy in her back and chest. She also had a fever. She guesses she would be considered obese. Concomitant medications included paracetamol (TYLENOL). The patient received the first dose of the Pfizer COVID vaccine last week and she has experienced several side effects and is very anxious and nervous. She experienced redness and itchiness at the injection site, pinching sensation on inner thigh that she thinks may be blood clot or a muscle but not really sure, fever of 100.3F from 24Apr2021, burning sensation in her ear, tiredness, headache, heaviness on her back and chest on the left side, no appetite, nauseous, diarrhea, had a feeling of heat on her neck, face, and ears, throbbing sensation to the left side of her belly button from 26Apr2021 and she felt dizzy from 22Apr2021. The patient stated there was a bad connection and she was having difficulty hearing. The patient was a little nervous. Maybe this was a psychosomatic issue and she was thinking of things too much. She was sick for 5 weeks. She was never in the hospital or intubated. The site where she had the injection was large, red, hot, and itchy. It was from 22Apr2021 (Thursday) for the next maybe 3 days. Now the color is diminishing, the color is going down more like to pink and smaller and it not itching anymore. Once in a while she got a pinching sensation on her inner thigh ever since she had the injection. In the last couple days, she has been feeling a that a little more. She wanted to make sure it was not a symptom of a blood clot. She doesn't feel short of breath. She was nervous talking the call handler so that is why she is talking fast. She doesn't want to feel so sick like she did last year when she had it in March or April. She wanted to know that it's not a symptom of a blood clot. It was a throbbing pinching pain that goes and doesn't come back for a little bit, but it might come back a little bit later. It happened when she woke up. She has no swelling in her legs or thighs or anything else. She says she would not be talking this fast, but her heart was beating fast and she was nervous. She tended to be an anxious and nervous person. The patient never had blood clot issues. She wanted to make sure with everything that she has heard about Pfizer she hasn't heard of anyone having blood clot issues. She had to read to calm herself down a bit. It is a sharp pain with throbbing that comes and goes. She didn't read where it could be a blot clot, she just wanted to know. She is horrible at running to the hospital when she feels something because she gets so nervous and she thinks knowing is better because she's a realist. It takes her a minute to go to the hospital to figure it out. If she continues to feel like this she and her daughter will go to the emergency room. It is 5 blocks away. It is a small little hospital and they will be able to ease her mind. It could be her nerves getting to her too. Her fever got up to 100.3 and that was only on Saturday, 48 hours after the vaccine. Once she took Tylenol it was gone and didn't return again. She took her temperature; it was a beeping one. She always says she would take like 2 out of 3, and every time she took it went up. She felt a weird sensation of burning in her ears, the same as when she first had Covid, feeling like a fever. It brought her back to a bad place and it freaked her out. She is on disability and has people go to the store for her. She did that for 3 to 4 months. She is not agoraphobic, but she hadn't gone out until she got the vaccine. It took her all day to get back home because she loves the outdoors. It is kind of sad, and she knows she is not the only one who experienced that. She was able to actually stay at home, and when she went out, she wanted to stay. She still has her second dose to take, not everyone in has this and she doesn't want to feel that sick again. Eventually she will perish away one day, from God knows what but a slow death of not being able to breathe she cannot picture for herself or anybody else. She tries not to watch the news, it was depressing, because it is all over the news, she tries to stay in the loop. She was tired and had a headache. She took Tylenol and slept for an hour or hour and half. When she woke up she felt heaviness on her back and chest on the left side, and as she moved around more it was on her back and less on her chest. It was the same as she felt when she had Covid. She didn't have any aches or pains. The other thing was she had no appetite for the next 3 days. Every time she woke up, she felt extremely nauseous but had nothing to vomit. For the next 3 days or 72 hours, she had diarrhea. If she ate anything, she was in the bathroom. On 24Apr2021 (Saturday) after 48 hours she started to feel the heat in her neck and face and ears like right on her ears. She was talking to her daughter and her daughter said these are normal. Where she got the injection was itchy and a little more red. She told herself not to scratch it in her sleep, she is one of those people if something itches, she scratches. What she would do is rub her arm up and down on the site. It was almost the size of an 8 ounce tomato sauce can or maybe the size of a baseball. Then the third day it got redder. In her sleep she was rubbing her arm because it got itchy. Today the swelling went down, the color is like a light pink, and the size is also minimized. The fever lasted that night. She took her temperature again the next day and it was 97.9. That is usually what it is when she wakes up. She is not just tired; she is exhausted and feels like she has to go to sleep. Her daughter came with her granddaughter who is a baby, and she didn't know how to tell them. She was happy to see them but so exhausted. She worries about the sharp pain in her thigh. The other thing is she started getting pain in the middle of her thigh, her inner thigh. A sharp pain with like a throbbing is almost like a band-aid is too tight. If she rubbed her hand across her thigh, she could feel crushing and throbbing. She can feel it from touching the area. She had this before like when she is stretching. It started maybe 3 months ago and went away but then after she took the injection and heard about thing, she worried about a blood clot with Johnson & Johnson, not that she would know because she has never had a blood clot. It could be psychosomatic and all working in her head. It started the last 2 days when she woke up, she felt fine and as she was lying in bed, she started feeling a sharp throbbing pain that eventually goes away. She has no swelling of her legs or thighs, and her daughter said it looks fine. She is semi-terrified of hearing bad news. It takes her longer to go to the hospital. If she starts feeling worse, she will be there in no time. She does not want to wait until it is worse, but she does not want to spook herself into going. She suffers from anxiety. She definitely had the fever not like she was just tired it was like she was exhausted. She got up early and would take a little nap because she was doing a bunch of stuff. That hasn't happened, but that's her. It will be 2300 when she goes to sleep. She was doing a bunch of stuff and felt like she just needed to take a nap. Maybe it is part of that too, but usually she doesn't feel tired like this. After her daughter left, she read something on her phone and passed out. When she woke up, she saw she actually dropped her phone. Her thigh is now not a pinch but more a little bit of a muscle pain. Now it is not like the inner thigh, it is more behind the thigh now, but not below the knee, right behind the thigh, closest to the knee but not on the knee. It is the same thing as if the middle had gone behind her thigh a bit. The little pillow on her chair is not helping anything either. It feels like it maybe muscular, its deep feeling. It feels like it could be muscle, if she rubs it, she can feel it. When asked has it improved persisted or worsened, caller states it is there, but it is dull. She can say there is pain, but it is a little duller just because it is more in the muscle. It is hard to explain, it was not the same throbbing pain but there is a dull pain, it goes around the chunkier part of her thigh, like the inner thigh. When she rubs it there is pain but a dull pain. When she rubs it, it feels better but she can still feel the site where it hurts. When she rubs it, it is still located right in the lower middle going toward her knee but not at the knee, maybe 3 to 4 inches away from the fold of her knee, almost at the center of her thigh almost. Almost like a dull muscle ache, there is a bit of throbbing with it. She will go to the doctor if something weird happens and will call back when they have an idea of what happened to her. This will sound crazy. The next thing she felt was a light throbbing where her belly button is but more to the left side, but not at the belly button. It was like at her stomach, not right at the belly button but right on the same line as her belly button but more at her waist. It was a small throbbing started today about an hour ago. She is hoping it is gas. Her fever went away pretty fast. She was on the phone and took her temperature to tell what it was. The woman said to take some Tylenol. It went from 99.9 to 100 to 100.3. She thought oh no. That was the highest she saw. Then eventually it started going down to 99.4, and then by morning it was back to normal. She only took Tylenol the one time. She is thinking maybe it is from being nervous and causing her body to heat up. She doesn't know she is just thinking. She thinks the fever went away the same day within an hour to 2 hours. She also wasn't drinking enough water. When asked if her fever has recovered completely or with last effects, caller states that is fine now, her temperature today was 99.4 without the fan on, she says she thinks that was pretty normal. When she first wakes up it is 97.9 usually. There was also a 98.4. The redness and itching at the injection site started 3 hours after the injection. She took her 2 sons with her. She took it and then her son took it. They said to wait 15 minutes. As soon as she stepped out, she looked up and felt so dizzy. It looks like when in summer and it seems to be boiling hot, that is how it got for her. Things got blurry. It was not like she was going to black out, but she had to close her eyes because the room was going to spin. She knocked back on the door and took a seat, so she sat down because she was not feeling right. When she gets nervous, she chews gum as a coping mechanism. Her son got some gum for her. She felt better but kind of nervous waiting for 15 minutes to go by, what if she felt dizzy again. She let 20 minutes go by and she got up and was fine. She wanted to be out of there and in the cool air outside. That is the first reaction that she had. She is one of those people that feel so nervous she is sure that happens that they feel like, oh they are so nervous, and they read so much, and it is in our faces everyday no matter what. Maybe it had nothing to do with the injection, maybe more that she was so nervous, but it was a weird sensation after. She knows when people first started getting the COVID vaccine, people were just like falling to the ground, she was like that would be terrible. She went with high expectations and was also nervous. Her heart was beating, and she could hear her own heartbeat. She still feels tired and like she can go take a nap now. She asks if that is normal. She would rather talk to Medical Information now. She is over this statistics part of it. She doesn't feel a release, she is just giving her information and she doesn't feel any better. Outcome of the event throbbing sensation to the left side of her belly button/It was like at her stomach was not recovered; of the event dizzy was recovered; of the events the injection was large, red, hot, and itchy/ the swelling went down, tiredness was recovering; of the other events was unknown. Information about lot/batch number has been requested.
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| 56 | 2021-05-13 | anxiety, nervousness |
Following 15 min observation period, patient reported tingling face and lips and throat closing. Pr...
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Following 15 min observation period, patient reported tingling face and lips and throat closing. Prior to vaccination, patient was nervous and reported anxiety regarding the vaccination. Vitals 6:39 p - BP 170/85, SpO2 95%, 71 bpm 6:50 p - BP 156/81, SpO2 96%, 78 bpm 6:55 p - BP 135/73, SpO2 96%, 80 bpm Patient reported tingling went away; left clinic with daughter who could drive.
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| 56 | 2021-05-14 | delirium |
Delirium; swelling inside of throat; dizziness; Slurred speech; neck pain; flushed skin; Heart palpi...
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Delirium; swelling inside of throat; dizziness; Slurred speech; neck pain; flushed skin; Heart palpitations; Headache; worse throat itchiness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 28Apr2021 15:30 (Lot Number: ER8736) as 2nd dose, single for COVID-19 immunization. Medical history included myocarditis from COVID, elevated BP and known allergies: Cipro and IV contrast dye for CT scans; all from an unknown date and unknown if ongoing. The patient previously took BNT162B2 (lot number: EW0150), 1st dose, on 07Apr2021 04:00 PM in the left arm for COVID-19 Immunization and experienced swelling inside of throat, dizziness, slurred speech and delirium at 56 years old. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had other unspecified medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Apr2021 04:45 PM, the patient experienced swelling inside of throat, dizziness, slurred speech, delirium, immediate base of neck pain, flushed skin, heart palpitations, headache and worse throat itchiness. The patient did not received treatment for the events. The outcome of the events was recovered on unspecified date. Information on lot/batch number is available; additional information has been requested.
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| 56 | 2021-05-14 | delirium |
delirium; swelling inside of throat; dizziness; slurred speech; This is a spontaneous report from a ...
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delirium; swelling inside of throat; dizziness; slurred speech; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EWO150), via an unspecified route of administration, administered in arm left on 07Apr2021 at 16:00 (at the age of 56-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included myocarditis from COVID, elevated BP and allergies to IV contrast dye for CT scans, all from an unknown date and unknown if ongoing. Concomitant medications included other medications (unspecified). The patient previously took cipro and experienced allergies. For both shots, the patient experienced swelling inside of throat, dizziness, slurred speech and delirium on 07Apr2021 at 16:45. There was no treatment received for the events. The outcome of the events was recovered on an unspecified date.
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| 56 | 2021-05-14 | feeling abnormal |
this time she began to pass out; tingly sensation in her left arm and left hand; numbing feeling; br...
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this time she began to pass out; tingly sensation in her left arm and left hand; numbing feeling; brain has a swooshy feeling; she was in a position of where she might pass out; did not feel so great; she felt weird; like she is groggy; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 28Apr2021 at 14:00 (at the age of 56-years-old) as a single dose in the right arm for COVID-19 immunisation. Medical history included car accident in 2019 (two years ago; she slammed her hand into the steering wheel and she was not sure if that was the injury that caused her hand to hurt like arthritis), arthritis from an unspecified date and unspecified if ongoing and history of passing when she gets shot or blood drawn as a young girl from an unspecified date and unspecified if ongoing. Medical history (including any illness at time of vaccination) and family history relevant to the adverse event were both reported as no. The patient stated that she had never had symptoms or adverse events after prior vaccinations. Concomitant (other) products were reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine or on the same date as the COVID-19 vaccine. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8737) via an unspecified route of administration on 06Apr2021 at 12:15 (at the age of 56-years-old) as a single dose in the right shoulder upper arm for COVID-19 immunisation and experienced she felt high, inflamed bursitis in the knees, could not walk, felt a little depressed, could not form words very well, she felt sleepy and her arm and her hand was hurting. On 28Apr2021 the patient experienced this time she began to pass out, tingly sensation in her left arm and left hand, numbing feeling, brain has a swooshy feeling, she was in a position of where she might pass out, did not feel so great, she felt weird and like she is groggy. The clinical course was reported as follows: The patient stated that she was supposed to wait 15 minutes after getting the second dose of the vaccine and within a few minutes she had a tingly sensation in her left arm and left hand that was more so towards the pinky and her ring finger area. She used to have a history of passing when she got a shot or blood drawn as a young girl, but as her brain had experienced this over and over again she had been fine; however, this time she began to pass out. Since she knew it was coming with the tingling, she knew it was not normal, so she immediately went and told the employees that she was in a position of where she might pass out. So, she laid down and did not feel so great, but probably 20 minutes went by and she felt weird. It took her 45 minutes to decide to sit up and then 15 minutes later she left. The tingly sensation in her left arm and left hand was gone, but she had a left-over numbing feeling. The patient also reported that her brain had a swooshy feeling, like she was groggy, and she did not want to turn her head too fast because she felt like she would not like it. Relevant tests were reported as no. The clinical outcomes of the events this time she began to pass out, tingly sensation in her left arm and left hand, she was in a position of where she might pass out, did not feel so great and she felt weird were recovered/resolved on 28Apr2021 while the clinical outcomes of the events numbing feeling, brain has a swooshy feeling and like she is groggy were not recovered/not resolved.
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| 56 | 2021-05-14 | sleep disorder |
fluttering in chest; Nauseous; Dizzy; extreme fatigue; cold like symptoms; sore throat; slept on and...
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fluttering in chest; Nauseous; Dizzy; extreme fatigue; cold like symptoms; sore throat; slept on and off for 2 days; sinus drainage; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in arm right on 21Apr2021 at 12:45 (at the age of 56-years-old) as 2nd dose, single for COVID-19 immunisation. Concomitant medication included omeprazole taken for an unspecified indication, start and stop date were not reported. The patient previously took minocycline and had allergies. The patient also previously received the first dose of BNT162B2, administered in right arm on 31Mar2021 at 12:45 PM (at the age of 56-years-old) for COVID-19 immunisation. The patient experienced nauseous, dizzy, extreme fatigue, cold like symtoms with sore throat - sinus drainage, fluttering in chest and slept on and off for 2 days on 22Apr2021 at 04:00. The patient went to the doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 28Apr2021. There was no treatment received for nauseous, dizzy, extreme fatigue, sore throat, fluttering in chest and slept on and off for 2 days. The outcome of the events was unknown.
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| 56 | 2021-05-23 | feeling abnormal |
Dizziness within minutes of shot; burning sensation as injection site; Exhaustion lasting all day lo...
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Dizziness within minutes of shot; burning sensation as injection site; Exhaustion lasting all day long, extremely foggy brain, blood circulation is poor; feet get red while sitting, hands getting red and prickly feeling. Zingers to the stomach, only on the first day. Zingers to the upper left chest area on 5-24-2021. My joints have been sore since day of injection.
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| 56 | 2021-05-26 | excessive sleepiness |
Vaginal bleeding in a menopausal woman with blood clots.; Vaginal bleeding in a menopausal woman wit...
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Vaginal bleeding in a menopausal woman with blood clots.; Vaginal bleeding in a menopausal woman with blood clots.; Also slept for 13 hours the day following the shot and had a continual headache with nausea; Also slept for 13 hours the day following the shot and had a continual headache with nausea; Also slept for 13 hours the day following the shot and had a continual headache with nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06May2021 at 09:45 at single dose in left arm for COVID-19 immunisation at the age of 56-year-old. Lot number EW0183. Medical history included menopausal woman. Concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 at 10:30, Lot number EW0164, dose number: 1, in left arm. On 06May2021, the patient also slept for 13 hours the day following the shot and had a continual headache with nausea. On 10May2021, the patient experienced vaginal bleeding in a menopausal woman with blood clots. It was very concerning; the patient was going to Ob/Gyn soon. The patient underwent ultrasound and biopsy. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Follow up needed, further information has been requested
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| 56 | 2021-05-27 | feeling abnormal |
For 14 days from vaccination in the following order varying from day to day Day 1 and2-sore arm and ...
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For 14 days from vaccination in the following order varying from day to day Day 1 and2-sore arm and fatigue Day 3-Fever, chills, joint pain Day 4,5,6-bad headache Day 7-felt better thought clearing out Day 8-terrible sore throat and heavy sweating at night gone by next day Day 9-ok just fatigue Day 10-fatigue and Brain Fog Day 11- Woke up with flush leg rash that was alarming took a picture, it was gone by lunch time Day 12-Brain Fog and Fatigue Day 13-Brain Fog and Fatigue Day 24-Brain Fog and Fatigue
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| 56 | 2021-05-28 | depressed mood, abnormal dreams |
headache; intermittent nausea; bloating; sweats/day sweats; chills; hot flashes; leg weakness/ legs ...
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headache; intermittent nausea; bloating; sweats/day sweats; chills; hot flashes; leg weakness/ legs "tired" for no reason; feeling depressed; stressful dreams; aches; night sweats; This is a spontaneous report from a contactable consumer (patient) via A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 25Feb2021 13:00 as second dose single for covid-19 immunisation. Medical history included asthma and latex allergy. Concomitant medications included clonazepam, naproxen sodium (ALEVE) and ALBUTEROL (SALBUTAMOL) all are taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient previously took hydrocodone and gluten intolerance and experienced known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient received second dose of the Pfizer vaccine, last Thursday 25Feb2021 around 1pm. Patient reports having a headache on and off ever since. Her worst day was yesterday, today is the first day she actually is going on a walk. She has experienced nausea, bloating, headache on 27Feb2021 17:00 and had to cancel a dental appointment. Patient does not remember exactly when the symptoms started but probably later in the day on Thursday. That night she had sweats, chills, but never had a fever the two times she checked. Patient did feel hot, like hot flashes though. Patient also experienced leg weakness starting on Sunday similar to if you had done strenuous activity the day before. Patient also reports feeling depressed from feeling run down and has had some stressful dreams, aches and night sweats on 27Feb2021 17:00. She declined being transferred to safety because she waited on hold for over 2 hours and then was hung up on. Patient did not receive treatment for the adverse events. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 56 | 2021-06-01 | feeling abnormal |
changes in breathing; it just feels different; a little nauseous; a little achy/body aches; headache...
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changes in breathing; it just feels different; a little nauseous; a little achy/body aches; headache in the top of her neck; tiredness/extremely tired; chills; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 05May2021 at 15:45 (Batch/Lot Number: EW0167) as, single dose for covid-19 immunization. Medical history included ongoing hyperthyroidism, seasonal allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 25May2021, morning she woke up, 20 days after receiving her first vaccine and patient was extremely tired, she had to lay back down. She was a little nauseous, a little achy, had a headache in the top of her neck and changes in her breathing stated that it just felt different. She does think it was related to the Covid 19 vaccine because her husband woke up with the same symptoms last week on 19May2021. She took a powernap this morning and she felt better. She also had chills, not shivering, just kind of like a chill and then she was fine. That was this morning also. She had a sweatshirt on. She started blaming her symptoms on seasonal allergies. She still had a little headache at the top of her neck. She was still tired, she could lay down and go to sleep. She has hyperthyroidism so being tired is not normal for her. She was leery over getting the second Covid 19 vaccine because she was heard that people get sicker after the second dose. The outcome of the events nausea, changes in breathing was unknown and other events was not recovered.
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| 56 | 2021-06-01 | insomnia |
muscle pain; headaches; swollen glands; the arm where the vaccine was injected could not be lifted a...
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muscle pain; headaches; swollen glands; the arm where the vaccine was injected could not be lifted and I still have difficulty lifting it; stiff neck; pain it causes in my back, legs, neck; lack of strength making it difficult for me to sleep; lack of strength making it difficult for me to sleep; The levels my doctor sees for the CReactive protein QT test have doubled.; 4 days with fever; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received BNT162b2 (BNT162b2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) via an unspecified route of administration on 07-APR-2021 11:30 (Lot number: GW0151, Expiry date: Unknown) as 2nd dose, single dose for COVID-19 immunisation. Medical history included Ankylosing Spondylitis, Hypothyroidism, uveitis. The patient previously received first dose of BNT162b2 on 07-MAR-2021 11:45 (Lot number: EN6207, Expiry date was unknown) for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not diagnosed with COVID 19 since the vaccination. Concomitant medications included levothyroxine sodium (SYNTHYROID), folic acid (MANUFACTURER UNKNOWN), methotrexate and adalimumab (HUMIRA) for an unknown indication. On 08-APR-2021 09:30(after 21 hours) experienced fever and on an unknown date muscle pain, headaches, swollen glands, the arm where the vaccine was injected could not be lifted and still have difficulty lifting it, stiff neck, pain it causes in her back, legs, neck, lack of strength making it difficult for me to sleep, lack of strength making it difficult for me to sleep, the levels her doctor seen for the C-Reactive protein QT test have doubled. The patient visited doctor and told him that since she received the vaccine her body was not the same and the pain do not stop. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included C-Reactive protein QT test have doubled on 12Apr2021 was 7500 and on 26Apr2021 was 8510. Therapeutic measures were taken for the events with Medrol-Valium-Mobic. The outcome of the event fever was not recovered and rest of the events was unknown. Follow-up attempts are possible. Further information is expected.
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| 56 | 2021-06-01 | sleep disorder, feeling abnormal |
Loss of taste smell hearing and blurred vision about 10% after second injection. Increase in Psorias...
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Loss of taste smell hearing and blurred vision about 10% after second injection. Increase in Psoriasis all over my entire body! Gout !Everywhere. I felt horrible for three weeks, no energy unable to eat or sleep. My bones still ache in May 2021. I did not tell anyone for fear they would not get vaccinated.
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| 56 | 2021-06-02 | anxiety, anxiety |
Acute anxiety; Adverse effect of COVID-19 vaccine; Heart palpitations; Numbness and tingling of righ...
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Acute anxiety; Adverse effect of COVID-19 vaccine; Heart palpitations; Numbness and tingling of right arm and leg
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| 56 | 2021-06-02 | feeling abnormal, insomnia |
she felt dizzy first.; Within 2 minutes heart was racing; felt numb in stomach area; she couldn't sl...
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she felt dizzy first.; Within 2 minutes heart was racing; felt numb in stomach area; she couldn't sleep; She felt like contractions in her stomach, like cramping; her whole stomach area getting hard; Her legs/knees were weak.; felt weird; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 31Mar2021 (at the age of 56-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Within 2 minutes of receiving the vaccine, heart was racing, felt numb in stomach area and felt weird. It lasted for two weeks. Primary care physician and cardiologist checked her out. It has been 6 weeks and was advised not to get the second dose. Should she get the dose? She feels like this is a severe reaction. She states she felt dizzy first. When she got home, she thought she was going to die. She laid down and thought she was going to pass out. A few hours later, her heart was racing, and she couldn't sleep. Symptoms alternated between feeling dizzy and her heart racing. She felt like contractions in her stomach, like cramping, and her whole stomach area getting hard. Her legs/knees were weak. She's dealt with this for 4 weeks "really bad". An ultrasound was done, and her heart is fine. The cardiologist said there is nothing to worry about. She feels better now since 6 weeks ago. She went to a cardiologist and her heart is fine, so it's nothing with her heart, but they don't know what it is. The extreme dizziness lasted for 4 weeks and it got a little better. Now she is kind of fine, she is not getting dizzy that bad anymore. Her heart is also fine, it's not that bad anymore. She was asking if she can get the second dose, can it happen again, and should she not take it? Her doctor told her she should wait. She went to her doctor who advised her to not receive the second dose of the vaccine. Should she take the risk of getting the second dose of the vaccine or maybe no? Her doctor doesn't know what to do. Now the first dose was 6 weeks ago, and she doesn't know how long she has to get the second dose. The patient underwent lab tests and procedures which included ultrasound scan: no result on an unspecified date. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 56 | 2021-06-07 | anxiety |
Patient reports 10 days of high BP, tachycardia, anxiety, stomach ache, difficulty breathing followi...
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Patient reports 10 days of high BP, tachycardia, anxiety, stomach ache, difficulty breathing following first dose of Pfizer vaccine. Per patient, the patient's doctor stated this reaction was likely anxiety-induced. Patient reports also having a rash a week later, which was resolved by Benadryl. Patient's doctor recommended second dose of Pfizer and patient requested to receive second dose despite reaction.
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| 56 | 2021-06-07 | feeling abnormal |
It started with feeling run down, are started hurting, started running fever, so then it proceeded t...
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It started with feeling run down, are started hurting, started running fever, so then it proceeded to feel nothing on my left side, feeling like with no strength at all. My left side start going down with no feeling. It stated with CIDP. GBS. Then I was admitted into the hospital on Sunday 03/28/2021. I was there for four days. Discharged on 03/31/2021.
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| 56 | 2021-06-07 | impaired work ability |
The participant did not have symptoms right away but she is diagnosed with the diabetes and still is...
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The participant did not have symptoms right away but she is diagnosed with the diabetes and still is sick. She had to take off work for a couple of days. She went to the ER and had tests done and checks up with the doctor regularly. When i went to the ER i was in the worst condition for two hours. The second vaccine made her body weak, according to the patient she thinks all of the medical conditions she has been experiencing is because of the vaccination. I had a lot of trouble sitting and working for a long period of time because my blood pressure kept shooting had to go the doctors a couple of time.
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| 56 | 2021-06-07 | sleep disorder |
she is having sinuses; it happened at night time as soon as night comes, my nose are close; because ...
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she is having sinuses; it happened at night time as soon as night comes, my nose are close; because there is no way I can't take sleep like that; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8737) via an unspecified route of administration, administered in arm left on 26May2021 (at the age of 56 years) as 1st single dose for COVID-19 immunisation. Medical history included hyperactive sinus from 2007 about roundabout for a while. Patient stated no family medical history of sinuses. The patient's concomitant medications were not reported. On an unspecified date in May2021, last night the patient had sinused and she took Sudafed. Patient enquired if it was okay that she had Sudafed in the dose of Pfizer Vaccine will this interfere wanted to know more information about this situation. Patient wanted to know if this was gone a affect her vaccine in any way that she took Sudafed other day, because she was going to watch tonight and see what happens tonight, If she can take another one or not. Patient informed it happened at night time as soon as night comes, her nose are close. Patient know it's not from the vaccine, that's just something that happens. Patient just wanted to make sure it was okay with taking Sudafed because she read about taking any Ibuprofen or any Tylenol prior to take a shot. Patient was not able to take sleep like that, so that's why, she just wanted to make sure that's okay. Patient clarified she did not have any sinus at the time of vaccination, just that night and this was something that happened all the time, not all the time whenever feels up, it just happens every now or then it just happened that night. Patient informed that the second dose will be on 16Jun2021. As therapeutic measure patient took Sudafed pill orally night only as per needed. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected
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| 56 | 2021-06-08 | feeling abnormal |
"Feel a little funny' "Had reaction first injection" seen by EMS @facility and released. Husband wil...
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"Feel a little funny' "Had reaction first injection" seen by EMS @facility and released. Husband will drive her home. Patient felt better after 5 minutes with EMS Pt. released. Recorded by RN.
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| 56 | 2021-06-08 | feeling abnormal |
Felt really bad; Strange tingling in fingertips and hands; Her hand goes numb. It is like a tingling...
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Felt really bad; Strange tingling in fingertips and hands; Her hand goes numb. It is like a tingling feeling; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: UNKNOWN), via an unspecified route of administration on 01May2021, as 2nd dose, single dose, for COVID-19 immunization and co-suspect drug included celecoxib (CELEBREX; Capsule, hard; Lot Number: Unknown) for arthritis. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: UNKNOWN), via an unspecified route of administration on 02Apr2021, as single dose for COVID-19 immunization. On 01May2021 at night, after the second shot, the patient experienced a strange tingling in her fingertips and hands, which continued. Patient wondered if it was a side effect and does not know if it improved, persisted or worsened. Patient had no prescribing doctor and she went to pharmacy. Patient felt really bad and had not moved around a lot. It started off with her fingers, and then her hand gone numb. It was like a tingling feeling, as if she laid on it , or slept on it. The clinical outcome of the event strange tingling in fingertips and hands was not resolved. The clinical outcome of all other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 56 | 2021-06-10 | feeling abnormal |
Broken out in a rash, felt extremely tired and fatigued, and brain fog; Broken out in a rash, felt e...
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Broken out in a rash, felt extremely tired and fatigued, and brain fog; Broken out in a rash, felt extremely tired and fatigued, and brain fog; Broken out in a rash, felt extremely tired and fatigued, and brain fog; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0178), via an unspecified route of administration on 27May2021 as 1st dose, single dose for COVID-19 immunization. Patient's medical history included osteoporosis, lung disease but it is very mild. It was reported that, a few months ago, on 28Mar2021, patient had a series of shingle shot and with the second shingle shot, patient also broke out in the same type of rash but this time, the first time with the shingle, patient had a rash on arms, legs, and chest but that cleared up. Patient waited longer than they told me to before getting the COVID-19 vaccine, the rash got cleared up, patient waited probably two to three more weeks, then patient got COVID-19 vaccine. Concomitant medications included prolia taken for osteoporosis from 14May2021, protonix (pantoprazole) and Valtrex. The patient experienced broken out in a rash, felt extremely tired and fatigued, and brain fog on 31May2021. The patient mentioned that she started noticing it 4 days after getting the first dose. The rash was still present, not getting any better; seem to be getting worse and was now being treated with cortisone. So, now the rashes are back, and patient just have a concern about getting second dose and asked what to do about that. Patient looking for some assistance and some support or advice. Patient shared that, would be travelling to the state of (withheld) and is required to have a COVID-19 Test just a few days after getting the COVID-19 vaccine. Patient mentioned the test is scheduled on 17Jun2021, and flight would be on 21Jun2021. The patient was not recovered from rash and the outcome of the events felt extremely tired and fatigued and brain fog was unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 56 | 2021-06-10 | feeling abnormal |
Head spinning; Body ache/Intense body ache; Aching or having such an intense ache that even her thum...
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Head spinning; Body ache/Intense body ache; Aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs; Felt horrible; Aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs; Temperature of 101/Had a temperature of 101; She just feels like the remnants of how you feel after you have a headache ; did not want to move; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 03Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 04Jun2021 the patient experienced head spinning , body ache/intense body ache, aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs, felt horrible, thumbs and ears on the inside were aching, aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs, Temperature of 101/Had a temperature of 101. Also, At 5:00 am this morning, she took 325 mg Aspirin (treatment) and is feeling so much better now. She just feels like the remnants of how you feel after you have a headache ; did not want to move. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The outcome of event was recovering. Follow up attempts are needed. Further information has been requested.
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| 56 | 2021-06-10 | sleep disorder |
Following my second shot, I have been experiencing pain in my legs. I describe it as feeling like it...
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Following my second shot, I have been experiencing pain in my legs. I describe it as feeling like it's in my bones, not necessarily my joints. It requires numerous position adjustments when sitting and lying down. It wakes me up several times in the night. I had none of these issues prior to receiving the vaccine.
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| 57 | 2021-01-01 | feeling abnormal |
Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired....
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Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired. Arm bruised and more sore than regular I'M injection. Feeling "off".
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| 57 | 2021-01-03 | sensation of foreign body |
right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headach...
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right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headache. I also had a chlorine taste in my mouth. I told the nurse I wasn't feeling well. she sat with me and was asking about how I was feeling. I the started trying to clear my throat. it felt like I had something in my throat. I kept trying to swallow and it just felt like my throat was getting tighter and tighter. that's when they got me on a stretcher and took me to the ER
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| 57 | 2021-01-04 | feeling abnormal |
Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swel...
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Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swell and break out in hives. Approx. 45 minutes later she became flushed, felt lightheaded/intoxicated/giddy/silly while driving home. She said she was extremely hungry ("like a big dose of steroids"). She states her ears were ringing and when she laid down at 2130 she could feel her heart beating throughout her body. This AM she reports feeling "hungover/groggy/nauseated". She denied any lip/tongue swelling, any lip or extremity tingling, difficulty breathing, any injection site redness/heat/swollen/painful area, fever, chills, or ever having a vaccine reaction previously. Spoke with individual w/pharmacy. Advised to report to VAERS. Not an expected reaction. Possibly related to aleve vs. covid vaccine.
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| 57 | 2021-01-04 | feeling abnormal |
01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss conscio...
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01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss consciousness. Pt was aroused by Spouse to awake after fall and checked pt blood pressure 115/63 and sugar levels 93. Pt feeling weakness afterwards, pain in back and neck from fall. Awaiting calls from PCP and Neurologist for appointments.
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| 57 | 2021-01-04 | impaired work ability |
First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I ...
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First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I also experienced headache, nausea, diarrhea and fever. I continue to have tingling in my face. I called employee health, and they told me to isolate. Because they were trying to rule out if it was COVID, but test was negative.
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| 57 | 2021-01-05 | feeling abnormal |
Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left ey...
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Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left eye and left forehead above the eye. The patient reported feeling ?out of sorts? with a tingling or numbness from her shoulder to her neck and tingling in the left side of her face. She felt light headed when standing and her feet hurt. She was given diphenhydramine 25 mg and observed for an hour and a half at which time she reported feeling better . Her temperature was 97.5 F at 13:23 and 97.9 at 13:45. She left work early and went to the walk-in clinic later that evening. She reported that the clinic said all of he vital signs were normal and they did not note any specific problems. She took second diphenhydramine 25 mg. She was contacted at around 8:30 AM on 1/6/2021 and reported that she was feeling better.
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| 57 | 2021-01-05 | nervousness |
Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a h...
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Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a headache about one hour after. Took 1000 mg of Tylenol; and I was feeling okay. Just arm was sore. Not extremely sore. 8 pm at night - started shaking; knees were knocking together; severe chills; and it took a few minutes to recognize what was happening - took temp. 99.4; took another 1000mg tylenol; went to bathroom and without notice - puked; woke up an hour after going to bed with worsened chills; 10:30 pm - temp 102.4; too early to take more Tylenol and so took pharmacy's version of Nyquil. Slept through the night after Nyquil but woke up with chills continuing - temp 103. 8 at 4:30 am; and then sat at side of bed and took tylenol 1000 mg and got up to go to bathroom and couldn't walk forward and felt my arm hurt really really bad; couldn't walk forward; I leaned against the wall and bounced against the next wall and kept walking and grabbed a bedroom doorknob and got into the bathroom and fell on toilet and then crawled to couch because I couldn't walk straight. Stayed on a couch for two hours and then it was gone. Fever and chills continued that whole day on 24th. Didn't eat/had no appetite. Christmas day -no fever. Felt shaky though - like I'd been super sick. No appetite still. Felt woozy and shaky inside (felt shaky inside) and that lasted for several days. Appetite still remains poor. 02 stats were low through all of it - four liters (up two liters than normal. Contacted: a pulmonologist - Dr. and she helped with O2 questions.
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| 57 | 2021-01-05 | sleep disorder |
Mild URI symptoms started approximately 4 hours post vaccination. By 6 p.m. (5 hours post vaccinatio...
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Mild URI symptoms started approximately 4 hours post vaccination. By 6 p.m. (5 hours post vaccination), severe chills and fever of 105. Took 800 mg of Ibuprophen and 50 mg of Benadryl. Temp down to 102 by midnight. Fevers persisted, especially at night with extreme night sweats for 11 days often requiring a change of clothing up to 6 times through the night. No further respiratory symptoms past initial presentation. Night sweats have persisted but with less severity as of Day 15. Please note, I am also a healthcare provider and infectious disease epidemiologist, hence enterring my own VAERS.
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| 57 | 2021-01-06 | anxiety |
After being given the vaccine the patient was asked to wait 15 minutes before returning to work. Aft...
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After being given the vaccine the patient was asked to wait 15 minutes before returning to work. After 5-10 minutes she reported shortness of breath and an anaphylactic type reaction. Patient was administered an Epi-pen by a nurse and the facility, and reported feeling "a little better." She was also given oxygen and put on a pulse oximeter. Her O2 sat was 99% throughout. She reported before that she had no allergies and no adverse reaction to a vaccine in the past, but after this happened she said something similar also happened in the past with a flu shot. Patient believes this reaction was due to anxiety and not an allergy. 911 was called and arrived about 15-20 minutes after administration and patient was taken to the hospital. A nurse called the hospital 2 to 3 hours later and they reported she was "doing fine" and would be discharged home later today.
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| 57 | 2021-01-06 | feeling abnormal |
On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early a...
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On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early am got up at 5 am. Took Tylenol 1000mg. Went to work. Around 9am of 1/6/21 chills more pronounced body aches. Temp 99.3. Continued to feel poorly, rechecked temp 1.00 pm. Now 99.9. Sent home. At 2:15 pm temp 104.00. More severe chills and body pain, nauseous. Toast for dinner, Tylenol again at 6 pm , recheck temp 100.8. Went to bed. 1/7/22 am some body aches, not as severe, nauseous and migrai. Type headache. Did no take temp, because didn't feel one. Call to nurse at covid vaccine holiness. Check temp while on phone 97.4.
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| 57 | 2021-01-07 | anxiety |
Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. ...
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Pt. started feeling tingling in lips and facial flushing within 2 minutes after administration. Dr. in clinic for pt. assessment. Pt. uneasy/anxious with increased facial flushing to face and some mild swelling to lips. Pt. with tingling sensation to right side of body. Benadryl 100mg IM administered immediatly per Dr.'s order. Epi-Pen also available if needed. Pt. with improved redness to face and lips after administration.
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| 57 | 2021-01-07 | depressed mood |
Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection ...
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Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection site; This is a spontaneous report from a nurse (patient herself). A 57-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 Vaccine, lot E"JI"1685 but not clarified), via an unspecified route of administration on 21Dec2020 at single dose, for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included levothyroxine. The patient got her first Covid Vaccine on 21Dec202 and got the minimal pain at the injection site which was no big deal but about 10 days later (31Dec2020), she started getting sick. She was getting sick with Covid type symptoms, so she was off of the work and get swabbed yesterday and waiting her result to come out. She had typical body aches, headaches, cough and nasal congestion everything was along with that. She does not think these were side effects of the vaccination but just "quite" (not clarified) wondering how you she felt. She was so upset. She took Ibuprofen and Alcazar. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain and headache were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-01-10 | confusional state, amnesia |
experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elev...
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experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elevated blood pressure; This is a spontaneous report from a contactable Other-HCP(Patient). A 57-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm, on 22Dec2020 08:15 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included herpes simplex on lips, post menopause, elevated cholesterol w/lifestyle changes. Known allergies reported as no. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization. On 04Jan2021 08:30, the patient experienced symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure. The patient admitted to (Hospital name) (still here, hospitalization days reported as 2). Symptoms resolved except very mild aphasia. The patient had very few risk factors for TIA but did have family history of cardiovascular(CV) disease at young age, low density lipoprotein(LDL) was 192. The patient did not have diabetes, HTN, or known heart disease. She did not have severe anxiety. She did not smoke or use any substances. She walked about five miles 4x a week. Weigh reported as 157. Events reported as serious due to hospitalization. The patient had no Covid prior vaccination. Covid(nasal swab) was tested post vaccination on 04Jan2021, Covid test result was Negative. The event resulted in emergency room/department or urgent care. Treatment received for the adverse event included clopidogrel bisulfate(PLAVIX), acetylsalicylic acid (ASPIRIN), statin; potassium, CT, MRI, "telemet". The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
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| 57 | 2021-01-10 | feeling abnormal |
nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day ...
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nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day the vaccine was given. injection site pain swelling, severe headache, developed chills at night joint pains, rashes on my face, feeling weak as if I dont have energy. At night time i went to the restroom 5 times with an interval of 5-10 minutes and i cannot even control my bladder it comes out continuously. Slow to comphrend or response. I stayed fully awake the whole night on the night when the vaccine was given to me and was able to sleep only the following day (sat) at 5 pm.
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| 57 | 2021-01-10 | impaired work ability, feeling abnormal | feeling really bad. called in sick to work. |
| 57 | 2021-01-10 | impaired work ability |
5 days after vaccine developed hives. Day 6 and 7 was really really bad hives. Did a tele appt. List...
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5 days after vaccine developed hives. Day 6 and 7 was really really bad hives. Did a tele appt. List of meds: Pepcid - 20 mg 2 x/day; Satirazine - 10 mg 1 day per day; benydryl 25 mg - several times a day - took over the weekend (over the counter). On 28th they prescribed Prednisone: 20 mg two times/day for five days. There was a fever with the hives so I wasn't allowed to work; off work for six days (three scheduled and three were scheduled off). Resolved after prednisone. Still a bit itchy but no hives.
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| 57 | 2021-01-10 | sleep disorder, disorientation |
Approximately 15 hours after injection, was awoken with very severe chills and incontrollable shakin...
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Approximately 15 hours after injection, was awoken with very severe chills and incontrollable shaking. Was so cold, had to get a heating blanket to put over me, along with 2 blankets. Was shaking so bad, could hardly walk. Was slightly disoriented at the time. This lasted for 4 hours. Temperature is normally 95.6, did rise to 98.7. Had severe body aches that lasted until the next day, but were not as severe. the following day was very tired and muscles were achy. I did take tylenol, which seemed to help.
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| 57 | 2021-01-11 | feeling abnormal |
At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describ...
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At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describes sensation as tingling throughout her head and body. Denies shortness of breath, difficulty swallowing, tingling of the tongue or lips or lip/tongue swelling. Denies palpitations or tachycardia. Patient states that she did not eat breakfast this morning. Initial BP 151/92, HR 62, 96% on RA. Patient states that she did take her morning dose of metoprolol. Response team was called for patient to be further assessed. Repeat blood pressure at 08:42 was 124/82, HR 62, 96% on RA. Team assessed patient. Patient provided water and crackers. Physician instructed patient to be monitored for 20-30 minutes. 08:56, BP 136/82, HR 66, 97% on RA. Patient verbalizes resolution of all symptoms. Patient discharged from clinic ambulatory and stable at 09:25.
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| 57 | 2021-01-11 | feeling abnormal |
Patient received vaccine around 10 am. She waited 30 minutes in the clinic with staff due to history...
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Patient received vaccine around 10 am. She waited 30 minutes in the clinic with staff due to history of numerous allergies (zantac, demerol, amoxicillin, paxil, gluten). After patient left the site, she returned around 11:18am reporting she was feeling poorly (specifically with nausea, headache, and itchy/sore throat). No lip swelling , shortness of breath, hives noted. Vital signs were monitored and were stable. Diphenhydramine 50mg given orally and EMS notified as per our company protocol. Patient left via ambulance at 11:32 in stable condition to Hospital .
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| 57 | 2021-01-13 | feeling abnormal | tingling and numbness in Right hand (5 min) sweating and anxiety felt foggy 20 min. |
| 57 | 2021-01-13 | feeling abnormal |
exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay ...
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exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay down and go to sleep; freezing cold; slightly nauseous; not feel as zippy as she normally do; Arm hurting a little; This is a spontaneous report from a contactable consumer (patient herself, a dental hygienist) via Medical Information team. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK5730, expiration date: Mar2021, NDC number was unknown), via an unspecified route of administration on the right arm (also reported as upper shoulder) on 07Jan2021 at 11:30 30 at a single dose for COVID-19 vaccination. The patient had no medical history. There were no concomitant medications. The patient reported she was feeling exhausted, freezing cold, slightly nauseous, and did "not feel as zippy as she normally do" on 08Jan2021. She wanted these effects recorded, and would like to know if they were normal, and would they happen to the same or higher intensity with the second dose. The patient further reported she had no adverse reaction on 07Jan2021 other than her arm hurting a little. Starting on 08Jan2021, she had felt exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous. She had been reading and was sure or was guessing this was normal, but wanted to verify that. She was not running a fever as of yet. Every time she tried to get up, she just laid back down. She felt fairly decent when she woke up, these events started later at the time of the report on 08Jan2021. She would not say these events were life threatening, but the CDC patient vaccine record card said to call to report any adverse events. She was scheduled for a second dose on 28Jan2021 and at this time did not plan to change dosing unless event worsening would occur. The patient had the vaccination, because she was always coming into contact with people with COVID at work. The patient had no investigation assessment. The reporter assessed the events as non-serious. The patient was recovering from the event "arm hurting a little," she was not recovered from the events "exhausted/exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous," while the outcome of the event "not feel as zippy as she normally do" was unknown.
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| 57 | 2021-01-13 | feeling abnormal |
LATER THAT DAY PT STATES SHE STARTED EXPERIENCING INCREASED SOB, FATIGUE , HEADACHE, AND MENTAL FOG....
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LATER THAT DAY PT STATES SHE STARTED EXPERIENCING INCREASED SOB, FATIGUE , HEADACHE, AND MENTAL FOG. THE SOB DID RESOLVE AND SHE WAS NOT SEEN IN ED
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| 57 | 2021-01-13 | feeling abnormal |
I had fatigue, headache, pain, weakness and I was so miserable decided to go to ER on (12/24/20) and...
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I had fatigue, headache, pain, weakness and I was so miserable decided to go to ER on (12/24/20) and then was transferred to hospital admitted (12/25/20) one day - discharged on 12/26/20 at night
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| 57 | 2021-01-14 | confusional state |
Confusion (encephalopathy) and fatigue. Onset about 10 hrs after shot. Did not know how to dial a ...
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Confusion (encephalopathy) and fatigue. Onset about 10 hrs after shot. Did not know how to dial a cellphone, did not realize I did not have glasses on, sent pt prescription to wrong pharmacy. Was also extremely fatigued. Slept most of 1/14/21. Confusion resolved 1/15/21, but still tired although better by 60% at 10 am on 1/15/21.
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| 57 | 2021-01-14 | sleep disorder, delirium |
Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt ...
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Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt swollen, especially the right. Within a few more hours my arm became heavy and I had some general muscular achiness. By approximately 11pm I had intense muscular pain on the back of my legs making it difficult to stand. It felt like I had been hit repeatedly with 2x4s. About that time my posterior ribcage hurt also. I couldn't sleep, turning frequently as my hips hurt. This is what I felt like when I had COVID. Intense pain. At 0630 (1/14) I got out of bed and felt I was going to faint, was extremely nauseous (I did not vomit) and had a very bad, global headache. I had to lay down again. My temp was 100.1 orally. I could not go to work. I was able to take Tylenol. It helped the pain but two hours later my temp was 100.8. I could not get out of bed until 6pm, I felt delirious when I tried. I was able to go to work on 1/15. Of note, following my first dose of COVID vaccine (Pfizer BioNtech Lot #EH9899 on 12/23/20) I had site soreness, heaviness of my left arm, T of 99.5 same day (about 10-12 hours post vaccination), and mild body aches for about a day.
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| 57 | 2021-01-15 | sleep disorder |
Day after 2nd shot fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain,...
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Day after 2nd shot fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain, unable to sleep, vomited once, took Tylenol, went to walk in at 7 am, did blood work, urine and Covid screen, all normal and negative, pain improved after about 15 hours Day 6 , today, pain came back, mild at 10 am and then severe at 11, nausea, vomited once, took Tylenol at 11 and feels better but still quite uncomfortable. Able to drink, normal stool, no other symptoms
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| 57 | 2021-01-18 | insomnia |
Reported day following vaccination: headaches, unable to sleep, feeling very tired, and weakness beg...
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Reported day following vaccination: headaches, unable to sleep, feeling very tired, and weakness beginning day of vaccination
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| 57 | 2021-01-18 | loss of personal independence in daily activities |
slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not ...
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slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not able to work; chills; 102.9 F/low-grade temperature (99.2-99.8 F); This is a spontaneous report from a contactable nurse. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had side effects that are "fluctuated but up until now". She had 1 episode of chills (102.9 F), slight nausea, low-grade temperature (99.2-99.8 F) almost everyday, dizziness, body weakness, 3 types of diarrhea, starting to resolve, most concerned (lasting almost 11 days now). The patient received the first COVID vaccine on 29Dec2020 and she has been sick ever since. Patient was negative for COVID. She already sought help from doctor and went to the ER last night. She had slight to moderate symptoms and not fully recovered. She was not able to work. She was relating this to the vaccine as she was fine before. She went travelling back in March and became ill. They were not testing for COVID back then and she recovered. I wonder if I had COVID back then. She was glad it is her turn. She has been waiting a long time. It has been a concern. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses are expected for most people. On 30Dec2020 she had chills and temperature of 102.9. That subsided by taking Tylenol and rest. After that she felt sick like headache, dizziness, and low-grade temp until now. She hasn't been back to work. She has already sought advice from her doctor. She went to the ER last night to make sure she is ok because it was not resolving. Her COVID test was negative two days ago. Before the COVID shot she was healthy, working, and no symptoms of anything. After the shot, all this. Patient then asked if anyone else experienced these and if these were vaccine related. She would like to know what to do to confirm it was vaccine, how long will she be off work. The ER doctor said that she could have had the virus before she had the shot or after, but it is a slim chance now that she is COVID negative. Before she knew if she was COVID negative or positive, she went on the website and filled it out. Now that she has confirmed that she is negative what could cause this illness after the shot. She did that before she knew she was COVID negative. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses is expected for most people. Outcome of the event "102.9 F/low-grade temperature (99.2-99.8 F)" and chills was recovered, while outcome of the other events was unknown. Information on batch/lot number has been requested.
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| 57 | 2021-01-19 | feeling abnormal | Headache Narrative: spine pain, balance issues, dizziness, feeling spacey. |
| 57 | 2021-01-19 | feeling abnormal |
I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I w...
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I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I was very fatigued the rest of the day and had a headache. During the night I had chills and was dizzy. My temp was only 99.1 but I felt awful. I still had a temp this morning (day 2) No dizziness but I do have an awful headache and my arm is very sore where I received the injection.
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| 57 | 2021-01-19 | impaired work ability, loss of personal independence in daily activities |
Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday...
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Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
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| 57 | 2021-01-20 | feeling abnormal |
Numbness and tingling to mainly L face as well as L arm and foot. Feeling as if I am going to pass o...
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Numbness and tingling to mainly L face as well as L arm and foot. Feeling as if I am going to pass out at any time. Have not passed out, just very "Fuzzy". Started approximately 15 minutes after injection and slightly worsened for the next two hours. After one night sleep, L face and L hand remain mildly numb and tingly as well as the foggy feeling mentally.
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| 57 | 2021-01-21 | feeling abnormal, irritability |
received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/...
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received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/tested positive for COVID-19; irritable all day; the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on.; eyes were also hurting; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the vaccine on 04Jan2021 and yesterday (11Jan2021) she tested positive for COVID-19. Patient would like to know if she should follow-up for the second dose of the vaccine on 25Jan2021. Patient mentioned that maybe she should follow up with the second dose. It was also reported that the patient wanted to know if the vaccine could have given her COVID-19 and tested positive. Patient further clarified it to be the Pfizer BioNTech COVID-19 Vaccine. Patient mentioned she is a caregiver and received the vaccine on last Monday (04Jan2021). On Friday (08Jan2021), the patient started to notice she was getting headaches. The headache started in the morning. Patient realized she was irritable all day and as a caregiver, this is not an attitude to have. Patient did not feel great that day. Patient also realized that the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on. That night patient got home and was able to eat, but the next day on Saturday (09Jan2021), she did not have any sense of taste or smell. Patient had lost her sense of taste and smell. Patient realized this when she woke up at 6 am for coffee and could not taste or smell it. Patient was calling to find out if there was any way one could get Coronavirus only after the first shot and if she still needs to go and get her follow-up vaccine on 25Jan2021. Patient stated she forgot the name of her HCP. Patient also mentioned she has chest pressure. Patient noticed it about an hour ago, later stated it was like 11 something. It comes and goes. Patient mentioned that it was like shortness of breath. Patient would breathe in a little bit and it will bring the chest pressure back down. Patient would also walk around a bit to get the blood pumping back through. Patient also added, that due to these symptoms, she's locked off in a different room away from her husband. Patient stated they are both quarantining since her husband was exposed too and has not had the shot yet. Patient's eyes were also hurting, but that is due to the headache. Patient also stated that her eyes hurting has gone away. Patient will be getting to get a Coronovirus test done later today. When probed for the time of vaccination, patient that she was not sure. She knew she had to wait 30 minutes under observation because she had allergies. Patient initially stated that she would guess she received the vaccine thirty minutes prior to 3:55. Patient later clarified and stated it was possibly 2 something when she got it. Patient tested positive for COVID-19 on 11Jan2021 (COVID-19 virus test positive). Outcome of the event 'eyes were also hurting' was recovered, while unknown for the remaining events.
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| 57 | 2021-01-21 | feeling abnormal |
Approximately 5 minutes after receiving the COVID19 vaccine patient reported feeling 'weird'. Denied...
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Approximately 5 minutes after receiving the COVID19 vaccine patient reported feeling 'weird'. Denied any specific symptoms. Denied feeling light headed, dizzy, short of breath, difficulty breathing, sensation of foreign body in throat, itching. Also denied sensation of tongue, lip or throat swelling. Patient was taken by wheelchair to a treatment room and placed on a gurney. Pt preferred to sit up. Initial BP of 174/111, HR of 105. Shortly after patient reported starting to feel better. States she did not eat that morning. Repeat BP 163/95 HR 97. Patient continued to report symptom resolution. BP repeat again 163/94 HR 96. Denied history of hypertension. Advised patient on following up on BP. Patient discharged after monitoring for approximately 30 minutes. Follow up precautions discussed.
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| 57 | 2021-01-21 | sleep disorder |
2 days after receiving the 2nd dose of COVID vaccine I developed itchiness on upper arm below the in...
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2 days after receiving the 2nd dose of COVID vaccine I developed itchiness on upper arm below the injection site. Symptoms progressed to a patch of redness,diffuse and bumpy induration, and warmth measuring approximately 8x10 cm. Skin is intact with no pustules or vesicles. Indistinct margins. No symptoms or involvement of the inner aspect of the arm or axilla. No adenopathy. Have used topical Hydrocortisone and oral Benadryl with some relief, but symptoms persist now 6 days post vaccine. Symptoms are enough to wake me at night due to arm itchiness and discomfort.
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| 57 | 2021-01-23 | excessive sleepiness |
By 830 pm I was aching, had a headache, by 9 bad chills, the fever, skin was very hot. Lasted all ni...
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By 830 pm I was aching, had a headache, by 9 bad chills, the fever, skin was very hot. Lasted all night. By am I was dizzy once, Achey all day, no energy. Slept all day. Today, dizzy again for a moment. Headache when I woke up. No energy, abit Achey. Not as bad.
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| 57 | 2021-01-23 | impaired work ability |
Around 3 am on 1/18/2021 I woke up with a very sore lymph node on my lower head left side. Within a...
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Around 3 am on 1/18/2021 I woke up with a very sore lymph node on my lower head left side. Within a few hours lympnodes in my neck, behind my ear and on my collar bone were all swollen and painful. On Wednesday 01/20/2021 I developed hives on my scalp, in my left ear, and on and around all swollen lymph nodes. I left work on 1/20, still couldn't go to work 1/21 on 1/22 I saw Dr. Who have me a shot of Kenalog and some triamcinolone cream for hives. I tried to work, but only lasted 4 hrs and went home. It is now one week since vaccine number two and on top of still raw spreading hives, and swollen glands , I now have a sharp pain constantly shooting through my left temple which is relentless. I am miserable.
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| 57 | 2021-01-24 | excessive sleepiness |
Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contacta...
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Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer for herslf. A 57-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EL1284) vaccine , intramuscular in the right arm on 30Dec2020 10:30 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Since 03Jan2021, the patient has been sick. Her fever started out at 99.7 degrees Fahrenheit with a terrible cough and then it just kept getting worse. This weekend it was 102.7 degrees Fahrenheit all weekend. Her cough improved. She took some Delsyn one day. The cough improved but is not gone away. Headaches started on day 4 or 5. Lot of pressure in forehead and eyes. Fever kept going up day after day been up to 101.2°F and then up 102.7°F all weekend. Then she just felt weak all weekend. Just walking to bathroom is short of . Yesterday fever was 101.5°F and she went to doctor and they did a rapid COVID test and it came back positive. Slept a lot more this weekend. Done nothing but slept. She did not think it would make her this sick. only vomited once. she is supposed to get second dose on Saturday. She is afraid to get second. The patient also reported the following information: Fever 08:30 Terrible Cough 08:30 Headache 10:00 Weakness 12:00 Shortness of breath when walking 12:00 Increased sleepiness 12:00 Positive for Covid 09:21 Diarrhea 08:00 Vomiting 14:00 The patient underwent lab tests and procedures which included body temperature: 99.7 Fahrenheit; 102.7 Fahrenheit; 101.2 Fahrenheit then up 102.7 Fahrenheit ; 101.5 Fahrenheit. Sars-cov-2 test: positive on 11Jan2021 . Further information has been requested
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| 57 | 2021-01-25 | sensation of foreign body |
Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaint...
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Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Intermittent episodes of acute sharp back pain; This is a spontaneous report from a contactable pharmacist reported that a 57-year-old female patient (no pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL1284 and Expiration Date unknown) via Intramuscularly on 30Dec2020 03:00 PM (Left arm) at single dose for covid-19 immunisation. Medical history includes mild asthma, B-Cell Thymoma (Resected), multiple allergies. Diagnosed allergies included Sulfa drugs-swelling; Celebrex-Itchy; Clindamycin- Unknown reaction; Doxycycline- Sick to stomach; Iodinated radiocontrast dyes- Iodinated radiocontrast dyes cause generalized swelling (takes diphenhydramine prior to contrast use when needed); Keflex- Rash; TDAP Vaccine; Levofloxacin- Unknown Reaction; Penicillin; Prednisolone- Itchy; Septra- Eyes get glossy and lips swell.The concomitant medication was not reported. There is no other vaccines within 4 weeks prior to the COVID vaccine. About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine (30Dec2020 30Dec2020 08:00 PM), Patient went to Emergency room (ER) with complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling. Also had intermittent episodes of acute sharp back pain while in ER. Upon arrival in ER, patient received routine precautionary care with peripheral IV placement. She was kept under observation in ER for approximately 5 hours until subjective symptoms resolved. On exam patient did not have objective signs of throat obstruction. Vitals were stable and O2 saturation on Room Air was within normal limits. Patient did not receive any medications, oxygen, fluids, or any interventions other than observation. Once symptoms resolved, patient was discharged from ER in improved condition. The outcome of event was recovered on an unknow date without treatment. There is no covid tested post vaccination.
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| 57 | 2021-01-26 | sensation of foreign body | pt has history of asthma, c/o of lump throat |
| 57 | 2021-01-26 | sensation of foreign body | pt has history of asthma. c/o lump in throat |
| 57 | 2021-01-27 | feeling abnormal, disturbance in attention |
generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulde...
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generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulder, she thought it was cause of the injection site/muscle pain from the injection; pain in shoulder immediately after getting the injection and it was really swollen; body is in pain/lot of pain all of her body; achy like she is having flu like symptoms; injection was administered higher in her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 (16:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) injection in left deltoid/shoulder on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history was reported as "none". There were no concomitant medications. It was reported that the patient received the first dose on 22Dec2020 and the second dose on 12Jan2021. After she received the second dose of the vaccine, she immediately had pain in her shoulder, she thought it was cause of the injection site (12Jan2021 16:00). She had the pain in shoulder immediately after getting the injection and she got it at 4pm, and it was really swollen now. She mentioned this injection was administered higher in her left shoulder (pending clarification) and it feels like they may have gotten the injection in more of the arm muscle and she was thinking that is why she had muscle pain from the injection. She added that it was like her body is in pain, achy like she is having flu like symptoms that started the evening she got the vaccine, like 6PM or 7PM. The next day, yesterday (13Jan2021), she had a lot of pain all of her body. She also started to have a headache yesterday at noon (13Jan2021 12:00PM). The headache started at noon on 13Jan2021 and it continued for at least 8 hours and it was constant. It started to subside over the next 12 hours. She mentioned she also suffers from migraines (pending clarification). It feels like she is having residual migraine, like she is coming off of having a migraine. It is presenting, but she is not in severe pain. It is a feeling like she is coming off her migraine medication even though she did not take her migraine medication. She went to work yesterday (13Jan2021) even though she did not feel like it. She went home a few minutes early. She let her supervisor know she was in severe pain and had a headache. She was advised to stay home today and has not gotten better. However, the headache subsided. She feels foggy, like she could not just quite wake up. It is like she is in a daze or haze. She is having a hard time functioning. She continued to reiterate she was having a hard time concentrating. Now (14Jan2021) she is generally weak and is pale. In addition, the pain has not gone away. She stated she is weak, very weak. She felt it most of the day and it is worse today. She feels like she can hardly stand. She is trying to get fluids in her and trying to make coffee, however, it is a struggle. She stated, she has not gone yet, but she will call her doctor's office next and the health nurse as well to advise them she has been having symptoms. She stated she did not have a fever last night. Her temperature during the call was normal for her, 97.3. The outcome of events vaccinations site pain, vaccination site swelling, general body pain, flu like symptoms, weak, and pale was not recovered; while the outcome of other events was unknown. Information on lot/batch has been requested.
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| 57 | 2021-01-30 | delirium |
Face got numb for about an hour (30 min after ) Severe arm pain Fever Chills Delirium, couldn?t thin...
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Face got numb for about an hour (30 min after ) Severe arm pain Fever Chills Delirium, couldn?t think clearly Extreme fatigue Bad headache Whole body ached, especially back and neck Lasted about 48 hours
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| 57 | 2021-01-31 | feeling abnormal, disorientation |
Anaphylactic episodes starting the next day after the vaccination. This went on intermediate, for f...
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Anaphylactic episodes starting the next day after the vaccination. This went on intermediate, for four days, the fourth day by far was the worst. Closing of throat, labored breathing, lightheaded, mental fog, somewhat disoriented, slight headache, and fatigue. Use of oxygen 3.0, Ativan and Benadryl rotated 3 of 4 days.
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| 57 | 2021-01-31 | impaired work ability |
I had extreme pain in my shoulder at the vaccine site; then I had extreme pain - my whole upper back...
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I had extreme pain in my shoulder at the vaccine site; then I had extreme pain - my whole upper back (especially my right side) - like someone had taken a hammer and beaten my back. I exercise a lot and I'd exercised cross country skiing and downhill skiing the day of the vaccine and the next day I worked. I could barely use my right arm to treat my patients. I was sore and as the days went on I was really fatigued. I felt like I had a low grade fever. I usually have lower than normal temperature and it was 99.4-99.7 range. So on Monday I called the Occupational Health Dept of the Hospital - and they told me stay off work. And they had me test for COVID - negative. It took about a week until I started to feel better. To treat during the course of it I just took Advil. Recovered before my second dose on January 20th, 2021. I did not exercise before that second dose vaccine or work the next day and I stayed very hydrated and went into it rested.
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| 57 | 2021-01-31 | mental impairment |
Patient states felt hot flashes following injection in waiting room went home became lethargic that ...
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Patient states felt hot flashes following injection in waiting room went home became lethargic that evening having difficulty answering questions at night patient states she became apneic and husband had to watch her breathe. Did not go to the ER. Patient states fully recover the next day and fully recovered 5 days later. No rashes fever generalized weakness that resolved.
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| 57 | 2021-01-31 | sensation of foreign body |
Driving home 40 minutes after vaccination ears and throat started to feel tight and felt like a lum...
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Driving home 40 minutes after vaccination ears and throat started to feel tight and felt like a lump in my throat , almost 2 hours after vaccination ears ringing and lump in throat. I took 2 Benadryl and in about hour the lump feeling was not as bad, lump feeling subsided. I had muscle joint pain the next 4 days and stayed on Benadryl those days until throat and ears felt better. On day 5 my left arm started stinging and broke out in hives , some on torso but mainly vaccinated left arm. I went to primary care to talk to her about my reactions on day -7 . She documented in my records but told me to report through Vsafe app. I did. I do not want to take 2nd dose after having this happened and no one able to tell me the 2nd wont be worse,
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| 57 | 2021-02-01 | amnesia, thinking abnormal, nervousness, anxiety |
Pain injection site; short term memory problems/short term memory loss; reduction in mental clarity/...
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Pain injection site; short term memory problems/short term memory loss; reduction in mental clarity/feels like she has not been clear headed; scary feeling; worried; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140), via an unspecified route of administration on 12Jan2021 at 13:30 at single dose to prevent Covid. The patient's medical history included ongoing blood pressure high, ongoing cholesterol, ongoing anxiety, ongoing sleep disorder, fatigue from 10Jan2021 to 10Jan2021, and spacey from 10Jan2021 to 10Jan2021. Concomitant medication included pravastatin for cholesterol, amlodipine besylate for blood pressure high, lisinopril for blood pressure high, zolpidem tartrate (AMBIEN CR) for sleep, olanzapine for anxiety, all ongoing; and naproxen sodium (ALEVE). The patient previously received the first dose of BNT162B2 (Batch/lot number: EJ1685) by injection in left arm on 22Dec2020 for COVID-19 immunization and experienced fatigue and spacey on 10Jan2021, and pain at injection site on an unspecified date. The patient experienced short term memory problems and reduction in mental clarity from 14Jan2021. The patient called and wanted to know if there were reported cases in the clinical trials that experienced "brain fog" and "memory loss" after taking the COVID 19 vaccine. The patient asked if anyone else reported spaciness, brain fog and short term memory problems after receiving the Pfizer COVID 19 vaccine. The patient reported that she received the second dose of vaccine on 12Jan2021. She reported reduction in mental clarity and short term memory loss. On 10Jan2021, the patient experienced fatigue and "spacy". The patient stated that that she has had both doses of the vaccine, she got the second dose last Tuesday. She was wondering if there were any known side effects of the product including mental clarity, or foggy brain, or memory loss, because the patient felt like she has not been clear headed. She received her 2nd dose on 12Jan2021, and has been experiencing short term memory problems and reduction in mental clarity. She stated that on 10Jan2021, she noticed feeling fatigue and spacey. The patient stated that seriousness criteria for short term memory problems and reduction in mental clarity was not serious, but stated that it was a scary feeling. She laughed and stated that she was worried, is she getting dementia or is it just the shot. She received her 2nd dose of the vaccine on 12Jan2021 at 13:30PM. Lot: EL0140, No Expiry/NDC written on card. She stated that she did get some pain at the injection site; did not clarify after which injection. She stated that she took Aleve 2 capsules as needed. The patient asked if there have been any reports of patients experiencing this after having the vaccine. It was reported that the patient works in the lab. The outcome of the events short term memory problems/short term memory loss and reduction in mental clarity/feels like she has not been clear headed was not recovered, while the outcome of the other events was unknown.
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| 57 | 2021-02-01 | feeling abnormal |
Brain fog followed by muscle and joint aches then severe vomiting diarrhea and chills. Blood in stoo...
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Brain fog followed by muscle and joint aches then severe vomiting diarrhea and chills. Blood in stool
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| 57 | 2021-02-01 | feeling abnormal |
pain at the injection site; fatigue; spacey; This is a spontaneous report from a contactable consume...
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pain at the injection site; fatigue; spacey; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on 22Dec2020 at 15:00 at a single dose in the left arm to prevent Covid. The patient's medical history included ongoing blood pressure high, ongoing cholesterol, ongoing anxiety, and ongoing sleep disorder. Concomitant medications included pravastatin for cholesterol, amlodipine besylate for blood pressure high, lisinopril for blood pressure high, zolpidem tartrate (AMBIEN CR) for sleep, olanzapine for anxiety, all ongoing. On 10Jan2021, the patient noticed feeling fatigue and spacey. On an unspecified date, the patient stated that she did get some pain at the injection site and took Aleve 2 capsules as needed. The patient considered the events fatigue and spacey as non-serious. The outcome of the events fatigue and spacey was recovered on 10Jan2021, while unknown for the other event.
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| 57 | 2021-02-01 | impaired work ability |
Staff described having the chills, headache, and body aches throughout the day, 1 day after receivin...
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Staff described having the chills, headache, and body aches throughout the day, 1 day after receiving the vaccination. She also had injection site pain in her arm that made it difficult to perform lifting movements. Adverse event was severe enough the staff felt she could not attend work the day after vaccination.
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| 57 | 2021-02-03 | excessive sleepiness, impaired work ability |
she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 w...
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she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 with the symptoms she has now; was feeling bad; she lost her taste and her smell; she lost her taste and her smell; tired; sleeping all the time; she is sick; She still hasn't eaten a whole meal since Friday; not able to eat; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL0142, exp date not reported), intramuscular (by injection once left arm, below shoulder blade in muscle) on 13Jan2021 for COVID-19 immunization (because of job). Medical history included two stroked from 1998 and 2005. Concomitant medication included oral donepezil started taking 3 months ago (Oct2020) for something having to do with muscles because of stroke. She takes a blood thinner, as she had 2 strokes; and takes muscle relaxers too. By 15Jan2021 (Friday morning) the patient was feeling bad, she couldn't go to work, she lost her taste and her smell, part of smell. Part of taste was back at the time of reporting, but she was tired and sleeping all the time (onset date reported as 15Jan2021). She saw her neurologist because she had 2 strokes, they referred her to Pfizer, as they said she may have already had COVID 19 with the symptoms she has, but as far as she knows, she didn't have it, she took a test with the center a month before giving the vaccine, she took the vaccine because of her job, because of the kind of job she has, and they wanted her to let Pfizer know she was sick. She doesn't know if she wanted to get the other dose, as she was not feeling well at all. She was laying down sleeping every day. Her doctor said to tell Pfizer what was going on. She still doesn't feel good the day of reporting. She still hasn't eaten a whole meal since 15Jan2021. She thinks she was probably getting better, but was getting better slowly, she has no taste, she was not able to eat, no smell at all, which was really not a good thing. She can't tell the outcome of no smell she thinks. She can't smell nothing at all. She can't smell what she was cooking. It was the same as taste, she thought that is probably why she can't eat, she can't taste what she was eating. Taste was improved, but not well enough for her, it is hard to explain, you know how you enjoy food, like how it tastes, and if you can't taste, you can't eat. She sleeps all day, she was up now, but is probably going to go to sleep, she feels tired and needs to lay down. She told her doctor she will call and see what Pfizer says, they will go from there. She doesn't know if she will have to go see if she has COVID 19, or what was going on. No further investigation assessment was performed. The patient took a test a month before (results unknown). No taste was recovering (ongoing at the time of reporting) while outcome of other events was not recovered.
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| 57 | 2021-02-04 | anxiety |
Patient developed chest tightness, palpitations, and SOB approximately 8 min after vaccination. At 1...
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Patient developed chest tightness, palpitations, and SOB approximately 8 min after vaccination. At 12min post-vaccination patient developed throat tightness/itching. 0.3mL epinephrine auto-injector was administered at the vaccination site and the patient was transported to the emergency department for further treatment. Patient reported epinephrine made her symptoms worse. Emergency Department provider diagnoses symptoms as anxiety and gave a dose of lorazepam which improved the patient's condition. The patient was discharged from the ED after being monitored for 4 hours with improvement in symptoms. No further treatment was given.
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| 57 | 2021-02-07 | feeling abnormal |
First Vaccination on 01/13/21 right arm - pain at injection site for several days following. Brai...
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First Vaccination on 01/13/21 right arm - pain at injection site for several days following. Brain fog and some fatigue. Second vaccination on 02/3/21 left arm - approx. 3 hours later felt a little woosie and spacey. Pain at injection site. At approx. 3am the following morning experiencing chills and body jerks along with long deep breathing. Temperature 100.1. Also had a painful headache and full body aches along with some nausea and very fatigued and pain at injection site was growing in size and was also hot and red and swollen. Contacted primary care doctor about these side effects. On 2/5/21 the temperature reached 100.7 and the previous days aliments continued and fever came down to 99.6. Lots on pain in left side of neck and left arm. Let arm continues to be swollen, red and hot and is itchy. Fever finally broke on the night on Feb. 6th.
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| 57 | 2021-02-08 | anxiety |
Patient received her vaccine about 11:50 AM and waited in the parking lot (because she is under quar...
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Patient received her vaccine about 11:50 AM and waited in the parking lot (because she is under quarantine and not allowed to enter the facility) for the appropriate 15 minutes. Within about 10 minutes she began experiencing shortness of breath, throat felt restricted and severe nausea. Myself, another pharmacist, and several members of the staff met them in the parking lot and assessed her condition. Because of her symptoms, we determined it was appropriate to go ahead and administer the EpiPen 0.3mg and call 911 at that time. About 10 minutes later we gave her a 25mg oral dose of Benadryl while we waited on the ambulance to arrive. The ambulance arrived within the next 10 minutes and by then the patient stated she was feeling much better. The EMT examined her and declined any further medical assistance. I called the patient at her home 2 hours later and she said she had some light itching and dizziness. I told her the dizziness could be due to the after-effects of the EpiPen but if it worsened or there were any other signs of an allergic reaction to report to the ER immediately or call 911. This may have been more of an anxiety related reaction due to there being no signs of swelling around the lips or mouth, but we decided it would be best to be overly cautious in this situation.
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| 57 | 2021-02-09 | fear, feeling abnormal, impaired work ability |
103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it wa...
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103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it was burning; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) by injection once to right deltoid on 25Jan2021 at single dose for COVID-19 immunization. Medical history included she had COVID, she was diagnosed, was positive on 29Dec2020, and spent 9 days in the hospital. concomitant mediation was none. Patient calling about the COVID vaccine; her boss texted, she had to leave work, she had a 103.5 fever (26Jan2021), she felt horrible, she got her first COVID vaccine yesterday, and woke up this morning and felt horrible. a girl touched her arm, said it was burning, and she was very nauseous, and was trying to pass meds, and took her temperature and it was 103.5, and the thing is when you come into the facility, they took her temperature and it was 97.2, but those thermometers suck and she has an oral thermometer, and it was 103.5. It's improving. Also has severe back pain and body aches, she was scared with the fever. Felt nauseous this morning (26Jan2021), had chicken noodle soup and crackers, but it was pretty bad to point she had to pull the trash can behind her. she was on a ventilator in March for a week, not with COVID, she doesn't want to die, she thought she was going to die with COVID, she had every symptom. No Investigation Assessment. The last outcome of 103.5 fever, nausea and severe back pain was recovering, body aches was not recovered, outcome of other events was unknown. Reporter seriousness for 103.5 fever was Medically significant. For severe back pain, body aches and Nausea was Not serious. Relatedness of drug to reactions/events 103.5 fever, severe back pain, body aches and Nausea per source of assessment of Primary Source Reporter and Method of assessment of Global Introspection with drug result of Related.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event pyrexia and remaining events cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-09 | impaired work ability |
On Dec 31, 2020 I began having pressure in chest, neck and headache and rapid heart rate. Normal B/P...
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On Dec 31, 2020 I began having pressure in chest, neck and headache and rapid heart rate. Normal B/P was now 150's/ diastolic 100's for 7 days. Saw PCP, referred to Cardiologist. Had Echo, EKG and stress test. EKG changes noted, "probably normal" stress test. B/P normalized by January 7 2021, tachycardia improved January 9. Missed several days of work due to symptoms.
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| 57 | 2021-02-09 | loss of personal independence in daily activities |
Severe hip joint and back pain, vomiting, high fever, headache, extreme fatigue all lasting 4 days. ...
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Severe hip joint and back pain, vomiting, high fever, headache, extreme fatigue all lasting 4 days. I was not able to take care of myself. I had two such reactions after the first dose and two following the second dose with a 24 hour bout with milder symptoms as the third after the second dose. It comes on with no warning and lasts from 3-4 days.
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| 57 | 2021-02-10 | anxiety |
Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded with some t...
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Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded with some tingling in her extremities. EMS evaluated patient on-site. Patient was instructed to remove her mask and take deep breaths to settle her anxiety. Patient was hypertensive (175/104), SPO2 97%, and a FSBG of 95mg/dl. Several minutes later, the patient reported a return of dizziness and tingling. EMS obtained a 12-lead EKG that was unremarkable. Patient refused transport to the hospital.
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| 57 | 2021-02-10 | feeling abnormal |
Throat itchy, heart racing, feeling sensation throughout my body and feeling very faint within 5 mi...
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Throat itchy, heart racing, feeling sensation throughout my body and feeling very faint within 5 mins from injection. The Dr on call and nurse or PA gave me benadryl and checked my vitals twice. The itchy feeling went away after about 15/20 mins. My vitals were normal both times. I have had anxiety/panic attacks in the past, but this felt different. I stayed total 45 mins to make sure no other reaction occurred.
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| 57 | 2021-02-10 | impaired work ability |
rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp...
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rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
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| 57 | 2021-02-10 | loss of personal independence in daily activities |
bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid ca...
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bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; This is a spontaneous report from a contactable physician. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3284), intramuscular into the left arm on 11Jan2021, at 16:00 as second single dose for covid-19 immunization. Medical history included Obstructive sleep apnea from an unknown date, oligodendroglioma from 1996 (noted as history of oligodendroglioma status post resection 25 years ago with stable follow up and no residual deficits). The patient had no known allergies to medications, food, supplements or herbal remedies. There were no concomitant medications; Patient was not taking any OTC medications, prescribed medications, supplements or herbal remedies at the time as well as in the period prior to her vaccinations. The patient previously received BNT162B2 (lot number EH9899 ) on 22Dec2020. On 18Jan2021, at 08:00, the patient experienced bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands, which was medically significant and had not recovered, as it was persisting. This was elaborated as follows: patient experienced one week following 2nd Pfizer covid-19 vaccine patient developed bilateral feet, left worse than right, burning, itching sensation. the symptoms progressed up to her mid calves and to a slight extent. The events were considered medically significant. Details were as follows: The symptoms were quite intense and interfered with her life, requiring gabapentin prescription for control of neuropathic complaints. Patient denied any significant weakness, low back pain, neck pain, balance problems, dizziness, bowel or bladder involvement. Patient saw physician who performed workup for common associated etiologies of polyneuropathy, which were negative. Patient underwent EMG/NCS which were normal, and subsequently skin bx (skin biopsy) to rule out small fiber neuropathy (results pending). The patient further described the incident as a week after receiving the second dose of the covid vaccine, the patient experienced new onset bilateral feet burning that went into her upper legs, mid calves and to a slight extent in both hands. The burning was experienced more in the left foot than the right foot. Reports it was severe enough for the patient to reach out to her primary care provider. (PCP) to start Gabapentin for neuropathic pain. PCP ordered labs to rule out infection and other causes for neuropathy which all came back negative. Patient has no known underlying risk factors that would predispose her to neuropathy. Neurologist did an EMG which showed no evidence of neuropathy. The patient went into to the office, and she had a skin biopsy to rule out small fiber neuropathy. She does not have results to provide for the skin biopsy at this time, however, the neurologist feels if the skin biopsy is positive, there may be an association with the vaccine in regards to the burning pain the patient is experiencing. She is calling to ask if this is a reported side effect. Treatment was confirmed as gabapentin was prescribed by PCP, and the patient started on it a few days after the onset of the burning pain. Outcome was noted as it has not improved, and has not resolved. No COVID tested post vaccination was noted. The outcome of the events was not recovered; the condition was persisting. Causality for the events was noted as related.; Sender's Comments: Based on a compatible temporal association contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events pruritus, burning sensation, condition aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-02-10 | sleep disorder, insomnia |
dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness...
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dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness; chills; tired; This is a spontaneous report from a contactable registered nurse (patient). A 57-year-old female nurse received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) injection at single dose via an unknown route in the left deltoid on 20Jan2021 for Covid-19 immunization. Medical history included hypothyroidism. Concomitant drug included ongoing levothyroxine sodium (EUTHYROX) started about 12 years ago as of 27Jan2021 at 75mcg once a day for hypothyroidism. Patient had first dose on the 20Jan2021, Wednesday and the last two nights (as of 27Jan2021) patient had chills. Onset date of chills was 25Jan2021. She assumed it would be sooner than further out close to the second one getting side effects. She also experienced weakness and was really really tired. Onset date of tired was 24Jan2021. She was unsure if she should get the second dose, or if she needs to contact her provider about this. She did not know if these are normal side effects or not. She looked at the side effect list, which said chills and headache, which she has experienced both. She also had dizziness. She used Flonase for the fluid in her ears. She thought the headache and dizziness was from fluid from pressure or something. The FLONASE helped with that. She had no fever. She was a week out from getting the dose and was wondering if she should still be having these side effects. Headache/ dizziness and weakness started a few days after she got the vaccine. She thought the weakness started that Friday or Saturday. If she got enough sleep she was okay, but she would wake up in the middle of the night. She thought the chills were from the weakness. She was also jittery and shaky as part of the weakness. Patient was always being really really tired later in the day. She thought that if she were working full time she would be missing work and that was medically significant. Treatment included FLONASE and took paracetamol (TYLENOL) for the headache early on. The events (chills, weakness, tired, headache and dizziness) were reported as serious with seriousness criteria of other medically important condition. No Investigation Assessment performed. Outcome of the events chills, weakness, tired was not resolved. Outcome of headache and dizziness was resolved. Outcome of the other evens was unknown.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-02-11 | insomnia, restlessness |
Unable to sleep all night, highly restless, tried to eat in the morning but vomited. Then only ate...
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Unable to sleep all night, highly restless, tried to eat in the morning but vomited. Then only ate a little and slept all day and night the next day. (Of course arm was sore too.)
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| 57 | 2021-02-14 | feeling abnormal |
Delayed adverse effects occurred about 8 hours after 2nd dose administered. Injection site tenderne...
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Delayed adverse effects occurred about 8 hours after 2nd dose administered. Injection site tenderness and bruising. Headache, chills, fatigue, achy joints, runny nose but no fever. Symptoms continued for 2 days after vaccine although not as severe by the 2nd day. Experienced nausea, dizziness or fogginess for 3-4 days after.
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| 57 | 2021-02-14 | excessive sleepiness |
diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feelin...
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diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feeling; slept all day long/; poor appetite/No appetite; slept all day long/Had no energy; severe aches; woke up with 102° temperature; diagnosed with strep; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 57-years-old non-pregnant female patient (nurse) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), intramuscular in the left arm on 06Jan2021 at 16:30 as a single dose, Lot number Unknown for COVID-19 vaccination. The patient medical history was not reported. The patient has no know Allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE), alprazolam (XANAX). On 07-JAN-2021 at 12:00, the patient experienced diagnosed with Covid, sore arm, more tired/very fatigue, overall unwell feeling, slept all day long, poor appetite/no appetite, slept all day long/had no energy, severe aches, woke up with 102° temperature, diagnosed with strep. Adverse event start date was reported as 07JAN2021 at 12:00 PM However, the consumer reported the sequence of events as follows. Morning after the vaccination patients complaint was a sore arm. As the day proceeding, She became more tired. The following day was Friday. Very fatigue overall unwell feeling. On the weekend, Saturday and Sunday slept all day long. Had no energy. Very poor appetite. Once again overall unwell. Was able to work approximately half days on Monday Tuesday and Wednesday. She work Hospice and did enter a facility with known positive cases but was in Full PPE with every precaution as per my norm. On Thursday in the a.m. early she woke up with 102° temperature and severe aches. Was seen at the local urgent care and diagnosed with Covid. The adverse event result in Emergency Room Visit and Physician Office Visit The patient underwent lab tests and procedures which included body temperature of 102 on 07Jan2021 and ,SARS-CoV-2 test ( Nasal Swab) Positive on 14Jan2021. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Treatment received for the events were unknown but it was also reported 'she is on second round of antibiotics And steroids. Numerous exposures over last 10 month'. The clinical outcome of the events Covid-19, sore arm, more tired/Very fatigue, overall unwell feeling, Sleep excessive, poor appetite/No appetite, slept all day long/Had no energy, severe aches, fever was recovering; while Drug ineffective was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. ,
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| 57 | 2021-02-14 | sleep disorder |
After first shot no significant adverse effects until Day 8 my right upper arm started to exhibit se...
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After first shot no significant adverse effects until Day 8 my right upper arm started to exhibit severe pain and decreased mobility. Did NOT have redness, only minor swelling at injection area. Initially treated with Tylenol and ice with no relief. Day 9 increased pain, difficult to lift or move arm. Seen in clinic- Rx Motrin 600mg 3x daily, ice/heat. Day 10- returned to urgent care with severe right arm pain- could hardly move arm, unrelieved with Motrin. unable to sleep last 2 nights. RX with Medrol pack (6 days). Now day 3 have most arm function back and only mild pain in right arm.
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| 57 | 2021-02-17 | impaired work ability, sleep disorder |
At 3:00 AM on 1/18/21 she was awoken from sleep with shoulder pain, hip girdle pain, long bones of t...
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At 3:00 AM on 1/18/21 she was awoken from sleep with shoulder pain, hip girdle pain, long bones of the thighs, could not raise arms above head, neuropathy of the palms, pain in wrist, tingling, numbness, stiffness of wrists, stiff fingers, hurt to bend fingers with pulsing capillaries. Started more centrally then extended down to extremities, did have some pain in ankles, neuropathy to the feet. Much worsening of the mucosal dryness of her eyes, mouth, lips, throat to the point that she was hoarse, and also her vaginal mucosa started to dry up as well. She took Acetaminophen, etc. She then was given some narcotics, which did not help the pain symptoms either. Her doctor had no answers, and did not prescribe her anything. Her eyes and throat dryness has waned somewhat. She is still having pain in her shoulder girdle. Does have the neuropathy pain, still hard to bend fingers. She had a very severe reaction this past weekend where she could not eat from Saturday to Wednesday due to nausea. She did get an order for Zofran on Monday, 2/15/21. She is still taking the Acetaminophen and Naprosyn, not taking the Norco due to constipation. Started taking her Synthroid again, but low dose. She is an RN and not able to work due to this condition. She also become leukopenic, her WBC's were lower than normal at 2.9, and her neutrophils dropped to a suboptimal level as well. She is now immunocompromised, and another reason for her not going to work as she works in an overflow unit for COVID patient's.
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| 57 | 2021-02-19 | insomnia |
Severe body aches, headache, left earache pain, unable to sleep entire night, diarrhea, itching, sto...
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Severe body aches, headache, left earache pain, unable to sleep entire night, diarrhea, itching, stomachache.
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| 57 | 2021-02-22 | confusional state | Imbalance and confusion |
| 57 | 2021-02-22 | feeling abnormal |
Approximately 10 minutes after vaccination (during post vaccination observation), patient reported f...
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Approximately 10 minutes after vaccination (during post vaccination observation), patient reported feeling ?off? and that her throat hurt. I was contacted via radio to aid with assessment. Upon my arrival, patient reported that that she was experiencing slight difficulty swallowing, was feeling ?off? and felt ?like her head was in a fog?. Assessment of vitals revealed an intial vital signs of respiration rate of 18 breaths per minute, pulse of 74 beats per minute, 97% oxygen saturation levels. Blood pressure was obtained prior to arrival and was reported as 121/74. Lungs were clear to auscultation bilaterally. Clear S1 and S2 were present upon cardiac auscultation with no mumurs or gallops noted. Patient appeared slightly pale with a slightly hoarse voice. Patient did not have noticeable pharyngeal edema upon examination. Patiney had no increased work of breathing and was not using accessory Muscles for breathing. Patient was given a swallow test using bottled water and then solid food and demonstrated intact ability to swallow with no regurgitation, choking or drooling noted. Continuous oxygen saturation monitoring revealed 02 that never fell below 96%. Continuous pulse monitoring revealed a pulse that was between 74-79. Given the stability the vital signs, demonstrated ability to swallow and inappropriately labeled IM medication in emergency kit (ie three loose syringes were not drawn up by myself. Medications were labeled by hand with no expiration date, route or dose), I elected to give the patient 25 mg of oral diphenhydramine. Patient declined to seek emergency medical attention several times. Patient?s daughter was then called so that the patient could be driven home. Patient was advised to seek emergency medical attention if her symptoms worsened, she developed increased difficultly breathing or otherwise felt unwell. Advised to follow up with PCP within next 24 hours.
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| 57 | 2021-02-25 | sleep disorder |
Chills, fever, headache, malaise, fatigue. Stayed in bed most of day after shot. Awoken at night by ...
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Chills, fever, headache, malaise, fatigue. Stayed in bed most of day after shot. Awoken at night by chills. *NOTE: This is nearly everyone's experience I've spoken with but they are never going to take the time to fill out this form. There needs to be active interviewing post-vaccine going on. I know of someone who had a ministroke after their vaccine and others who became very ill. None of them are reporting, because they don't know how, and it's a difficult reporting system. *
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| 57 | 2021-02-28 | impaired work ability |
"57yoF requesting covid eval teacher, got 2nd covid vax 2/24 at 12:15pm, had ha started that night m...
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"57yoF requesting covid eval teacher, got 2nd covid vax 2/24 at 12:15pm, had ha started that night maybe 8 hrs later, fatigue also since 2/24 night and missed work 2/25 and 2/26. started feeling better fri 2/26 around 1pm. needs dr note to rtw or covid test. 1st vax asx other than little bit of arm pain."
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| 57 | 2021-03-03 | feeling abnormal, disturbance in attention, nightmare |
Feeling light headed and very tipsy. I feel like my mind is in a fog. Very difficult to concentrate....
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Feeling light headed and very tipsy. I feel like my mind is in a fog. Very difficult to concentrate. Nightmares. Headache.
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| 57 | 2021-03-06 | nervousness |
Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left delt...
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Patient arrived for her first dose of pfizer covid vaccine. She received it at 1708 in the left deltoid and, was escorted to the 15 minute observation area. She noted feeling burning sensation in her chest and bilateral arms after a few minutes. Patient brought to EMS for evaluation. EMS obtained several sets of vital signs, notable for hypertension (170's/90's). Patient placed on stretcher. She was flushed, had a dry/thick tongue, developed rash on bilateral arms, began shaking and shivering but stated she was not cold only nervous. She was given 50 mg benadryl IM, 18 g IV started in her right antecubital. She declined solumedrol due to past experience with steroids. Her flushing and rash began to resolve, patient stated her tongue felt better. Patient was transported by EMS for evaluation. She had her phone with her, but her husband took her other belongings and will meet her there.
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| 57 | 2021-03-08 | confusional state |
According to onsite fire company client symptoms, 8:38 am-alert to name but couldn't recall year and...
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According to onsite fire company client symptoms, 8:38 am-alert to name but couldn't recall year and date, confused, slow to react, slow speech, dilated pupils. 8:40 am-BP 145/78, pulse 78, O2 Sat 97%,. 8:42 am-Client verbalized feeling nauseous and dizzy but she was okay, pupils semi dilated, able to follow command. 8:43 am-Per paramedic client needs further evaluation. 8:45 am-BP 142/80, pulse 79, O2 sat 100%, Blood glucose 79. 9:01 am-rescue crew arrived on scene. 9:08 am-Client transfer to hospital for further evaluation due to in and out periods of confusion.
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| 57 | 2021-03-08 | loss of personal independence in daily activities |
on the 7th, started experiencing grogginess and gassy stomach. next day on the 8th, symptoms worsene...
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on the 7th, started experiencing grogginess and gassy stomach. next day on the 8th, symptoms worsened and began to feel dizziness. severe numbness on the right side of her body. right arm/right leg, trouble with breathing and cannot perform daily activities
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| 57 | 2021-03-09 | anxiety |
After client received the vaccine client stated that she feels dizzy and anxious. Client has a hist...
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After client received the vaccine client stated that she feels dizzy and anxious. Client has a history of anxiety attacks. Vital signs obtained by EMS. BP 131/85, HR 83, O2 sat 100%. Client stated that she feels better. Client discharged home.
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| 57 | 2021-03-09 | disorientation |
Dizzy, elevated BP. Her other vitals were normal. Pt was disoriented. Had taken BP meds that morni...
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Dizzy, elevated BP. Her other vitals were normal. Pt was disoriented. Had taken BP meds that morning, had not eaten food since previous evening. During time pt was being monitored approx 45mins, she became nauseous, SOB, lightheaded and had chest pain with exertion.
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| 57 | 2021-03-09 | feeling abnormal | Fever, chills, sweats, body aches, fatigue, brain fog Lasted 24 hours |
| 57 | 2021-03-10 | feeling abnormal |
brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; ex...
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brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; extreme burning in her lower extremities and hands; nerve pain 9 out of 10; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ON5318), via an unspecified route of administration in the left arm on 08Feb2021 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient has been having a lot of side effects. The patient experienced common weakness on 09Feb2021 which was expected, extreme burning in her lower extremities and hands but it was worse in her lower extremities which occurred 4-7 days after vaccination in Feb2021, orthostatic hypotension and dizziness on 12Feb2021, nerve pain 9 out of 10 in Feb2021 which has subsided as of 20Feb2021 or 21Feb2021, super weak, brain fog and sleepy on unknown date. As of 24Feb2021, patient still had orthostatic hypotension and weakness. Stated they have done a CBC on her and everything looks good, her basophils are a little elevated but it is nothing serious. The patient is concerned about the second dose, does not think patient is going to get it. Outcome of events weakness, orthostatic hypotension and dizziness was not recovered, events extreme burning in her lower extremities and hands and nerve pain 9 out of 10 was recovered in Feb2021. Outcome of other events was unknown.; Sender's Comments: The causal association between the reported event nerve pain which was 9 out of 10 according to the patient and the BNT162B2 COVID-19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-03-11 | feeling abnormal |
Approximately 10 minutes post Pfizer 1st dose vaccination patient began to complain of dizziness. Pa...
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Approximately 10 minutes post Pfizer 1st dose vaccination patient began to complain of dizziness. Patient walked on own to stretcher and was assisted to lay down. Vital signs were assessed 158/72 70 18 99 % RA. Patient stated dizziness was continuing and she was feeling like she had an "out of body experience" she noted she feels strange like she was floating. She also reported feeling a sensation of warmth through her body which was concentrated from her knees down. Patient began dry heaves and stated she feels like she felt when she had chemo. After 20 minutes of observation the patient's symptoms were not improving. The patient stated she was genetically tested at the medical center due to her body's response to certain medications and she stated she was concerned due to her reaction to the vaccine. She never became short of breath and did not have itching. Her dry heaves subsided quickly and she did not have any nausea.
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| 57 | 2021-03-14 | anxiety |
11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizzin...
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11:45 AM ? Patient approached me and stated she had numbness and tingling of lips, and slight dizziness, she denied any SOB or breathing difficulty. Assisted Pt. back to sitting in chair. 11:50 AM ? Client states she had her vaccine at 11:20 AM and stayed for 30 min at which time she started to experience the numbness and tingling of lips. B/P 150/70, Pt had own O2 Sat monitor which included pulse, O2 sat was 96%, pulse 92, no respiratory distress noted. 11:51 AM- 12.5mg Benadryl given P.O. Pt states she gets very tired with ?full dose?. Pt states she is ?queasy?, light-headed, dizzy and has vasovagal responses to vaccines. She carries an Epi-pen for various food allergies, an O2 sat monitor and emesis bags in case she has a vagal response which she states this is what she feels like. 12:00 PM ? B/P 156/90, HR ? 92, O2 sat 97%, RR ? 20, No swelling, redness or irritation at Right Deltoid injection site. 12:06 ? Pt denies any dizziness or lightheadedness at this time but continues with tingling at lips and thick front of tongue, numbness B/P 152/92, HR 76, o2 sat 95%, RR- 20, cool cloth applied to back of neck, lower legs elevated on chair. Pt wearing compression hose. 12:20 PM ? Consult with Pharmacist who stated another dose of Benadryl would not be recommended and suggested lying down on stretcher and possible anxiety reaction. Pt refuses to lie down on stretcher and states is fine sitting with legs elevated. 12:24 PM B/P 146/90, P ? 64, RR ? 20, O2 sat 97%, Pt has flushed face and states her cheeks feel tight. She states she has Rosecea but her cheeks aren?t usually very flushed. She c/o warmth on cheeks and numbness in front area of tongue. No difficulties noted with swallowing water. Daughter arrived. Site director consulted to determine next steps and decision made to transfer to ED. Discussed transfer to ED with pt who verbalized agreement. 12:34 PM Pt states dizziness resolved however she now has a H/A and possible onset of a migraine. 12:35 PM B/P 162/90 P- 80, RR-20, O2 sat 98%. Pt denies any respiratory distress, refuses food due to many food allergies. Continues to tolerate water without swallowing difficulty or emesis. 12:40 PM Assisted Pt to wheelchair and transferred to Emergency Department for further evaluation and observation. Dtr present and verbal report given to ED RN.
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| 57 | 2021-03-14 | impaired work ability |
. Caregiver for my 78 y/o Day 1: 3/9/21 - low grade headache. Day 2: 3/10/21 - headache stronger (...
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. Caregiver for my 78 y/o Day 1: 3/9/21 - low grade headache. Day 2: 3/10/21 - headache stronger (took Tylenol); Day 3: 3/11/21 - debilitating headache. Couldn't work. Eyes hurt. Headache felt like hammers hitting the side of my head. I was so concerned I wanted to go to the hospital. The headache stopped around 2pm on March 11. Day 5: 3/14/21 - face has welts on my left cheek (shot was in the left arm).
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| 57 | 2021-03-14 | impaired work ability |
Patient contacted her employer 2 days after vaccination with complaint of new onset rash. Was seen ...
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Patient contacted her employer 2 days after vaccination with complaint of new onset rash. Was seen by her PCP and was reportedly being treated for Shingles. Missed work week of 8-12 March for same. When didn't report to work today (3/15/21), supervisor went to home to conduct a safety check and found the patient dead in her home.
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| 57 | 2021-03-15 | insomnia |
Blocked/muffled hearing in left ear; loud, constant ringing (tinnitus) in left ear; loud ringing pro...
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Blocked/muffled hearing in left ear; loud, constant ringing (tinnitus) in left ear; loud ringing progressed to right ear; tinnitus is so loud that it wakes me up at night and makes falling asleep difficult
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| 57 | 2021-03-16 | anxiety |
Pt has history of mast cell disease and has numerous medication, food and environmental allergies. S...
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Pt has history of mast cell disease and has numerous medication, food and environmental allergies. She also develops histamine related reactions to stress. She has a history of recurrent anaphylaxis and carries an epipen. She notes that she felt anxious prior to the shot and developed lightheadedness several minutes after injection. Symptoms were mild to moderate but did not resolve. The pt declined EMS services and decided to go home after approximately 40 minutes. She is aware of the risks. BP 140/90, SP02: 98%, HR: 80
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| 57 | 2021-03-16 | emotional distress |
Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told ...
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Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told me that this was acute thyroiditis. My heart rate was very high (122 bpm) when I visited my doctor's office and it was 130 bpm when I was triaged in the Emergency Room. Upon my doctor's advice, I went to the ER in the afternoon of 03/12/2021 where I was further tested. I was given medications to counteract inflammation, nausea and headache. In addition, I was given medication (beta blocker) to lower my heart rate. When my blood pressure was taken after a couple of hours, the readings revealed that my pressure had also started to fall. I spent overnight in the telemetry unit of the ER - I was given 2 liters of IV fluids to stabilize my vitals. The following day (03/13/2021), I met with endocrinologists who told me to what extent my thyroids were affected and what further medications to take. I had told them and other ER doctors as to what precipitated all of this. I was given anti inflammatory medication and a beta blocker that day before I was discharged in the evening. I have no history of thyroid issues or heart issues. I do not suffer from any chronic illness. I was not sick before I took the second dose of the vaccine. I started to feel ill within 5 hours of taking the vaccine shot, and the symptoms worsened over nearly the following two weeks. Now, following medical intervention, I am continuing treatment with various medications. I don't feel well yet, and I understand that the process towards recovery is going to be slow and unpredictable. I wanted to report this, since I feel that scientists and researchers should have this knowledge that thyroiditis can happen as an adverse reaction to the COVID-19 vaccine (Pfizer/BioNTech).
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| 57 | 2021-03-16 | irritability |
Fatigued; Arm sore; Irritable; This is a spontaneous report from a non-contactable Other Health Prof...
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Fatigued; Arm sore; Irritable; This is a spontaneous report from a non-contactable Other Health Professional (the patient). A non-pregnant 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249), via an unspecified route of administration, in the left arm on 09Feb2021 at 11:30 AM (at the age of 57 years) as a single dose for COVID-19 immunization. Medical history included covid-19, prior to vaccination. The patient did not have any known allergies to medications, food, or other products. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Feb2021, the patient experienced fatigued, arm sore, irritable. Therapeutic measures were taken as a result of fatigued, arm sore, irritable, which included 2 Tylenol. The clinical outcome of the events fatigued, arm sore, irritable was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 57 | 2021-03-17 | sleep disorder |
Intractable headache, fever 102.4, arthralgia, myalgia, vertigo. These symptoms awakened me at 2am 3...
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Intractable headache, fever 102.4, arthralgia, myalgia, vertigo. These symptoms awakened me at 2am 3-18-21.
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| 57 | 2021-03-19 | anxiety |
patient experienced an anxiety attack after second dose of vaccination. patient was examined by para...
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patient experienced an anxiety attack after second dose of vaccination. patient was examined by paramedics on site and recovered well
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| 57 | 2021-03-20 | mental impairment |
mental cloudiness; Febrile; fatigued; generalized aches; This is a spontaneous report from a contact...
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mental cloudiness; Febrile; fatigued; generalized aches; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration in the left arm (also reported as left deltoid) on 02Mar2021 12:15 as single dose for COVID-19 immunization. Medical history included obstructive sleep apnea (OSA), hypertension (HTN), obesity from and hypothyroidism. The patient had no known allergies. The patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID), estradiol and hydrochlorothiazide, losartan potassium (LOSARTAN HCT). No other vaccine in four weeks. The patient experienced mental cloudiness, febrile, fatigued and generalized aches on 03Mar2021. The patient received treatment for the events including Tylenol and work absence. No COVID prior vaccination and not COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event mental cloudiness cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-03-21 | feeling abnormal |
Patient was sat out in lobby after vaccine, around 11:05am patients spouse grabbed provider patient...
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Patient was sat out in lobby after vaccine, around 11:05am patients spouse grabbed provider patient was complaining of chest tightness, throat closing sensation, "weird" feeling over body.
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| 57 | 2021-03-22 | sleep disorder |
Felt fine, no pain in right arm where vaccine was injected. Next day around 2pm felt muscle pain in ...
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Felt fine, no pain in right arm where vaccine was injected. Next day around 2pm felt muscle pain in lower part of left arm and right leg, thought it was just muscle pain like the flu. My arm and leg started tingling and going numb, would wake me up at night. Had a Dr. appt. on March 18 when I mentioned I had numbness and tingling, but thought it was just side effect from the injection. Saturday, March 20 called 811 and nurse recommended I get it checked out. Monday, March 22 called my Dr. office, but no openings. Started noticed tingling and numbness is left leg as well. March 23 went to ER regarding my concerns. Dr. checked me and said to keep an eye on my symptoms; GBS was brought up and he said it could show in up to six weeks.
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| 57 | 2021-03-23 | anxiety | dizziness and itching....progressed to anxiety and chest pain. |
| 57 | 2021-03-23 | feeling abnormal |
Tingling in lower lip and numb feeling on left side of face approximately 30 min (5:40pm) after vac...
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Tingling in lower lip and numb feeling on left side of face approximately 30 min (5:40pm) after vaccine. Within 1 hour the feeling was almost gone. Next few days left lower side of face still felt different. 10:00 pm (29 hours after vaccine) started with chills and body aches. Next morning 6:00am was very tired and felt the same. Took 2 Ibuprofen. Dozed on and off in morning. Felt better in afternoon. Around 6pm started feeling chills and achy. Took 2 more ibuprofen. Arm was sore. Next morning, had to work. Felt tired and brain fog all day. Slight achy. Next day, felt about 90% back to normal.
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| 57 | 2021-03-23 | excessive sleepiness |
Body aches, fever, upset stomach, chills, very tired. I basically slept the whole next day. Tylenol ...
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Body aches, fever, upset stomach, chills, very tired. I basically slept the whole next day. Tylenol seemed to help.
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| 57 | 2021-03-23 | insomnia |
complete insomnia I can go 3 days without sleep and try all kinds of medication and nothing works, s...
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complete insomnia I can go 3 days without sleep and try all kinds of medication and nothing works, sinus problems worse then before and headaches and sore body. right now the sides of my face feels swollen and my lymph nodes are swollen
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| 57 | 2021-03-24 | feeling abnormal |
I had had a severe reaction to the flu shot I received on 9/28/21...developed Bell's Palsy. The sym...
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I had had a severe reaction to the flu shot I received on 9/28/21...developed Bell's Palsy. The symptoms lasted a few weeks. Most of the symptoms resolved, but I still have areas of weird sensations that has not gone away. For the immediate treatment, I was given a prescription for steroids and was told I shouldn't have any additional problems for future vaccinations. I was scared to get the COVID vaccine thinking I could have another severe reaction, but I was assured it should not happen again. I had the COVID vaccine on 3/10/21. Yesterday, 3/24/21, exactly 2 weeks to the day, I'm feeling like the Bell's Palsy symptoms are returning. I have had a large fever blister on my mouth and one side of my face is feeling somewhat numb.
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| 57 | 2021-03-24 | irritability |
Initially intense headache, body aches, irritability, chills followed by severe angioedema of lips a...
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Initially intense headache, body aches, irritability, chills followed by severe angioedema of lips and face with urticaria
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| 57 | 2021-03-25 | disorientation |
Blood pressure and heart rate increased to 163/100 and heart rate was 105. I almost passed out and w...
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Blood pressure and heart rate increased to 163/100 and heart rate was 105. I almost passed out and was very dizzy and disoriented. Fatigue for 7 days and heart rate is still elevated. Also experienced green bulging veins in hands and feet.
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| 57 | 2021-03-27 | confusional state, feeling abnormal |
fuzzy; confused; got really hot; dizzy; flash of heat; This is a spontaneous report from a contactab...
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fuzzy; confused; got really hot; dizzy; flash of heat; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207) intramuscular in the right arm on 10Mar2021 (time the vaccination was given: 08:45-09:00) at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had no family medical history. There were no additional vaccines administered on same date of the Pfizer suspect. No previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations within 4 weeks. Adverse event (AE) following prior vaccinations were noted as none (never had a reaction to a vaccine before). It was reported that the patient would like to know if she should receive her second dose of the Pfizer BioNTech COVID-19 vaccine based on the side effects she experienced after receiving her first dose yesterday. She already has an appointment scheduled for second dose. She waited in store 10 minutes after receiving it and felt fine. On the drive home, she felt a little fuzzy or confused and then got really hot and felt a little dizzy, but that went away within 15 minutes. It was further stated that within 15 minutes of getting the vaccine on 10Mar2021, she "got kind of fuzzy" (felt fuzzy) and first confused 09:10, then felt hot and then dizzy 09:15; these events were assessed as serious medically significant. Additionally, she experienced a "flash of heat that went through her body" on 10Mar2021 which went away within 10 minutes. No ER or physician's office required. She felt like if she just got some water, she would be fine. No test was done. The feeling of confusion was what lasted the most and the dizziness did not last very long. The outcome of the events was recovered on 10Mar2021. The events felt fuzzy, confused, hot and dizzy was related to BNT162B2 per reporter.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events fuzzy, confused, feeling hot and dizzy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-03-27 | excessive sleepiness |
On day after shot, Low grade fever (100°), chills, slight headache, shot location arm pain, extreme...
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On day after shot, Low grade fever (100°), chills, slight headache, shot location arm pain, extreme fatigue (slept for hours) Second day fever was gone and only slightly tired. By 3rd day only thing was a little pain at shot site.
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| 57 | 2021-03-28 | anxiety |
I felt a little strange during the waiting period, but could not define anything specific. I waited ...
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I felt a little strange during the waiting period, but could not define anything specific. I waited 20 minutes to be safe and put it down to a possible anxious feeling, although I was not anxious before I arrived. I felt fine after arriving home. At midnight when I went to bed I noticed a tingling feeling in my arms , hand and , legs and a slight bit across my chest. It was obvious enough that it prevented me from sleeping well. This morning I still feel the tingling but notice that it is most obvious if I am sitting still vs up moving around.
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| 57 | 2021-03-28 | nervousness | Felt nervous, vital signs wnl |
| 57 | 2021-03-29 | disturbance in attention |
Strong dizziness for three days. Then intermittent dizziness and unwell feeling in head for the next...
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Strong dizziness for three days. Then intermittent dizziness and unwell feeling in head for the next five weeks up to present. Unwell feeling in head interferes with mental processing. Noticed faint ringing in ears approximately a few weeks ago. Then two days ago 3/28 (1 1/2 weeks following 2nd shot on 3/19), tinnitus became very noticeable. Volume was 4/10. And last couple days has ranged in volume between two and four. Have contacted doctor, but not been seen.
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| 57 | 2021-03-29 | feeling abnormal, insomnia |
I was tired and lethargic feeling Friday evening then Saturday was basically the same Sunday was the...
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I was tired and lethargic feeling Friday evening then Saturday was basically the same Sunday was the worst I felt like I was going to throw up I had pain in my lower right side of my back also pain in my neck lymph node areas also pain in my knees it seems like it targets previous injuries also I had a low-grade fever nauseousness chills couldn't sleep fatigued just terrible feeling this morning is Tuesday March 30th I'm starting to feel better but I still really weak just really weak and my throat has been sore since like Saturday.
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| 57 | 2021-03-29 | feeling abnormal |
fever, chills, severe headache, achey bones, freezing, foggy brain, nausea almost 12 hours after sh...
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fever, chills, severe headache, achey bones, freezing, foggy brain, nausea almost 12 hours after shot, last symptom left 4 days after administration
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| 57 | 2021-03-29 | feeling abnormal |
PATIENT REPORTED FEELING TINGLY AND "FUNNY". PATIENT WAS FLUSHED ON HER FACE AS WELL AT THE END OF ...
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PATIENT REPORTED FEELING TINGLY AND "FUNNY". PATIENT WAS FLUSHED ON HER FACE AS WELL AT THE END OF THE 15 MINUTE OBSERVATION TIME. ADVISED PATIENT TO CONTINUE TO WAIT. PATIENT CONTINUED TO FEEL "STRANGE" AND PHARMACY STAFF PROVIDED HER WITH SOME COLD WATER. PHARMACIST ASKED IF SHE WAS HAVING ANY TROUBLE BREATHING AND PATIENT RESPONDED NEGATIVE. PHARMACY STAFF ALSO CHECKED HER BP AND IT WAS AT 166/88. EMSA WAS NOTIFIED WHEN PATIENT'S SYMPTOMS HAD NOT CHANGED AND ARRIVED AT 10:50. PATIENT WAS TAKEN BY EMSA TO ED.
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| 57 | 2021-03-30 | excessive sleepiness |
Severe Body aches headache severe weakness sleeping constantly diarrhea abdominal pains dizziness na...
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Severe Body aches headache severe weakness sleeping constantly diarrhea abdominal pains dizziness nauseous
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| 57 | 2021-03-30 | impaired work ability |
excessive itching and rash all over my body that wasn't controlled by taking over the counter Benadr...
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excessive itching and rash all over my body that wasn't controlled by taking over the counter Benadryl. Called urgent care and talked to doctor on phone. He prescribed 6 days of steroids plus take Benadryl every 4 hours. I was unable to work and missed two days of work. It took until 3/20 for the itching to relax
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| 57 | 2021-03-30 | nervousness, anxiety |
reported left arm "tingling" on exit of a parking lot after having waited 30 mins (observation lot)-...
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reported left arm "tingling" on exit of a parking lot after having waited 30 mins (observation lot)- asked to be seen by medical. "nervous" anxious" " involved in 911 and anthrax- had to take meds and this brought me back" Given emotional support. mask removed - fresh air. additional wait time - 25 mins. monitoring. Drove off lot when calm & felt able.
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| 57 | 2021-03-31 | anxiety |
Itching on arms shoulders back and head. No rash. Blood pressue146/88, HR 84 pulse ox if 98%. Pat...
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Itching on arms shoulders back and head. No rash. Blood pressue146/88, HR 84 pulse ox if 98%. Patient is anxious about itchiness. Benadryl 25 mg given refused to take 50 mg.
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| 57 | 2021-03-31 | feeling abnormal |
Participant c/o nausea, light-headedness and 'eyes burning'. B/P 160/102; stated "feeling funny". ...
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Participant c/o nausea, light-headedness and 'eyes burning'. B/P 160/102; stated "feeling funny". EMS called - arrived at 0835, BS 133. Continued with symptoms; initially refused to go to E.D., but then agreed to be transported to ER at 0848.
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| 57 | 2021-04-02 | fear |
Severe HA, muscle pain, fever, chills, nausea, stomach pains, shortness of breath, cough, sore arm ...
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Severe HA, muscle pain, fever, chills, nausea, stomach pains, shortness of breath, cough, sore arm and breast
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| 57 | 2021-04-02 | feeling abnormal | Low grade fever, chills, body aches, brain fogginess |
| 57 | 2021-04-03 | confusional state, panic reaction, feeling abnormal |
Injection painless. Within 30 seconds tingling in left arm. Within an hour confusion/brain fog, ting...
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Injection painless. Within 30 seconds tingling in left arm. Within an hour confusion/brain fog, tingling and swelling in arm and at injection site, body aches, fever, chills, feeling unwell, racing heartbeat, feeling panicky, felt unwell in my brain for a period of two weeks. After day 12 still having side effects, numbness, tingling in my arm shoulder and across my back. I have canceled my second vaccine and do not intend I?m getting another until I get a call from you. I would like to speak with someone about the symptoms and why they occurred.
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| 57 | 2021-04-03 | feeling abnormal |
Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. F...
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Within a few hours of shot, my headache worsened significantly and got nauseous and lost appetite. Felt terrible and went to be early. Did not sleep well. Woke up Wed 3/31 feeling better but lightheaded/dizzy; dull headache; arm swollen /sore. Thursday 4/1 still lightheaded and more dizzy when I bent down or turned suddenly; arm still sore. Friday 4/2 morning left side of face started to feel numb/tingling , then left fingers/hand, then left toes/foot, then left calf. Checked possible stroke symptoms and no other symptoms so called Dr. NP said to go to ER since it was unilateral numbness/tingling. Admitted to ER about 11:15am and did stroke protocol to rule out stroke...got CT scan, EEG, and MRI with & without dye. All normal. Discharged about 5:45pm. Very lethargic. Sat 4/3 still lightheaded/dizzy and lethargic. Woke up about 3am early Sun (Easter 4/4) in cold sweat and nauseous; vomited; hardly slept. Feel very lethargic today and still lightheaded/dizzy.
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| 57 | 2021-04-03 | feeling abnormal | Lightheadedness, slight SOB, feeling foggy/might pass out. |
| 57 | 2021-04-03 | insomnia |
nerve damage; she didnt sleep; Fatigue; This is a spontaneous report from a contactable consumer (pa...
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nerve damage; she didnt sleep; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux which was under control. She has been good for last 2 months. Two years ago (2019), she did have her polyps removed from uterine wall, it was done as outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She has had no positive antibody or COVID test prior to the vaccine. Concomitant medication included famotidine (PEPCID) for acid reflux. The patient previously took flu vaccine. She was getting flu shot every year with no issue. She had a previous reaction to anesthesia (unspecified) which include feeling tired ang groggy. The patient had a weird, not the usual reactions, like she had read about. On 20Jan2021, she experienced fatigue, achy pain, and shoulder and joint pain. She even went to the doctor yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which was a good thing, but her question was if she should take the second shot. The nerve damage started on 20Jan2021 at 10:00 that night causing shoulder pain, back pain, and lower back pain; because of it, she was not able to sleep. She only slept for 3 hours on Thursday night. She is a teacher and even had to miss school on Friday. It was just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in her shoulder went to the arms, back across to the front of the chest, she could follow it with her hand, it was achy all on the left side. She went to the doctor and said it was nerve damage. When she got the actual shot, she felt nothing, she couldn't even feel it from nurse, it did not hurt. It was not going away. The patient spoke with her friend, and her friend told her that it sounds like what she was experiencing or how she was responding was as if she has the COVID virus. Then, she was diagnosed with nerve damage by a healthcare professional. Her first dose was on 20Jan2021, the nerve damage symptoms began that same night. She was schedule for the second dose on 10Feb2021. She further reported that the symptoms were ongoing, but it was better. Her lower back pain was gone. Now, it was just localized to her shoulder, upper back, and across the chest. The patient was not taking any new medicine. She actually read to not even take TYLENOL OR ADVIL 2 days prior as it can lessen the effectiveness of the vaccine. That was why she didn't take TYLENOL until Friday afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she could take ADVIL right now. The healthcare professional did not do any test, she really just left the office hoping that it would resolve on its own. The outcome of the event nerve damage was recovering and unknown for all other events. Follow-up attempts are completed. No further information is expected.
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| 57 | 2021-04-03 | sleep disorder |
I got very dehydrated. I had cramping in both legs and feet. I drank a lot of water before and after...
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I got very dehydrated. I had cramping in both legs and feet. I drank a lot of water before and after I received the vaccine. I had to keep waking up to drink more water. After drinking 2 bottles ( 23.7 fl oz each) I was hydrated enough that the cramping stopped. 4/3 and 4/4 I am still feeling a little dehydrated.
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| 57 | 2021-04-04 | abnormal dreams, feeling abnormal, sleep disorder |
This was my 2nd shot. On the first shot my arm was ?tingly? like pins and needles and my elbow hur...
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This was my 2nd shot. On the first shot my arm was ?tingly? like pins and needles and my elbow hurt . 2nd shot was Tuesday at 11 am. I felt fine until about 9 pm and then my arm started hurting couldn?t lift it over chest level. It hurt from shoulder to elbow. Didn?t sleep well at all kept waking up. Day after shot was Wednesday and I had a slight headache and arm still hurt a little. Very tired but I hadn?t slept well. Worked all day. Thursday I worked all day, arm no longer hurt but elbow still feels weird. Friday, 3 days after the shot, I felt fine until after lunch. I got a headache that wouldn?t go away. Started feeling nauseous about 5 PM. Went home and had chills and shivering. Temp went up to 100. Massive headache and horrible nausea. Extremely fatigued. Fell asleep about 7 PM and woke up at 9 PM. Back to sleep by 9:30 PM and slept till 1 am. Back to sleep at 2 am and slept till 8 am so about 12 hours of sleep which o rarely sleep more than 7. This was 3 days after the shot. Woke up Saturday and felt ok as I have since then. My elbow still hurts and there may be a small lump under my skin at the elbow...or some swelling. Had very strange vivid dreams on Friday night as well.
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| 57 | 2021-04-04 | depression |
24 hours later I experienced the following Rash on inner upper thighs Rash below the left breast o...
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24 hours later I experienced the following Rash on inner upper thighs Rash below the left breast on rib area Lathargy or Depression
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| 57 | 2021-04-04 | disorientation |
Random, temporary buzzing or vibrating sensation in chest. Sometimes also appears in upper arms, ha...
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Random, temporary buzzing or vibrating sensation in chest. Sometimes also appears in upper arms, hands, neck and lower jaw. Sometimes accompanied by a brief sensation of dizziness or disorientation.
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| 57 | 2021-04-04 | feeling abnormal |
1) Sore arm that went up into my shoulder blade 2) Chills 3) Fever 4) Headache 5) Pain in joints &...
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1) Sore arm that went up into my shoulder blade 2) Chills 3) Fever 4) Headache 5) Pain in joints & jaw 6) Exhaustion 7) Red face 8) Simply don?t feel good at all This this Monday 4/5/21... the symptoms lasted all weekend. This morning the pain in arm and joints has gone down but is still there; this is the first morning I woke without a fever but low grade fever returned this afternoon as did the redness in my face & headaches.
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| 57 | 2021-04-05 | feeling abnormal | vomiting, nausea, feeling bad. |
| 57 | 2021-04-05 | feeling abnormal | EXTREME FATIGUE, NAUSEOUS, VOMITING, HEADACHE, BRAIN FOG |
| 57 | 2021-04-05 | insomnia |
At 7pm the evening of the vaccine I was very tired but tried to stay awake until at least 11pm so th...
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At 7pm the evening of the vaccine I was very tired but tried to stay awake until at least 11pm so that I could hopefully sleep through the night. I could don't fall asleep until around 5am. I have never experienced that before - ever! I go to bed and sleep almost immediately. I did have my first photoflash of the wee hours right before I was able to fall asleep, and that too was unusual so perhaps it was some weird post-menopausal thing but since I didn't see insomnia anywhere I thought I should write in. The next day I was ok. Tired at around 6pm and based on the night before I thought I should try and nap right then since I didn't get much sleep the night before. I could not fall asleep - at first - did sleep a few hours later for about an hour and woke up great!
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| 57 | 2021-04-05 | panic attack |
pre vaccination symptoms of a patient : panic ; sweating; headache; tingling her hand and leg; very...
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pre vaccination symptoms of a patient : panic ; sweating; headache; tingling her hand and leg; very week; shaking and chils. Symptoms was resolved and patient went home after she took her vaccine.
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| 57 | 2021-04-06 | feeling abnormal, disturbance in attention |
on day 2 extreme tiredness and joint pains, Day 3 and 4 added by dry heaving. stomach ache, diarreah...
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on day 2 extreme tiredness and joint pains, Day 3 and 4 added by dry heaving. stomach ache, diarreah general malaise including some brain fog ( inability to focus on work tasks) Day 5 cold sweats on exertion, symptoms subsided on day 7. on day 9 started with light dry cough, it has progressed to the point of bronchitis now. Dr. prescribed course of prednisone, and Zithromaycin and recommends not taking second dose of this vaccine which is due on Fri, April 9th 2021
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| 57 | 2021-04-06 | feeling abnormal, loss of personal independence in daily activities |
Extreme stiffness that was from shoulder up into neck. Extreme nausea dizziness chills extreme head...
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Extreme stiffness that was from shoulder up into neck. Extreme nausea dizziness chills extreme headache and fatigue. for 7 days. Would never go completly go away and would intensify and start again severely making it impossible to leave the house. On day 7 and 8 still nausea with diarhea. The heaasche dizziness and brain fog were from days 4-7 Shaking and delayed movement of legs numbness around lips and tongue on day7 Was told noone knew what to do and just drink water. Awful to be this sick for one week.
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| 57 | 2021-04-06 | feeling abnormal |
1100 vaccine was given 1125: Patient feels headache, metal taste in her mouth. She feels some dizzin...
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1100 vaccine was given 1125: Patient feels headache, metal taste in her mouth. She feels some dizziness, vision feels blurred. She is breathing with her mouth open and feels out of sorts. After 15 minutes she had a "funny feeling in her throat" Transferred to the ED at 1140, first responder team was called
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| 57 | 2021-04-06 | feeling drunk | Felt drunk for 10 hours Lightheaded and weak |
| 57 | 2021-04-08 | sleep disorder, feeling abnormal |
Pt started feeling foggy headed and light headed. Complained of stomach pressure that would go away ...
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Pt started feeling foggy headed and light headed. Complained of stomach pressure that would go away when she put pressure on the area. Pressure on chest went away around 1:35. Spoke to pt at 4 pm. She is now feeling fine. pt has had history of anxiety in the past and thinks part of reaction may be due to anxiety. She also mentioned that she didn't sleep much last night due to stress of getting the vaccine today.
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| 57 | 2021-04-10 | insomnia, feeling abnormal |
Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symp...
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Severe Abdominal Pain and skin rash in face, neck, chest and left arm for over ten days. Other symptoms: lack of taste, muscle pains in lower extremities/back/arm, ringing ear, itching, throat narrowing/shortness of breath, weight loss, extreme fatigue and weakness for several days; brain fog, dizziness, difficulty swallowing/sleeping.
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| 57 | 2021-04-11 | anxiety | ANXIOUS - Treatment cold packs - laid supine with feet elevated - hydration 20 fl oz water. |
| 57 | 2021-04-11 | feeling abnormal | Day after woke up In a fog. Dizziness. Tremors. |
| 57 | 2021-04-12 | anxiety | Anxious, shaky BP 180/100, 130/92, HR 98, O2Sat 98 1:03pm pt. felt ok to leave. |
| 57 | 2021-04-12 | confusional state |
While walking a patient from urgent care to radiology at approximately 1632 on 4/12/21, I witnessed ...
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While walking a patient from urgent care to radiology at approximately 1632 on 4/12/21, I witnessed another patient (patient affected by event) fall to the floor by the pharmacy window. I rushed to the patient's side and began an initial assessment of airway, breathing, and circulation. No active bleeding or head injury detected. The patient was lying to her right side and appeared to be unconscious. No response when called or tapped on the shoulder several times. Patient's eyes appeared to be half-open without apparent movement. I asked for assitance from nearby security officer to call an ERT. Approximately 30-45 seconds into event, patient's daughter appeared on scene and attempted to call patient without response. While daughter assisted with supporting the patient's head, the patient suddenly took a deep breath and appeared to blink eyes several times (approx 5 seconds) before returning to previous unconscious state. No response when called by daughter throughout event. Another staff member appeared on scene at this time and recorded the second unconsciousness episode, which lasted for 90 seconds. ERT, urgent care providers, and other staff members were on scene at this time. 911 called. Vital signs taken and further assessments conducted. A pillow was placed under the patient's head and cervical collar applied. Patient appeared to be confused and in and out of consciousness at this moment. Patient was not able to identify name, date of birth, or current location but did state she had pain in her neck when asked in Spanish by another urgent care staff member. 911 staff on site at approximately 1645. Patient left in stable condition via ambulance gurney to higher level of care, accompanied by daugher and paramedics.
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| 57 | 2021-04-12 | loss of personal independence in daily activities |
Daily migraine headaches since receiving the vaccine. Not severe, but definitely impacting ability t...
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Daily migraine headaches since receiving the vaccine. Not severe, but definitely impacting ability to do daily activities. I haven't experienced this many consecutive migraines at this rate/period of time prior to now. No treatment. Still ongoing.
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| 57 | 2021-04-13 | disorientation | Disoriented, fever, chills, headache |
| 57 | 2021-04-13 | sleep disorder |
The following day after the vaccine, I woke up with a headache, and tenderness in my left armpit, ba...
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The following day after the vaccine, I woke up with a headache, and tenderness in my left armpit, back of arm and neck. Was only able to raise my arm 1/4 way. No relief with Aleve. The symptoms worsened as the evening progressed. Took Tizanide 5 mg. Mild relief. Awoken in the middle of the night with excruciating pain in the left arm, neck and shoulder. Applied Ulta Tiger Balm, placed a heating pad to the areas and took Aleve. Received some relief. Mild to moderate pain continued the rest of the day despite continuing with the same regiment. Once a gain I awoke with increased pain, now it was radiating to my scapula, upper back and left side of chest. I sat up in the bed and continued with the regiment.
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| 57 | 2021-04-14 | feeling abnormal | Fever, headache, body aches, run over by a truck feels, lung pain on inhalation, diarrhea, fatigue |
| 57 | 2021-04-14 | sleep disorder |
Severely swollen lymph nodes in left arm pit arm of the injection also swollen lymph nodes on collar...
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Severely swollen lymph nodes in left arm pit arm of the injection also swollen lymph nodes on collarbone at neck. Painful to put my arm down or lift anything with my left arm, stabbing pain in lymph nodes in armpit, feels like an underwire stabbing me in the armpit Going on day three. Pain Keeps me awake at night.
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| 57 | 2021-04-15 | excessive sleepiness |
Sore arm, sore armpit, chills/shaking, extreme fatigue, fever reached 102.3 before going to bed on d...
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Sore arm, sore armpit, chills/shaking, extreme fatigue, fever reached 102.3 before going to bed on day of vaccination. Day after(4/11/2021) fever hovered around 100.5 all day, had a massive headache on top of my head, couldn?t keep anything down the entire day, arm was still very sore, slept a good part of the day. On 4/12/2021 I woke up with a migraine on my left side, arm was still sore all day, fever was 99.5, worn out/tired until mid afternoon. Was able to eat today. On 04/13/2021 my arm was slightly sore and I had muscles in my body that hurt. For example my right cheek was sore. On 04/14/2021 no lingering symptoms.
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| 57 | 2021-04-15 | insomnia |
Symptoms first occurred approximately 26 hours after injection (4:30 pm following day). Initial sym...
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Symptoms first occurred approximately 26 hours after injection (4:30 pm following day). Initial symptom was mild headache progressively increasing in severity with pain between the eyes and at top of left eyeball. Pain in both shoulder joints, swollen fingers, inability to sleep, dry throat, abdominal pain in liver & spleen, pain in mouth, nausea, vomiting. Symptoms lasted approximately 14 hours until 6 am.
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| 57 | 2021-04-15 | poor quality sleep, nervousness, sleep disorder |
Early morning after second dose: severe pain in left side of neck progressing up to forehead causing...
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Early morning after second dose: severe pain in left side of neck progressing up to forehead causing severe headache, dry hacking cough, difficulty breathing. Saw PCP, Dr that day and was prescribed steroids to assist with breathing and cough syrup. Next day same side effects but meds helping, nervous energy. Note: had nervous energy after first dose on first few days as well. April 10, 2021, four days after second dose: phlegm building up in head and chest, coughing with little phlegm, so thick it causes choking with eyes and nose running, leading to loss of breath and almost loss of consciousness, severe headaches, continued neck pain with swelling appears to have radiated from left arm injection site, continued difficulty breathing, severe nausea and stomach cramping, body aches especially in legs, hot flashes mixed with chills (back and forth.) No fever, however. Contacted PCP. As of April 16, 2021, side effects continue with weakness in limbs, extreme lethargy and sleepiness, but restless sleep that's interupted by coughing/choking.
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| 57 | 2021-04-15 | sleep disorder |
I woke up at 3 am Sunday pukeing then real bad nausea along with dry heaving through Thursday. I hav...
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I woke up at 3 am Sunday pukeing then real bad nausea along with dry heaving through Thursday. I have not been able to keep anything but a couple bites of bread and a few sips of water. Friday nausea way less nodry heaving. My copd got really bad at the same time as well i was gasping for air the whole time. I had to have aero care bring me a new oxygen canister that i could wear continuously. That adversed reaction also is much better now. The hospital would have kept me if i went to the emergency room.
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| 57 | 2021-04-16 | anxiety, panic reaction |
Approximately seven minutes after my injection, I tasted a metallic taste in my mouth and I began ...
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Approximately seven minutes after my injection, I tasted a metallic taste in my mouth and I began experiencing extreme rapid heartbeat , extreme shakiness and extreme panic and anxiety.. I quickly alerted a nurse who had me lay down and took my vitals and gave me something to eat and drink. They observed me for an additional half hour and then released me as I was feeling mostly better but still shaking a little.
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| 57 | 2021-04-16 | nervousness |
The patient had reported to the site for her second shot of COVID. During her assessment she did not...
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The patient had reported to the site for her second shot of COVID. During her assessment she did not mention any adverse reactions with the first shot. She did mention a hx of pseudoseizures during blood draws. She mentioned that her husband was waiting in the paring lot for her in case she had any reactions after her second shot, and that she would know during the first 15 minutes if she would have one or not. After receiving her vaccination, the patient reported to the observation area. The nurse in the observation area had checked on her, and in response the patient mentioned that her arm felt tingly. The nurse asked if this happened during her first shot, and she said yes. The patient then stated that she felt shaky. The nurse signaled for the medics to assess her further. The medics transferred as a two assist, as the patient was unable to support her own weight. The patient was then brought to a private area, and her husband was called by one of the nurses to come into the site per the patients request because he knew what to do for her when she had pseudoseizures. Medics maintained the patients safety throughout the event. As the husband approached the entrance of the vaccine site, he was escorted to the private area where his wife was. Upon reaching his wife, the patient began to shake and breathing hard. The husband stated that she hadn't had any of these pseudoseizures in awhile and that it must have been from the shot. The medics advised bringing her to the hospital at that time for further evaluation and support, and the husband agreed.
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| 57 | 2021-04-17 | feeling abnormal |
headache; Total bodyache; fatigue; feeling unwell; fever; Chills; Joint pain; Fogginess of mind; Thi...
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headache; Total bodyache; fatigue; feeling unwell; fever; Chills; Joint pain; Fogginess of mind; This is a spontaneous report received from Pfizer-sponsored program. A contactable female consumer(patient). A female patient of an unspecified age received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/lot no: EK5730) second dose via an intramuscular administered in left arm 19Jan202 0.3ml as single dose for COVID-19 immunization. The patient family medical history Father- Deceased was Diabetic, HPN, Kidney Transplant, Dialysis. Mother- Alive-Osteoporosis, Mild Dementia. Sister-Diabetic, HPN. The patient concomitant medications were not reported. The patient experienced with second dose - 19Jan2021 - 1st Day foolness of mind,2nd day -Chills, joint pain,3rd day- Fever, 4th day- feeling unwell,5th day fatigue total body ache, 6th day -feeling unwell' 7th day then 11th day Headaches-pain score-4-5,12th day feeling back to normal about 50-90, 13th day-back to normal. First dose - 30Jan2020 - Dull Headaches for 8 Days straight starting on left side of Forhead radiating to left side of face to left jaw. 1st Dose - 30Jan2020 - Dull Headaches for 8 Days straight starting on left side of Forhead radiating to left side of face to left jaw. The outcome of the events was recovered on unspecified date in 2021. No follow-up attempts are needed. No further information is expected.
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| 57 | 2021-04-17 | feeling abnormal |
tip of left ring finger turned white and numb/finger was completely white and the rest of her hands ...
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tip of left ring finger turned white and numb/finger was completely white and the rest of her hands were blue and red and white and yellow; tip of left ring finger turned white and numb; her finger felt funny; Reynauds phenomenon; sore arm; fever; chills; headache; swollen lymph node in the armpit of the arm she got her Covid 19 vaccine in; swollen lymph node started with a sharp pain and it's very sore; left foot, it was pulsing and throbbing all night; feet were modeled red, blue; feet were modeled red, blue; very sick; needed her glasses trying to give her primary care doctor's phone number; has something like gout in her foot; The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 57-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EW0150; expiry: 31Jul2021), via an unspecified route of administration in left arm on 31Mar2021 01:30 as single dose for covid-19 immunisation. The vaccination facility type was a warehouse. The vaccine was not administered at a military facility. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks) and no following prior vaccinations. Medical history included covid-19 in Nov2020. The patient had no concomitant medications. The patient had the first dose of bnt162b2 on 31Mar2021 and 12 hours later (on 01Apr2021), sore arm, fever, chills and headache. Got a swollen lymph node in armpit, same arm as injection left side, today tip of left ring finger turned white and numb. She thinks it was Reynauds phenomenon. The patient called and told nurse in her doctor's office and they said if it was painful, it could be a pain clot. It was painful at first, that lymph node started 24 hours later with a sharp pain, and then she just assumed it could be a lymph node. Swollen lymph node started with a sharp pain and it was very sore. The nurse told the patient to call Pfizer. The patient was fine until the tip of her finger happened. The patient said If it was painful it could be a blood clot, would need an x ray and asked if did the shot cause this. The complete ring finger left hand, the patient looked it up and it said it could happen to her feet and she looked, and her feet were modeled red, blue it was bizarre. Never happened before. The patient was not happy about getting the vaccine, she already had covid in November of last year (2020). The patient wouldn't have called if it wasn't for her finger. Not just her feet, her hands got like this too. The patient didn't want to get the second shot. The patient asked if there was any information or mandate on timing information for the second dose, should she needed to postpone it. The patient asked if what was the efficacy after first dose as she felt like she was immune because she had the virus and now the vaccine. She was very hesitant to get the Covid 19 vaccine. She thinks her body created Covid 19 antibodies. A couple days ago she was very sick. The swollen lymph node started with a sharp pain and could be a blood clot as far as she knows (in 2021). Even putting on deodorant she can tell it's there, it was very sore and there's a lump. Today (on 01Apr2021), she noticed the tip of her finger got white it was numb. She looked it up online and she thinks it was Reynaud's phenomenon. She has a picture if Pfizer needed it. The finger was on the same arm that she received her vaccine in. It was the ring finger on left hand. Once it started happening her finger felt funny and felt numb. She put her finger under warm water. She reported that the white color was maybe a third of the way down towards her knuckle. She was asking if this was normal or has this been reported. She had called her doctor today and spoke with the nurse who told her to call the CDC and report her symptoms. She needed her glasses trying to give her primary care doctor's phone number. The patient wanted to add that she has something like gout in her foot and on that side too, the left foot, it was pulsing and throbbing all night. She's had this pain in her left foot, she thinks its gout because it was all the symptoms of gout and she had it for a while, it hurts off and on but that night it was hurting and throbbing. She has not been diagnosed with gout in that left foot. She still has a headache but today she felt good except for her finger turning white and going numb. The lymph node in her armpit hurts. Her doctor's nurse told her if its painful to the touch it could be a blood clot so she was nervous about that. The tip of her finger was completely white and the rest of her hands were blue and red and white and yellow. She reported that her finger was back to normal now. She didn't want to get too inoculated since she also had the Covid 19 virus. The events did not require visit to emergency room nor physician office. The outcome of the events was unknown for thrombosis, Raynaud's phenomenon, erythema, cyanosis, illness, visual impairment, and gout while for the remaining events was recovering.
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| 57 | 2021-04-17 | sleep disorder |
After the first shot, I was lightheaded and dizzy; After the first shot, I was lightheaded and dizzy...
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After the first shot, I was lightheaded and dizzy; After the first shot, I was lightheaded and dizzy; muscle spasms in my chest, back, left calf and neck for over 24 hours/The chest and leg spasms were so painful; The pain was not constant and was sporadic; The evening of the 27th I was awakened out of my sleep; This is a spontaneous report from a contactable other hcp for herself. A 57-years-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration (at the age of 57-years-old), administered in Arm Left on 06Mar2021 09:00 (Batch/Lot Number: EN6202) as SINGLE DOSE, dose 2 via an unspecified route of administration (at the age of 57-years-old), administered in Arm Left on 27Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included telmisartan. The patient was reported to have allergy to lisinopril. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with covid-19 prior or post to the vaccination. Patient reported that after the first shot, she was lightheaded and dizzy for about an hour after. After the second shot, she experienced muscle spasms in her chest, back, left calf and neck for over 24 hours. The pain was not constant and was sporadic. The chest and leg spasms were so painful on 28Mar2021 02:00. And the evening of the 27th she was awakened out of my sleep. Treatment was not received for any event. Events were considered non-serious as reported. Outcome of all events was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 57 | 2021-04-18 | feeling abnormal |
Dizziness, inability to think clearly ("brain fog"), swollen and somewhat sore throat, pain at injec...
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Dizziness, inability to think clearly ("brain fog"), swollen and somewhat sore throat, pain at injection site
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| 57 | 2021-04-18 | excessive sleepiness |
Sore arm at injection site for a few days then on 3/30 began to feel flushed (red face, arms, trunk,...
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Sore arm at injection site for a few days then on 3/30 began to feel flushed (red face, arms, trunk, thighs), fatigue, mild headache, aches, nausea but no vomiting; took Benadryl just after shot at MD direction and an aspirin and slept first day a lot then took again on Tuesday and improved. Wednesday 3/31 felt good then Thursday evening 4/1 stated to feel like I was fighting off a cold - fatigue, nausea, flushed, slightly elevated temperature (@1 degree), chills, strong left arm injection site pain returned - iced arm, aches, mild headache, by Friday 4/2 morning still flushed red and all of above plus lungs felt icy (feeling I?ve had before having lung infection) and ozzie lungs - took Benadryl and lung icy and Ozzie feeling stopped in 30 minutes or less, continued to feel under weather with above symptoms for five to seven days. Took aspiring and Benadryl on and off during this time. Feeling better by 4/7 into 4/8/21
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| 57 | 2021-04-18 | sleep disorder |
I experienced they "typical" side effects of pain / aching at site of injection, chills, and muscle ...
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I experienced they "typical" side effects of pain / aching at site of injection, chills, and muscle aches. No problem. What alarmed me was that I also had greatly increased neuropathic pain. I have chronic headaches due to cervical spine damage but these headaches were greatly magnified. All my "usual" areas of pain due to existing injuries, mostly neuropathic, were greatly magnified. Extreme low back pain started, so painful it hurt to lay on my back. The trip to get vaccinated wasn't long enough to trigger such extreme pain. I hardly slept due to the discomfort and extreme pain. I experienced transient, strange pain, such as suddenly getting very sharp, stabbing pain in one toe on my right foot that lasted for about one (1) minute. Same strange sudden sharp pain in my left knee while laying down, even though no known problems with that knee. I am physically fit. Very health conscious. A vegan. This was easily one of the most total body painful experiences I have ever had. It reminded me of one time I had a terrible bout of food poisoning, but with horrible nerve pain and without intestinal problems. I started taking Ibuprofen 800mg the next morning and slept the rest of the day and night - since I got maybe 3 hours of interrupted sleep the night of the 2nd shot. The day after that I was not 100% but much improved. By the 3rd day post 2nd shot I felt normal. Two other women in my social circle experienced similar reactions to the 2nd dose. I read that more people with neuropathic and/or arthritic conditions are reporting similar reactions, and those with auto-immune conditions. I would still get the vaccine - I would just have prepared better (doctor approved sleeping pills and pain medications.)
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| 57 | 2021-04-19 | disturbance in attention | Dizziness, unfocused, high blood pressure 170/100 for weeks; now on lisinopril 10mg. |
| 57 | 2021-04-20 | sleep disorder, disorientation |
Experienced common side effects of injection site soreness, fatigue, headache and mild fever for 24-...
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Experienced common side effects of injection site soreness, fatigue, headache and mild fever for 24-48 hours. Unexpected side effect was positional vertigo (dizziness), which started approximately 16 hours after vaccination, while turning over in bed. Vertigo has continued with varying levels of dizziness and disorientation for 14 days. Went to the doctor to address this on-going issue.
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| 57 | 2021-04-21 | confusional state |
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo...
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Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient informed immunizing pharmacist of \"fear of needles\" before vaccine was administered. Pharmacist talked to patient prior to injecting to distract her. Immediately after puncturing and prior to injecting, pharmacist noticed patient was suddenly triggered, becoming faint and confused. Nausea, vomitting, dizziness and flushing followed. All events happened within 2 minutes post-injection. EMS was called but patient refused to be brought to hospital and called a friend to pick her up.
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| 57 | 2021-04-21 | feeling abnormal |
patient reports at 8:20am she began to feel "off balance". Staff spoke with patient for 15mins, at ...
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patient reports at 8:20am she began to feel "off balance". Staff spoke with patient for 15mins, at 8:42am her symptoms resolved.
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| 57 | 2021-04-21 | nervousness | Nausea, lightheaded, shaky, some spasticity related to underlying MS |
| 57 | 2021-04-21 | sleep disorder |
Very sore left upper arm still- 11 days post vaccination. Painful to put on and remove clothing fro...
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Very sore left upper arm still- 11 days post vaccination. Painful to put on and remove clothing from upper body. Some motions are A OK. Painful to sleep on.
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| 57 | 2021-04-22 | loss of personal independence in daily activities, sleep disorder, feeling abnormal |
I received my first Pfizer vaccine for Covid 19 on April 1, 2021 and had no side effects except a sl...
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I received my first Pfizer vaccine for Covid 19 on April 1, 2021 and had no side effects except a slight sore arm at the injection sight. Six days later I was abruptly awaken at 6:30 am with severe vertigo. I had never experienced vertigo ever in my life. I couldn't move my head at all. I took me 45 minutes to get out of bed. I was barely able to move around my house because I was so dizzy. I attempted to shower and nearly fell over. Prior to this point I had never heard of vertigo as a reaction to the vaccine. I read that vertigo could be a reaction to covid itself. I had a covid test and it came back negative. I went to see my doctor to discuss this. He looked up adverse reactions that were reported after the vaccine and found out that this has happened to many people. I was advised to not get the second shot. I will not get the second shot!! I have continued to be dizzy at times and Ive had brain fog. This has continued foe 2 weeks now.
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| 57 | 2021-04-22 | nervousness |
Patient c/o nausea and shaky. Patient reports that nausea started first. On call provider was notifi...
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Patient c/o nausea and shaky. Patient reports that nausea started first. On call provider was notified of reaction and patient was brought to treatment room. Patient was given 4mg ODT Zofran.
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| 57 | 2021-04-23 | disturbance in attention, sleep disorder |
While I already had mold tinnitus and occasional vertigo that I resolved with self- positional otoli...
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While I already had mold tinnitus and occasional vertigo that I resolved with self- positional otolith reset, after 2nd dose have had very loud tinnitus and changes in the sounds that make it hard to concentrate on computer programming work and hard to sleep. I have been adjusting white noise and using meditation to cope. Vertigo also is requiring more frequent otolith settling techniques. I hope the loudness of tinnitus ringing in my ears decreases. I am working to adjust my attitude and expectations, since I had to do this to deal with my initial tinnitus development after starting ACE inhibitor medication (a known ototoxic med lisinopril).
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| 57 | 2021-04-23 | impaired work ability |
Complete immobility due to severe pain in joints and muscles - could not leave bed for 2 days except...
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Complete immobility due to severe pain in joints and muscles - could not leave bed for 2 days except to toilet - was told the severity of my pain & immobility was to be expected- but not reported in advance - not just flu muscle aches - no fever or other symptoms except severe debilitating pain - could not work for 2 days - reduced pain - still in excess of fibromyalgia pain I have become used to - continued to 2nd dose - told to get it anyway
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| 57 | 2021-04-24 | feeling abnormal |
Within 25 minutes of injection, began having: Tingling in lips and tongue. Redness in lips. Itchines...
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Within 25 minutes of injection, began having: Tingling in lips and tongue. Redness in lips. Itchiness in face; later felt in legs. Scratchy throat. Red splotchy areas on both arms. Symptoms continued for over 2 hours. Took a Benadryl (25 mg) around 10:30 am. Most symptoms gradually went away, but continued to feel intermittent skin itchiness in limbs for the rest of the day. Felt bad all day.
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| 57 | 2021-04-24 | feeling abnormal |
symptoms were intensified by first COVID vaccine; heart pain; severe fatigue; pain in head; heart pa...
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symptoms were intensified by first COVID vaccine; heart pain; severe fatigue; pain in head; heart palpitation; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 19Mar2021 12:30 (lot number and expiration date were not reported) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS), asthma, allergies, early bone loss, allergy to penicillin, latex, lactose and sugar; all from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and unspecified allergy medications. The patient previously took codeine and experienced allergies. The patient had no other vaccine in four weeks prior to vaccination. It was unknown if the patient had COVID prior to vaccination. On 23Mar2021, the patient experienced heart pain, severe fatigue, pain in head, heart palpitation and brain fog. The patient described the events as having "long hauler" symptoms since 23Oct2020. The symptoms were intensified by first COVID vaccine. Four days after the first shot, the patient had severe fatigue, heart palpitation, heart pain, pain in head through out day which comes and goes and brain fog. The symptoms intensified and remained for 18 days after first shot. The patient had the second shot on 09Apr2021 on the left arm (lot number was unknown) and had no head pain for the first time since last Oct2020. The patient was not COVID tested post vaccination. The patient had a visit to a doctor or other healthcare professional office/clinic. There were no treatment given. The patient recovered with lasting effects on an unspecified date. Information on the lot/batch number has been requested.
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| 57 | 2021-04-25 | disturbance in attention, feeling abnormal |
3/4-first vaccine in left arm, only effect was sore arm when I laid on it. 3/25-second vaccine in ri...
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3/4-first vaccine in left arm, only effect was sore arm when I laid on it. 3/25-second vaccine in right arm, arm hurt to lift as well as lay on. Start approx 1515 hrs, severe headache anvil like pressure at back of head 3/26-body aches, some dizziness 3/26-3/28 temperature from 99-102+ with chill, aches, etc 3/28-4/1 extreme fatigue, brain fog. 4/1 to present: random fatigue, headaches, nose bleeds but 4/22 the fatigue brain fog became extreme again. 4/25 spend most of the day in bed sleeping or just laying there with no motivation or ability to get up and focus on a task 4/26: went to work, but again, extreme fatigue, just want to lay down, no focus
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| 57 | 2021-04-25 | insomnia, anxiety |
I started to experience pain in my right ear. Soon I felt pressure in my ear and sinuses. I felt l...
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I started to experience pain in my right ear. Soon I felt pressure in my ear and sinuses. I felt like I needed to unplug my ears but swallowing didn?t help. Additionally, my ears felt warm. At the same time the tinnitus in my right ear, which had been mild for years, became much more pronounced. It was debilitating and I had trouble sleeping. After the second shot, the symptoms continued except I started to feel them in my left ear as well. Now I also have tinnitus in the left ear, although it isn?t as loud as my right.
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| 57 | 2021-04-25 | loss of personal independence in daily activities |
Symptoms of rash growing in size at my left ear, quickly spreading and thickening with yellow liquid...
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Symptoms of rash growing in size at my left ear, quickly spreading and thickening with yellow liquid oozing, crusting over, breaking and oozing. Spreading down my neck to my collar bone area and taking over my whole ear front and back. Spreading further to my jawline and upward and behind the eat into the hairline as I was misdiagnosed and on three different antibiotics and a probiotic for two weeks prior to being sent to the ER for a IV of heavier antibiotics. The ER doctor declined the IV and immediately identified shingles, prescribing Valacyclovir which cleared it over another week and a half. The cost after insurance for just the ER visit was 860.00, plus an office visit for 65.00 together, and the RX prescribed. I was also in bed without energy, missing work due to the illness affect for a week.
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| 57 | 2021-04-27 | anxiety |
Pt developed dizziness and tingling shortly after vaccination. She notes that she felt very anxious ...
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Pt developed dizziness and tingling shortly after vaccination. She notes that she felt very anxious prior to vaccination. No skin, respiratory or ENT symptoms. BP 130/70, HR 66, SPo2 99%. Pt improved over the course of several minutes without intervention. She elected to drive home with a family member.
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| 57 | 2021-04-28 | anxiety |
HA, chills, anxiety, tongue and fingers go numb during anxiety attack 4-24-21ER was told she had a p...
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HA, chills, anxiety, tongue and fingers go numb during anxiety attack 4-24-21ER was told she had a panic attack
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| 57 | 2021-04-28 | sleep disorder |
Had been fine for 2 days. All of the sudden I couldn't lift my right leg - pain was from upper thigh...
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Had been fine for 2 days. All of the sudden I couldn't lift my right leg - pain was from upper thigh, hip, to mid waist. I was unable to drive, and that evening the pain was excruciating making it difficult to get comfortable to sleep. It has improved with rest, heat, and ice, but I still do not have full motion of my right leg. If it does not improve, I will go see my dr.
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| 57 | 2021-04-30 | crying |
swollen submandibular lymph nodes; swelling/swelling went to the back, the shoulder blade up the lef...
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swollen submandibular lymph nodes; swelling/swelling went to the back, the shoulder blade up the left side of her neck; swelling/swelling went to the back, the shoulder blade up the left side of her neck; redness; pain started at injection site; pain went from her elbow to shoulder and then up her shoulder and up to the neck; pain went from her elbow to shoulder and then up her shoulder and up to the neck/she still has arthritic type pain in left arm socket.; couldn't lift her left arm at all; deep ache/ to her back; crying; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Apr2021 at 16:30 (lot number reported as "EN or W 0161, EN0161 or EW0161") at a single dose for COVID-19 immunisation. Medical history included diabetic from 2008, blood clots , COVID-19 (reported as April; year unknown), insulin dependent in 2014 , Protein S deficiency, genetic disorder that makes her have blood clots, neuropathy. Concomitant medications included warfarin sodium (COUMADIN) taken for Protein S deficiency, genetic disorder that makes her have blood clots from 2007 to an unspecified stop date; gabapentin taken for neuropathy from Sep2019. Patient stated that she gets a mild case of the flu when she gets the flu vaccine, but she doesn't remember back to childhood. She got an MMR booster about 20 years ago and had no problems then. Family Medical History: both parents had diabetes; mother has Protein S deficiency as well that causes blood clots. The vaccine was administered at healthcare facility. The patient did receive previous immunization with a Pfizer vaccine. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient received her first shot on Monday 12Apr2021 and was fine until 12 hours later. Her arm swelled up and she couldn't lift it. Then the swelling went to the back, the shoulder blade up the left side of her neck. She could feel her lymph nodes and so she was icing it, taking Tylenol and the swelling has gone down. The redness was gone but she still has arthritic type pain in left arm socket. She can lift and move the left arm, but it hurts, and it also hurts when she turns her head to the right. She received the Pfizer COVID vaccine in her left arm. The pain started at injection site and then went from her elbow to shoulder and then up her shoulder and up to the neck. Her family was commenting on her neck being swollen. She received her shot at 4:30 PM on 12Apr2021. The redness and swelling started at around 5:00 AM on 13Apr2021. A couple hours after Pfizer COVID vaccine injection the pain started. She waited for 30 minutes because she takes coumadin for a history of blood clots, nurse wanted to wait to make sure her arm wouldn't bleed. She has been taking Benadryl ointment and icing it for 3 days as treatment for the events. She got up at two this morning to go to the bathroom and noticed she could still feel the pain when she turns her head to the right. She had swollen submandibular lymph nodes and could feel two of them before. When she woke up, she could not feel her lymph nodes. Everything has recovered except for the pain. The patient stated that on the first day the symptoms were disabling, and she couldn't lift her left arm at all. They got better once she started icing it and rested instead of doing chores. She keeps popping Tylenol every 6 hours, Benadryl and refilling ice bag with one ice bag on neck and one ice bag on arm. There was a deep ache right now in the socket that goes up her neck and down the shoulder blade to her back. Right now, she doesn't like to be in any pain and would say the pain was mild compared to how it was, the pain was so bad she was rocking and crying. Her brother gave her one of her mother's pain pills, one Vicodin because she was in so much pain. She can control the pain now with the extra strength Tylenol. She got the Pfizer COVID vaccine for lots of reasons. She has a lot of health problems, she had COVID virus last April and that was why she was having this reaction since she already has antibodies. She takes care of her mother who was sicker than she was. She was out in the real world and she doesn't want to bring anything home or get anything herself. She thought gabapentin would have made it to where she did not have the arthritic pain from vaccine. She takes gabapentin for neuropathy. She was diabetic and that may have something to do with it too. Patient stated that everyone else in her family got Johnson and Johnson and nobody had reactions. She was supposed to get at the Johnson and Johnson shot first but with the shortage it was switched over the to Pfizer COVID vaccine. This was her first dose of the Pfizer COVID vaccine. Redness and swelling started at around 5:00 AM 13Apr2021. Pain started around 6:30 PM. The events did not require emergency room visit or hospitalization. She was at the urgent care yesterday where she gets her INR checked and the nurse said she didn't see any swelling but believed she was in pain because the she didn't want to lift the left arm. The reporter assessed the events swelling, redness, and pain were considered serious (disabling). Outcome of the events vaccination site pain, neck pain, arthralgia, and back pain was recovering, for event crying was unknown, for event swollen submandibular lymph nodes was recovered on unspecified date, while for events swelling, joint swelling and redness was recovered on 16Apr2021. Information on the lot/batch number has been requested.dft; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
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| 57 | 2021-05-03 | mental impairment, depression |
2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea w...
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2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea was like morning sickness or being punched in the stomach; Stomach ache; She had terrible depression. She said she had a history of depression and took medication for the depression; She was having trouble expressing herself and speaking. She found it very difficult to find words during a conversation; her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose; she was having trouble processing information since her second Pfizer COVID-19 Vaccine shot. She said things get jumbled easily; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female consumer reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 09Mar2021 (at the age of 57-year-old female) as single dose for COVID-19 immunisation. The patient medical history included depression for at least 30 years and breast prosthesis user. She said when she takes her medicine, Fluoxetine, she could not even tell she had depression. She had been on Fluoxetine for a decade. She had breast implants placed from about 31 years ago and wondered if her old breast implants triggered an immune response. She grasped at straws to try and figure out what was going on. On an unspecified date in 2021, with her first Pfizer COVID-19 Vaccine, she only had a little fatigue, clarifying the fatigue was very slight. Concomitant medications were not reported. The patient previously took she her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021. The patient reported that her doctor encouraged her to report adverse side effects that happened after the second Pfizer COVID-19 Vaccine shot. She said that she was okay on 10Mar2021. On 11Mar2021, two days after her second vaccine shot, she had terrible nausea and stomach ache. She clarified the nausea was like morning sickness or being punched in the stomach and that her nausea had nothing to do with her bowels. In Mar2021, she said maybe the next day, she had terrible depression. She clarified of having a history of depression and took medication for it. She said it had been about a month since the nausea and depression started and she felt she had just turned the corner on both of them. Reported she had not been feeling too depressed since 14Apr2021 (last Wednesday). In Mar2021, she started having cognitive issues, struggling with words and following instructions since Dec2020. She was having trouble expressing herself and speaking as well. She found it very difficult to find words during a conversation. She also had trouble processing information and things got jumbled easily. Her cognitive issues worsened. She had been to see so many doctors with her nausea and enquired if other people had complained about terrible nausea and depression after receiving the vaccine. She was advised to be transferred to Pfizer Medical Information for further assistance with her questions. She said she was a teacher and had not gone to school since 08Mar2021 because she was so depressed and sick to her stomach. Report was not related to a study or programme. No further details provided. The outcome of events stomach ache and having trouble expressing herself and speaking was unknown while rest of all events outcome was not recovered. Information about lot/batch number was requested.
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| 57 | 2021-05-04 | mental impairment, depression |
she was spent; She had terrible depression. She said she had a history of depression and took medica...
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she was spent; She had terrible depression. She said she had a history of depression and took medication for the depression; 2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea was like morning sickness or being punched in the stomach; Stomach ache; she was having trouble processing information since her second Pfizer COVID-19 Vaccine shot. She said things get jumbled easily; She was having trouble expressing herself and speaking. She found it very difficult to find words during a conversation.; her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose; Event: her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose was reported as worsened.; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 via an unspecified route of administration on 09Mar2021 as SINGLE DOSE (at the age of 57 years-old) for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing for at least 30 years, breast implant placed about 31 years ago and started having cognitive issues, struggling with words, and following instructions since Dec2020. She said when she takes her medicine, fluoxetine, she couldn't even tell she had depression. She said she had been on fluoxetine for a decade fluoxetine. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) and experienced slight fatigue in 2021 and recovered. She said she was OK on 10Mar2021. In Mar2021, the patient was having trouble processing information since her second Pfizer covid-19 vaccine shot. She said things get jumbled easily on Mar2021, 2 days after her second pfizer covid-19 vaccine shot, she had terrible nausea like morning sickness or being punched in the stomach on 11Mar2021, stomach ache on 11Mar2021, terrible depression, having trouble expressing herself and speaking, found it very difficult to find words during a conversation on Mar2021, her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose on Mar2021, event: her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose was reported as worsened on Mar2021. She said she had seen many doctors with her nausea. She said her nausea had nothing to do with her bowels. She said it had been about a month since the nausea and depression started, and she felt she had just turned the corner on both of them. On an unknown date, she was spent. Treatment for depression worsened included depression medication. The clinical outcome of trouble processing information and cognitive issues had gotten worse was not recovered, recovering for nausea, stomach ache and depression and unknown for trouble expressing herself, spent and speaking. Information on the Lot/Batch number has been requested.
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| 57 | 2021-05-10 | feeling abnormal |
About 2 to 3 hours after shot, I felt woozy and then very nauseous. It was strong, came in waves. Bu...
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About 2 to 3 hours after shot, I felt woozy and then very nauseous. It was strong, came in waves. But I did not throw up. Ate a little, took some alive (two tablets). Was tired but not overly fatigued. My arm really hurt at injection site, pain traveled up to my neck. Unable to lay on arm at all. Then I just felt buzzing in waves. I went to bed (no chills) but couldn't go to sleep. Body felt wired and tired. Finally fell asleep at 8:30 am. Day after shot: Arm still sore but not as much. Still experience nausea but not as strong. Tired but not overly so. Later in evening (around 12:30 pm) developed some chills and had four sneezes in a row causing me to have a stuffy head. Not sure if that is allergies or a cold coming on.
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| 57 | 2021-05-25 | feeling abnormal |
I was sick with nausea, vomiting, headache, muscle aches, extreme exhaustion, and feeling extreme ho...
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I was sick with nausea, vomiting, headache, muscle aches, extreme exhaustion, and feeling extreme hormonal changes like extreme night sweats. Worse than anything I ever had during menopause. I was in bed for 1 week, and feeling sick for 2 weeks. I am still suffering with extreme night sweats almost 2 months later.
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| 57 | 2021-05-27 | feeling abnormal |
passing out/sort of out of body-ish awareness; Patient had never had a seizure, but it felt more lik...
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passing out/sort of out of body-ish awareness; Patient had never had a seizure, but it felt more like that than a faint; Felt heavy in upper arms/chest; Felt heavy in upper arms/chest; feeling uncoordinated walking through house; felt out of body; felt pain in knees/pain in right knee; joints seizing/cracking really hard; abrasions on both of knees; Moderate damage to L mcl; Must have fallen; stinging spot in the back of head; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0171) via an unspecified route of administration, administered in arm left on 01May2021 09:00 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included leukemia from 1998, breast cancer from 2001. No Known allergies. Concomitant medications were not reported. The patient previously received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0164) on 10Apr2021 08:00 AM (at the age of 56-year-old) in left arm for Covid-19 immunization, then experienced adrenal disorder and epinephrine increased. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient woke up Tues, 04May2021 08:00 AM. Felt heavy in upper arms/chest. Started feeling uncoordinated walking through house. Didn't remember actually passing out but felt out of body and felt pain in knees, and joints seizing/cracking really hard. sort of aware something was happening, but sort of out of body-ish awareness. Came back to awareness. abrasions on both of knees, moderate damage to L mcl. pain in right knee. must have fallen but no awareness of that - came to laying on back. Patient had never had a seizure, but it felt more like that than a faint. Also noticed a stinging spot in the back of head that seemed to travel up the back of skull for several days. Treatment was not received for the adverse event. Reporter assessed events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "passing out/sort of out of body-ish awareness" was recovered in May2021, of other events was unknown.
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| 57 | 2021-05-27 | feeling abnormal |
mouth no taste or smell; mouth no taste or smell; Mouth appears to be inflamed and beet red; Mouth a...
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mouth no taste or smell; mouth no taste or smell; Mouth appears to be inflamed and beet red; Mouth appears to be inflamed and beet red; cold symptoms/Worst cold she has had in her life; sneezy; headache; foggy; Woke up in the morning not feeling well; This is a spontaneous report from a contactable nurse (patient) reported that a 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179), via an unspecified route of administration, administered in arm left on 04May2021 10:30 (at the age of 57-years-old) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10May2021, the patient had cold symptoms and described as the worst cold she has had in her life, and experienced sneezy, headache and foggy. On 12May2021, the patient experienced mouth no taste or smell, and was concerned about her mouth appears to be inflamed and beet red. It was also reported that the patient woke up in the morning not feeling well on May2021. Therapeutic measures were taken as a result of the events as patient was treated with Claritin. The outcome of the cold symptom/worst cold she has had in her life, mouth no taste or smell and mouth appears to be inflamed and beet red was not recovered; outcome of sneezy, headache, foggy and woke up in the morning not feeling well was unknown. The events did not require a visit to emergency room or physician office. Reporter seriousness for the events was medically significant. Relatedness of drug to reactions/events: Reaction assessed: cold symptoms, mouth appears to be inflamed and beet red and no taste or smell. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179), to reported events is possible based on temporal association and known profile of the product.
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| 57 | 2021-05-28 | feeling abnormal |
dizziness; Noticed slight feeling of unbalanced gait; noticed a feeling of "things not quite right";...
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dizziness; Noticed slight feeling of unbalanced gait; noticed a feeling of "things not quite right"; headache; nausea; decreased appetite; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9265) via Intramuscular route of administration in right arm on 02Feb2021 10:30 and first dose (Lot Number: EL3248) via an Intramuscular in right arm on 11Jan2021 17:30 both at single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medications included vitamin b complex (SUPER B COMPLEX) 1 DF, ascorbic acid (VIT C) 500mg, colecalciferol (VIT D3) 2000 IU, asa (ASA) 325mg all one tablet daily. No allergies to medications, food, or other products and there were no prior vaccinations within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient not tested with COVID-19 post vaccination. On 02Feb2021, the patient experienced since 2nd vaccine having subtle headache, relieved by taking ASA dose X 1 daily, otherwise so subtle was tolerable, and subtle nausea that only has decreased appetite somewhat (no weight loss) accompanied by slight feeling of dizziness (VS WNL). Beginning 07Feb2021, awakened by severe feeling of dizziness, nausea, then headache. Noticed slight feeling of unbalanced gait, but able to be corrected without difficulty, just noticed a feeling of "things not quite right". Approx 03:00 today, 11Feb2021, awakened with another episode of severe dizziness accompanied by nausea and increased imbalance while walking through home. This time, these symptoms are intermittent, but constant intermittent and not going away, therefore have made an appointment with my PCP today 11Feb2021 at 15:00 to ask for a possible CT of my head d/t worrying about this dizziness to rule out nothing else is wrong since this dizziness w/nausea feeling is becoming persistent. Treatment received for adverse event was unknown. Reporter was assessed event as non-serious. Adverse event result in doctor or other healthcare professional office/clinic visit. The outcome for the events were not recovered. Follow-up attempts are completed. No further information is expected.
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| 57 | 2021-05-28 | insomnia |
breathing issue, difficulty breathing; headache; tender & soreness in the arm of her injection; trou...
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breathing issue, difficulty breathing; headache; tender & soreness in the arm of her injection; trouble sleeping; This is a spontaneous report received from a contactable consumer (reporting on herself). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration in Arm Left on Apr2021, as 2nd dose, single for COVID-19 immunization. The patient medical history and Concomitant medication(s) included acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. Patient received her first Pfizer Covid 19 Vaccine on 06May2021. A few hours later she felt a slight headache, tender and soreness in the arm of her injection. The following day she felt short winded and experienced trouble sleeping. She did call EMS out for the breathing issue but was treated at home. She had been working around in the yard. That night she took one Tylenol for her pain. Patient read in the Fact sheet about problems breathing may be related to a serious reaction. Patient asking if she will be okay to take the vaccine since she experienced the breathing issue the following day. While glancing at the fact sheet, she noticed that blood thinners are not allowed after the first dose. She was prescribed a blood thinner after her first dose. She called in to know if it was safe for her to take the second dose while on blood thinners or does she need to stop taking it until her second dose. Clarified and she said that she took the blood thinner after her first dose. She also experienced difficulty breathing the next day and called paramedics to check on her. She wants to know if it will happen again on her second dose. She has been prescribed aspirin 81 mg. She is scheduled to have her second dose on 27May2021. Patinet will receive her second Pfizer Covid 19 Vaccine on 27May2021. Asking if she safe to take the second vaccine. She mentioned that she experienced a headache and minor reactions that went away quickly after the first dose. At night, she had trouble sleeping. She also experienced difficulty breathing the next day and called paramedics to check on her. She wants to know if it will happen again on her second dose. She is scheduled to have her second dose on 27May2021. The outcome of the tender & soreness in the arm of her injection, trouble sleeping, breathing issue and difficulty breathing was unknown and for event headache was recovered on an unspecified. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 57 | 2021-05-29 | feeling abnormal, impaired work ability |
Patient is a 57 year old woman works as a cleaner with PMHx morbid obesity, HTN (on amlodipine, meto...
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Patient is a 57 year old woman works as a cleaner with PMHx morbid obesity, HTN (on amlodipine, metoprolol, triamterene-HCTZ), CKD3 (baseline Cr 1.1-1.2) who presented to the ED on 5/28 with worsening shortness of breath, cough with yellow sputum, fatigue, and weakness, found to be COVID-19 positive. She was subsequently admitted to the MICU for acute hypoxic respiratory failure. At baseline, she is independent in all ADLs and works as a cleaner at an office building. She got the first dose of the pfizer COVID vaccine series 5/10, scheduled for second dose 6/2. She lives with her husband and nephew in a house with additional family members who live downstairs. She says she only really goes to work and always wears a mask while there. Her daughter (lives downstairs) helps with grocery shopping. No recent travel or sick contacts that she is aware of. She was in her usual state of health until 5/22 when she said she started to feel poorly. She had increasing shortness of breath over the next few days with worsening fatigue and cough to the extent that she was considering calling off from work. She continued to feel poorly and decided it was time to go to the ED on Friday, 5/28. Today, she says she is feeling better and is less short of breath. She still has coughing that is occasionally productive for clear sputum. No fevers, chills, lightheadedness/dizziness, chest pain, abdominal pain, nausea, vomiting, diarrhea. Her appetite is improved, and she is eating and drinking better today. Patient is a 57 year old female with PMHx obesity, HTN, CKD3 who presented to the ED with shortness of breath, cough, fatigue, found to have COVID-19. In the ED, she was hypoxic requiring increasing amounts of oxygen, ultimately with 40% FiO2 via Ventimask and HFNC when admitted to the MICU. CT chest with GGO/patchy consolidation in posterior lung areas and bases as is typically seen with COVID-19 infection. She has been started on remdesivir and dexamethasone and is now requiring HFNC for oxygen supplementation. Likely her single dose of vaccine has helped to lessen her disease severity. She meets criteria for addition of tocilizumab. Recommendations: - Continue dexamethasone and remdesivir - Can add tocilizumab - Health care maintenance: Screened for HIV 2009, HCV 2018, HBV 2018. Last TDAP 2015. I saw and examined the patient. I strongly agree with the resident/fellow's findings and plan of care. Patient with risk factors for severe Covid including obesity underlying kidney disease and hypertension presents with fever fatigue malaise and infiltrates on chest CT a little over 2 weeks after initial mRNA vaccination Denies any anosmia Agree with current treatment plan including dexamethasone and 5 days of remdesivir duction and maintenance and okay for tocilizumab as she is less than 24 hours into the ICU Other health maintenance up-to-date HIV negative remote hepatitis negative I will ask lab for cycle threshold out of curiosity as she has been vaccinated which likely has mitigated severe disease Explained to patient in detail and questions answered. Spoke to ICU team please call back if questions
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| 57 | 2021-05-29 | sleep disorder |
The symptoms started the day of the 2nd vaccine dose. The pain has NOT changed since the vaccine sh...
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The symptoms started the day of the 2nd vaccine dose. The pain has NOT changed since the vaccine shot. The person administered the shot, injected the needle at the top of my shoulder, not in the muscle, like the person did with the 1st vaccine dose. My arm was sore after the 1st dose but went away after a couple of days. but now, I have pain in the area of the shot, it is painful to the touch. I have trouble sleeping in my left side, of my body, at night. I have pain going down my arm when I lie down. My arm is weak and can not lift normal things with it. I am VERY concerned that this pain will never go away and I have to live with it the rest of my life.
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| 57 | 2021-05-31 | abnormal dreams | Dreams every night |
| 57 | 2021-05-31 | anxiety | Had high blood pressure, felt anxiety. |
| 57 | 2021-05-31 | feeling abnormal |
Eye pressure; Light headed dizzy; Limbs feel like jello and wobbly; Felt like I was floating as if I...
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Eye pressure; Light headed dizzy; Limbs feel like jello and wobbly; Felt like I was floating as if I was 10 feet tall; Sugar bottomed out to 80; Fast heartbeat; Shaky hands and legs; This is a spontaneous report from a contactable Other Health Professional (patient herself). A 57-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 02Feb2021, 07:30 AM (Batch/Lot Number: EL9261) as 1st dose, single for covid-19 immunization. The patient's medical history included Diabetes mellitus type 2, Fibromyalgia, Hypothyroidism, Osteoarthritis, allergies to Penicillin from an unknown date. The patient received other medications within 2 weeks of vaccination. On 02Feb2021 at 11:30 am, 4 hours after the vaccination the patient experienced Eye pressure, Lightheaded dizzy, Limbs feel like jello and wobbly, felt like she was floating as if I was 10 feet tall, Sugar bottomed out to 80, Fast heartbeat and Shaky hands, and legs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was Recovering. Follow-up attempts are completed. No further information is expected.
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| 57 | 2021-06-01 | feeling abnormal |
Approximately 1 hour after receiving shot developed very painful stomach pains and vomiting for sev...
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Approximately 1 hour after receiving shot developed very painful stomach pains and vomiting for several hours. Woke up next morning feeling better until 1:00 pm when I spiked a fever, intense chills to the point I could not get warm, fatigue, headache. Then came the debilitating muscle aches that felt like every muscle was going through a ?wood chipper?! Symptoms lasted 2-3 days.
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| 57 | 2021-06-02 | anxiety, loss of personal independence in daily activities |
Cannot carry out my normal activities without feeling like I need to lie back down; Soft stools; Dia...
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Cannot carry out my normal activities without feeling like I need to lie back down; Soft stools; Diarrhea; Listless; Feeling worn out, listless, and uneasy 5 days after; Feeling worn out/Severely fatigued; Experienced GI issues; body aches; sore right arm; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 13:00 (Batch/Lot Number: ER87290) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included Allergies: Penicillin, Allergies: sulfa; (Allergies to medications, food, or other products: Penicillin, sulfa), breast cancer remission (Had breast cancer 3 years ago but am in remission). Age at vaccination: 57 Years. Patient was not pregnant: No. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Other. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Concomitant medication(s) included gabapentin taken for an unspecified indication, start and stop date were not reported; desvenlafaxine succinate (PRISTIQ) taken for an unspecified indication, start and stop date were not reported. List of any other medications the patient received within 2 weeks of vaccination: Gabapentin, Pristiq Reported. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Historical Vaccine included BNT162B2 for COVID-19 immunization (Start Date/Time: 24Mar2021 01:00 PM, Right arm, dose number: 1, Lot number: EP7534) (Age at vaccination: 57-year-old). The patient experienced soft stools (non-serious) on 14Apr2021 15:00, diarrhea (non-serious) on 14Apr2021 15:00, listless (non-serious) on 14Apr2021 15:00, feeling worn out, listless, and uneasy 5 days after (non-serious) on 14Apr2021 15:00, feeling worn out/severely fatigued (non-serious) on 14Apr2021 15:00, experienced GI issues (non-serious) on 14Apr2021, body aches (non-serious) on 14Apr2021, sore right arm (non-serious) on 14Apr2021, cannot carry out my normal activities without feeling like i need to lie back down (non-serious) on an unspecified date. Adverse event: Soft stools within 2 hours of vaccine, then Diarrhea for 1 day, then soft stools for 2 more days. Feeling worn out, listless, and uneasy 5 days after. Adverse event country: US. if patient recovered: Recovering. Was treatment received for the adverse event: No. Vaccine Facility information available. Ethnicity information is available. Race information is available. Does Pfizer have permission to contact your/the patient's healthcare provider about this report: Yes. Event: Experienced GI issues within a couple of hours following the 2nd vaccine on 14Apr2021; soft stools, then body aches and sore right arm the evening of the 2nd vaccine; Had diarrhoea the following day for 24 hours, then back to soft stools for a couple of days following that. Stools back to normal my 14Apr2021. Severely fatigued 15Apr2021, then felt a little less fatigued over the weekend. Then became extremely fatigued again on 20Apr2021 and continued on until today, 22Apr2021. Cannot carry out my normal activities without feeling like I need to lie back down. Have contacted my primary care physician and am waiting for a call back, but not sure what can be done. Have submitted a previous report of these symptoms as well. I also had blood work done 1 month prior to the 1st vaccine and all was good. This issue seems to be a direct effect from the vaccine itself. Would appreciate a call back to discuss due to the fact I do not see any of these types of long term adverse effects on your site. if patient recovered: Not recovered. For events, soft stools, outcome was recovered on unspecified date in 2021, Diarrhea, outcome was recovering, Listless, outcome was recovering, feeling worn out, listless, and uneasy 5 days after, outcome was recovering, feeling worn out/severely fatigued, outcome was not recovered, experienced GI issues, outcome was not recovered, body aches, outcome was not recovered, sore right arm, outcome was not recovered, cannot carry out my normal activities without feeling like i need to lie back down, outcome was not recovered. The patient underwent lab tests and procedures which included blood work: all was good in 2021. Information about Lot/Batch number is obtained. Additional information has been requested
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| 57 | 2021-06-02 | feeling abnormal, sleep disorder, loss of personal independence in daily activities |
severe headache; severe vertigo; Bed was spinning out of control and I was hanging on for life; Coul...
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severe headache; severe vertigo; Bed was spinning out of control and I was hanging on for life; Could not sleep laying down; Intermittent dizziness; motion sickness; ear and head feeling full, brain fog; head feeling full; ear and head feeling full, brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right at age of 57 years on 02Apr2021 11:30 (Batch/Lot Number: ER 8730) as single dose for covid-19 immunisation. Medical history included hashimoto's thyroiditis, migraine. The patient's concomitant medications were not reported. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left at age of 57 years on 05Mar2021 15:00 (Batch/lot number: EN 6206) as single dose for covid-19 immunisation. After first dose, just a sore arm but patient was taking meloxicam (since unknown date) for a knee injury and wondered if the anti-inflammatory tempered the reaction. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent covid-19 vaccine was administered was pharmacy or drug store.12 days after second dose (no longer taking meloxicam) had a severe headache that lasted for 5 days. The day it eased, patient woke up in the middle of the night with sudden onset of severe vertigo. Bed was spinning out of control and I was hanging on for life. No prior medical history (hx) of vertigo. Vertigo was severe when laying on right side for a week. Could not sleep laying down. Intermittent dizziness and motion sickness during the day - especially when bending over or turning my head to the right. It is over 4 weeks since onset of symptoms. Had intermittent days of strange headache, ear and head feeling full, brain fog, fatigue. Vertigo is improved but definitely still there when I lay down to the right or rollover. Have not been able to drive since onset. Adverse event start date/time reported as 14Apr2021 19:00 (as reported). The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient had PCR test via Nasal Swab on 15May2021 and Negative. Prior to vaccination, was the patient was not diagnosed with COVID-19. Treatment received for the adverse event included CT scan w/venogram, prednisone, meclizine (in 2021). Seriousness reported as no. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.
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| 57 | 2021-06-02 | feeling abnormal |
red rash wrist, itching, about a 3-4 inch area; red rash wrist, itching, about a 3-4 inch area; Jaw ...
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red rash wrist, itching, about a 3-4 inch area; red rash wrist, itching, about a 3-4 inch area; Jaw up to ear, under eye, eye lid, down her neck, left side of windpipe, back of neck, shoulder and left side of forehead lost sensation, lost sensation in part of arm above elbow.; tingling sensation in mouth, tingling lip; upper lip went numb; tingling half face; Headache; left arm swelled up; Elevated Heart Rate; Brain fog; dry mouth; funny sensation in her mouth; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0158, Expiration Date: 31Jul2021), via an unspecified date of administration in left arm on 14May2021 at 09:35 (at the age of 57-year-old) at first dose, single for COVID-19 immunization. The vaccine was administered at hospital. The patient did not receive other vaccine within four weeks prior to the first administration date of the COVID-19 vaccine. Relevant medical history included dental work to left upper molar done on 11May2021. She was given anesthesia and stated all this resolved. She had the procedure at 10:00. The patient was not receiving concomitant medications. On 14May2021 within 10 minutes of receiving shot the patient experienced tingling sensation in mouth, tingling lip, half face, and upper lip went numb. Her jaw up to ear, under eye, eye lid, down neck, left side of windpipe, back of neck, shoulder and left side of forehead lost sensation. Left arm swelled up and lost sensation in part of arm above elbow. The patient went to the emergency room for these symptoms and she was monitored there. The patient stated she is about 90% resolved of these symptoms, but they are not completely gone. On 14May2021 had headache that has resolved but she keeps having a sensation like she is about to get a headache on the left side of her forehead and also had elevated heart rate. She stated that her heart rate was elevated for many hours. It was still higher than normal for her when she left the emergency room. On 17May2021 had right red (rash), very itchy area on right wrist. Came on all of the sudden and was fire red and very itchy, was about a 3-4 inch area. Dissipated within an hour. She is still experiencing brain fog since an unspecified date in May2021, it is improving; but she had to take a half a day off of work the day before reporting to rest. Dry mouth and a funny sensation in her mouth are still lingering since an unspecified date in May2021. The patient stated that she called her doctor's office the day before and is awaiting a call back. She says the emergency room doctor told her to follow-up with her doctor and that the emergency room doctor also advised her not to get the second vaccine. They stated that she could potentially have a long-lasting vaccine effect. The patient asked what are the risks of her getting the second shot since she had such a severe reaction that is taking so long to resolve. Rash resolved on 17May2021, headache resolved on 14May2021, final outcome of heart rate increased was unknown, dry mouth and a funny sensation in her mouth had not resolved, while all the remaining events were resolving.
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| 57 | 2021-06-02 | loss of personal independence in daily activities, insomnia |
Pain from waist down so excruciating; Throwing up; Could not lay down/sleep; loss of mobility; Could...
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Pain from waist down so excruciating; Throwing up; Could not lay down/sleep; loss of mobility; Could not lay down/sleep; Could not stand up/walk; Completely disabled in lower extremities; Could not walk w/o holding on to chair/counter; Something else going on with nerves; This is a spontaneous report from a contactable consumer(patient). This 57-year old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0153) at single dose on 14Apr2021 13:00 via an unknown route in left arm for Covid-19 immunization. Medical history was "none". Patient was completely healthy, no known allergies. Patient did not have covid prior vaccination. No other vaccine in four weeks, prior to the COVID vaccine, no other medications in two weeks. Within 24 hours after Shot#1, patient could not walk without holding on to chair/counter. Within 48 hours, patient could not stand up/walk, pain from waist down so excruciating, patient began throwing up (lasted 3-4 days), could not lay down/sleep (for at least 3 weeks). Patient went to Emergency room, got x-rays, CT scans, blood workup, etc. All results normal. Patient experienced undetermined cause of loss of mobility. 5 weeks later, patient was still unable to stand up on own, pain unbearable. No pain pills provided, just ibuprofen, Chiro adjusted her 3 times/week since, ice every 1-2 hrs, but it only able to alleviate some of the pain. Patient also reported something else going on with nerves. Patient needed to see a Nerve specialist. She was completely healthy/running/walking on day of shot and next day forward, completely disabled in lower extremities. Patient reported that she knew Shot 1 had done something damaging to her nerves. Adverse event start date was reported as 15Apr202110:00 AM, which resulted in Doctor or other healthcare Professional office/clinic visit, Emergency room/department or urgent care. Other treatment information was unknown. Patient did not have covid tested post vaccination. The report was assessed as non-serious. Outcome of the events was not resolved.
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| 57 | 2021-06-03 | excessive sleepiness |
I woke up at 6 am with numbness in my left arm and hands, I went to work and it kept progressing, I ...
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I woke up at 6 am with numbness in my left arm and hands, I went to work and it kept progressing, I took Claritin, drove home and slept for 2 days, I was totally out of it, I only got up to go to the bathroom or drink something. I was good for 24 hours then I was so fatigued slept 2 more days, I woke on the 18th I was numb, I woke up drooling, my whole left side was numb I had some drooping in my face and my boob. I did a tele med visit that morning , My doctor started me on a prednisone pack, Lymph nodes and my breast for very tender on left side. I went to see neurologist bc symptoms were not getting better and I was extremely fatigued, which is not me, I also have sever hip pain, that I never have had before. The neurologist diagnosed me Sensory deficit disorder on the left side of my body.
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| 57 | 2021-06-03 | insomnia |
Debilitating leg cramps; Could barely walk; Could not sleep; This is a spontaneous report received f...
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Debilitating leg cramps; Could barely walk; Could not sleep; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old non pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot no: I 6198) via an unspecified route of administration in the left arm on 16Mar2021 at 08:30 hours (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included unspecified medications for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021 about 20:00 hours, the patient experienced debilitating leg cramps until 17Mar2021 12:00. On the same day, the patient could not sleep and could barely. The clinical outcome of the event debilitating leg cramps was recovered on 17Mar2021 12:00 and for the events could barely walk and could not sleep was reported as resolving. No follow-up attempts are needed. No further information is expected.
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| 57 | 2021-06-03 | loss of personal independence in daily activities |
IMy lower body was sore and I had a hard time getting out of bed. I could not put on my own shoes an...
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IMy lower body was sore and I had a hard time getting out of bed. I could not put on my own shoes and socks. My Flammatory numbers were very high. I submitted this information already but have not had any reply back. I went to a rhuematologist who said I now have Psoriatic Arthritis. I still have a hard time walking so she sent me to an Orthopedic Physican who said my bones are fine and the vaccine is affecting my cells. The only time I am able to function is when I am on steroids!
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| 57 | 2021-06-06 | sleep disorder |
Numbness and tingling in fourth and fifth fingers almost immediately after vaccine injection. This ...
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Numbness and tingling in fourth and fifth fingers almost immediately after vaccine injection. This resolved in about 30 minutes. A few days later I have sharp pain on range of motion in my left shoulder that continues to this day, pain in my left shoulder if I sleep on my left side.
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| 57 | 2021-06-07 | excessive sleepiness |
First dose: Swelling at the injection site; The first dose was annoying and she slept for a day; Thi...
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First dose: Swelling at the injection site; The first dose was annoying and she slept for a day; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection) via an unspecified route of administration, in arm right on 06May2021 (at the age of 57-year-old) (Lot Number: EW976) as 1st dose, single dose for covid-19 immunization. The patient medical history included ulcer (Diagnosed in 2020 and patient could not take Ibuprofen because of this). The patient concomitant medications were not reported. On 06May2021 (reported as after 6 hours of first dose of vaccine), the patient experienced swelling at the injection site. The patient reported that the first time she had a swelling the size of her hand at the injection site. The first dose was annoying, and she slept for a day on an unknown date in 2021. The patient was prone to swelling, she never progressed after the second round of allergies shots because of the swelling. The swelling happened after every allergy shot, she ever had this was 20 years ago. The swelling would start about a day later. The patient would get one allergy shot on a Monday (date unspecified) and then one shot on a Friday (date unspecified). The outcome of the event was swelling at the injection site was recovered on 10May2021and for hypersomnia was recovered on 2021. No follow-up attempts possible. No further information expected.
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| 57 | 2021-06-08 | confusional state |
Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat t...
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Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; felt sensation of lacking oxygen to brain similar to high altitude sickness; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; Numbness in face from bridge of nose,across cheek bones,below chin.Numbness tingling tongue.Throat tightening.Muscle aches thighs of legs,worse on left leg.Stumbling while walking.Chills,Sore arm, fatigue, confusion.; muscle aching in legs, hips and lower back; off balance; room spinning; Headache; throat swelling; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 57-year-old female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EW0151 and Expiration date was not provided), via an unspecified route of administration in Arm Left on 16Apr2021 08:30 (age at vaccination 57-year-old) as 1st dose, single dose for COVID-19 immunization. The patient was not pregnant. Medical history included spondylosis, hypothyroidism, diverticulitis, Allergies to medications, food, or other products penicillin, arithamyacin and tetracycline. Concomitant medications included tizanidine (TIZANIDINE); sulindac (SULINDAC); thyroid (ARMOUR THYROID). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The adverse event result in any of the following Emergency room/department or urgent care. On 16Apr2021 09:30, the patient experienced numbness in face from bridge of nose, across cheek bones, below chin. Numbness tingling tongue. throat tightening. muscle aches thighs of legs, worse on left leg. stumbling while walking. chills, sore arm, fatigue, confusion, felt sensation of lacking oxygen to brain similar to high altitude sickness, muscle aching in legs, hips and lower back, off, room spinning, headache, throat swelling. Therapeutic measures were taken with Intravenous Benadryl and Pepcid. The outcome of events was Recovered/Resolved with Sequel on an unspecified date in Apr2021. Follow-up attempts are needed. further information is expected.
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| 57 | 2021-06-08 | disorientation |
Irregular high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of...
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Irregular high blood pressure; dizzy; disoriented; loss of balance; pain in neck left side; loss of hearing; impaired blurry vision; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:45 as a single dose for COVID-19 immunization. Medical history included Bell's palsy ebv (as reported) from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril (manufacturer unknown); clarithromycin (CLARITIN); ascorbic acid (VITAMINS C); colecalciferol (D3) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:30, the patient had an irregular high blood pressure, was dizzy and disoriented, had a loss of balance, pain in neck left side, loss of hearing and impaired blurry vision. The events resulted in a visit to the emergency room and hospitalization for 2 days. The patient had an MRI, CT scan, EKG and an echocardiogram (results unknown). The patient had a nasal swab COVID-19 test on 28Apr2021 with an unknown result. The outcome of the event was recovering. Information about batch/lot has been requested.
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| 57 | 2021-06-09 | crying |
c/o facial numbness and heart palpitation after taking the vaccine dose #2. Denies PMH, psych hx i...
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c/o facial numbness and heart palpitation after taking the vaccine dose #2. Denies PMH, psych hx includes bipolar with patient admitted noncompliant with medications. Allergies-NSAID, PCN, Ibuprofen and tomatoes. V/S BP 142/76, P 95, R 18, O2 Sat 98%. pt. appears very emotional and cries often. Advice pt. to follow up with psych dr. Pt. verbalized understanding. Pt. taken home by the sister in no distress with symptoms resolved.
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| 57 | 2021-06-09 | disturbance in attention, memory impairment, feeling abnormal |
loss of balance 4/11/21 dizziness / unsteady walking 4/11 lightheaded / near falling to ground 4/24 ...
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loss of balance 4/11/21 dizziness / unsteady walking 4/11 lightheaded / near falling to ground 4/24 vertigo 4/28 - ER and hospialized for 2 days (4/28-4/30) Increased blood pressure Increased hear rate blurred vision, trouble concentrating, brain fog, short term memory impacted nystagmus hearing loss inflamation of 7th and 8th nerves, face twitching itchy head, tinglingly pain / burning in feet, achy hands joints,
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| 57 | 2021-06-09 | impaired work ability |
"I got shaking chills 11 hours after vaccine and then severe headache and fatigue, and had some naus...
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"I got shaking chills 11 hours after vaccine and then severe headache and fatigue, and had some nausea. I missed work 1/11 and 1/12."
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| 58 | 2021-01-04 | insomnia |
Patient reports chills, joint and muscle aches, extreme fatigue, nausea, insomnia and a general se...
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Patient reports chills, joint and muscle aches, extreme fatigue, nausea, insomnia and a general sense of not feeling well.
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| 58 | 2021-01-05 | disorientation |
Headache, dizziness, disorientation, upset stomach. Headache not resolved with tylenol. Symptoms r...
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Headache, dizziness, disorientation, upset stomach. Headache not resolved with tylenol. Symptoms resolved after 36 hours.
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| 58 | 2021-01-05 | thinking abnormal, sleep disorder, irritability |
Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to s...
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Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to sleep; Irritable mood; Muscle spasms; dry eyes; Dry mouth; brain fog, inability to multitask; This is a spontaneous report from a contactable nurse. A 58-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number: EJ1685; intramuscular in left arm on 18Dec2020 at 14:45 (at the age of 58 years-old) as a single dose for COVID-19 immunization. The vaccine was given in a hospital. The patient did not receive any other vaccines in the past 4 weeks. Medical history included asthma, mitral valve prolapse and an allergy to latex. Concomitant medication included calcium (CALCIUM), metoprolol (METOPROLOL), magnesium (MG [MAGNESIUM]), ergocalciferol (VIT D). The patient previously took penicillin and experienced an allergy. The patient did not receive any other vaccines in the past 4 weeks. She did take other medications (concomitant) in the past 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. In Dec2020, at 14:45, the patient experienced rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth, brain fog, and an inability to multitask after 1 week following COVID-19 vaccine. The patient was not hospitalized for the events and no treatment was administered. The outcome of the events: rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth. brain fog, inability to multitask, was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-01-06 | loss of personal independence in daily activities |
"By around 7p that evening 12/17/20, i was unable to life my arm to undress. the next morning the i...
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"By around 7p that evening 12/17/20, i was unable to life my arm to undress. the next morning the injection site was a little tender but i could move the arm"
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| 58 | 2021-01-07 | feeling abnormal | Swelling of the tongue, feeling "not right", tightening of the airway (all mild and short duration) |
| 58 | 2021-01-07 | feeling abnormal | Felt "not right", minor 'thickness of my tongue', tightness of airway (all minor in severity) |
| 58 | 2021-01-07 | feeling abnormal |
Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad t...
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Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; caused her to go into the flare; Muscle joints pain; Extremely tired; Muscle joints pain; Experiencing flu like symptoms; Body ache; Headache; sick; feeling bad; The initial case was missing the following minimum criteria: specific product. Upon receipt of follow-up information on 01Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 vaccination. Medical history included having something called Adult Still's which is bad Rheumatoid Arthritis. The patient's concomitant medications were not reported. The patient reported that she got the vaccine and was experiencing sever cramps in her legs and thighs, and muscle joints pain. She mentioned on a scale of 1-10 it is 20. The patient also experienced flu like symptoms which were body ache and extremely tired. The patient reported that she called because she received her first Covid shot on 17Dec2020 and she was really sick from then, she was talking like super sick. In Dec2020, she had muscle cramps, headache, no fever but like she had the flu. She has something called Adult Still's which is bad Rheumatoid Arthritis, so it caused her to go into the flare but she was still sick. She was still feeling bad. She was still having muscle pains in her leg. The patient mentioned that she had to go to the emergency room because she could barely move her leg. They told her that it was a combination of Adult still's and her Covid 19 shot, so they gave her some medications. They gave her Lyrica 75 mg, twice a day and it messed me up that she couldn't even function. So, now she had to come home from work and now she was still having the leg cramps and just not feeling well so what can she do to feel myself better. The outcome of the event cramps in legs was not recovered while the outcome of the other events was unknown. Information on the batch/lot number has been requested.
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| 58 | 2021-01-07 | sleep disorder |
Start with the normal sore arm continues on day five, normal headache two days. On the second day, v...
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Start with the normal sore arm continues on day five, normal headache two days. On the second day, very stomach pain so bad could not sleep now for three days.
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| 58 | 2021-01-08 | impaired work ability |
Headache, Myalgia, Fatigue Narrative: Received vaccine on 12-21-20. Came to work the next day, by n...
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Headache, Myalgia, Fatigue Narrative: Received vaccine on 12-21-20. Came to work the next day, by noon was not feeling well. Headache, myalgia and fatigue. Left work at 2pm - which was 2 hours early. Slept it off, came to work the next day.
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| 58 | 2021-01-09 | disorientation, impaired work ability, confusional state |
Pt experienced confusion, disorientation, dizziness, lightheadedness, weakness, & stiff neck followi...
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Pt experienced confusion, disorientation, dizziness, lightheadedness, weakness, & stiff neck following vaccination. Patient was sent home from work and symptoms persisted after rest.
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| 58 | 2021-01-09 | insomnia |
Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than ...
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Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than the first dose. Tired in evening so went to bed early. Around 2100pm chilling/fever began lasting about 5 hours. This was associated with headache, nausea, and arthralgias. No sleep. All day on 1/9/21 very lightheaded, headache, and some nausea. Spent the day lying on the couch. On 1/10/21 while headache still there in am, much improved. Still some uneasiness of stomach. L axillary soreness. Over all feel much better though not fully normal on afternoon of 1/10/21.
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| 58 | 2021-01-10 | agitation |
Patient had a "psychiatric seizure" apparently has a history of these. Became agitated and aggressiv...
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Patient had a "psychiatric seizure" apparently has a history of these. Became agitated and aggressive. 911 was called and medics took the staff member to the hospital.
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| 58 | 2021-01-10 | feeling abnormal | Fatigue, muscle aches, mental fogginess, syncope, cold hands |
| 58 | 2021-01-10 | impaired work ability |
Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Sym...
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Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Symptoms of fatigue began approx. 12 hrs. late, then fever after midnight, chills, body aches, severe headache, abd cramping, and extreme fatigue. Highest fever recorded was 101.8 the next day (Sunday) around 4pm. Didn't take Tylenol or Motrin. As of writing this (Monday 12:07 pm) my fever is gone but headache and extreme fatigue remain. Injection site still sore and today I notice I have a very swollen and painful lymph node left axilla opposite injection site. I had to call in sick today and possible will tomorrow if the extreme fatigue and headache don't go away.
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| 58 | 2021-01-10 | sleep disorder |
tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head ...
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tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing. The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
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| 58 | 2021-01-11 | feeling abnormal, disturbance in attention, impaired work ability |
Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. ...
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Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. A few days later, I felt like my head, on the side of my right ear, had a great deal of pressure in it and it felt "funny " but it did not really hurt. It was uncomfortable and distracting. I waited to see if it would go away. I noticed my hearing was decreased . On 01/06/20 when I woke up, my hearing was completely gone in my right ear. I could hear nothing out of that ear. I had a noise in my head. Just a loud roaring noise. I had severe vertigo and could not walk across the room. I describe this as I felt like I was on a merry-go-round and someone was spinning me really fast. (continue) Additional information for Item 18: Vaccine Adverse Event Reporting System, continued: I also experienced severe vomiting and could not stop. My husband took me to the doctor. Since I could not get in to my regular doctor that day, we went to an ear doctor I had visited a couple of years ago because that was the only person I could find to see me on short notice. I had regular hearing test in the past and my hearing was normal last time he checked it. After doing a hearing test, he verified my Hearing was severely decreased in my right ear. I explained to him, I also feel "foggy" and I have problems concentrating, was having vertigo, and vomiting. I am not sure if that is because of the constant sound in my ear that distracts me but it is a definite problem and interferes with my work. I cannot concentrate. He started me on Steroids (Prednisone) 60 mg a day for 7 days, then 40 mg for 3 days, then 20 mg for three days, Antivert 12.5 mg three times a day as needed, and Zofran for the vomiting if I needed that. I have not experienced anymore vomiting and the Vertigo has been very limited. Mostly when I lay down now instead of when I stand up. My blood pressure has also been slightly elevated, but it could be from the Steroids. I was scheduled to take the 2nd Pfizer Vaccine on 01/09/21. Since I was receiving the high doses of Steroids, I was concerned that the vaccine would not be effective or may interact with the steroids so I went to my family doctor 01/08/21, for a visit. He said he would check and let me know if it was contraindicated for me to take the Vaccine on high doses of steroids. When I did not hear from him, because I had to take the vaccine the next day, I called the Pharmacy and talked to someone there and they told me the agency was still recommending you take the Vaccine even if you are on the steroids. I received the second Pfizer Vaccine on 01/09/21. My hearing is now coming and going but I can hardly hear anything out of that right ear. . There is a constant noise, like a roaring, in my head and I still have problems concentrating. I have had no more vomiting and my vertigo has hot been as severe but I have experienced some at times. I reported to the Pharmacy the day I received my vaccine, 01/09/21, about the things I had experienced this since my first vaccine. They took my information and said they would call me but today is 01/12/21 and I have not heard from them yet so I thought I would go ahead and report this. I am concerned this was an adverse reaction to the vaccine. I return to the doctor 01/20/21 for a repeat hearing exam. The Doctor expressed this condition could be a permanent and disabling issue but currently being treated and will follow up with more testing. I am also concerned about how the second vaccine affected me because I was receiving the high doses of Steroids at the time I received it. I am sending this from a work email so if you reply, please reply to personal email.
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| 58 | 2021-01-11 | feeling abnormal |
Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild...
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Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild headache, cotton headed, fatigue, left arm pain, neck/shoulder aches
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| 58 | 2021-01-11 | feeling abnormal |
Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grad...
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Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grade fever, chills, muscle/body aches, nausea, vertigo, primarily muscle/body aches. My symptoms resolved aprox. 36 hours later. Aprox. 60 hours later, I had a couple of episodes of diarrhea, and was just feeling a little "spacey" and slightly tender behind my eyes.
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| 58 | 2021-01-11 | impaired work ability, feeling abnormal |
tested positive for COVID-19; tested positive for COVID-19; loss of taste and smell; loss of taste a...
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tested positive for COVID-19; tested positive for COVID-19; loss of taste and smell; loss of taste and smell; excruciating headache; runny nose; congestion; shortness of breath when she started talking; having aches and pains; lightheaded, experienced dizziness; tied; This is a spontaneous report from a contactable consumer(patient). The 58-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, intramuscular injection ), intramuscularly in left arm on 23Dec2020 at single dose for COVID-19 vaccination in nursing home. Medical history included she had a right knee injury so she had some inflammation, She had stomach issues in the past- Barrett's syndrome, H. pylori(Helicobacter infection), GERD(Gastrooesophageal reflux disease), so, Pantoprazole is just a maintenance medicine, she was stable right now. She had a Vitamin D deficiency at one point. Ongoing concomitant medication included meloxicam for inflammation, thyroid for thyroid(Thyroid disorder), pantoprazole for stomach issues, colecalciferol (VITAMIN D 3) for supplementation therapy. There was no vaccination within 4 weeks. She received her first vaccine on 23Dec2020. There no other vaccine received in the same day. By 26Dec2020, she started with symptoms and then she tested positive for COVID-19 on 29Dec2020. She felt horrible with an excruciating headache and was wondering if she was going to die now. She can really feel for the residents she works with who get it. Right now, she was hopefully going back to work next week, but she was wondering about the second vaccine. People are saying she got COVID-19 because of receiving the first vaccine and she was hoping it was not the case. Is it going to be an issue getting the second vaccine after testing positive? The caller declines to include her healthcare professional for this report, stating she has been talking with her doctors over the week. Her symptoms included runny nose, congestion, and what seemed like shortness of breath when she started talking. She started having aches and pains over the weekend. By Monday, 28Dec2020, there was loss of taste and smell, it was totally gone. She also was lightheaded, experienced dizziness, was tied. She went through a lot of symptoms which was shocking to her. She clarified these symptoms first began the morning of the 26Dec2020. Christmas she was fine, and then she to go out to get snow off of her car and do some running around on 26Dec2020 and she noticed she started having symptoms. When probed for outcome, the caller state she was most definitely feeling better. She was having some excruciating headaches and she has worked with her doctor on what they needed to do. She is still working with the doctor on her lightheadedness. She has set up a follow-up appointment, but she was feeling better. There was no emergency room nor physician office. Relevant test was none. It was also reported lot number was either EJ1685 or EJ1085, she can't tell. Outcome of loss of taste and smell was recovered, of dizziness was not recovered, of other events was recovering.
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| 58 | 2021-01-11 | impaired work ability |
Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell. By We...
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Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell. By Wed evening had chills and low grade fever 99.4. Called out of work Thursday. Felt terrible. Thursday morning lower abdominal cramping consistent and pain scale between 4-5 with occasional spikes to 8. Also felt terrible. Had body aches, could only lay on couch. Called my gastroenterologist. Office returned call late afternoon and stated probably from vaccine and if it worsens or fever to call primary and to fill out VAERS form. Thursday evening had temp of 100.4 and started with a cough where it felt I couldn't take deep breaths. Only lasted a few hours. Abdominal pain persisted. Friday morning woke up and now have headache, but abdominal pain is now down to a 2 and I feel achy, but feeling a bit better. Had to call out of work still too sick to go in. No cough. No fever. Since I was feeling better my hope was since it was vaccine related that I would wake on Saturday and be totally fine, unfortunately, not the case. Saturday morning abdominal pain same at a 2 and headache was on and off through the day into the night. Still pretty much rested all day into the night. Sunday morning much better. Headache gone and abdominal pain down to a 1 and sometimes just vague. Although I'm feeling better my head feels out of sorts, kind of like my brain can't keep up with my eyes? And new symptoms? right ear crackling and teeth on right side feel sensitive also, pain under left armpit. It's tender and lasts through the day. Monday still feeling a bit lightheaded and fatigued and armpit pain still there but not worse and feel able to go to work to see if I can. Tooth sensitivity also still there but ear pain gone. Called primary doctor she suggests getting Covid test and have appointment for phone conference for Tuesday with doctor, also had Covid test today at work (was Covid tested last Monday also for work and negative) into Monday night head is still feeling "off". Tuesday armpit pain still same and dizzy head feeling same, mild abdominal pain comes and goes - Not bad enough to stop daily activity. Spoke with primary doctor and she said side effects could possibly last this long and let her know when yesterday's Covid test comes in.........
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| 58 | 2021-01-11 | nervousness, feeling abnormal, irritability |
immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really swe...
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immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease. She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck, back, and knees. She said the joint pain felt like "flu" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days. She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events "She clarified she had some injection site pain" "and the injection site was a little itchy" and Shoulder pain were recovered on an unspecified date, "Chills" and "feels shaky inside" were not recovered, "Joint pain" "Nausea" "Numbness facial" were recovering, while outcome of other events was unknown.
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| 58 | 2021-01-12 | poor quality sleep |
Received vaccine at 4:40pm. Approximately 8pm I started with stomach cramps and had those for a few ...
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Received vaccine at 4:40pm. Approximately 8pm I started with stomach cramps and had those for a few hours. During the night I tossed and turned and my hips were very achy. I woke with a fever that went as high as 101 and was very shivery all day. Fever reduced with Ibuprofen around 6 in the evening. Seemed to feel better. Very restless though the night and hips achy and awoke with a fever. Took Iuprofen. Fever reduced and slight headache. Tired but much better today.
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| 58 | 2021-01-13 | feeling abnormal |
"I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When...
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"I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When I awoke on Saturday the 9th my arm was very sore at injection site but later went away. I had a dull headache, nausea, I was yawning all day, muscle fatigue, esp my quads, lightheaded enough to lay on the floor a few times during day. These symptoms did not stop me from painting, but I did feel horrible but I pushed through it. Sunday still nauseous, just feeling not my self..... I awoke on Monday morning and I was 100% fine!"
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| 58 | 2021-01-13 | impaired work ability |
Employee had irritated skin and rash extending down her trunk area and sides. Employee took liquid b...
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Employee had irritated skin and rash extending down her trunk area and sides. Employee took liquid benedryl for the minor allergic reaction.
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| 58 | 2021-01-14 | impaired work ability | Severe headache, nausea, fatigue, bodyaches. Unable to work that day after receiving vaccine |
| 58 | 2021-01-14 | impaired work ability | vomiting, headache, nausea, joint pain. called in sick to work. |
| 58 | 2021-01-14 | sleep disorder, impaired work ability |
After 15 minutes felt dizzy when got up to walk. Sat back down for about half hour. Still felt dizz...
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After 15 minutes felt dizzy when got up to walk. Sat back down for about half hour. Still felt dizzy, but went home. Began to feel nauseated and headache which continued from Saturday through currently. On Wednesday 4:00 a.m woke up to feeling of itchyness in chest. It spread to stomach, then legs, arms, face, back head in about an hour and a half. Took a shower and then felt burning. called doctor next morning at 10:30 and told to start benadryl and allegra. Stared about 1:00 pm. very drowsy and increased headache and nausau. Could still feel burning. Continued with about 3 does. Work up 12:38 on Thursday morning with increased burning and itching and benadryl was last taken 7 and half hours before. Did not take benadryl on Thursday due to drowsyness. Did not work Wednesday or Thursday. Friday early morning hours, woke up several times with itchiness and burning. This is all over my body. No rash at any time. Continued headache and nausea.
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| 58 | 2021-01-16 | insomnia |
1/15/21 at 0900 injection. some mild headache between then and 2300 when I had chills, headache, bod...
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1/15/21 at 0900 injection. some mild headache between then and 2300 when I had chills, headache, body aches, Nausea, T 100.2 F. 1/16/21 0200 took Tylenol 500mg nausea, chills HA T 100.8 at 0410 symptoms continue and I i still had insomnia (that is not uncommon for me) symptoms were a bit milder. 0420 took 500mg Tylenol, 1030 500 mg tylenol HA nausea dizzy T 100.8F. 2345 bad again. took 1000 mg Tylenol and a 3mg tab of Lunesta. body aches HA nausea chill dizzy T 100.7. Overnight I had a bout of terrible night sweat and the bed and pillow and night clothes were soaked (not menapausal related) 1/17/21 0830 T 97.8 feel a bit better. as the day goes on I notice when I move around, especially quickly I have a horrible pain in my head and dizziness. at 1700 T99.9 nausea, dizzy HA.
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| 58 | 2021-01-18 | anxiety, loss of personal independence in daily activities |
The evening of receiving the vaccine every muscle and joint in my body was achy, started feeling anx...
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The evening of receiving the vaccine every muscle and joint in my body was achy, started feeling anxious and depressed, just to the point that I could not leave my bed for a week, extreme fatigued. I feel a little better, started making myself get up and do stuff and went back to work on 01/11/2021.
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| 58 | 2021-01-18 | anxiety |
Late Entry 0952: Patient not feeling well. Reports shortness of breath, tongue tingling and has a ra...
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Late Entry 0952: Patient not feeling well. Reports shortness of breath, tongue tingling and has a rash to left upper arm. 0954: O2 sats 99%, HR 130 bpm, BP 150/90. Offered PO Benadryl per vaccine standing orders for adverse reactions. Patient refused PO Benadryl. O2 at 2L/NC applied at this time. EMS notified and in route. 1000: Patient remains very anxious and complains of dry mouth, dizzyness and tingling tongue. Attempted to administer EpiPen per vaccine standing orders for adverse reaction. Patient refused EpiPen. 1002: EMS on site. Patient continues to refuse EpiPen. O2 sats 99% on 2L/NC, HR 123 bpm, and BP 137/76. Patient ambulated with EMS personnel outside. After ambulating with EMS personnel, patient stated she felt better and refused to be transported to the hospital. Returned inside for follow up and monitoring. Late Entry 1025: Patient waiting to sign AMA form and had another episode in the hallway. Patient stated she did not feel right and squatted in the hallway. Staff assisted her to a chair. EMS notified and in route. Dr. notified. 1028: O2 sats 99%, HR 94 bpm and BP 138/102. Patient refused EpiPen at this time. Patient complains of feeling dizzy and short of breath. O2 at 2L/NC applied for comfort. 1032: O2 sats 98% on 2L/NC, HR 88 bpm, and BP 128/84. 1035: Dr. at bedside assessing patient. 1040: EMS here. Patient agreed to be transported to the local hospital for evaluation. O2 sats 98% on 2L/NC, HR 86 bpm, and BP 140/81.
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| 58 | 2021-01-18 | loss of personal independence in daily activities |
I had a sore arm right away. The next morning I felt like I could have a fever and had body aches an...
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I had a sore arm right away. The next morning I felt like I could have a fever and had body aches and did not feel good. When I got to work I talk to Dr. and he gave me a shot of Depomedrol and Solunedrol shot.. The shot helped for a while but starting feeling worse, I took a second dose of Advil. I woke up the next morning with a head ache and body ache, I stayed home from work. I rested all day and by that evening I felt all better.
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| 58 | 2021-01-19 | feeling abnormal |
I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet w...
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I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive.; I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day; I woke up at midnight and felt extreme malaise; I was covered in sweat; vomited; I checked my temp and it was 99.7°F; sore; I think I had either a seizure or a vasovagal response.; This is a spontaneous report from a contactable nurse (patient). This 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular at single dose in the left arm on 09Jan2021 06:00 for Covid-19 immunisation. Medical history included atrial fibrillation on unknown date (1 episode), allergic to Keflex. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular in the left arm on 22Dec2020 for Covid-19 immunisation. On 10Jan2021 01:00 AM, the patient experienced: I began to pass out and yelled for my husband, he said when he came in i was sitting on the toilet with my head back, eyes rolling back not responsive (loss of consciousness) (medically significant), I had my 2nd vaccine at work early sat the 9th and felt increasingly worse all day (feeling abnormal), Iwoke up at midnight and felt extreme malaise (malaise), I was covered in sweat (hyperhidrosis), vomited (vomiting), I checked my temp and it was 99.7°F (pyrexia), sore (pain), I think I had either a seizure or a vasovagal response (seizure). No treatment required. The outcome of the events was recovered. The events were described as follows: I am healthy RN with no active medical problems. I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day, I expected this so was not alarmed and went to bed around 10pm. I woke up at midnight and felt extreme malaise and went to the bathroom in case I might vomit, etc. and I tried to have a BM. I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive. He yelled at me for about 10 seconds and I came to, I was covered in sweat. I asked him to walk me back to the bedroom where I again passed out, fell to the floor and hit the bed, then was unresponsive again for about 10 seconds then came to again and vomited. After this I felt completely relieved of my malaise. I checked my temp and it was 99.7°F. After this I was sore but otherwise completely okay, the next day I had a temp of 99.5°F. Today I am back to normal. I think I had either a seizure or a vasovagal response. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event "began to pass out" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-19 | impaired work ability |
On Tues, 1/12 I started feeling like I was getting a cold because I got the chills when I got home,...
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On Tues, 1/12 I started feeling like I was getting a cold because I got the chills when I got home, but not the flu because I had my flu shot in Oct.2020 Wednesday 1/13 I left work because I started with vomiting, diarhhea , a light headache and my arm was real sore. That continued on through that night and into the next morning. So I had to call in at work that morning 1/14. I finally started feeling better by friday night, 1/15. The headache was gone and the chills were only slight and I could finally keep some toast down. Before that I could only slightly keep liquids down.
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| 58 | 2021-01-20 | feeling abnormal |
1525 - states she is experiencing vertigo. Transported via w/c to private observation area. EMT on s...
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1525 - states she is experiencing vertigo. Transported via w/c to private observation area. EMT on site in attendance. Patient able to transfer from chair to w/c without difficulty. States, "my head is swimming and I have nausea" States she has hx of vertigo but this is different as per statement above. HR 86; BP 148/68; O2 97% on room air. States she drove self, has service dog with her. States she ate a late breakfast. States she had a COVID test this morning at for pre op biopsy to be done this Friday 1/22/2021. Denies exposure to COVID. 3:50, examined per Dr. Gave patient gatorade and granola bar. Also drank about 2 ounces of water and tolerated with n/v. Ate about 1/4 granola bar. O2 98%; HR 88 4:02 PERRL - NO nystagmus noted. Tol. 10oz gatorade without n/v. States she has too much nausea to eat anything. Offered ambulance transport for further evaluation. Patient unsure what to do. 4:05 - Had patient stand up next to w/c. Mobility steady. Patient looking down at her dog without any swaying noted. Patient sat back down. 4:08 Patient ambulated independently to end of hallway. Gait steady, no assistance required. Reached outside doors. No symptoms of vertigo. No n/v. States she will go home and rest. Advised to seek medical attention if vertigo returns. Declined transport to hospital. Left with her service dog to personal vehicle
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| 58 | 2021-01-20 | nervousness, feeling abnormal |
I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe/when my throa...
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I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe/when my throat get bad; I brushed my teeth and then all of a sudden my throat closed up and I couldn't breathe; I started hyperventilating because I was scared; I started hyperventilating because I was scared; I felt strange but not sick or anything like that, it hit me like with a ton of bricks; I was shaking so bad I couldn't even hold anything; I was aching all the way from head to toe; I got my first Pfizer BioNTech COVID 19 Vaccine on 22Dec/And then I had my second one on 08Jan; I have residual like I am sill aching in my back; I tasted the food, it tasted funny, like not the same but then at the end of the day I could taste food like normally; I had sort of a cough but not like I urge to cough but it was not like chronic; Muscle soreness; still tired; This is a spontaneous report from a contactable consumer reported for herself. A 58-years-old female patient received the second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on right deltoid on 08Jan2021 08:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on left deltoid on 22Dec2020 at single dose for covid-19 immunisation. The patient stated she got her first Pfizer BioNTech COVID 19 Vaccine on 22Dec2020 and had no issues really with that one. And then she had second one on 08Jan2021. The first she got in her left deltoid and the second one she had on 08Jan2021, she had in her right deltoid. It's towards 8:30 in the morning roughly is when she had it. So, during the day went on 08Jan2021, she felt strange but not sick or anything like that. And the day went on to eat something and then came home. And then she'd say at around 7:30 it hit her like with a ton of bricks. She was shaking so bad, she couldn't even hold anything. And then she was aching all the way from head to toe. And she was like she will get her tooth brush at least. So, she brushed her teeth and then all of a sudden her throat closed up on 08Jan2021 around 7:30 pm and she couldn't breathe. And she stated she was like "oh my gosh and then it sort of opened up enough for me to scream for my husband, I yell for him to come and then it did it again, it closed up again. And when he came, I started hyperventilating because I was scared. And he calmed me down and rub my back and everything, and it went away. But it scared me. But the shaking lasted probably all through night maybe till 3 in the morning because I tried not to take anything and I probably took 2 Advil. And now I have residual like I am sill aching in my back. And it's weird, in morning I tasted the food, it tasted funny, like not the same but then at the end of the day I could taste food like normally. And then I had sort of a cough but not like I urge to cough but it was not like chronic. Not a lot but it's there like if you urge to cough, it doesn't happen a lot. " The patient stated "It started on 08Jan2021 around 7:30 pm, when my throat get bad. I have muscle soreness specially in my back and I don't know in the taste in the morning the food doesn't taste right but then like it's fine towards the afternoon. And I am still tired and a slight like cough. But the cough isn't really anything, if I get urge to cough. It's not all day, it's not chronic at all." The patient started to took Advil as a treatment and stated "Well I started to because it was like 3:30 in the morning, or 2 or 3 in the morning I did take 2 Advil. And they helped with that pain." The outcome of the event taste abnormality was recovered, outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 58 | 2021-01-22 | agitation | tiredness, agitated, fever that lasted about 4 hours |
| 58 | 2021-01-25 | feeling abnormal |
This is a spontaneous report from a contactable consumer. A 58-year-old female patient received firs...
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This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication included metformin from 2012 and ongoing for diabetes. The patient stated on 21Dec2021 "I received my first dose of the COVID-19 vaccine, I was supposed to get the second dose yesterday, I couldn't go because I am home sick on 10Jan2021, I don't know if I have COVID or not." Her job gave it to her. She started having chills yesterday on 11Jan2021. On 11Jan2021, it was reported that he has hot and cold sweats, she has body aches and a slight headache. She is weak. She is frequently urinating every hour. She has a light headache. Her body feels weird like she cannot stand because she is really weak. She is in pain. She was supposed to get the second dose 11Jan2021. She took the vaccine for her safety. The outcome of the event sick was unknown, while not recovered for the other events.
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| 58 | 2021-01-25 | impaired work ability |
Fever 102.5 with hard Rigors chills x 15 hours, back and hip pain, body aches, fatigue, elevated li...
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Fever 102.5 with hard Rigors chills x 15 hours, back and hip pain, body aches, fatigue, elevated liver enzymes. I missed work the following day due to fevers and hard chills. Had fever x 48 hours .
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| 58 | 2021-01-25 | sleep disorder | HEADCHE, BACK PAIN, AND SLEEP. TOOK TYLENOL. |
| 58 | 2021-01-26 | insomnia |
Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date ...
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Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date vaccine date on 04Jan2021; Day 6 -10 migraines hit; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 23:30 on 04Jan2021 at single dose for COVID-19 immunization and other vaccine same date vaccine date on 04Jan2021 on left arm. Medical history included allergies to penicillin, allergy to bananas, wheat (patient do eat products w wheat), dairy; Melanoma 3rd degree 1987 & 2005, allergies, sinus surgery resolved problems. Concomitant medication included venlafaxine, omeprazole, bupropion hydrochloride (WELLBUTRIN). It was reported that patient had no other vaccine in four weeks. The patient previously took ampicillin and experienced drug allergy. No issues until middle of night of first injection. The patient experienced intense pain in left injection arm; fever; could not sleep, other aches all over on 05Jan2021. Used ice packs & Motrin. Fever left after two days. Intense pain continued. 5th day switched to heating pad & took 2 tablets of Tylenol every 6 hours. Called patient's doctor on days 6 & 8. Suggested patient alternate Tylenol & Motrin every 6 or 8 hours. Day 6 -10 migraines hit. The outcome of event fever was recovered on 07Jan2021. The outcome of events migraine and Product use for unapproved combination was unknown. The outcome of rest events was not recovered. Information on the LOT/Batch number has been requested.
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| 58 | 2021-01-27 | sleep disorder, impaired work ability |
About 5 hours later, I startd feeling like I was having flu symptoms; Late afternoon - 99.5 fever an...
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About 5 hours later, I startd feeling like I was having flu symptoms; Late afternoon - 99.5 fever and fatigue. By 8:00 p - fever was 100; joint and muscle aches and fatigue; Took Tylenol finally before bed - slept a little bit but woke up with 101 temperature and I took another Tylenol and went back to bed but couldn't sleep because of pain with muscles; sore throat and it went up to 101.4 - it would go down with Tylenol but it would shoot back up after 4 hours. Rollercoaster with that up through Sunday 10th - all day fever was over 101.4 - 101.6 with extreme fatigue; really bad muscle and joint pain; eat a little and pushed fluids. Didn't have to work Monday. Rested and I felt a little tight in my chest and took Albuterol. Monday morning temp was 101; but started going down to 99 range fever; I had a previously schedule visit with my dr. and it ended up being a sick visit. He said to keep an eye on it. He told me not to go to work on Tuesday or Wednesday. Things were getting better but still had sore throat; shortness of breath and muscle aches/joint pain but lower temp. Wednesday night I called out from work because things got worse with my breathing/chest got tight etc but not fever anymore Had a virtual Urgent care visit - for the COVID test. COVID test on Thursday. Went to back to work - and I still have a slight bit of joint pain.
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| 58 | 2021-01-27 | sleep disorder |
The night of injection; woke up several times once with pain in the arm from neck to elbow; diaphore...
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The night of injection; woke up several times once with pain in the arm from neck to elbow; diaphoretic, pain to entire right side; right side teeth and jaw pain; general malaise. I took 2 -650mg Tylenol before bed. Pain in the right arm from neck to elbow lasted for 1 week, used 2-650mg Tylenol to tx
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| 58 | 2021-01-28 | feeling abnormal, thinking abnormal |
Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the...
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Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the top of her head felt funny. At this point on site ARNP was called over to Patient. and both myself and ARNP noticed flushing on face and neck and hives on neck area. On site EMS notified and came over. Patient then self medicated with 2-25 mg Benadryl. Patient exhibited mild cognitive slowing with some mild speech and thought degradation...felt funny....not sure what she felt.... Physical symptoms noted above showed some mild sign of improvement? Clinicians insisted that patient should be taken to hospital of choice via ambulance. Patient was taken to clinic where she was under observation, put on IV saline and administered IV steroid, dexamethasone. After approximately two hours patient was released and instructed to take over-the-counter Benadryl every six hours for six days and one Pepcid per day for six days.
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| 58 | 2021-01-28 | excessive sleepiness |
After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, ...
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After COVID vaccines (first 12/17/20) she started having her hair come out in clumps in the shower, and shedding an excessive amount when brushing. She started noticing this about 1-2 weeks after her first vaccine, and it got worse after the second vaccine on 1/7/21 (Pfizer Lot#EK9231). It is an even thinning, no patches of hair loss. She was diagnosed with COVID on 10/7/20 which resulted in hospitalization. Reporting fatigue, continued loss of sense of taste and smell, decreased appetite, and hair loss. Experiencing fatigue and decreased energy, worse in the evening, falls asleep easily when she gets home after work, started when she got COVID.
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| 58 | 2021-01-29 | anxiety |
15 seconds after injection patient felt tired and like she was going to pass out. Patient was anxiou...
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15 seconds after injection patient felt tired and like she was going to pass out. Patient was anxious appearing. Patient taken to the Emergency Room for further evaluation. Upon presentation to the ER, patient diagnosed with vasovagal syncope, treated with fluids and zofran and discharged home.
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| 58 | 2021-01-30 | sleep disorder |
Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immedia...
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Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immediately after injection. They sent me to doc on site and applied ice. After 29 minutes symptoms started to subside. By the evening pain moved across back of shoulders blades. Increased headache with chills and alternating fever. Could not sleep due to pain. Next morning,today. Had abdominal pain cramping and diarrhea. Unable to sit up or walk much due to weakness and feel will pass out.
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| 58 | 2021-01-31 | feeling abnormal |
She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Dia...
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She feels a bit of congestion; Really bad fatigue; Ear ache; Runny nose; Bodyaches; Sore throat; Diarrhea; She felt really bad; She experienced what felt like "a very bad cold"; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3302), via an unspecified route of administration at site of right arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included fibromyalgia from 2018 and ongoing, borderline diabetes from Feb2020 and ongoing. Concomitant medication included ongoing duloxetine for fibromyalgia, ongoing meloxicam for fibromyalgia, ongoing semaglutide (OZEMPIC) for borderline diabetes. Clinical course: After vaccination, Patient felt fine the first couple of days. On 15Jan2021, she experienced what felt like "a very bad cold", she had a severe headache. She also had diarrhea, a sore throat and she felt really bad on 16Jan2021. It was controlled with taking paracetamol (TYLENOL). Paracetamol made her headache better when she took it. On 18Jan2021, she felt a bit of congestion, an earache and really bad fatigue. She didn't know if these are side effects from the vaccines and if so, how long will last. The episodes of diarrhea came and went. Her sore throat is not as bad. She also had a runny nose and body aches on 17Jan2021. She received the vaccine because she worked as a front-line worker as a dental assistant. She felt like she has the symptoms of COVID. The outcome of event a very bad cold, felt really bad, body aches and earache was unknown; of events fatigue and runny nose was not recovered; of rest events was recovering.
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| 58 | 2021-02-03 | anxiety |
nausea; Feels tired; anxiety; This is a spontaneous report from a contactable pharmacist. A 58-year-...
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nausea; Feels tired; anxiety; This is a spontaneous report from a contactable pharmacist. A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284), intramuscular (left arm), on 23Dec2020 18:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported nausea, but it went away, feels tired and after conversation, possibly just anxiety. These adverse events started on 23Dec2020 18:00. No treatment was received for the events reported. The patient recovered from the events on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. The COVID call center advised to return to work.
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| 58 | 2021-02-05 | sleep disorder |
Two hours after injection severe soreness, next day loss of range of motion, persistent pain around ...
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Two hours after injection severe soreness, next day loss of range of motion, persistent pain around shoulder, radiating pain down arm and tingling in fingers which continues into sixth day. Unable to sleep, loss of appetite, taking Tylenol prn, was taking Motrin prior.
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| 58 | 2021-02-06 | sleep disorder |
Soreness at injection site which subsided after several days with only mild tenderness. Muscle pain...
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Soreness at injection site which subsided after several days with only mild tenderness. Muscle pain at injection area started getting tender again to touch around 5 days after injection then shoulder pain becoming sore enough on Friday 2/5 to interfere with sleep. Shoulder pain on movement of arm today 2/7 and muscle feels very tender to the touch.
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| 58 | 2021-02-10 | insomnia | Migraine headache, body & muscle aches, fever, insomnia |
| 58 | 2021-02-11 | feeling abnormal, feeling drunk |
I felt "fuzzy" and sort of "tipsy" as though I'd drunk a couple of pints of very strong beer for abo...
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I felt "fuzzy" and sort of "tipsy" as though I'd drunk a couple of pints of very strong beer for about 30 minutes. No other effects, no treatment sought or given.
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| 58 | 2021-02-12 | feeling drunk |
Extreme drunken feeling that lasted over 2 hours and then returned in waves the following two days, ...
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Extreme drunken feeling that lasted over 2 hours and then returned in waves the following two days, in addition to facial numbness that lasted over an hour
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| 58 | 2021-02-15 | anxiety, crying |
I fainted almost immediately but I was extremely anxious and crying/hyperventilating. I also had nau...
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I fainted almost immediately but I was extremely anxious and crying/hyperventilating. I also had nausea and retching, My blood pressure went up. A couple of hours later I had a sever head ache, chills and sweats with body aches that lasted through the next morning.
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| 58 | 2021-02-15 | feeling abnormal |
Dizzy, headache, feeling weird/off, stomach off. Happened once the first week, felt crappy the seco...
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Dizzy, headache, feeling weird/off, stomach off. Happened once the first week, felt crappy the second week, more sporadic the 3rd week, but happened again today for the first time in 4 days, for a few hours. Starting my 4th week.
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| 58 | 2021-02-16 | disorientation |
The morning after 2nd dose of Pfizer. I was weak and actually couldn't get my legs to go forward the...
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The morning after 2nd dose of Pfizer. I was weak and actually couldn't get my legs to go forward they gave out and I was on the floor unable to get back up on my own without staff assistance. I was very sweaty very dizzy and disorientated. not knowing who was around me. I had pain at injection site, no headache no body pain. Very tired slept took tylonal.
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| 58 | 2021-02-24 | impaired work ability |
The day after the vaccination had symptoms that effected my work. The symptoms were fever, body/mus...
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The day after the vaccination had symptoms that effected my work. The symptoms were fever, body/muscle aches, and headache.
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| 58 | 2021-02-25 | feeling abnormal |
On the third day after my first vaccination, I began feeling badly in the late morning, when I got h...
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On the third day after my first vaccination, I began feeling badly in the late morning, when I got home in the afternoon, I was experiencing all the classic symptoms described on the pamphlet I had a fever of 100.8, chills, muscle aches, could not get warm, headache. By the following morning the fever was gone, still did not feel good but much better. Have has a constant dull headache ever since.
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| 58 | 2021-02-27 | feeling abnormal |
Per the patient, she received her 2nd COVID vaccine on 2/17/21 around 9:00 am. She woke the next mo...
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Per the patient, she received her 2nd COVID vaccine on 2/17/21 around 9:00 am. She woke the next morning on 2/18/21 with severe "brain fog", exhaustion, dizziness, headache and nausea. This was severe enough to cause her to "not be able to complete a sentence by 2/22/21. She was taken to the ER at hospital for evaluation and then had follow up with me on 2/23/21 and again 2/28/21. Most of her symptoms are dramatically improved now other than the exhaustion. She still has minor headaches and occasional dizziness, but these are improved. Thus, this feeling has been present for 11 days after her vaccine. She had similar symptoms to a much lesser extent lasting 4 days after her first vaccine (also Pfizer given the same location on 1/27/21 EL3247). She returned to her baseline health in between.
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| 58 | 2021-02-28 | mental impairment, feeling abnormal |
24 hours after the 2nd injection I experienced the following: Slight soreness at sight Low grade fe...
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24 hours after the 2nd injection I experienced the following: Slight soreness at sight Low grade fever 101 Extreme fatigue Brain fog - or difficulty focusing on work related tasks These symptoms resolved within 24 hours, 3 days after the 2nd injection I developed a lemon sized nodule in my arm pit that was mildly painful to touch. This resolved within 3 days.
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| 58 | 2021-03-02 | panic attack |
After about 10 minutes I felt a wave of heat wash over me. Then I felt brief light-headedness and be...
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After about 10 minutes I felt a wave of heat wash over me. Then I felt brief light-headedness and begin experiencing shortness of breath. The shortness of breath would intensify and then abate but not like a panic attack it was directly related to the shot. After about 20 minutes is subsided 9 days later I still feel weak and fatigued. There was no emergency rescue precautions available for me had at the site had the situation worsen 3 weeks prior I had The first shot of my shingles vaccination.
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| 58 | 2021-03-03 | excessive sleepiness |
zapped of energy; chilled; body aches; mild sore throat; slept about 15 hours; This is a spontaneous...
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zapped of energy; chilled; body aches; mild sore throat; slept about 15 hours; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN5318), via an unspecified route of administration single dose arm left on 29Jan2021 09:00 (at the age of 58) for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced zapped of energy on 31Jan2021 16:00, chilled on 31Jan2021 16:00, body aches on 31Jan2021 16:00, mild sore throat on 31Jan2021 16:00, slept about 15 hours on 31Jan2021 16:00. No treatment administered. The events outcome was recovered.
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| 58 | 2021-03-03 | nervousness | shakey and light headed |
| 58 | 2021-03-04 | confusional state |
Pulse in 160s ... leveled at 150 ... dizziness, confusion, feeling faint, nausea, chest pain, hard t...
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Pulse in 160s ... leveled at 150 ... dizziness, confusion, feeling faint, nausea, chest pain, hard to swallow, hard to breath. Taken to ER via ambulance.
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| 58 | 2021-03-04 | depression |
Pain on my extremities, unable to hold things with my hands, pain going down my left leg , pain from...
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Pain on my extremities, unable to hold things with my hands, pain going down my left leg , pain from my neck down my arms, deep depression, strong flare up of my Fibromyalgia and Arthrities together, Severe Headaches and very weak no energy at all and vomiting, nauseated. Dr. stated the shot case a neurological disorder causing the reaction stated above.
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| 58 | 2021-03-04 | feeling abnormal |
Brain fog, malaise, fatigue, swelling and pain at injection site. Sore/scratchy throat. Arm pain o...
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Brain fog, malaise, fatigue, swelling and pain at injection site. Sore/scratchy throat. Arm pain occurred first. Exhaustion a few hours later and exists two days later. Throat became scratchy and swelling came on the next day. Second day (today) brain fog as evidenced by a lack of energy and poor test taking .
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| 58 | 2021-03-05 | sensation of foreign body | Patient felt like something was in her throat, cleared by EMS |
| 58 | 2021-03-07 | excessive sleepiness |
felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Simila...
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felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Similar to a migraine; tired; slept for a long time; light and sound was very painful; light and sound was very painful; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration from 28Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included chronic sinus infections. Patient was not pregnant at the time of vaccination and the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone, xylometazoline hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC), and fluticasone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took clarithromycin (BIAXIN) and experienced allergies (reported as know allergies). About an hour after the injection, on 28Jan2021 11:00 AM, patient felt lightheaded, had a low grade fever, chills and sweating, light and sound was very painful - similar to a migraine even though patient have never had one previously, and patient was very tired and slept for a long time. These lasted for 5 days. The events required doctor or other healthcare professional office/clinic visit in response to the events. Patient received treatment for the adverse events and was reported as unknown. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events reported was recovering. Information on the lot/batch number has been requested.
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| 58 | 2021-03-07 | sleep disorder |
Just 12 hours later experienced severe headache that woke me up in the middle of the night. Fever ...
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Just 12 hours later experienced severe headache that woke me up in the middle of the night. Fever (100), chills, all over body aches, sore throat, alteration of taste, heaviness in chest, nausea. The headache lasted a few days .... each morning for the next 4 days I awaoke with headaches
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| 58 | 2021-03-09 | impaired work ability, excessive sleepiness |
I began feeling cold sweats and very tired that evening a few hours after taking the vaccine. Durin...
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I began feeling cold sweats and very tired that evening a few hours after taking the vaccine. During the night, I began having a severe headache, body aches, extremely lethargic and continued being feverish with sweats. I basically slept the next 2 days as These symptoms lasted in their severity until Friday, February 26th. I continued with a headache and lethargy until Saturday February 27th and finally felt better by Saturday evening and was 100% back to normal by Sunday. I missed 3 days of work dealing with the response to the vaccine but would do it all over again as I work as medical support and fully support the vaccines.
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| 58 | 2021-03-10 | confusional state | Headache, Fever, Chills, Aches, Slight confusion, |
| 58 | 2021-03-10 | disturbance in attention, feeling abnormal |
Within 20 minutes of jab: Lightheadedness, pressure in the head Within 60 minutes: Slight fatigue W...
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Within 20 minutes of jab: Lightheadedness, pressure in the head Within 60 minutes: Slight fatigue Within 90 minutes: Headache, foggy brain, slight focus/concentration issue Within 2 hours: Extreme fatigue After 6 hours: All issues better but still present. Fatigue especially better but still an issue.
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| 58 | 2021-03-10 | loss of personal independence in daily activities, sleep disorder, impaired work ability |
I could not move my right side from neck to finger tips by 5:30 p.m. I have never been in more pain ...
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I could not move my right side from neck to finger tips by 5:30 p.m. I have never been in more pain in my whole life. It was difficult to do anything and laying down hurt the most. This has been 8 nights now that I cannot sleep through the night because I wake up with shooting pains in my shoulder blade/shoulder/arm area. Even with ipruprophen and/or Tylenol - the pain still comes back. As of yesterday, I can use my arm better as the day goes by but lifting my arm over should height is extremly difficult and painful without the assistance from my other hand. I believe this is called a Shoulder Injury Related to Vaccine Administration. I writhed with pain the first night and got no sleep. I took 2 days off of work and even working today is difficult to write on the board, lift things or reach higher than my shoulder. Even last night I woke up 4 times because of the pain. I couldn't get back to sleep for about 1 hour each night since this happened 8 nights ago. When I visited my Doctor 2 days ago, she said maybe it was Shoulder Injury Related to Vaccine Administration. She said to come back for another visit if the pain lasts for a few more days. Physical Therapy, Steroids or ? I just want to be able to sleep, be able to dress myself and to wash my hair without pain.
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| 58 | 2021-03-13 | impaired work ability |
Approximately 12 ours after the injection I was awoken with chills, and malaise, then felt tightenin...
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Approximately 12 ours after the injection I was awoken with chills, and malaise, then felt tightening around my back and abdomen and then started vomiting, dry heaves as if my stomach was cramping into knots. By morning , the nausea and vomiting continued and I had asked my health care provider to order Zofran. The Zofran helped , but I continued with some stomach cramps and general flu like symptoms for a total of about 48 hours. . My temp ranged from 100.3-102.4. After my symptoms subsided, I was still feeling weak enough that I was glad I did not have to go to work. It was probably after 3-4 days that I felt up to going to work.
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| 58 | 2021-03-14 | feeling abnormal |
First chills; Vomiting; body aches; Head still doesn't feel normal; severe dizziness; head pressure;...
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First chills; Vomiting; body aches; Head still doesn't feel normal; severe dizziness; head pressure; This is a spontaneous report from a contactable consumer. A 58 -year-old female (not pregnant) patient received her first dose on an unspecified date, second dose (lot number: EN2601) on 12Feb2021 of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), both via an unspecified route of administration (at the age of 58 -years-old), single dose for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included clonazepam. The patient experienced First chills, vomiting, body aches, head pressure, severe dizziness and vomiting. Head still doesn't feel normal (The events were reported also to happen then 12 days later), all events started 23Feb2021 0600. The outcome of the events was recovering. The events were reported to cause 3 days hospitalization. No other vaccine in four weeks. AE Treatment: Meclizine, Zofran, EKG, MRI, CT of head. The patient had a covid swab test on 23Feb2021 with negative result.
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| 58 | 2021-03-15 | confusional state, insomnia |
-1.5 hours after shot, intractable vomiting for 14 hours, could keep nothing down, not even ice chip...
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-1.5 hours after shot, intractable vomiting for 14 hours, could keep nothing down, not even ice chips,- ended up treating with ondansetron 2- 5 mg doses-no appetite for at least 4 days and resultant weight loss of 6-8 lbs -balance impaired, vision blurred about 12 hours after-lasting 12 hours -confusion from about 12 hours post vaccine until 24 hours post vaccine -weakness, and hand and leg diskinesia about 12 hours after -lasting 12 hours -sore throat, phlegm 48 hours after for 12 hours -hyper alertness and unable to sleep almost 48 hours -twitching during sleep (throughout body, arms and legs) and in evenings which lasted 6 days, slowly abating over time -headache -multiple hot flashes 3-4/hour first 2 days mostly at night, way more than I normally have (I usually have 2-3 a night and 1-2 during the day-4 days/week) Shot on 2/8/21 and finally felt back to normal, resumed all normal activities including exercise 2/14/2021
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| 58 | 2021-03-16 | irritability |
Swelling, pain, burning sensations under skin, sore/tight muscles, headache, nausea, irritability, t...
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Swelling, pain, burning sensations under skin, sore/tight muscles, headache, nausea, irritability, tired
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| 58 | 2021-03-17 | anxiety |
Patient was observed post Covid-19 immunization Patient in observation for 15 minutes upon checkout ...
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Patient was observed post Covid-19 immunization Patient in observation for 15 minutes upon checkout patient voiced feeling light headed, patient had VS checked at 1045 with BP-120/80, P- 103, O2 99%, T- 97.6, offered water and drinking, at 1050, BP- 122/82. P- 88, voices feeling better reports that she feels like she was having some anxiety. She denies any further issues, was provided with Vaccine Information Sheet and instruction to access the V-Safe system.
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| 58 | 2021-03-17 | feeling abnormal |
extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like...
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extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like jelly; felt unsteady & like I would fall; felt so bad/felt awful/talking about end of life wishes; no appetite; chest tightness; This is a spontaneous report from a contactable other health care professional reported for herself. A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 09Feb2021 16:30 (at the age of 58-year-old) at single dose in left arm for covid-19 immunization. Medical history included Heart Failure, Sarcoidosis, Asthma, Obesity and Covid from Apr2020 to an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included prednisone, carvedilol (COREG), spironolactone (ALDACTONE), hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The day of injection on 09Feb2021 at 16:30 PM that same night 8 pm the patient started experiencing some chest tightness. Since the patient live in country when she left work(hospital). At that point she took 50mg of P.O. benadryl (diphenhydramine). So the patient just took time and hung around town. She went to family dollar then publix. She felt better at 9 pm so and went home. The next morning (on 10Feb2021 her legs were like jelly when she woke up to go to bathroom. She felt unsteady and like she would fall. Next thing she just felt so bad and no appetite so she ate nothing that day. Her temp started rising and by 2PM on 10Feb2021 it was up to 102.4, the patient felt so awful then the feeling of doom set in so she was talking about end of life wishes. She had Covid back in Apr2020 and it was like reliving it again. On 11Feb2021 she felt better but had to call out low grade 99.4 only she was able to eat some but extremely weak and right shoulder pain (moderate). Friday (on 12Feb2021) she went to work but still felt weak. She felt better over the weekend (Feb2021). Here we were 17Feb2021 and still not completely there but 90% better. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for other adverse event. The patient underwent lab tests and procedures which included body temperature: 102.4 on 10Feb2021, body temperature: 99.4 on 11Feb2021, Nasal Swab Covid-19/SARS: negative on 16Feb2021. The outcome of the events was reported as recovered in Feb2021. Information on the lot/batch number has been requested.
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| 58 | 2021-03-17 | feeling abnormal |
Starting the morning after the Vacinne I felt woozy, tired and had mild headache. I was not safe ...
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Starting the morning after the Vacinne I felt woozy, tired and had mild headache. I was not safe to drive that day and today. Head still feels achey and I am still tired and spacey feeling. Patients should be cautioned to have no activities for several days after both doses.
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| 58 | 2021-03-18 | feeling abnormal |
Day 1. 3/10/2021- In the evening my left arm was sore and achy. Day 2. 3/11/2021- In the morning, ch...
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Day 1. 3/10/2021- In the evening my left arm was sore and achy. Day 2. 3/11/2021- In the morning, chills, headache, sweats. Early afternoon in the car I had trouble breathing, cold sweats, chills, coughing trying to breathe. My husband went immediately to the pharmacy to purchase Benadryl and opened the capsules and poured in my mouth along with water as my body became completely limp. At home my husband helped me get to bed and gave me 2 rapid release Tylenol tablets. Day 3. 3/12/2021- In the morning, I felt better until I had a cup of coffee and the chills, sweats, nausea, vomiting and blood pressure started escalating 135/98. I had no previous concerns with blood pressure before the vaccine. I had difficulty speaking (stuttering, confusion and brain fog. I was still so so tired. Day 4, 3/13/2020 - Unable to remain awake after having a sip of water. Blood pressure 150/101 and ate 3 nuggets and body became limp again and unable to walk and husband carried me to bed. (Difficulty speaking and repeating words over and over-confusion). Day 5, 3/14/2020- In the morning, I felt better and my husband gave me a blood pressure pill (Triamterene/Hctz) . I slept most of the day and had no water, no food. I was extremely exhausted and ate in the evening. I had chills, sweats, headache and my body became limp again and husband carried me to bed. Day 6. 3/15/2020- In the morning called Dr. for tele-visit and gave her details of what was happening. I had no food or water and still felt tired. I went to office for lab work around 4:30. I was walking, but extremely exhausted and speech difficulty. Day 7. 3/16/2021 -. In the morning blood pressure was 139/96 - took another blood pressure tablet and had a smoothie and felt much better only chills, no headache. Blood test were normal, and I ate dinner and then chills, sweats, headache and husband helped me walk to bed. After about 30 minutes, legs were movable, but upper body was numb for an additional 30 minutes and then everything seemed fine. I got up and walk around and went back to bed later in the evening. Day 8. 3/17/2021-First day no meds at all, no BP meds, no Tylenol and I was feeling so much better. I ate throughout the day with few symptoms except stuttering and repeating words when speaking. Day 9. 3/18/2021- I spoke with Dr. for appointment on the 19th. I felt stronger and ate breakfast, Lunch and dinner and was feeling normal except for occasional stuttering in speech. Day 10 3/19/2021 - No food in the morning, I visited Dr. at 8:35 for examination and she sent me for ct-scan. Blood pressure was back to normal 122/82 with no meds. I felt fine and later today received normal results from CT-scan. I am hopeful that in the coming days, my speech will completely back to normal.
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| 58 | 2021-03-18 | insomnia |
night before (second dose) she was in atrial fibrillation; was tired but she didn't sleep the night ...
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night before (second dose) she was in atrial fibrillation; was tired but she didn't sleep the night before second dose/exhausted; was tired but she didn't sleep the night before second dose/exhausted; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269; Expiration Date: 31May2021), intramuscularly, administered in left arm on 29Jan2021 as single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation (has a pre existing atrial fibrillation), patient also has under active thyroid from unspecified date. The patient's concomitant medications included magnesium taken daily from an unspecified date and for unknown indication, an unspecified medication for atrial fibrillation and an unspecified low dose medicine for cholesterol. The patient previously received the second dose of unspecified shingles vaccine on an unspecified date for immunization and felt sore arm maybe a little under the weather. On 22Feb2021, the night before the second dose of vaccine, patient reported she was in atrial fibrillation, she was tired but she didn't sleep the night before second dose because she was in atrial fibrillation and was exhausted. She took extra of her atrial fibrillation medications. She does not think she took Tylenol after first one. Does not think arm was sore after the first one. The patient was vaccinated at a mass vaccination site. The events did not require emergency room or physician's office visit. The outcome of the events was unknown.
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| 58 | 2021-03-18 | restlessness |
arm sore to touch; swollen/puffed up underneath her arm, thinks is a swollen lymph node; swollen/pu...
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arm sore to touch; swollen/puffed up underneath her arm, thinks is a swollen lymph node; swollen/puffed up underneath her arm, thinks is a swollen lymph node; Itchy; restless; seems like she has a rash in her upper chest neck area, neckline; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EK9231) via an Intramuscular route of administration on 27Jan2021 at single dose on left arm for covid-19 immunization. The patient medical history included allergies. The patient concomitant medications were not reported. On 27Jan2021, in evening patient was really restless that night because she was itchy. Physician stated that patient has been experiencing some itching, but it seems like she has a rash in her upper chest neck area, neckline. The itching/rash has stayed the same so far. On 28Jan2021, next day morning It was really sore to touch, like when patient was putting deodorant on, its all puffed out underneath her arm that she had the vaccine administer in. It's swollen, but patient thinks its her lymph node. It doesn't feel like its effected any other one, but just that one lymph node. The outcome of the event Itchy, rash was not recovered while outcome of rest all events was unknown.
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| 58 | 2021-03-18 | sensation of foreign body |
hives, itching, facial swelling. woke up next morning after vaccine with just one or two hives, prog...
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hives, itching, facial swelling. woke up next morning after vaccine with just one or two hives, progressed by evening of that day, lips swelled and were numb feeling, felt like a lump in my throat, throat felt swollen but no pain or difficulty breathing. Took 2 Benadyl(generic) at 9:30pm and again at 3:30am
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| 58 | 2021-03-20 | anxiety |
lip tingling and throat tightness started minutes after vaccine was given. Vitals unremarkable. Brea...
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lip tingling and throat tightness started minutes after vaccine was given. Vitals unremarkable. Breath sound clear, no post oropharyngeal edema, no angioedema on exam. No urticaria or skin changes. Suspected anxiety vs. mild allergic reaction, offered Benadryl, which pt accepted, was given Benadryl and observed for 30 minutes, at whichpoint she felt symptoms had nearly resolved completely
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| 58 | 2021-03-21 | feeling abnormal |
Patient states she had hot flashes and feeling funny, tingling in fingers. Had patient sit. BP monit...
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Patient states she had hot flashes and feeling funny, tingling in fingers. Had patient sit. BP monitored every 5 minutes x 7. Patient states she had not eaten this morning. Patient was given water and a snack, tolerated well. BP 191/93 HR 73 8:50 am, 187/100 HR 69, 188/89 HR 61, 148/87 HR 61,130/64 HR57, 155/80 HR 65,156/90 HR 68 Patient transported to Urgent care Walk in clinic. Reported off to urgent care nurse.
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| 58 | 2021-03-22 | anxiety |
Patient received first dose Pzifer vaccine on 3/2/21. On 3/6/21, patient went to emergency room with...
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Patient received first dose Pzifer vaccine on 3/2/21. On 3/6/21, patient went to emergency room with right side body numbness, wheezing, and high anxiety. She was given nebulizer treatment , prednisone, and an albuterol inhaler. She was tested for covid and flu, and both were negative. She also states that since her dose, she has had "covid arm", which consists of pain at the injection site and hand/lower arm numbness.
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| 58 | 2021-03-22 | disorientation |
patient became clammy weak and almost fainted after shot she appeared pale and disoriented we call 9...
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patient became clammy weak and almost fainted after shot she appeared pale and disoriented we call 911 and EMT came checked vitals her blood pressure was low and they took her by ambulance to hospital
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| 58 | 2021-03-22 | feeling abnormal | Complained of itchy throat and feeling funny. Difficulty swallowing. 25 mg Oral Benadryl given |
| 58 | 2021-03-23 | disturbance in attention |
Within 1 minute I felt it run down my arm and my 3 fingers , middle , ring, pinkie finger when ting...
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Within 1 minute I felt it run down my arm and my 3 fingers , middle , ring, pinkie finger when tingling , then I felt it run across my chest and my heart or lungs physically hurt then it went to my head and from the moment on if I turned my head in any direction left or right I would be very dizzy. I could keep my head and vision straight ahead and only felt a distance and had to concentrate very hard .
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| 58 | 2021-03-24 | anxiety | epigastric discomfort and nausea, anxiousness |
| 58 | 2021-03-24 | feeling abnormal |
58 Y female here for concern of allergic reaction due to covid vaccine. Received second dose of pfiz...
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58 Y female here for concern of allergic reaction due to covid vaccine. Received second dose of pfizer vaccine yesterday. Today awoke feeling funny, felt some tightness in throat, trouble swallowing, more sob, palpitations, headache. When she arrived at work this morning, started dry heaving very nauseated and had to go home. Driving home, she saw her face and noticed it was swollen. No prior hx of allergic reactions. No other new meds or foods in that time. No chest pain. 58F with likely allergic reaction anaphlyaxis to pfizer vaccine. No severe facial swelling, tongue swelling, wheezing but symptomatically concerning given throat tightness, subjective facial swelling (I did see some mild periorbital edema but unable to observe other differences but she could). Not on any ace inhibitor. Less likely chf, acs, pna/ ptx, asthma Pt symptomatically improved a lot after epi, benadryl Observed and deemed stable Dc with prednisone and pepcid
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| 58 | 2021-03-24 | feeling abnormal |
Within 2 or 3 minutes my left arm was itching, within 10 minutes my head, chest and other arm were i...
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Within 2 or 3 minutes my left arm was itching, within 10 minutes my head, chest and other arm were itching. I got lightheaded and for an instant felt like I was going to black out but didn't, in 15 mins my entire body was itching. I was given 1 Benedryl capsule orally and told to wait 15 more mins. The itching kept spreading, I started feeling like I was going into an asthma attack. They had me wait 15 more mins. It seemed to stop getting worse as quickly. They gave me another Benedryl and I left since I did have an Epi-pen with me. I got home and took another Benedryl about an hour later and about every 6 hours. I got up the next morning and felt horrible and was still itching so took more Benedryl. Tuesday night it felt like it was getting a little better but felt like I was having a slight asthma attack but my inhaler wasn't helping. On Friday I went to my family doctor and was put on a short dose of Prednisone, 20 mg twice a day for 5 days. It did help. Since I've gotten the shot, when I eat it's like my stomach bloats up and diarrhea and generally don't feel like myself. I was really tired until I got on the Prednisone. Each day I feel more like myself but not back to 100% yet. I started taking my Brio again to see if it would help.
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| 58 | 2021-03-24 | impaired work ability |
1/14 received vaccine. Presented to clinic 1/19 with headache and dizziness. Blood presure at home 1...
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1/14 received vaccine. Presented to clinic 1/19 with headache and dizziness. Blood presure at home 157/80, took an additional 5mg amlodipine and tylenol and came to work. Headache and dizziness returned, BP in clinic 168/90. She ended up taking a leave of absence from work and is currently complaining of neuropathy and headaches, has been referred to neurology.
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| 58 | 2021-03-25 | feeling abnormal |
3/24, 8 a.m. shot 5p, right arm was a little sore 6p, right arm, shoulder, and neck could not move 8...
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3/24, 8 a.m. shot 5p, right arm was a little sore 6p, right arm, shoulder, and neck could not move 8p, massive chills all through the night. 3/25, 6a, clammy, whole body sore, back ache, headache 7a, massive chills again, went back to bed. 11a, then a slight fever all day, stayed in bed 5p, chilled again. laid on couch all day until going to bed 3/26, Morning started out foggy, arm hurts just a bit, by my back aches terrible. Hoping by 3/27, I am back to normal.
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| 58 | 2021-03-26 | insomnia |
Trouble sleeping during night, achey legs started around 6am and continued throughout day along wit...
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Trouble sleeping during night, achey legs started around 6am and continued throughout day along with some chills, fever of 100.6, headache. Fully better by next morning.
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| 58 | 2021-03-30 | agitation |
allergic reaction to the first dose; Felt like her throat was constricting; Very flustered while dri...
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allergic reaction to the first dose; Felt like her throat was constricting; Very flustered while driving home, somehow missed her exit; face is swollen; fast heartbeat; heart racing really fast; This is a spontaneous repot from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199), intramuscular in the muscle of upper left arm (deltoid left) on 03Mar2021 17:15 at a single dose for COVID-19 immunization. The vaccine was administered at a pharmacy, not a facility. No other vaccines were administered on same date of BNT162B2. The patient did not receive any other vaccines within 4 weeks prior to receiving BNT162B2. Medical history included hormone replacement therapy, high blood pressure, and "very sick she guessed from a cold and had asthma" on 2011 (from 10 years prior to the report; this was the only time she had asthma, and her physician said her asthma can come on because of being sick). The patient stated that she generally has higher blood pressure than she would like, but she is otherwise very healthy, and never had an allergic reaction to anything. Family history relevant to the adverse events was none. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) for high blood pressure, valacyclovir (VALACYCLOVIR), rosuvastatin (ROSUVASTATIN), omega-3 nos (OMEGA-3 NOS, capsule), estrogen (ESTROGEN) for Hormone replacement therapy, progesterone (PROGESTERONE, 100 mg capsule) for Hormone replacement therapy, all were from unspecified date and ongoing. It was reported that patient gets her flu shot every year and never had an adverse reaction. The patient reported that she had an allergic reaction to the first dose of PFIZER-BIONTECH COVID-19 VACCINE she received last Wednesday (03Mar2021) after an hour after she received it (18:45) while driving. She mentioned that she saw on the package insert what a severe allergic reaction would include. She experienced swelling of the face and a fast heartbeat but no difficulty of breathing on 03Mar2021. The patient further explained that she had her first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 03Mar2021 around 17:15 at a pharmacy. She left the pharmacy around 17:30. While she was driving home, she started to feel her heart racing really fast and felt like her throat was constricting within about 30 minutes of being administered the vaccine, by around 17:45. She was very flustered while driving home which is usually about 30 minute drive; but somehow she missed her exit and it was rush hour so it was about 18:15 when she got home. When she got home her husband asked her if she had been crying because he said her face looked weird. She told him he thinks her face is swollen. All of these events lasted maybe 1-2 more hours or less after she got home around 18:15, maybe a few hours before she recovered completely. She was expecting soreness and pain from the PFIZER-BIONTECH COVID-19 VACCINE but was not expecting the fast heartrate or swelling. She was reading through the information she got from the pharmacy for the PFIZER-BIONTECH COVID-19 VACCINE because she was a little concerned about getting the second dose due to these events. She has never had an allergic reaction to anything before and wondered if she should go to a hospital for her second dose of the PFIZER-BIONTECH COVID-19 VACCINE in case she has these events again, or a worse reaction. She asked about these events and dosing recommendations for the Pfizer. The reported adverse events did not require a visit to the emergency room or physician office. The patient was not hospitalized. Outcome of the events was recovered on 03Mar2021.
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| 58 | 2021-03-31 | amnesia, disturbance in attention |
Dizziness & weakness, N/T. "Severe headache. My worst day was 8 days after shot. But I felt like I...
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Dizziness & weakness, N/T. "Severe headache. My worst day was 8 days after shot. But I felt like I had the flu. Also could not focus. Felt like I had memory loss. Had a covid test to make sure I did not have that
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| 58 | 2021-03-31 | sleep disorder |
All was well initially after receiving the injection on 03/15/21. At 3:30 A.M. on 03/20/21, I was a...
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All was well initially after receiving the injection on 03/15/21. At 3:30 A.M. on 03/20/21, I was awakened from sleep by persistent itching. I discovered light hives running along the inside of my right arm and along the right side of my torso, from the side of my right breast to my waistline. I immediately took two (2) Benadryl capsules that we had in the house. I also washed the hives with soap and water in case this was from an external source. I had immediate relief from the itching and the hives immediately began to disappear, so I returned to bed and slept. When I awoke in the morning at my normal time, I did not have any additional itching and there were no hives present anywhere on my body. I went about my day and was at an appointment outside of the home when itching returned at approximately 1:00 P.M. on 03/20/21. This time it started on the outer side of my right breast and spread completely across the torso beneath both breasts within 45 minutes. Also at 1:45 P.M., I felt a couple of episodes of light chills and "goose bumps." When I arrived home by 2:00 P.M., I discovered that there were hives not only beneath my breasts, but also across the torso from one side to the other underneath the waistband of my jeans, as well as in a couple of random spots on my stomach. I immediately took two (2) Benadryl capsules and took my temperature as well, which indicated a low-grade fever of about 100 degrees even. I called at 24-hour Nurse Hotline, described my situation (including that the Benadryl I had just taken was immediately working on the new set of hives and itching), and was told to continue taking the Benadryl for a complete 24-hour cycle, as well as given information about what to watch for regarding the hives and instructed to obtain further medical help if the hives worsened despite taking the Benadryl. Over the next several hours, the hives continued to recur (as well as the itching) and to spread throughout my torso and onto my back and arms. I ended up in the Emergency Room after midnight when the Benadryl no longer did anything and the hives continued to worsen in both color and size. I received an IV treatment of Benadryl, Prednisone, and Pepcid, and got immediate relief. My heart rate reached 105 for a bit in the ER, but lowered to 95. I had to continue taking these meds over the next several days at home, during which my hives eventually left some areas but spread down my legs to the tops of my feet before disappearing completely by 03/25/21.
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| 58 | 2021-04-01 | feeling abnormal |
3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours afte...
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3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours after vaccination - chills, body ache, headache, lethargy. 3/23/2021 - woke with nausea and anorexia, took triple usual hydrocortisone dose (30mg) with yogurt, very lethargic, brain fog with cognitive difficulty, anorexia, stayed in bed all day, eating drinking veyr little. 3/24/2021 - woke with worsening lethargy, generalized weakness, nausea, took hydrocortisone 30mg with yogurt. by noon, very dizzy and weak, unable to get out of bed, friend drove her to Hosp. Emergency Room. Noted hypotension systolic BP 80, clinically dehydrated, Na 129, K 3.2, cr 1.2 (nl 0.97) Diagnosed Adrenal Crisis admitted 3 days to 3/27
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| 58 | 2021-04-01 | panic attack |
Patient complained of feeling light headed. She said she felt she was having a panic attack. Patient...
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Patient complained of feeling light headed. She said she felt she was having a panic attack. Patient was brought to triage in wheelchair. Patient's vitals taken twice. She sat for 30 minutes and said she felt better then left to go home.
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| 58 | 2021-04-03 | feeling abnormal |
high fever; vomiting; nausea; headaches; Second dose has been quite doozy; This is a spontaneous rep...
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high fever; vomiting; nausea; headaches; Second dose has been quite doozy; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), dose 2 via an unspecified route of administration, on 09Feb2021 (Lot number: UNKNOWN) (at the age of 58-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), dose 1 on 20Jan2021 for covid-19 immunisation and experienced slight fever and just felt little poorly. On an unspecified date in Feb2021, patient had the COVID second dose vaccine on Tuesday (09Feb2021) and has been quite doozy, she had experienced the high fever for 2 days, vomiting and nausea and the vomiting stopped 24 hours ago but still have significant nausea and a headache that is from 1 to 10 it's a 9. It started about 24 hours after she took the vaccine. She reached out to doctor and took a COVID test because doctor have not heard the vomiting and nausea and result was negative on 12Feb2021. Therapeutic measures were taken as a result of vomiting, nausea included Zofran. The outcome of the events vomiting was recovered on Feb2021, high fever was recovering, nausea and headaches was not recovered and has been quite doozy was unknown. Information on batch number has been requested.
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| 58 | 2021-04-04 | feeling abnormal |
I got the second dose of the vaccine and I felt bad the next day. I had headaches, neckaches, terrib...
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I got the second dose of the vaccine and I felt bad the next day. I had headaches, neckaches, terrible fatigue, body aches. I had not improved after six days and I went to the doctor. My doctor did a Covid-19 test, and it was positive. I think I actually had the Covid-19 at the same time as getting the second dose. My Covid-19 test indicated that I had had the Covid-19 within the last 7-10 days. I am still unable to work after 12 weeks and still taking a lot of pain medication and I have severe fatigue. I still have really bad headaches and neck aches. I had brain fog which has gotten a little better. My doctor believes that the combination of having the vaccine at the same time as the disease may have made the effects worse.
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| 58 | 2021-04-04 | impaired work ability |
Headache, extreme fatigue, low-grade fever (1 day), body/muscle aches Vaccine on Friday. Stayed in ...
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Headache, extreme fatigue, low-grade fever (1 day), body/muscle aches Vaccine on Friday. Stayed in bed all day Saturday. Sunday felt a little better but still very fatigued that prevented me from doing anything. Monday still fatigued and stayed home from work. As of late Monday morning, feeling a little better but still not well enough to resume normal activities. Hoping Tuesday am better.
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| 58 | 2021-04-05 | feeling abnormal |
pt states that she got a strange feeling in the left side of her face. She had a hot streak across ...
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pt states that she got a strange feeling in the left side of her face. She had a hot streak across her ear and her face. She had some heat that she felt was moving through the left side of her body. Her left arm is numb from her elbow to her fingertips. Her left foot became numb. Her right foot has also become numb. She says it feels like her lips and her mouth are numb. Pt went to bed and when she woke up the numbness was getting worse. She contacted her PCP that instructed to go to the ER. She went to Medical Center ER on 4/1 /2021 where they treated her as a stroke patient. She was given MRI, CT, blood work. All tests were negative for stroke. She spent the night and then released to go home to FU w/ Neuro Dr. Pt saw Dr. and will do more blood work. She was told these symptoms would probably dissipate. Pt says she still has some numbness at this time.
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| 58 | 2021-04-05 | excessive sleepiness |
I was given 80ml of steroids two days after my second vaccine. Woke up two days later feeling like I...
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I was given 80ml of steroids two days after my second vaccine. Woke up two days later feeling like I was in a fight with someone in my sleep... beat up, exhausted. Went online to see if it could be from the steroids and found out that I should not have gotten steroids so close to Covid vaccine - I didn?t know and they didn?t ask. If you need people to track the use of steroids with vaccine efficacy it seems as I am now a test patient like it or not. No one seems to know, including state Epidemiologist, if I have messed up the vaccine or not, so if I can get an antibody test, or be included in any studies relating to steroids or vaccine boosters/third shots, I would love to. I have been basically cloistered except for my steroid shots so am very anxious to have the necessary antibodies to be safe.
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| 58 | 2021-04-05 | sleep disorder | Migraine headaches that woke me from sleep at the same time for four nights. |
| 58 | 2021-04-06 | feeling abnormal |
slight fever; Felt little poorly for 24 hours; This is a spontaneous report from a contactable consu...
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slight fever; Felt little poorly for 24 hours; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced slight fever and felt little poorly for 24 hours on an unspecified date. It was reported that patient had the COVID second dose vaccine on Tuesday and you know the first dose patient did not have significant side effect, patient had slight fever and just felt little poorly for 24 hours but the second dose has been quite doozy, patient had experienced the high fever for 2 days, vomiting and nausea and the vomiting stopped 24 hours ago but still have significant nausea and a headache that is from 1 to 10 it's a 9 and patient had it for you know, It started about 24 hours after patient took the vaccine, her question was you know, when she reached out to her doctor and she had me take a COVID test because she have not heard the vomiting and you know nausea to be one of the common side effects of the COVID Vaccine so I took a COVID test yesterday, and she got it back this morning and it is negative so thank god she didn't have that but she was wondering how, A was the nausea, vomiting and the severe headaches normal if so how long can she expect these symptoms to occur and is there anything she can do, can she take something for this, she had been very reluctant to take anything because they, you know she hear that you did not want to take things because you want to immune, you want to immune system it to work. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Feb2021. Outcome of the event slight fever was recovering and outcome of the other event was unknown.
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| 58 | 2021-04-06 | feeling abnormal |
Woke up this morning feeling fine, showered, went downstairs to make tea, felt suddenly strange. Int...
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Woke up this morning feeling fine, showered, went downstairs to make tea, felt suddenly strange. Intense nausea and faintness. Lost consciousness for about 30 seconds (according to my husband).
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| 58 | 2021-04-06 | sleep disorder |
Within a few hours my arm was so painful that I found it difficult to lift it and it remained that w...
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Within a few hours my arm was so painful that I found it difficult to lift it and it remained that way for 3 days. Approximately 10 hours after the injection I began to feel a racing heart, headache, body aches. I had difficulty sleeping the first night because I felt achy and my heart was racing as if I had too much caffeine. The next day, 20-24 hrs after the injection the body aches and racing heart continued and I felt nausea, chills and began with a fever of 100.5 The fever continued for approximately 20 hours and reached averaging 101.2 for several hours with a high of 101.6. I did not take any fever reducer/pain relievers. The fever and headache stopped the next day though the body aches, nausea, and racing heart continued for a few more hours.
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| 58 | 2021-04-08 | feeling abnormal |
Dizziness, lightheaded, struggling to find everyday words when speaking. This occurred an hour or s...
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Dizziness, lightheaded, struggling to find everyday words when speaking. This occurred an hour or so after the vaccine. Right arm was very sore for 24 hours. The following day (Wed, April 7) while I was putting gas in my car, I had a strange experience. I was in the car, which was in park. I felt as though the car was moving as I was sitting in it at the pump. I kept holding down the break, but then realized I was still in the same spot. Very disturbing sensation. Since that day I have experienced periods of faster heart rate, dizziness, lightheadedness, and vertigo.
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| 58 | 2021-04-09 | depression, amnesia, anxiety, delirium, panic attack |
developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming....
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developed acute delirium; redness in arm; Right arm swelling; After that very wild, I was screaming. Very scary. My memory was gone; she passed out at home; she is very depressed has anxiety; she is very depressed has anxiety; panic attack; gained 16 pounds; vomited; loss of appetite; body ache/pain; This is a spontaneous report from a contactable Other HCP (patient). A 58-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: NN6206 and expiration date: Not available), via an unspecified route of administration in the right arm on 04Mar2021 12:00 as a single dose for COVID-19 immunisation. Medical history included removed brain tumor, she has sciatic nerve damage on left arm and left leg and is paralyzed, coma, chronic body aches, seizures, bad vision, high blood pressure and three brain surgery, short term memory. The patients historical vaccine included Flu vaccine injection in right arm deltoid muscle. The patient's concomitant medications included Oxycodone (5mg three times a day tablet) been taking for 3 years since she has brain tumor removed and for chronic body aches and Lyrica. On an unknown date, the patient gained 16 pounds. In Mar2021, the patient experienced she passed out at home and she was very depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite. On 04Mar2021, the patient experienced right arm swelling, screaming, scary, memory was gone. On an unknown date, she experienced developed acute delirium. On 06Mar2021, the patient had redness in arm. The patient was in the hospital for 4 days and was admitted on 14Mar2021. Her memory came back little by little and side effect of vaccine it says that if she had side effects from first one do not take second dose because it is worse and she is scared to be admitted to the hospital and does not want to experience that again. She was taking pain medication and did not tell her she cannot take Tylenol of course with body aches they did not tell her. It was not specific acute delirium it is a psychiatric disorder and she was wild and has never been like that before, she was tied up to the bed. The reporter states that she is disabled. She has bad vision and she is by herself at home. She is 5 1/2 already going down. She is not going to get the second one until get report results because it is ridiculous, and she is very nervous as she was admitted at night to the hospital. Body ache happened 24 to 36 hours after vaccine not that severely unusual as it went away, and she has a chronic illness and is in a wheelchair from chronic pain. Reporter stated she could not swallow liquid or eat food and she was scheduled for a cat scan, but she could not go since she has been on the phone with Pfizer to get truth and fairness. Reporter stated yesterday this started getting better. Reporter stated was discharged from hospital last Tuesday but had pain at home. Developed acute delirium: stated when she woke up in the ER the next day in few hours she was admitted and in the ER she was crazy and tried running even though she cannot run because she is paralyzed and she did not remember nothing. Reporter stated no she did not get it that when she was discharged, it had been 48 hours. Pain started 48 hours after the vaccine. She has chronic pain the pain is not that excruciating, and it has stopped. She could not remember what happened but just knew it was redness and hurt a lot. Her memory and everything came back. States she had MMR (as provided by Reporter ) done, because of pain in her whole body and everything came back negative. She had terrible pain, she asked to be given pain medication, and was given pain medication. Reporter stated it disappeared about one week now it disappeared and has recovered completely. Reporter stated black and blue inflammation and it does not hurt and the pain it went away. She was discharged from the hospital and discharge paper said second vaccine on 26Mar2021. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The patient did not take any vaccines with 4 weeks. No Relevant Tests were performed. While providing an AE for the COVID vaccine she took Tylenol and Motrin as treatment, on top of it, but the pain didn't go away. She has been taking Oxycodone pain medication, reporter thinks she even got a higher dose since the pain was excruciating. The clinical outcome of events gained 16 pounds, passed out at home, depressed, anxiety, panic attack, body ache/pain, vomited and loss of appetite, right arm swelling, screaming, scary, developed acute delirium, redness in arm was unknown whereas of memory gone it was recovering/resolving.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events peripheral swelling, amnesia, delirium, loss of consciousness, depression, anxiety, panic attack, and erythema and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-04-09 | sleep disorder |
Sore arm at injection site. Unable to sleep. Feeling cold followed by being too warm and back and fo...
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Sore arm at injection site. Unable to sleep. Feeling cold followed by being too warm and back and forth between the two. Nausea. General feeling of malaise.
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| 58 | 2021-04-10 | anxiety |
When I got to the car my face felt hot and flushed, but went away. then about 45 mins later I felt d...
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When I got to the car my face felt hot and flushed, but went away. then about 45 mins later I felt dizzy and my feet, hands and tongue were tingling . I kept having dizzy feeling and light headed. The next day I felt nauseated and had blurry vision with not tingling in hands or feet. I felt Anxious and my heart was vibrating, I still felt light head and would have dizzy spells. On the 3rd day after the vaccination I felt like I was having a hard time breathing.
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| 58 | 2021-04-10 | anxiety |
My husband and I drove 65 miles to get the vaccine and I was fine at the facility and left after the...
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My husband and I drove 65 miles to get the vaccine and I was fine at the facility and left after the mandatory 15 minutes. At around the 25 minute mark after the shot, I got dizzy, I was hot and sweaty, had anxiety and it was hard to swallow. I had my husband drive me to the hospital where we stayed in our car in the ER parking lot in case my reaction became life threatening. We stayed there about an hour and when my heart rate decreased and I could sip water again (and my anxiety subsided), then we left for home. However when we got several blocks away from the ER, my anxiety kicked back in because we had to drive over an hour on the highway to get home so back to the ER parking lot we went. After another hour, we were able to drive home.
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| 58 | 2021-04-10 | excessive sleepiness |
24 hours after Vaccine... injection site pain, chills, fever, fatigue, headache, feeling unwell, aw...
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24 hours after Vaccine... injection site pain, chills, fever, fatigue, headache, feeling unwell, awoken lymph nodes. Stayed in bed 16 hours. All symptoms disappeared in 24 hours.
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| 58 | 2021-04-11 | feeling abnormal | Co weird sensation in the throat. V/S 116/68, HR 78. |
| 58 | 2021-04-12 | depressed mood |
I felt very down, lymph nodes appeared in my left clavicle. Very painful. I put ice on and take ibup...
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I felt very down, lymph nodes appeared in my left clavicle. Very painful. I put ice on and take ibuprofen for the pain. Today 5 days later I feel better the lymph nodes and the pain have diminished.
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| 58 | 2021-04-12 | feeling abnormal | Brain fog,doctors can't find anything |
| 58 | 2021-04-12 | sleep disorder |
SEVERE, DIBILITATING HEADACHE - Start about 4-5 hours after the shot I began experiencing a stiff, p...
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SEVERE, DIBILITATING HEADACHE - Start about 4-5 hours after the shot I began experiencing a stiff, painful neck - primarily on the right. Within a short time I felt extreme pain in the top of my head - as if an ice pick or meat cleaver were splitting my head open. The pain was so severe I felt almost sick to my stomach. This pain continued with severe pangs to the point of interrupting my sleep. I saw a MS specialist, on April 1, 9 days after the shot. He said that the headache was related to the vaccine. I didn't seem alarmed even at that point. I had a video appointment with my primary care doctor on April 7 and she also did not seem to think that I should be worried over headaches lasting 2 weeks (at that point.) As of this morning, I woke up with the stiff, sore neck and a headache - 3 weeks after vaccine.
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| 58 | 2021-04-13 | feeling abnormal, impaired work ability |
Monday at 2:00 I received my vaccine. Tuesday, The morning after I received the vaccine I had gone...
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Monday at 2:00 I received my vaccine. Tuesday, The morning after I received the vaccine I had gone to work. I started to feel like I was coming down with the flu. I started to feel very tired and almost weak. I stayed at work as I?m a caretaker for two young children, but I began to feel more and more achy and my joints began to hurt. I drove home at 4:30 and cranked up the heat my hands were so cold they felt like ice. I cranked up the heat. My face became extremely red and my cheeks brilliant red and flushed. I had taken a Tylenol the day of the vaccine and a Tylenol that morning and I took another Tylenol when I got home. I went straight to the couch and spent the next few hours in sweats and feeling generally lousy with aches and pains and joint pain and generally cursing those responsible for this disease process I was now experiencing. I felt much better by 10 o?clock this morning, Wednesday, but by noon was suffering from nausea. Trying to get up and do a few small things but generally having to stay quiet as I just don?t feel very good.
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| 58 | 2021-04-14 | feeling abnormal |
I had vertigo upon sitting up from bed on Saturday ( a few days after ) then quickly had pain in joi...
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I had vertigo upon sitting up from bed on Saturday ( a few days after ) then quickly had pain in joints, muscle spasm that bent me over. Dizzy, headache bad, fever and chills, abdominal bloating, lost appetite, tummy hurt, foggy headed, deep stretchy yawns many times the first day, then they stopped. Oh! the shaking and trembling. I waited to see if it would get worse but it didn't 4 degrees high, dropped to 2. Most of the symptoms were gone in 24 hours. The fever in two days but lower. Headache and some muscle aches remained but tylenol helped. Some vertigo remains but not barfing bad.
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| 58 | 2021-04-14 | impaired work ability |
I had a flare of my ischemic colitis on Sunday evening following my vaccine on Friday morning. I ha...
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I had a flare of my ischemic colitis on Sunday evening following my vaccine on Friday morning. I had been in remission for about a year, with no other symptoms before the flare. Since I didn't have any blood, I did not go to the hospital or see a physician, per long-standing instructions from my gastroenterologist. I did increase my medication for two days, also per his long-standing instructions. The attack lasted from about 9pm until 3am. Afterwards, I slept. I missed work on Monday. I have gotten better since the attack. Today is Thursday, and I am back to nearly normal eating.
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| 58 | 2021-04-15 | insomnia |
I experienced sleeplessness for two days following the shot. As a side note, I have difficulties s...
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I experienced sleeplessness for two days following the shot. As a side note, I have difficulties sleeping in general. Secondly, my left arm is still sore 16 days after the shot.
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| 58 | 2021-04-16 | anxiety |
Fever 101.1, chills, lymph node under left arm swollen and very painful, neck aches,bilateral should...
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Fever 101.1, chills, lymph node under left arm swollen and very painful, neck aches,bilateral shoulders ache,upper back aches,bilateral wrist aches,nauseous,extreme fatigue, chest pain anxiety short of breath
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| 58 | 2021-04-16 | anxiety |
Patient felt dizzy and "throat tightness" during post-vaccination monitoring period. Patient denied ...
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Patient felt dizzy and "throat tightness" during post-vaccination monitoring period. Patient denied difficulty breathing. Patient was assessed by onsite EMTs, no other problems noted and throat appeared clear. Patient stated that she has anxiety. She denies any other medical concerns. Patient recovered and EMTs released her to go home of own volition due to her reports of feeling well again.
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| 58 | 2021-04-16 | feeling drunk |
9 days after 2nd covid vaccine Awoke with severe vertigo and nausea/vomiting Lasted 6 hours Then sta...
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9 days after 2nd covid vaccine Awoke with severe vertigo and nausea/vomiting Lasted 6 hours Then started to subside Since then no dizziness but feels "drunk" dizzy. Her husband needs to drive her. Does not feel comfortable with big body positions did not have any particular head motion that started the vertigo.
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| 58 | 2021-04-16 | impaired work ability | Extreme fatigue that is ongoing as of 4/17/21; unable to work or function normally |
| 58 | 2021-04-17 | nervousness, feeling abnormal, insomnia |
shaky inside my body; Felt like passing out; ears feel clogged; had a hard time falling asleep; unse...
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shaky inside my body; Felt like passing out; ears feel clogged; had a hard time falling asleep; unsettled stomach ( a little queasy).; Felt pressure with slight headache; Felt pressure with slight headache/felt pressure in my head; Loud Ringing in both ears; dizzy/dizzy spell; nauseated/unsettled stomach ( a little queasy)/sick to my stomach; body felt uneasy like it was fighting something inside; pain at injection site and side of left neck; pain at injection site and side of left neck; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Mar2021 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included vitiligo and known allergies. The patient had no COVID prior to vaccination. There were no concomitant medications. The patient has no other vaccine in four weeks. The patient was not tested for COVID post vaccination. On 22Mar2021, the patient got the shot and later (at 18:00) had pain at injection site and side of left neck. On 23Mar2021 10:30, the patient experienced loud ringing in both ears, felt dizzy and nauseated, and body felt uneasy like it was fighting something inside. On 24Mar2021, the patient was still having ringing in both ears, feel nauseated on and of lasting at least 30 seconds or so. From 25Mar2021 to 29Mar2021, ringing in ears sometimes get louder than other times, he also felt pressure with slight headache. On 30Mar2021, ringing in ears intensified and had a hard time falling asleep. The patient felt pressure in her head. She also had slight headache and an unsettled stomach (a little queasy). On 31Mar2021, ringing seems lower today; ears feel clogged. She still has pressure in head with slight headache and had one episode of dizzy spell for a few seconds only. At night, ringing in ears intensified. On 01Apr2021, lower ringing in ears noted. On 02Apr2021, the patient had pressure in head, clogged ears, sick to her stomach, shaky inside her body, and felt like passing out. Ringing was intensified at night. On 03Apr2021, headache and pressure in head were noted. The events resulted in doctor or other healthcare professional office/clinic visit but were not treated. The outcome of the events was not recovered. No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
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| 58 | 2021-04-18 | memory impairment |
58 y/o W female with onset of LOC with involuntary UE/LE movements approximately 3-5 minutes after r...
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58 y/o W female with onset of LOC with involuntary UE/LE movements approximately 3-5 minutes after receiving vaccination. Member was transferred to wheelchair and after brief period of time regained responsiveness. Member reported nausea, unable to recall recent events and denied any medical hx to include current medication. Member with multiple episodes of vomiting. Member's care was transferred to EMS and transferred to University of Hospital for elevation of care.
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| 58 | 2021-04-18 | nervousness |
Tingling and numbness in three left toes of left foot; tingling in pinkie/ring fingers of left hand;...
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Tingling and numbness in three left toes of left foot; tingling in pinkie/ring fingers of left hand; random "pings" (nerve-related) around body; mild tingling/numbness in lips. These symptoms concern me because I was hospitalized for Guillain-Barre Syndrome in July, 2020 and numbness/tingling in the feet was one of the initial symptoms of GBS. GBS is an auto-immune condition which can cause temporary paralysis and, depending upon its severity, death. It is is usually self-limiting but can take months or years to resolve. In early stages it can be treated with IV immunoglobulin to replace "bad" antibodies with "good" ones and that is the five day treatment I had at Hospital over the summer. I am very nervous that the Pfizer vaccine may be triggering another GBS episode though everything I have read says that there have been reported instances of this happening. Still, I thought it concerning enough to contact my primary care physician and website because GBS is no joke.
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| 58 | 2021-04-19 | sensation of foreign body |
I felt an intense sensation of heat throughout my body, a strange sensation in my mouth and an odd t...
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I felt an intense sensation of heat throughout my body, a strange sensation in my mouth and an odd taste. A lump formed in my throat with phlegm that caused me to need to cough to clear my throat. I felt very jittery. Staff at the clinic reported I felt clammy to touch and that I became pale. I was given oral Benadryl and staff reset the clock. I experienced several of these intense body-wide heat waves while at the clinic. Staff told me I was not having an allergic reaction but that my "body was reacting to a foreign substance introduced into my body." I was told to return for the 2nd shot on 5/5/21 and staff will premedicate me with Benadryl.
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| 58 | 2021-04-20 | agitation |
8 hours post vaccine , Headache, vomiting, full arm pain, agitation, lasting approximate 3 hrs. I...
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8 hours post vaccine , Headache, vomiting, full arm pain, agitation, lasting approximate 3 hrs. Ice on arm and Advil 2x 500mg
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| 58 | 2021-04-20 | feeling abnormal |
Severe vomiting & diarrhea, body aches, chills, headache, fatigue, beginning 12 hours after dosage. ...
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Severe vomiting & diarrhea, body aches, chills, headache, fatigue, beginning 12 hours after dosage. Vomiting and diarrhea lasted approximately 6 hours. Body aches, headache and extreme fatigue lasted throughout day 2 after shot was administered. Felt some relief by the evening of the second day, but still had some body achiness, considerable fatigue and brain fog. By day 3 felt much improved, but depleted from the ordeal. By day four was pretty much back to normal but still felt slightly foggy and weakened. Improvement continued. I have had some recent intestinal issues in the past two weeks, in the form of bloating and gas, and will follow-up with my physician if they do not improve.
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| 58 | 2021-04-20 | feeling drunk, agitation |
I got a Mighty sore arm about 4 hours after injection. 30 hours later I began to feel agitated and g...
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I got a Mighty sore arm about 4 hours after injection. 30 hours later I began to feel agitated and grouchy. I woke up about 44 hours after vaccine with a painful and swollen left thumb joint. I felt strangely tired. While walking a couple of hours later I felt drunk and dislocated from my body. 48 hours after receiving the vaccine, I felt a shocking jolt to my entire body. Immediately my left arm began a deep painful tingling from my shoulder to my fingertips, then began to feel numb and tingling and as if it were swelling. I lost my vision, felt like I was going to pass out, turned extremely pale, broke out in a cold sweat, then my shins and feet began to tingle. I felt as though I couldn?t breathe. My vision came back but my body felt dislocated and my head a cinder block. It took great concentration to move my limbs and speak. I couldn?t find the words I wanted. This lasted for about 15 minutes just like a complete shock to my nervous system. I was very irritable and exhausted for 4 days following.
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| 58 | 2021-04-20 | sleep disorder, loss of personal independence in daily activities |
Vaccinated 3/23 at 1:30 p.m. 5 hr post: fatigue body aches mild. 9 hrs post Temp 101.7 increased jo...
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Vaccinated 3/23 at 1:30 p.m. 5 hr post: fatigue body aches mild. 9 hrs post Temp 101.7 increased joint pain, severe body aches nausea. Tylenol taken. Fever broke 18 hrs post. Felt better. on 3/24 at 12 noon 22 hrs post vaccination: HA, increased joint pain, body aches, fatigue. Temp 101.7. Tylenol taken. At 4 p.m. Temp 100.1. Symptoms continued. At 8 p.m. 30 hrs post vaccine Temp: 102.7 Increased symptoms of joint pain, HA, fatigue, nausea. 3/25/21 Approximately 34 hrs post vaccine at 0015 a.m. Temp 103.4. Severe joint pain, full systemic body aches, fatigue, HA, nausea. Tylenol taken w/continued increase fluids as tolerated. Approximately 40 hrs post vaccine at 0600 significant diaphoresis, fever broke down to 100.2. Slept 4 hrs. Awoke to temp 99.8 approximately 44 hrs post vaccine. Employee health notified. Wanted VAERS report filed and also COVID 19 test done this day. (COVID Neg 3/25) On 3/26: Severe lower back pain occurred. One area only and non-radiating. Pain Sharp and burning. This was not typical chronic pain and it occurred without any trauma or significant event. This back pain lasted from 3/26 through a.m of 3/30. ( It was not relieved by any oral pain medication. It made any ADLs difficult. Unable to sleep due to pain. It remained severe and constant until 3/30 in which it went away Phone call to primary physician. Back xrays were ordered and negative. Lab tests normal.
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| 58 | 2021-04-21 | impaired work ability, feeling abnormal |
Woke up with bad headache next day went to work and left at 12 felt so bad. No fever, just severe h...
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Woke up with bad headache next day went to work and left at 12 felt so bad. No fever, just severe headache, full like symptoms, freezing, body aches, ear ache, jaw ache, teeth hurt, also my eyes were weird like not clear in seeing. I also have woken up with my body completely wet but not sweating g or cold. So weird. This has happened each night after second shot. I had lower back pain and that started after first shot but I didn?t realize that it was from the 1sr shot done on 03/30/2021.
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| 58 | 2021-04-21 | sleep disorder |
awakened from sound sleep with intense sharp pain in upper torso that radiated to my back as well. P...
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awakened from sound sleep with intense sharp pain in upper torso that radiated to my back as well. Pain was so intense that my BP was 166/94. Nauseous, lightheaded, couldn't even sit up. Crumbled to a ball on the floor. Cold sweats. Lasted almost over 30 minutes. Within an hour BP was back to normal 122/70.
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| 58 | 2021-04-22 | confusional state |
Uncontrollable shivering Chills Body aches Mild fever(99.2F) Cough HEADACHE Fatigue Confusion Nausea...
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Uncontrollable shivering Chills Body aches Mild fever(99.2F) Cough HEADACHE Fatigue Confusion Nausea Shivering and chills resolved within 7 hours All other AES ongoing at 5 days
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| 58 | 2021-04-22 | impaired work ability, feeling abnormal |
Severe vertigo, entire room spinning with nausea for 24 hours. Went to urgent care for treatment. Ha...
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Severe vertigo, entire room spinning with nausea for 24 hours. Went to urgent care for treatment. Had very difficult time getting there. Had to crawl on the ground. Not much in the way of dx/treatment. Dx vertigo and gave me anti nausea meds. Tried epley, but didn't help. Spinning episodes subsided by early evening, but still felt awful. Laid in bed/slept in upright position. 2nd day: woke with no vertigo, but still not feeling well at all. Feeling like hung-over/brain fog/poor balance, couldn't do any work at computer. 3rd day: woke with slight vertigo. Turn head and objects would shift 10 degrees back and forth, but would stop if I kept my head still. No more vertigo by middle of 3rd day, but continued feeling off, like hung over, with trouble doing work at computer for long periods. Slight dizziness constant. Severe dizziness if I move my head down fast. Don't feel I should drive a car or ride my bike until it resolves. It has now been one week since symptoms started. Probably 80% gone.
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| 58 | 2021-04-23 | feeling abnormal |
severe ringing in ears, sever fatigue still 8 days later, body aches, head ache, stomach upset, seve...
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severe ringing in ears, sever fatigue still 8 days later, body aches, head ache, stomach upset, severe brain fog, weakness - all running for 8 days since I was vaccinated! What is the point of getting sick for 8 days and running?? Its like having covid again!!
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| 58 | 2021-04-23 | nervousness |
A few minutes after injection felt a quick electric-like shock across top of head and momentary fain...
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A few minutes after injection felt a quick electric-like shock across top of head and momentary faintness. A few minutes more, I began to have a tight feeling in my throat and swallowing was difficult. Felt the need to swallow frequently. Got nervous so stayed past 15 minutes. At 30 minutes, it wasn't getting worse and my breathing felt fine so I left (foolishly) the vaccination site. Throat felt tight the rest of day. Kept feeling the the need to clear my throat. Sore. Hard to swallow. At 10:15pm, the tightness and swallowing issue abruptly stopped. Throat felt sore for next 2 weeks. Asked pulmonologist if my allergy and asthma medication could have suppressed a more insidious reaction. Did not know. Saw allergist. She did not know either but gave me an epi-pen if I was going to try shot 2. Also suggested J&J as an alternative. Ordered blood tests for reactivity to 2 chemicals close to PEG. (no blood test for it). Results not back. Noted that I was taking lisinopril which is an ACE inhibitor. Said they can cause swallowing problems. Cardiologist did not think so but changed my medication to a calcium channel blocker instead. Called Pfizer. They classified my reaction as an immediate adverse event and took a record of it. I canceled my second Pfizer shot appointment because the CDC site says not to take second shot if you have an immediate adverse reaction. Very disappointed and confused how to proceed. Mixed advice from doctors. Really wanted to be vaccinated. Really don't want to have a worse anaphylactic reaction which my pharmacist could happen if i tried it again. Don't feel safe trying it at the mass vaccination site at the beach.
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| 58 | 2021-04-23 | sleep disorder |
I have developed a rash in three areas of my body. I first developed a fungal rash in my vagina. I w...
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I have developed a rash in three areas of my body. I first developed a fungal rash in my vagina. I was given prescriptions for Nystatin Ointment USP 30 g (1.1 oz.) and Triamcinolone Acetonide Ointment USP 0.1%. Then I developed a different type of rash on my upper thighs which spread to the bottom and then to the first half of my stomach. During my annual exam with a new gynecologist, she said that the rash in my vagina was not visible. After I showed her the rash on my upper thighs and stomach, she prescribed Hydrocortisone Ointment 2.5% and told me to immediately make an appointment with a dermatologist. When my new dermatologist examined me, he said that I am suffering from Atopic Dermatitis Eczema and prescribed a large jar of Triamcinolone Acetonide Cream USP 0.1% 454 grams. I had been alternating between using the Hydrocortisone Ointment and the Triamcinolone Acetonide Cream. Neither of these treatments has helped me at all. I have suffered from shingles twice in my life. This itching feels different from shingles. I had a rash that felt like it was burning. This rash is itching me so much that I can barely sleep at night. I went to a primary care physician yesterday who gave me a steroid injection and oral steroids. That has not helped me at all. Today I noticed a slight rash on my neck. I am itching so much and do not know if it is from my second Pfizer injection or from something else.
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| 58 | 2021-04-24 | feeling abnormal |
numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side; ...
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numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side; tongue has been numb; really feel weird on her face; burning sensation that shot across the top of her left ear and nose/burning sensation down the left side of her body; left side of her face started to feel hot; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left, at the age of 58-year-old, on 31Mar2021 18:45 as SINGLE DOSE for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 31Mar2021, a half an hour later, as the patient was driving home, the left side of her face started to feel hot and she kept putting her right hand on it to cool it off. The patient got a burning sensation that shot across the top of her left ear and nose. Once at home, she started to really feel weird on her face, and she had a burning sensation down the left side of her body. Her face felt strange for 1 hour and then declined. The patient went to bed at 09:30P.M. and she noticed numbness in her left leg. The next morning, the numbness in her left leg was much worse and she had numbness in her left arm down to fingers. States she called the doctor when they opened at 09:00 A.M. and they said to go to the ER right away because of all the numbness. The ER treated her like a stroke patient, and wanted to make sure she didn't have a stroke so she had a full MRI, Cat Scan, and Bloodwork done that all came back normal. The patient was in the ER on 01Apr2021 morning and she was admitted for observation and she came out of the hospital 02Apr2021 before 5:00P.M. The doctor ordered more bloodwork and a CT with contrast was ordered for her spine to see if she has any spinal damage. The patient saw a neurologist on 05Apr2021, she has had more numbness on the right side. Clarified that her right foot feels numb intermittently along with the right side of her face. Her tongue has been numb on 31Mar2021, like a line across it, most of the time. The numbness ebbs and flows and where she feels it, moves around. It is not as strong as a week ago but it moves around. No treatment was given in response to the events. She stated the neurologist and no one has recommendations on if she should receive the second dose. Outcome of left side of her face started to feel hot, really feel weird on her face was recovering; tongue has been numb was not recovered;Burning sensation recovered on 31Mar2021, numbness in her left leg/ numbness in her left arm down to fingers/more numbness on the right side was unknown. Follow-up attempts are completed. No further information is expected.
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| 58 | 2021-04-24 | feeling abnormal |
Sinuses felt congested/Feels like left side of head is congested; Left ear ache/inflammation; Moment...
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Sinuses felt congested/Feels like left side of head is congested; Left ear ache/inflammation; Momentary buzzing sound in left ear; Vertigo at night; Feeling foggy; Autoimmune fluid response (injection left arm); Left eye felt inflamed; Face felt swollen/fluid; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in the left arm, on 30Mar2021 at 14:00 (Batch/Lot Number: 8733), at the age of 58 years old, as a single dose, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, Crohn's disease, and asymptomatic mild thrombocytopenia. The patient had allergy to penicillin, sulfa, preservatives, azithromycin (ZPACK), dust, mold, and sulfites; she also had seasonal allergies. Additionally, allergy to food included wheat, rye, oats, barley, quinoa, tomato, potato, celery, peas, banana, cantaloupe, strawberries, chocolate, tea, beef, and caffeine. In 1982 the patient reacted to an unspecified allergy shot with anaphylaxis and 4-day delayed reaction of serum sickness including liver dysfunction, swelling, rash, nausea, not being able to keep food or liquid down, treated with hydroxyzine (ATRAX) (started at day 5 of serum sickness which helped clear it up). The patient had not had COVID-19 prior to vaccination withy BNT162b2. Concomitant medications included mesalazine (LIALDA), cetirizine hydrochloride (ZYRTEC), mometasone furoate (ASMANEX), fluticasone propionate (FLONASE), and vitamin D. The patient had not received any other vaccines during the 4 weeks prior to BNT162b2 administration. The patient stated that 20 minutes after vaccination her left eye felt inflamed and 3 hours after vaccination her face felt swollen/fluid. The patient stated waking-up on 04Apr2021 at 06:00 AM with momentary buzzing sound in the left ear, ear ache/inflammation, sinuses feeling congested, lightheaded/dizziness all day, vertigo at night and on the following morning when lying on the left side, and feeling dizzy/lightheaded for 3 more days. The patient also reported feeling foggy, feeling like her left side of head was congested, and autoimmune fluid response (injection left arm) (as reported), all on 04Apr2021. Due to the events, the patient consulted a doctor or other healthcare professional office/clinic visit. No treatment was required for the events. The patient was not tested for COVID-19 after vaccination. The patient was recovering from all reported events with the exception of buzzing year which resolved on 04Apr2021.
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| 58 | 2021-04-24 | loss of personal independence in daily activities |
8 hours after receiving injection, started having a sore throat. 48 hours after injection noticed a...
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8 hours after receiving injection, started having a sore throat. 48 hours after injection noticed a small grape size lump/knot close to collar bone (lymph node?) on left side which is the injection side. 72 hours after injection, I had lost my voice, not totally. Sounds like I'm whispering when I talk. I also had the normal reported sore arm, but was quite bothersome for 3+ days. I have also noticed some shortness of breath and still quite tired after doing several small chores. I am currently on day 11 after injection, and have another smaller lump/knot beside the first one that appeared by my left collar bone. The only side effect that has dissipated is the sore arm, I still am having fatigue, shortness of breath, lumps near collarbone and loss of voice. I have not seeked medical treatment since I have no health insurance. I felt like these would subside, but have not so far. I am really hesitant to receive my 2nd dose since claims are that it is worse that the first, regarding side effects. I feel that my body has not recuperated from trying to build up my immunity. As stated above, my side effects have not subsided as of today's date, 11 days after receiving the 1st dose injection.
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| 58 | 2021-04-24 | mental status changes, loss of personal independence in daily activities |
Dramatic increase of ringing in ears, loudest in right ear. Loud enough to affect daily life, mental...
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Dramatic increase of ringing in ears, loudest in right ear. Loud enough to affect daily life, mental health. High pitch sound with no cessation in 3 weeks.
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| 58 | 2021-04-25 | anxiety |
The next day, just a sore arm. A headache for 16 straight days. I started having a lot of anxiety. I...
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The next day, just a sore arm. A headache for 16 straight days. I started having a lot of anxiety. I had to get medication for it. I did an online visit and then I went to NOW clinic to get my blood pressure system checked. My blood pressure was fine. Medicine I was prescribed: Alprazolam. I recovered from my headache just before the second dose of vaccine which was 2/8/2021.
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| 58 | 2021-04-25 | anxiety |
Next day - sore arm. The next day, as well. Then it went away about 24 hours later. The joints in m...
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Next day - sore arm. The next day, as well. Then it went away about 24 hours later. The joints in my hips both sides and both of my knees started to hurt so bad. They still hurt. I sold my truck because I couldn't get in and out. I started taking some Glucosamine for joints. Anxiety symptoms after first dose of vaccine had continued and they are still continuing. They have not stopped.
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| 58 | 2021-04-25 | feeling abnormal | 1. left forearm ached 2. very tired 3. jittery 4. very cold 5. felt unlike my self for 2 days |
| 58 | 2021-04-26 | anxiety | Patient experienced anxiety post vaccination, recovered and released |
| 58 | 2021-04-26 | insomnia |
INSOMNIA THAT HAS BEEN LASTING UP UNTIL NOW. IT IS SLOWLY GETTING BETTER, BUT I HAVE NEVER EXPERIENC...
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INSOMNIA THAT HAS BEEN LASTING UP UNTIL NOW. IT IS SLOWLY GETTING BETTER, BUT I HAVE NEVER EXPERIENCED THAT BEFORE. I WAS ABLE TO SLEEP 2 HOURS AFTER GOING TO BED AND THEN WAKING UP AND NOT BEING ABLE TO FALL ASLEEP AGAIN. I FELT TIRED BUT NOT SLEEPY.
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| 58 | 2021-04-26 | sleep disorder, anxiety |
itchy neck - 6 hours later (continued until present- now is red and chapped) uncontrollable noseblee...
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itchy neck - 6 hours later (continued until present- now is red and chapped) uncontrollable nosebleeds 40 hours later and 7 days later (2 ER visits) ENT Specialist followup - no known cause for these nosebleeds! elevated aPTT level - will see Hematologist anxiety (can't sleep at night) Never had this in my life! CT scan Sinuses
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| 58 | 2021-04-28 | excessive sleepiness |
Post Vaccine ten days fatigue and hypersomnolence still having symptoms as of 4/13/21 (date of offi...
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Post Vaccine ten days fatigue and hypersomnolence still having symptoms as of 4/13/21 (date of office visit). Also reports huge hive two inches from injection site that lasted for ten days.
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| 58 | 2021-04-29 | feeling abnormal |
Light headed, blurred vision, foggy headed & felt medicated, balance off, weakness and dizzy. Starte...
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Light headed, blurred vision, foggy headed & felt medicated, balance off, weakness and dizzy. Started after woke up and progressed to the point of having to call husband home because of fall risk. Then fever came. Most concerning and alarming are the symptoms of vision change like smog in front of my eye sight, feeling weak, light headed and dizzy like walking on a rocking ship. Such a medicated feeling, this all progressed from between 7:30 am to about 10:30, had fever come 100.1 dizziness and weakness and vision gradually got better around 11:30. But when fever spiked again in the evening dizziness came back for a hour or more. Next day a milder episode of dizzy and that passed. These are the most concerning symptoms and Doctor advised I do not get second dose. I had many other symptoms and still have some.
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| 58 | 2021-04-29 | irritability, memory impairment |
This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose ...
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This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose Pfizer on 4/27/21 (Lot# EW0151). Of note, the patient was in a motor vehicle accident on 4/12/21 with a diagnosis of concussion and cervical/thoracic strain/sprain (see history under patient information). On 4/29/21, the patient's sister contacted the patient's primary care clinic with the following documented concern: "Pt's sister calling to report that two days ago pt got 2nd dose Pfizer vaccine and has been sick. This morning they found her passed out against the her bedroom door. Pt reports that she can't remember much other than going to the bathroom. Pt's sister states that patient totaled her car a week ago, and that it was determined she had a concussion. "She hasn't been herself since the wreck and I am very concerned." This caller recommenced the Ed or UC but caller denied stating that either needs to see her today. This writer is reaching out to nurse to see if they can advise from here." A RN assessed the patient virtually with the following documentation: "RN note: Call transferred from patient's sister. Pt noted to be found on her floor this morning. Pt unsure if she hit her head. Spoke to patient. She reports body aches, and feeling weak. Pt is slow to answer questions, and had a lot of difficulty hearing me (sister did not have any difficulty hearing me). Pt is noted to have more rapid breathing, and some slight wheezing. Speech is clear when she is speaking. Sister gave patient water to drink. She drank out of bottle and was able to hold on her own (though had difficulty with this at first). Sister noted some water dripping down face, but was able to swallow okay. Sister also noted that patient's lips seem to be pursed. Plan: Given recent concussion, and patients change in behavior per sister (pt more irritable, speaking more slowly, moving slowly, breathing faster, and wheezing), recommended patient be taken to the ED today--recommended ambulance since it took 2 men to help patient back to bed this morning. Sister states patient is not agreeable to going to ED at this time. Advised to try to encourage her to drink more fluids, and continue to monitor her sxs, and if any worsening, to call for ambulance transport. Sister agreeable to plan, and will discuss with sister, and recommend ED visit today." On 4/30/21, the patient's sister contacted the clinic to inform them that the patient was found dead that morning. The medical examiner is completing the further investigation. If additional information is needed from the primary care physician for this patient.
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| 58 | 2021-04-30 | feeling abnormal, anxiety |
A-Fib; The Pfizer covid vaccine made her heart worse; anxiety; injection site was swollen, red, and ...
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A-Fib; The Pfizer covid vaccine made her heart worse; anxiety; injection site was swollen, red, and warm to the touch; injection site was swollen, red, and warm to the touch; injection site was swollen, red, and warm to the touch/her arm at the injection site was swollen, red, hurting and tender to touch; injection site was swollen, red, and warm to the touch/her arm at the injection site was swollen, red, hurting and tender to touch; heart rate also went up because she is scheduled for chemo, radiation and has an a-flutter/Fast heart beat; heart rate also went up because she is scheduled for chemo, radiation and has an a-flutter; Extreme tiredness; Bad headache; Fever of 99.4, 99.7, and 100.8; Chills; feeling yucky; Body aches; Feeling unwell; sick all day the day after but was fine by Sunday; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 09Apr2021 at 11:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included neuropathy on the bottom of her feet, cancer and cannot sleep from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate at 275 mg, daily (125mg of metoprolol succinate in the morning and 150mg of metoprolol succinate in the evening) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 19Mar2021 at 10:00AM (at the age of 58-years-old) in left upper arm for COVID-19 immunisation. The patient received her 2nd dose of the Pfizer COVID Vaccine on 09Apr2021. She was sick all day the day after (10Apr2021) but was fine by Sunday. On Monday, 12Apr2021, she mentioned that she underwent radiation therapy, then noticed that her injection site was swollen, red, and warm to the touch on 13Apr2021. On 10Aapr2021, her heart rate also went up because she is scheduled for chemo, radiation and has an a-flutter. She mentioned that the COVID shot made it go up. She is asking how long these side effects should last and for what to do. She mentioned that the nurse at her doctor's office told her to contact Pfizer on what to do. She is a high-risk cancer patient. She received her second dose of the COVID vaccine on 09Apr2021. The next day, she experienced tiredness, a headache, chills, and body aches. She also had a fever of 99.4, 99.7, and 100.8. She was feeling unwell. Then she got a fast heartbeat. She has been having that problem. She has A-Fib and A-Flutter. She has been doctoring every week about her A-Fib and A-Flutter. Then she was fine. On Monday, she had radiation. After radiation, on Tuesday, 13Apr2021, her arm at the injection site was swollen, red and hurting. Then her heartbeat started back beating fast. She has had a headache on and off. She had a headache on Monday, Tuesday and Wednesday. She does not look at her weight. She has gained so much weight since cancer. She retains liquids because of her cancer. She is probably about 230 pounds. She has been tired because of her cancer. But this was different, this was extreme tiredness. Began on Saturday, 10Apr2021 whenever she woke up. With her cancer, she cannot sleep. After the second dose of the covid vaccine, she was so tired, she actually rested well. She was feeling yucky, with chills, a headache and a fever. She is grateful that she was able to get some sleep. It was completely resolved on Sunday morning, 11Apr2021 whenever she woke up. Bad headache began on Saturday, 10Apr2021 whenever she woke up. Sleeping relieved her headache. She took some Tylenol even though she is not supposed to take Tylenol because of her chemotherapy. Tylenol could affect her liver because of the chemotherapy. She took the Tylenol for her fever and to help her headache. Her headache is on and off, but it is a lot better since her first headache. Her headache was the worst on the first day. She thought her symptoms were clear until her arm at the injection site was swollen, red and hurting. It was also hot to touch. Chills, body aches and fever of 99.4, 99.7, and 100.8, feeling unwell began on Saturday, 10Apr2021 whenever she woke up. Completely resolved on Sunday morning, 11Apr2021 whenever she woke up. Her heart started racing on Saturday, 10Apr2021. Then it resolved on Sunday, 11Apr2021. Then her fast heartbeat came back whenever her arm at the injection site started to get swollen, red and hurting. She thinks that her fast heartbeat could be anxiety too. She has anxiety. She takes heart medications that are supposed to slow her heart down. The medications are not working. Chemotherapy makes her heart worse. She called her doctor about her heart beating fast. She has not heard back from her doctor yet. Usually her doctor will up her mediations. Now tomorrow, she will be filling her body with poison. Chemotherapy makes her heart worse. Chemotherapy name, lot number, NDC and expiration date: Not provided. The Pfizer covid vaccine made her heart worse. She is supposed to get chemotherapy tomorrow. She does not know what will happen tomorrow. She thinks that her doctor is going to have to up her medications. She has been seeing her heart doctor every week. Because of radiation, she has not seen her as much. She is going to see her heart doctor on Tuesday. Her heart doctor has been doctoring her for forever, and she sees her every week since she was diagnosed with cancer. She prefers for Pfizer to contact her heart doctor if there are any follow up questions. She had to have surgery, and after that she went into A-Flutter. Her heart doctor has been on it since. Clarified that her heart medications normally do work. She thinks that the COVID vaccine counteracted her heart medications. Normally her heart rate is under 100. After the COVID vaccine, at 7:00PM, her pulse was 104. On Saturday, at 4:30PM, her heart rate was 111. At 8:00PM, it was 109. On Sunday, it got better. At 7:30AM, it was 96. At 6:00PM, it was 90. On Tuesday, whenever the injection site turned red, was hurting and swollen, her heart rate was 104. Currently her heart rate is 94. She has A-Fib and A-Flutter. She has been doctoring that every week about that. After that she was fine. On Monday, 11Apr2021, she had radiation. After radiation, on Tuesday, 13Apr2021, her arm at the injection site was swollen, red, hurting and tender to touch. Her heart started beating fast again. The redness is the whole width of her arm. She is asking how long she can expect this redness to last. She does not know if radiation triggered this. It happened right after radiation that she started on Monday. Her daughter told her that this is normal, and a lot of people have this happen. The day before the second dose of the COVID vaccine, she had internal radiation. That was her third radiation treatment. She told her oncology doctor about the COVID vaccine and her doctor talked to her about it. Her doctor told her to go on and get the COVID vaccine, and that people like her needed the vaccine. She did not have radiation with first dose of the COVID vaccine. Therapeutic measures were taken as a result of bad headache and fever of 99.4, 99.7, and 100.8. The outcome of the events sickness, fever, chills, feeling abnormal, body aches and feeling unwell was recovered on 11Apr2021, headache was recovering, while of the rest was unknown.
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| 58 | 2021-05-14 | hallucination |
painful to move left side of body; left sore arm; hurt her back; Headache; Dizzy; hallucinating/ hal...
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painful to move left side of body; left sore arm; hurt her back; Headache; Dizzy; hallucinating/ hallucination; Nauseated; the lady shot her arm, she said ouch; hadn't eaten a whole lot; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in upper left arm on 27Apr2021 11:30 (Batch/Lot Number: ER8729) (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing back problems started a good 20 years ago in 2001. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2, via an unspecified route of administration, administered in left arm on 06Apr2021 (Batch/Lot Number: ER8727) (at the age of 58-years-old) as a single dose for COVID-19 immunization and she had a sore arm on 07Apr2021 and that's about it. The patient was hallucinating last night and had a left sore arm on 28Apr2021 and painful to move the left side of body on 29Apr2021. After the lady shot her arm, she said ouch on 27Apr2021. The first lady didn't hurt, but whatever the second lady did, maybe hit a nerve or whatever. It was scary. She had never had hallucinations before. The patient felt that she was wasted and not wasted, and that's how she felt today. The patient did not have her glasses as she had been laying in bed. She hated wearing glasses. After the second shot, the patient clarified that it was hard to move. She had so much pain. She clarified that she was not paralyzed but it hurt to move that side. Maybe she was trying to compensate, because she received the shot in the shoulder area and maybe hurt her back that way on 28Apr2021. Last night she woke up because she had s tornado alert. An amber alert went off on her phone that was in the kitchen. It scared her, she realized there was a tornado warning sent to everyone. She took her purse and dog under the table and was she was cramped; this made it all worse. She felt the same, as the hallucinations today. She was not sure where she was, what date it was, scary stuff. Her symptoms started Tuesday, late in the evening and continued to get worse. Yesterday, she felt that she threw out her whole back. When she went to move, she could barely move and it was getting worse this morning. The patient could barely lift the telephone to her ear on that side. It was persisting pain and she laid on the keypad all night. She had a headache on 28Apr2021. It radiated to her neck from her shoulder and down. The shot made it worse she thought since the neck muscle went to the arm, maybe. Her arm was really bad last night and was ongoing with no relief. She took methocarbamol (ROBAXIN) and that didn't help. The patient tried to prevent moving her arm, and thought she threw her back out like that. The patient got up on the call and got really dizzy after getting up on 28Apr2021. The patient hadn't eaten a whole lot in Apr2021. She felt the shot kicked her butt after she texted her daughter and had the arm pain for a couple days. She couldn't and didn't want to get out of bed. She was pretty bummed right now. She was nauseated on 27Apr2021 and it's been off and on, but on for longer and was persisting. Yesterday she did not lay around like she had today. The patient underwent lab tests and procedures which included weight: between 147-148 pounds on an unspecified date. Therapeutic measures were taken as a result of left sore arm. The outcome of events, painful to move left side of body, left sore arm, hurt her back, headache, dizzy and nauseated was not recovered; the outcome of event, hallucinating/ hallucinations was recovered on 29Apr2021; the outcome of events, the lady shot her arm, she said ouch and hadn't eaten a whole lot, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021482506 same patient/drug, different event/ first dose
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| 58 | 2021-05-15 | feeling abnormal |
Tinnitus, brain fog, blurred vision/double vision, ear pain, ear congestion, fatigue, fever, body ac...
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Tinnitus, brain fog, blurred vision/double vision, ear pain, ear congestion, fatigue, fever, body aches
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| 58 | 2021-05-23 | feeling abnormal |
Strange feeling to head. Tingling running down right arm and eventually down to feet. Tightness in...
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Strange feeling to head. Tingling running down right arm and eventually down to feet. Tightness in throat. Red chest and red face. Elevated blood pressure 170/100. elevated heart rate. Tingling in head in first 10 minutes. Began running down arm and then on into leg within 30 minutes. tightening in throat and dry cough within 15 minutes. Given 25 mg Benadryl within 10 minutes of onset of symptoms. Given sprite and peanut butter crackers which did nothing. Benadryl began to help. Given another 12.5 mg 15 minutes after initial dose. Pulse Oximeter good oxygen level 97-98 after benadryl. Ambulance was called and I refused. I was told to go to ER. My husband is a registered respiratory therapist and said he would watch me and not leave me alone. He said he would take me if symptoms got worse. Called my dr. Was told to take Benadryl around the clock for 48 hours.
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| 58 | 2021-05-25 | feeling abnormal |
2nd dose received. AFter a few minutes, patietn reporting "fuzzy lip" sensation. No swelling, angioe...
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2nd dose received. AFter a few minutes, patietn reporting "fuzzy lip" sensation. No swelling, angioedema, chest pain, shortness of breath, tongue swelling, airway obstruction or difficulty speaking or diaphoresis. No issues with 1st dose. Monitored for 30 minutes. Symptoms improved/resolved and patient was discharged from clinic.
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| 58 | 2021-05-26 | insomnia |
shingles; couldn't sleep; limping; arthritis is acting up/ throbbing, aching, tightening, and painfu...
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shingles; couldn't sleep; limping; arthritis is acting up/ throbbing, aching, tightening, and painful; pain is in one leg in the thigh; leg was swollen and painful and spread up to her hip; muscle spasms in her legs; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 28Apr2021 09:00 am (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included ongoing diabetes had for about 6-7 years, ongoing arthritis patient has had for years, started when she was little; family medical history included her dad had rheumatic fever and high blood pressure. Concomitant medication(s) included ongoing metformin taken for diabetes. Patient was borderline due being overweight, if she lost weight it would probably go away. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No additional Vaccines Administered on Same Date of the Pfizer Suspect other than the first dose. Prior Vaccinations (within 4 weeks) was none. Patient received first shot on 02Apr2021 8:40 am (Lot: EP7334) in left arm for covid-19 immunisation. It was noted that with the first shot, there was pain and it turned red at the injection site that last 6 days and then that went away. She took Tylenol and hot water in the shower to treat this event. Caller reported that the first dose just swelled her arm. Expiry and NDC are unknown for both shots. The patient experienced arthritis is acting up/ throbbing, aching, tightening, and painful; pain is in one leg in the thigh; leg was swollen and painful and spread up to her hip and muscle spasms in her legs on 29Apr2021, shingles, couldn't sleep and limping on an unspecified date. Caller stated that she had both doses of the vaccine. Agent called back to verify that the doses were the Pfizer covid 19 vaccine and the date of the second dose. Caller stated that her second dose of the Pfizer covid 19 vaccine was on 28Apr2021. Caller reported that after the second dose she was diagnosed with muscle spasms in her legs by one doctor and the ER doctor told her that her arthritis is acting up. Caller stated it felt like she got the second shot in her leg. Caller reported that the pain is in one leg in the thigh on the side that she got the shot on. Caller stated her doctor wants her to go to a neurologist thinking it could be shingles. Caller stated the doctor called a medication in for her for shingles. Caller stated she was using the heating pad and taking flexeril and neurontin. Caller stated she has not gotten any sleep. Caller stated she missed work yesterday and today. Caller stated she has pain in her legs and wanted to know how long that will last. Caller, reporting on the Pfizer COVID shot, and who explained that after getting the shot her leg started acting up the next morning. She explained that it has been throbbing, aching, tightening, and painful. She went to the emergency room and they told her they think is it is her arthritis; that the shot irritated and made it worse. She was given a shot, they thought maybe it startd with a T or like Tylenol, but it was something for pain. They wanted to give pain medication to take with her but she refused; told them she would just do Aleve and Tylenol. She still got no relief so she went to her medical doctor and they told her it was muscle spasms, the nurse said she could feel a knot. They treated it and that didn't help. Finally her doctor gave her Neurontin yesterday. She has been taking that since 12 noon yesterday through today and she will say it is getting better explaining that she hasn't able sleep but now can get cat naps. Caller reported she is a caretaker, like a medical assistant. She had been missing days from work because of this. The doctor was going to try and find her a specialist, a neurologist. When asked Primary / Prescribing Healthcare caller stated she saw in the emergency room and as a medical doctor because her normal primary care doctor retired. She didn't have contact details for either of these doctors. The shot was given by some people. It was clarified that this was after the second shot. The second shot was on 28Apr2021. She explained she was limping cause it hurts so bad, ever since she got the second shot. Neurontin was started yesterday and since starting it she is better, she was able to sleep some where she couldn't sleep before. Caller reports the product is in a pharmacy bottle with the NDC: 65862-0523-05. Name and NDC captured as provided by the caller. When asked about the products taken that didn't offer relief, everything prior to the Neurontin the caller only had the Flexeril bottle handy. She didn't have the name of the medication, the shot given in the emergency room and didn't want and pain medication from there because she didn't want to get hooked on pain pills. She also took Aleve and Tylenol. Gave her Flexeril, on 06May2021 it was filled. It is in a pharmacy bottle, no manufacturer, Lot or Expiry, NDC: 48547-0400. There are little number and hard to read but confirmed it is in pharmacy bottle. Treatment: she did have blood work but was told her cholesterol and everything was fine, everything was good. AE(s) required a visit to emergency room on 02May2021. And resulted in physician office, doctor on 10May2021. AE(s) following prior vaccinations was none. Caller received her second dose of the covid-19 vaccine and the next day woke up and her leg was swollen and painful and spread up to her hip. Caller went to the emergency room and was given medication which she states helps a little. Investigation included blood test with unknown result on unspecified date. The event outcome for all events was unknown.
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| 58 | 2021-05-28 | feeling abnormal |
Generally feeling horribly; Four days later terrible body aches; chills; vomiting and a headache tha...
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Generally feeling horribly; Four days later terrible body aches; chills; vomiting and a headache that lasted for 36 hours; Headache; Seven days later, still lethargic and fatigued; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL9266) via an unspecified route of administration, administered in left arm on 22Feb2021 at 10:30 AM as 1st dose single for covid-19 immunisation. The patient medical history included breast cancer on an unknown date in 2015. The patient had known allergy with penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included tamoxifen, ergocalciferol (VIT D), calcium,, acetylsalicylic acid (BABY ASPIRIN) and ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos (MULTI VIT) in two weeks of vaccination. On 22Feb2021 (the night of 1st shot vaccination), the patient experienced headache. On 26Feb2021, four days later, the patient experienced terrible body aches, chills, vomiting and a headache that lasted for 36 hours. The patient was generally feeling horribly and seven days later still lethargic and fatigued was continued. The patient did not receive treatment for the events. The patient had not covid tested post vaccination and patient had no covid prior vaccination. The outcome of the events was recovered on an unknown date in 2021. It was reported that patient was recovered with lasting effects. No follow-up attempts are possible. No further information is expected.
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| 58 | 2021-05-28 | feeling abnormal |
headache; body aches; Extreme pain/discomfort at the injection site; hazy feeling in brain; Extreme ...
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headache; body aches; Extreme pain/discomfort at the injection site; hazy feeling in brain; Extreme pain/discomfort at the injection site; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration, administered in left arm on 03Mar2021 at 15:00 (at the age of 58-year-old) at a single dose for COVID-19 immunisation at Pharmacy or Drug Store facility. Medical history included seizure disorder, seasonal allergies, depression, low back injury, DVT (Deep vein thrombosis) and obesity. Patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications (in two weeks) included Oxcarbazepine (TRILEPTAL), Sertraline, Acetylsalicylic acid (ASPIRIN LOW DOSE), Colecalciferol (VITAMIN D). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 15:15, the patient experienced headache, body aches, extreme pain/discomfort at the injection site and hazy feeling in brain. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 58 | 2021-05-31 | insomnia |
Severe chills; rapid heart rate; muscle aches; fever; insomnia; headache; This is a spontaneous repo...
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Severe chills; rapid heart rate; muscle aches; fever; insomnia; headache; This is a spontaneous report from a contactable pharmacist (patient) reporting herself. A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1283), dose 2 via intramuscular route of administration, administered in Arm Left on 03Feb2021 at 11:30 (at the age of 58-year-old) as SINGLE DOSE for covid-19 immunization. The patient received first dose of bnt162b2 (Lot number: unknown) on an unspecified date as SINGLE DOSE for covid-19 immunization. Medical history included hypothyroidism and seasonal allergy. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included estradiol (ESTRADIOL); progesterone (PROGESTERONE); citalopram (CITALOPRAM); thyroid (ARMOUR THYROID); levocetirizine dihydrochloride (XYZAL). Patient was not diagnosed with COVID 19 prior to vaccination. On 04Feb2021 at 01:00, the patient experienced severe chills, rapid heart rate, muscle aches, fever, insomnia and headache. The patient reported the seriousness s as non-serious. The Patient has not received any treatment for the adverse event. Since the vaccination, patient not been tested for COVID-19. The outcome for the events was not recovered. Follow-up attempts are completed. No further information is expected.
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| 58 | 2021-06-01 | feeling abnormal |
metallic taste in my mouth, chest pain, nausea, throat closed up. went to the ER via ambulance. migr...
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metallic taste in my mouth, chest pain, nausea, throat closed up. went to the ER via ambulance. migraines, brain fog , fatigue
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| 58 | 2021-06-03 | feeling abnormal |
Vertigo, dizziness, lightheaded. Start 10 days after 2nd shot and still continues today. It happe...
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Vertigo, dizziness, lightheaded. Start 10 days after 2nd shot and still continues today. It happens when I lay down, when I stit up in the morning and can happen anytime during the day. I feel like I am in a fog all day!!!
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| 58 | 2021-06-06 | loss of personal independence in daily activities |
Have been unable to lift or use my right arm since receiving my second shot, in severe pain have bee...
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Have been unable to lift or use my right arm since receiving my second shot, in severe pain have been to 3 different doctors received various medications ( steroids, pain meds anti inflammatory meds and cortisone shots. Also every joint, muscle and bone in my whole body is and has been in severe pain. The shot has seemed to agrivate my arthritis and I can not function or do normal everyday life. I was told my shot was given into my bursa muscle and is due to lack of experience but that doesn't help with all the pain I am in. I need help getting dressed and I have to shower every time I have a bowl movement because it hurts so bad that I can not put my arm back to wipe myself. It has really destroyed my life and the arm could have been avoided if only the person giving the shot was trained properly. I am still going to doctors, I was told to see a rheumatologist. Alot of doctors visits money and medications and still no relief.
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| 58 | 2021-06-07 | disorientation, anxiety, feeling abnormal |
I was sitting after I got the shot and I started to feel a little off. I felt light headed and wish ...
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I was sitting after I got the shot and I started to feel a little off. I felt light headed and wish I would have drank more water before I received the vaccine. I was kind of okay, sitting there waiting, but then I started feeling a weird sensation from the top of my head to the tip of my toes. My skin felt like it was tingling. While I was sitting there I was thinking that I was experiencing anxiety. I received a phone call from my sister that distracted me from my feelings and I felt okay. When I started to leave, I felt light headed and disoriented. I thought I may have been dehydrated. I went to the car and my lips felt like they were swollen, but were physically not. I started feeling like there were pins and needles in my skin. I started to itch in the back of my throat and started experiencing breathing complications. I sat in the parking garage for 40 minutes and debated if I wanted to go back. It was a long walk from my car to the vaccination area. I had my service dog with me and decided to go home. The itchiness went away and I started feeling better for about 24 hours. The next day, I ended up in the ER. I was given Benadryl and in 10 minutes I was fine. Over the next couple of weeks, I started experiencing random heart palpitations. It felt like my heart would skip and jump from time to time. I have not seen anyone yet in regards to my heart. I have had multiple ocular migraines. I still get them now and then after receiving the vaccine. It affects my vision for up to 20 min to an hour after the headache. Bright lights and too much time on my phone and computer causes a problem for my vision.
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| 58 | 2021-06-07 | feeling abnormal |
This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0171), via an unspecified route of administration on 28Apr2021 as 1st dose, single dose for COVID-19 immunization. Medical history included immune deficiency 2 months prior in 2021. The patient's concomitant medications include unspecified medications that the patient has been taking "forever". The patient did not start any new medications recently. She did not have any other vaccinations the same day as the Pfizer COVID-19 vaccine or in the four weeks prior. She says she hadn't had a vaccine in years. The patient reported that she got the vaccine then went grocery shopping and felt great, her arm didn't even hurt, and she didn't feel the shot going in. She says she went to bed and got up 4:00AM to get ready for work, and as soon as her alarm went off on 29Apr2021 she felt really weird. On 29Apr2021, she went to stand up and went to her knees since she couldn't walk and had to crawl to the bathroom. She was in the worst pain in her life/pretty bad pain. Her body was cramping. She was having cramps to her legs and just like every muscled from her foot to her hips and in her hips were cramping, severe cramping, the whole leg. She says she lost feeling and still has some numbness. Patient says her brain is a little foggy as well. The patient took pain medications and Neurontin which is helping her numb feet and tingling in extremities. She also had an icy feeling in her legs, though they are warm always although they feel icy, if she touches them they are warm, like normal body temperature. Patient clarified Neurontin as gabapentin 300 mg, says the doctor has started her out one at night before bed, and she just was given it, so she has only taken two days of it. She says they wanted to see how it affected her, and wanted her to call so they could decide how much to give her, so they started her at the lowest place. She says it didn't effect her worse than she already was, but she thinks they were holding off to see what the neurologist came up with too. The patient also had a little incontinence of bowel and bladder on an unspecified date in 2021. She says she went to the emergency room the day she woke up with the adverse reaction, on the "29th". She says that they gave her Morphine IV. She says that they did no tests, or blood tests, then they sent her home with pain meds and said that this will probably get worse before it gets better, and to follow up with her doctor. She says she followed up with her doctor the next morning. She says that the pain meds made her sleepy, but did not take care of the pain. She says that she went to see her doctor, who sent her to a different hospital, and there she was admit from emergency. She was given an unspecified muscle relaxer which was the one she threw out, her pain wasn't muscle, it was nerve, so she threw it out. She was given Hydrocodone, substituted for Norco. They also gave her, maybe a Tramadol pill, in the hospital. She says she spent 7 days in the hospital, had two ER visits, and doctor visits. The patient underwent lab tests and procedures which included antinuclear antibody: positive 2 months prior in 2021. The patient had her "proteins" tested which were good and also did a spinal tap and were still good in her fluid both on an unspecified date in 2021. The other neurologist wanted to do an EMG (not yet done), because sometimes it can still be fine and not higher proteins. She says mostly they have been going by her symptoms. She has not been diagnosed yet with Guillain-Barre, since she still needs to see a neurologist for the conduction study. She added she will consult with her neurologist, continue to take her Neurontin, and have the physical therapy. The outcome of the events was unknown.
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| 58 | 2021-06-07 | loss of personal independence in daily activities |
Heavy bruising and moderate soreness at injection site 2 hours after vaccination. One bout of Diarrh...
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Heavy bruising and moderate soreness at injection site 2 hours after vaccination. One bout of Diarrhea 3 hours after vaccination. Chills started 11 hours after vaccination and continued for 8 hours. Treated with 2 Bayer aspirin every 4 hours. Full body aches (Included head, eyes, back, arms, legs, and general all over body muscle ache) started 11 hours after vaccination and continued for 19 hours. Treated with heat and massage pad, and 2 Advil every 4 hours, but discomfort was not relieved. Occasional: irregular heartbeats. Constant: limbs felt strangely heavy, quickly tired on ordinary short walks, felt out of breath, weak, no energy. Ongoing 2-14 days after vaccination. No treatment received.
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| 58 | 2021-06-07 | restlessness |
Fatigue; Inner restlessness; This is a spontaneous report from a contactable consumer (patient). A 5...
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Fatigue; Inner restlessness; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN8203; Expiration date was not reported) on the left arm on 10Mar2021 (11:00) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247; Expiration date was not reported) on 17Feb2021 (at the age of 58 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 10Mar2021 (15:15), the patient had fatigue and inner restlessness. The patient had not received treatment for the reported events. The outcome of the events was recovered on an unspecified date in 2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are needed. No further information is expected.
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| 58 | 2021-06-08 | confusional state |
Shingles after second dose; Dizziness; confusion; Near syncope; This is a spontaneous report from a ...
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Shingles after second dose; Dizziness; confusion; Near syncope; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 12Mar2021 (at the age of 58-years) as single dose for COVID-19 immunization. Medical history included hyperthyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); levothyroxine sodium (SYNTHROID). The patient was not pregnant at the time of vaccination. Patient previously took sulfur, epinephrine, morphine and experienced known allergies. The patient previously received first dose of BNT162B2 on 12Mar2021 at 14:15 (Lot number: EN6199) in Left leg for COVID-19 immunization and experienced rash on face after first dose; still have the rash and it comes and goes now. Prior to vaccination it was unknown, if the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 13Mar2021 at 11:30, the patient experienced shingles after second dose, dizziness for 2 weeks, confusion, near syncope. The patient had near syncope after 24 hours and 4 days later. Therapeutic measures were taken as a result of events. Patient received treatment with antiviral medication and bed rest. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not resolved. No follow-up attempts are needed. No further information is expected.
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| 58 | 2021-06-08 | impaired work ability, memory impairment |
Ten days after the first dose vaccine I started to have Stroke like symptoms. I was coming home and ...
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Ten days after the first dose vaccine I started to have Stroke like symptoms. I was coming home and my daughter was driving. My daughter asked me why I was stretching my mouth. I did not know this was happening and my daughter said she was taking me to the ER. We called the 24 hour nurse. Two days before I did notice that I got a headache in the evening and it was still there all the next day. I just thought I was coming down with a cold. The headache was still present on the day of the facial symptoms. It was mostly on the left side of my head. The left side of my face is effected by Bells Palsy. I still had mild headaches for two weeks. I still have problems with memory and speech after eight weeks. I feel like I have some good days which are better than others. I have problems with dry eye and balance. The ER doctors diagnosed Bells Palsy. I have been unable to work for eight weeks so far.
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| 58 | 2021-06-09 | insomnia |
immobility in left arm; Headache through the night; Intermittent pain in right ear; Difficulty sleep...
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immobility in left arm; Headache through the night; Intermittent pain in right ear; Difficulty sleeping; Lethargy; Nausea leading to a single vomit; Nausea leading to a single vomit; temperature of 101 degrees fahrenheit; Chills; Rash covering entire trunk of body the following evening; This is a spontaneous report from a contactable consumer. This 58-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 11:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation . Medical history included from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 05Apr2021, administered at 11:15 AM on left arm. There were no concomitant medications and no other vaccine in four weeks. It was reported that on 27Apr2021 at 12:00 AM, the patient experienced headache through the night, intermittent pain in right ear, difficulty sleeping, lethargy, nausea leading to a single vomit, temperature of 101 degrees Fahrenheit, chills immobility in left arm, rash covering entire trunk of body the following evening. The outcome of the events was recovered on unknown date. Therapeutic measures were taken as a result of events included Ibuprofen. Patient had no covid infection or tested positive for covid prior to vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 58 | 2021-06-10 | anxiety |
6/11/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination ...
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6/11/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: facial tingling, dysphasia. Assessment : Time of assessment 0904. Alert and oriented and anxious. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 0924. VS at 0904- BP- 149/77, 0910- BP- 179/88. P- 58, O2- 100%, 0920- BP- 156/90 Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 0910. Administered by rn. Disposition:Patient evaluated and transferred to the hospital for further evaluation and care. Time of transport: 0924. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 6/11/2021 8:30 AM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8736 NDC: 59267-1000-1 Electronically signed by RN at 6/11/2021 11:05 AM Immunization on 6/11/2021 Immunization on 6/11/2021 Detailed Report Note shared with patient
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| 58 | 2021-06-10 | panic attack, anxiety | Anxiety and panic attack |
| 59 | 2020-12-31 | anxiety |
DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE...
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DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE FEELS FINE 20MINS AFTER THE EVENT.
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| 59 | 2020-12-31 | loss of personal independence in daily activities |
High injection site left deltoid resulted in moderately severe left shoulder joint pain, weakness a...
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High injection site left deltoid resulted in moderately severe left shoulder joint pain, weakness and reduced range of motion causing reduced ADLs for 10+ days
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| 59 | 2021-01-01 | feeling abnormal |
Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore a...
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Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore arms, fatigue then started getting brain fog , HA, body aches until current. my MD and I thought it was due to vaccine. Then add loss of taste and appetite on 12/30/20 along with rest of symptoms. I knew then I needed to get swab. Symptoms is still current.
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| 59 | 2021-01-02 | fear |
At 2 am woke to severe chills and hyperventilating. Took 45 minutes for everything to stop. (very s...
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At 2 am woke to severe chills and hyperventilating. Took 45 minutes for everything to stop. (very scary) At 6:30 am began running a temp of 101.1. Starting taking tylenol. Fever never did go away. Still had fever at 8 pm when I went to bed. Woke up next morning and was fine.
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| 59 | 2021-01-05 | feeling abnormal |
Total body and joints pain. On a scale of 1 to 10, most of the time 6 to 8. And also very weak with...
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Total body and joints pain. On a scale of 1 to 10, most of the time 6 to 8. And also very weak with no stamina. Lasted until 12 /25/2020. Felt horrible like I also had a fever. Although I never did run a temp.
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| 59 | 2021-01-05 | nervousness |
made my arm really sore; fever; nervous; This is a spontaneous report from a contactable consumer (p...
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made my arm really sore; fever; nervous; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunization. The patient's medical history was concomitant medications were not reported. The patient stated, "where I got my shot made my arm really sore for about three days. On the third day, I ran a low-grade fever-100F. The fever lasted 12 hrs. Now I'm fine. I was a little nervous about traveling but read that there was a side effect." The outcome of the event was unknown. Information on lot/batch number was requested.
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| 59 | 2021-01-05 | poor quality sleep |
It is warm; Even up to the back of the shoulder to the neck is painful; Even up to the back of the s...
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It is warm; Even up to the back of the shoulder to the neck is painful; Even up to the back of the shoulder to the neck is painful; Her whole arm is sore up to her neck and down the arm/It is very painful/it throbs; Last night she was up all night, every 3 hours; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiration date Apr2021), via an unspecified route of administration at left arm on 30Dec2020 09:30 at single dose for COVID-19 immunization, at a hospital. The vaccine was not administered at military facility. The patient's medical history included ongoing asthma from 2005 (diagnosed 15 years ago) and allergies. For asthma She has ProAir rescue inhaler to use as needed. Breo inhaler she uses at night. She has been on it for 2 years. She has been on different inhalers. Family medical history relevant to events was reported as none. Concomitant medication included montelukast sodium (SINGULAIR) from 2005 (had been on it probably 15 years) and ongoing at 10 mg, daily for allergies; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler via resp Inhalation from 2018 (has been on it for 2 years), uses it at night, for asthma; and salbutamol sulfate (PROAIR HFA) rescue inhaler via resp Inhalation, to use as needed for asthma. The patient had no history of previous immunization with the Pfizer vaccine. For historical vaccine, the patient received Tetanus for immunization and had allergic to Tetanus, her arm swelled and she couldn't move it (which was kind of like this, but not as severe). She didn't know the brand name for the tetanus vaccine she had reaction to. She didn't have NDC, lot, or expiry. It was 40 years ago. She had the reaction when she was 18 years old. There was no vaccine administered on same date of the Pfizer suspect, and tno vaccinations within 4 weeks prior to the Pfizer suspect. It was reported that last night (30Dec2020) she was up all night, every 3 hours. She was taking Advil. Her whole arm was sore up to her neck and down the arm. She had a nurse look at it this morning (31Dec2020) and it was not red. It was warm and it throbs. No rash. It was very painful. Even up to the back of the shoulder to the neck was painful. Her arm being sore and painful was ongoing at the time of report. She had been taking Advil. The pain had stayed the same even with the Advil. The events started probably between 14:00 and 14:30, it started off sore then became more painful. At the time of reporting, she was not at home and didn't have the bottle to provide NDC, lot, and expiry for Advil. She was taking some at the office, but that was in a travel bottle and didn't have the lot, expiry, and NDC. No emergency room or physician office visit. Relevant tests was none. The outcome of the events was unknown.
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| 59 | 2021-01-07 | feeling abnormal |
Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she ...
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Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she started with kind of chills and shakes; she was not feeling too good; real high heart rate that were in the 110's that last for lasted for hours; Fever; This is a spontaneous report from a contactable nurse reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231 and expiration date unknown), via intramuscular on left deltoid on 03Jan2021 09:13 at single dose for COVID-19 prophylaxis. The patient medical history and concomitant medications reported as none. The reporter is a registered nurse that reported that she had the first Covid-19 vaccine yesterday morning on 03Jan2021 and she had side effects. She reported that she had a fever, headache, and a real high heart rate that was in the 110's that last for lasted for hours. She said that she started with kind of chills and shakes 11 hours and 40 minutes after receiving the vaccine. One minute she was fine and the next minute she was feeling chilled. By the time she got home from her mother's house, which is a hours drive, she was not feeling too good. Her fever broke today 04Jan2021 at around 04:00 and when she checked her temperature it was 98.7 degrees. She said that 100.2 degrees was the highest temperature she recorded. The patient said that it was a mild fever. Her headache started about 22:00 03Jan2021. The patient said that she still has the headache a little bit and she has been treating it with Tylenol and it has gotten better. She said that she wears a fit bit that tracks her heart rate and she can hear her heartbeat in her ears and she could hear it going fast. Caller said that her heart rate was down to 98 beats per minute at 06:30 this morning. She said that her current heart rate was Body temperature. Caller said that her high heart rate had her very concerned. She said that it is not normal. She is supposed to go back on 30Jan2021 to get her 2nd injection. Should she still plan on getting the second part of the vaccine? The reporter assessed event real high heart rate that were in the 110's that last for lasted for hours as serious with medically significant. Other events were assessed as non serious. The outcome of the events fever and real high heart rate that were in the 110's that last for lasted for hours was recovered on 04Jan2020, outcome of the event headache was recovering, outcome of the other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event high heart rate with BNT162b2 can not be completely excluded.
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| 59 | 2021-01-07 | impaired work ability |
Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left ar...
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Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left arm a little itchy. Took Benadryl , slept and then felt better. Did fine with first shot.
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| 59 | 2021-01-08 | nightmare |
First vaccine injection 12/19/2020. Symptom of fatigue. Second vaccine injection 01/07/2021: Abou...
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First vaccine injection 12/19/2020. Symptom of fatigue. Second vaccine injection 01/07/2021: About 3 hours after receiving the 2nd injection, I had terrible headache requiring dosages of OTC Tylenol, terrible abdominal pain/pressure similar to menstral cramping, extreme fatigue requiring prolonged sleep, nightmares (which I never have). All symptoms lasted for approximately 38 hrs.
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| 59 | 2021-01-09 | impaired work ability, sleep disorder |
Six hours after being administered by the vaccine I started to feel soreness around the site. Within...
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Six hours after being administered by the vaccine I started to feel soreness around the site. Within the hour it progressed to pain in my left upper arm radiating down to my lower arm. By this time, I had difficulty raising my arm and limited ROM. This continued for three days. The symptoms eased up a little bit but there was constant pain whenever I raised my affected arm. When I went to work on the night of the Jan third, I felt my arm hurting during the night. I took ADVIL for the pain and continued to do so. Jan 6 and 7 At night, I was awoken with excruciating pain on the same arm. This lasted for approximately a couple of mins. I sought a virtual consultation with my PCP who advised me to take ten days off from work. I am currently on medical leave. I haven't experienced the same excruciating pain as I had those two nights. However, my ROM is still limited because there is still moderate pain involved. I've stopped taking Advil since it has started to upset my stomach.
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| 59 | 2021-01-09 | insomnia, feeling abnormal |
I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 210...
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I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 2100 on 1/8, began to develop a lot of pain at the injection site. Within 2 hrs of that time, I developed other symptoms, which include total body (bone and joint) pain (especially in my knees), and what I would describe as a "bad sunburn type" rash across my cheek bones, bridge of my nose, and orbital area. Small raised bumps to this area, with swelling, and a feeling of pins and needles stabbing me all across my face. My airway was fine, and at no time did I feel shortness of breath. I was unable to sleep due to the bone and joint pain, and felt the need to walk continually (it was more painful to stay in one position). These symptoms persisted throughout the day (Saturday 1/9/21), noting at 5pm I described myself "miserable" to my friends and family. All symptoms described above, were at their most elevated intensity between the hours of 1700 - 0400. At 0400 Sunday (1/10/21) I felt a gradual release of the body aches, enough so that I could sleep until 0800. At this time, 1300 (Sunday 1/10) I note that I still feel "flu type" body aches, but constant pain has diminished in intensity by estimated 50%. The sunburn type redness and swelling across my face/orbital area has also less by 50% (there is still redness, mild swelling, warmth, and some raised bumps across this area; pins and needles feeling is gone).
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| 59 | 2021-01-10 | anxiety |
soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 o...
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soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 of 101.3; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; had joint pains/knees and hip joint pain; severe fatigue; muscle pain; This is spontaneous report from a contactable nurse (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in right arm on 30Dec2020 14:15 at first single dose (0.3 cc, but really uncertain of dose) for covid-19 immunization. Medical history included COVID virus from Nov2020 to 2020 (The patient was not hospitalized. It was a mild case and lasted about 10 days. she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue). The patient's concomitant medications were not reported. The patient did not receive any other vaccines at the same time or 4 weeks prior. No problems with vaccinations in past or events. Caller reported she had the first injection of the Pfizer BioNTech COVID-19 vaccine on the 30Dec2020 and having some side effect symptoms and her supervisor recommended for her to report these things, they are not life threatening, obviously, but things were still lingering. Side effect of severe fatigue started on the 31Dec2020 and lasted for 72 hours. It was so severe, now it is mild. The patient reported soreness around the injection site. Had a fever on the night of the 31Dec2020 of 101.3 and had that for 6 hours then it dissipated and was gone. Had never had a fever after injections before. Had severe arm pain that usually goes along with an injection. It started also that night of 31Dec2020. She had rolled over in the middle of the night and it hurt. That lasted for about 48 hours, but it has improved. Had some muscle aches since 31Dec2020 but that had improved and had joint pains since 31Dec2020. What was worrisome was the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes, since 31Dec2020. The patient was still having that and that is why she was so concerned because shouldn't that have gone away after a week. Had knee and hip joint pain, but that had improved. Again, mentioned she had never had that before with an injection. The patient received vaccine at her workplace. Some of her coworkers got it the same day and no one else has this. Mentioned she did have COVID virus back in Nov2020 and wonders if this correlates with her getting the vaccine. Was not hospitalized or notified she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue. This is the same way she felt back when she had the virus back in November. The patient was concerned about having these side effects would it be okay for her to get the next injection in 3 weeks. AEs did not require a visit to emergency room and physician office. No further details provided. Outcome of the events Fever was recovered, of event swollen and painful lymph nodes was not recovered, of events knees and hip joint pain, fatigue, muscle pain, severe arm pain was recovering, of event soreness around the injection site was unknown. The reporter considered the events severe fatigue, fever, swollen lymph nodes and pain under right arm, knees and hip joint pain as serious (medically significant). The reporter considered the events severe fatigue, fever, severe arm pain, muscle ache, swollen lymph nodes and pain under right arm, knees and hip joint pain as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-11 | anxiety | Palpitations and anxiety. Resolved by the time she sought treatment in the ED. No rash, swelling. |
| 59 | 2021-01-11 | nervousness |
12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21...
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12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21; woke up 'not feeling well'; weakness, faint, shaky. You contacted your brother and proceeded to the ER. 2am started to feel better 3:30 am dishcarged home. Wope up at 6:30 am. Chills, achy. Went to work; felt chilled all Monday into the evening until eventually subsided. **2 negative COVID in Nov **Flonase for allergies **2nd Pfizer vaccination on 1/9/2020. Milder symptoms for couple of days, into Tuesday. 1/12/2021; mild chills, mild body aches.
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| 59 | 2021-01-12 | anxiety |
@0950 about 10minutes post vaccination, patient complaint of anxiety and rapid heart rate. Patient h...
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@0950 about 10minutes post vaccination, patient complaint of anxiety and rapid heart rate. Patient has a history of allergies - anaphylaxis. Vitals taken: b/p 197/116, hr 70, temp 97.5, 02 sat 99% on r/a. States she has HTN and takes meds. She did take her medication this morning. With meds she is around 140s/80s. Stayed with us for about 30 minutes. Repeat vs 186/104 hr 68, 98% RA. Still reporting anxiety but states she feels her b/p is high because she is anxious. She never experienced SOB, difficulty breathing. Stated at first a little bit of a scratchy throat but that went away shortly after. She stayed until she felt less anxious.
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| 59 | 2021-01-13 | poor quality sleep |
1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking o...
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1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking of hands, chills and present at this time 1/14/21
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| 59 | 2021-01-13 | sleep disorder |
Awoke at 3 am on 1/14/2021 with eye pain and swelling , at 6:30 am eye swelling in right eye was mor...
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Awoke at 3 am on 1/14/2021 with eye pain and swelling , at 6:30 am eye swelling in right eye was more prominent, rinsed eyes with cold water multiple times. Swelling still exists 1/14/2021 at 1315, (time of typing this information). Seeing slight improvement.
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| 59 | 2021-01-14 | sleep disorder |
I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had ...
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I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had taken one 325mg Tylenol and one 200mg Ibuprofen approximately 60 minutes prior to receiving vaccine (which is what I did prior to the first vaccine). I was doing great initially following the vaccine. I took another 325mg Tylenol and 200mg Ibuprofen when I went to bed at 2000 1-12-21. At 0300 1-13-21 I woke up feeling nauseated and when attempting to turn over to my right side I moaned loudly because I could not hardly move my left arm. My husband was woken and turned on the bedroom light and we noted a 3 inch bruise and large knot on my left deltoid at the injection site. He told me that I felt warm. I took my temperature that was 101.2 degrees. I took 650mg Tylenol and that time. At 0500 1-13-21 I was having chills, muscle and joint aches. I could not fully close my hands into a grip. My "brain" hurt, not a headache but literally it hurt to move my head. I would occasionally get a sharp pain in the front and back of my head. My temperature went to its highest at approximately 1500 1-13-21 to 102.5 degrees. I continued to offset Tylenol with Ibuprofen throughout the day. At 2000 1-13-21 my temperature was 101.8 and began to trend downward. I went to bed and when I woke up on 1-14-21 I felt 100% better with just a little fatigue from the inability to sleep the day prior.
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| 59 | 2021-01-15 | sleep disorder |
Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later ...
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Shot was administered too high, into shoulder joint. Shot was painful itself and 1 to 2 hours later severe pain in L shoulder with marked restriction in movements. Persisting pain in L shoulder which wakes me up at night. Unable to do my daily workouts and yoga.
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| 59 | 2021-01-16 | restlessness |
Vaccine administered approx. 1320, she was waiting in the observation area and about 20-25 minutes s...
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Vaccine administered approx. 1320, she was waiting in the observation area and about 20-25 minutes she started to feel a "pins and needles" sensation on her arms and head. Right after that, pt describes diffuse puritis on scalp, across upper and lower back. Itching continues down extremities while being observed. Red rash, 4-5 hives on upper and mid-back. She is visibly scratching her neck, head and back and appears restless because of the intense itching. Assessed by Dr (IM) and Dr(ID); 50mg po Benadryl ordered and given to pt. She endorses mild relief from symptoms.
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| 59 | 2021-01-17 | feeling abnormal |
Dizziness, weakness is extremities. Cramping in legs. warm sensation in chest, back arm legs. Shaki...
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Dizziness, weakness is extremities. Cramping in legs. warm sensation in chest, back arm legs. Shakiness. Feeling of passing out. Foggy thoughts.
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| 59 | 2021-01-19 | feeling abnormal |
Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy ...
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Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy head" feeling. Hypertensive at time BP left arm 171/95 HR 79, RR 26, 99% RA. Apple juice, and cracker provided, and emesis bag provided. Patient was already waiting for thirty minutes time (she was 15 minutes into her wait time). She reported having a progression of nausea and dizziness Repeat vital signs at 1345 139/100 HR 76, RR 24 Pox 96% RA. First responder was called and patient was assisted into wheelchair and taken to the ER for further evaluation.
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| 59 | 2021-01-20 | feeling abnormal |
she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hur...
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she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hurt (injection site); This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration in the arm on 02Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received her first Pfizer covid vaccine dose on 02Jan2021. She gets tested regularly at work. On 04Jan2021, she tested positive for the Covid virus. She had a headache, not feeling great on Friday, after she was diagnosed with the Covid virus, but no symptoms before. No side effects from vaccine, other than her arm barely hurt (injection site) in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 59 | 2021-01-20 | feeling abnormal | 2 Hours post vaccine pt started feeling dizzy, lightheaded and "weird inside"/jittery |
| 59 | 2021-01-20 | excessive sleepiness |
Violent chills; Temp up to 102.6; Body and joint aches; Joint aches; Slept x 24 hours due to headach...
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Violent chills; Temp up to 102.6; Body and joint aches; Joint aches; Slept x 24 hours due to headache; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL 3246, unknown expiration), via an unspecified route of administration in left arm on 12Jan2021 at 12:30 PM at a single dose for COVID-19 in a public health clinic/facility. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK 5730, unknown expiration) via an unspecified route of administration in left arm on 22Dec2020 at 12:30 PM for COVID-19. Medical history reported as none. The patient's concomitant medications were not reported. The patient previously took thimerosal and experienced allergies. By midnight of 12Jan2021, the patient experienced violent chills, temp up to 102.6, body and joint aches, and she slept x 24 hours due to headache. She started to feel better on 13Jan2021 at 8:00 PM, and 100% better on 14Jan2021 at 07:15 AM. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient recovered from the events on 14Jan2021 at 07:15 AM. The events were assessed as non-serious.
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| 59 | 2021-01-21 | anxiety |
Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and ting...
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Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and tingling of left arm, cheek, and tongue lasting 1.5-2 minutes. Numbness starts in elbow and radiates up and down arm. These episodes happen at various times thorughout the day. Sometimes her arm feels heavy. Has had an episode involving lip numbness that affected her seaking. Sometimes gets hot flashes lasting a few seconds. She contacted PCP to re-establish care on 1/11/21 after about 2 weeks of consistent, infrequent episodes. Never experienced this before. On 1/14 pt had an in person visit where she was evaluated by PCP. At ambulatory visit, BP 174/96. Other vital signs normal. Upper extremity exam: wrist (left, Phalen's test positive, Tinel test positive, no deformity, no crepitus), wrist (right, normal range of motion, Phalen's test negative, Tinel test negative), hand grips 5/5 bicep 5/5 tricep 5/5. Differential diagnosis: TIA, carpal tunnel syndrome, transient neurological event, shingles, hypertensive urgency. Anxiety could be component as well. Pt started ASA 81 mg QD and amodipine 5 mg QD. Plan to get carotid Dopplers to rule out TIA/stroke. Consider MRI in the future. 1/16/21: Pt developed left arm/leg numbness and tingling 0530 and reported to ED with stroke-like symptoms. During this encounter, pt states that she experiences these 1-3 minute episodes of tingling/numbness every hour or so (initially only had 1-2 per day, became more frequent in days immediately preceding 1/16). Pt reports not being able to stand that morning due to weakness in lower extremeties, though the symptoms resolved after sitting down. The patient denies any weakness to the right side, along with any family hx of stroke or headache. She takes omeprazole, amlodipine, and a baby aspirin daily. She does not currently follow up with a neurologist. The patient had lab work done yesterday and also recently had a US of her carotid artery which was unremarkable. She denies any weakness, numbness, or tingling currently. There are no other concerns at this time. The onset was 3 weeks ago. The course/duration of symptoms is worsening and episodic: lasting 3 minutes and with a frequency of every hour. Location: Left face, left upper extremity, left lower extremity. The character of symptoms is weakness, tingling and numbness. SBP 182/86. Temp 97.6 F. CT head ngative, bloodwork unremarkable, chest X-ray negative. Pt admitted for MRI of brain and C-spine. 1/17/21: Hospital notes note that symptoms apear to worsen when pt is stressed or she talks about it. MRI of brain w/ and w/o contrast completed and unremarkable. Pt declined C-spine MRI with and without contrast. Pt discharged. 1/19/21: Pt presented to outpt ambulatory appointment to follow up with worsening episodes of tingling in left arm/leg, numbness and tingling in mouth - is now effecting balance. Considering testing for other diseases such as syphilis, Lyme disease, multiple sclerosis, Guillaine-Barre. Priority status on referral to neurologist.
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| 59 | 2021-01-21 | impaired work ability |
Starting around 11:30am the day after my vaccine I started to get chilled. As the afternoon progres...
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Starting around 11:30am the day after my vaccine I started to get chilled. As the afternoon progressed the chills became stronger and I felt nauseous and had body aches. I left work 1/2 hour early. I woke up the next day with the same symptoms but the nausea and body aches were worse and now my kidneys were tender. I went to work but continued to feel worse. I left work early that day and went straight to bed. I woke up the next day feeling so much better.
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| 59 | 2021-01-23 | excessive sleepiness |
1/21 at 10:45PM-joint/muscle pain & bad chills. 1/22 all day--headache, nausea, slept alot. 1/24--ve...
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1/21 at 10:45PM-joint/muscle pain & bad chills. 1/22 all day--headache, nausea, slept alot. 1/24--very sleepy; bad balance--small steps and holding wall/furniture; lips swollen; slow cognition
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| 59 | 2021-01-26 | feeling abnormal |
Woke up at around 3:10 am this am with extreme chills and body aches. Had a temperature of 101.4 an...
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Woke up at around 3:10 am this am with extreme chills and body aches. Had a temperature of 101.4 and felt awful. Took some ibuprofen (didnt have any tylenol) turned the heat up to 76 and at this time (7:54) am I feel a little better but I stil have a temperature of 101.2. I'm just sending this for your information
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| 59 | 2021-01-27 | anxiety |
Edema of neck, face, shortness of breath, and anxiety ER visits 01/03/2021, 01/09/2021, 01/12/2021, ...
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Edema of neck, face, shortness of breath, and anxiety ER visits 01/03/2021, 01/09/2021, 01/12/2021, & 01/17/2021. Treatment with prednisone, hydroxyzine, alprazolam, diazepam, benedryl, buspar, fluoxetine Labs: cbc, cmp, tsh, ekg, cardiac enzyme labs PCP visits 01/05/2021, 01/11/2021, 01/20/2021, 01/28/2021 Psychiatrist: 01/25/2021, 01/28/2021, 02/02/2021; treating anxiety with fluoxetine Imaging: ultrasound neck Referral: Allergy Specialist
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| 59 | 2021-01-27 | sleep disorder, loss of personal independence in daily activities |
I received my vaccine Tuesday @ 1300, I felt good Wednesday morning taking Motrin alternating with T...
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I received my vaccine Tuesday @ 1300, I felt good Wednesday morning taking Motrin alternating with Tylenol around the clock. At 1400 I felt achy with mild chills, at 1700 symptom were a lot worse. Shaking chills, temp 100, back, neck, and leg pain. I went to bed slept off and on. Woke up this morning, Thursday feeling a little better thought I could work but after getting to work symptoms got worse again.
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| 59 | 2021-01-28 | poor quality sleep |
Pain in the arm pit of the arm vaccinated, painful to sleep with tired feeling next morning. Took ...
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Pain in the arm pit of the arm vaccinated, painful to sleep with tired feeling next morning. Took Aleve which minimized the pain.
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| 59 | 2021-01-29 | feeling abnormal |
Pfizer COVID- 19 Vaccine EUA Pt received 0.3ml Pfizer-BioNTech(Lot EL3249 exp 5/2021) at 15:25 today...
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Pfizer COVID- 19 Vaccine EUA Pt received 0.3ml Pfizer-BioNTech(Lot EL3249 exp 5/2021) at 15:25 today in left deltoid. Pt expressed "scratchy throat" and strange feeling radiating from shoulder to upper rhomboid muscles after 5 minutes. Gave patient drink of ice water with Diphenhydramine 25mg po (Lot 502605 exp 10/31/2021). After 10 minutes reassessed and still experiencing little improvement. Gave second dose Diphenhydramine 25mg po, and observed for next 30 minutes. Patient expressed feeling better and not so scratchy in her throat. Escorted to vehicle after stating that she felt well enough to drive home. Recommended she f/u with her physician and may need to pre-medicate with diphenhydramine 25mg prior to booster.
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| 59 | 2021-01-31 | feeling abnormal |
extreme arm pain---goes down to fingers. Also a general feeling of being "off" and dizzy spell/vert...
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extreme arm pain---goes down to fingers. Also a general feeling of being "off" and dizzy spell/vertigo post vaccination day 5.
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| 59 | 2021-02-01 | feeling abnormal, emotional distress, impaired work ability |
I received the Pfizer 2nd covid injection on Wednesday 1/27/2021 Thursday I was very foggy, and ti...
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I received the Pfizer 2nd covid injection on Wednesday 1/27/2021 Thursday I was very foggy, and tired. In the evening I was very emotional similar to feeling I would have before getting my period. I have been in menopause for over 8 years. Friday I was still very emotional and very tired. I called out from work.
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| 59 | 2021-02-01 | feeling abnormal |
Couple days later began to feel fatigued again, ear pain, brain fog, 101.4 temp so was sent from wor...
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Couple days later began to feel fatigued again, ear pain, brain fog, 101.4 temp so was sent from work to and tested neg for COVID and Flu. I was advised I had fluid on my ears and was advised I may have and Upper Respriatory infection and was given antibiotics and advised if the symptoms didnt get any better to return but I am still taking the antibiotics to date and still experiencing the no taste and smell, brain fog, fatigued and tired but feeling a whole lot better today.
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| 59 | 2021-02-01 | feeling abnormal |
(1) On-going facial sensation on left side, not quite tingling but some kind of nerve and.or muscle ...
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(1) On-going facial sensation on left side, not quite tingling but some kind of nerve and.or muscle sensation. (2) ED visit to Mass. Eye and Ear Infirmary for sudden onset PVD - posterior visceous detachment.
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| 59 | 2021-02-01 | impaired work ability |
I had covid and didnt know it when I got vaccinated. I went to work and a couple days later I start...
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I had covid and didnt know it when I got vaccinated. I went to work and a couple days later I started feeling crappy. I had no taste and smell, very fatigued and slept all the time so I went and got tested for COVID. While there my O2 level was 89 so I was given a steroid injection and was sent home with an antibiotic and was off for the 14 day quarantining and went back to work
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| 59 | 2021-02-01 | sleep disorder |
Started with 3 strong jabs. 1 in shoulder, 1 in stomach and 1 in groin. Very stabbing painful jabs...
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Started with 3 strong jabs. 1 in shoulder, 1 in stomach and 1 in groin. Very stabbing painful jabs but only lasted 1 second. Chills a few hours later that lasted about 4 hours. Next morning felt stomach sick. Couldn't eat or drink anything but water. Barely make it to the bathroom because joints hurt and just felt sick. Tried toast and coffee, tasted terrible. I am a very strong coffee drinker. Haven't been able to drink it since vaccination because nothing tastes or smells the same. Went to primary yesterday because haven't been able to sleep. Told him weird taste and smell, can't eat anything and I feel like my muscle is very weak. Trouble getting in car yesterday for work.
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| 59 | 2021-02-02 | impaired work ability, feeling abnormal |
My PCP advised I take benedryl and tylenol after the vaccine because of the AE I experienced to the ...
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My PCP advised I take benedryl and tylenol after the vaccine because of the AE I experienced to the 1st vaccine so I am unsure if because I was extra tired is d/t all of the vaccine or if the benedryl played a part in it. But about 2hr after I begin getting a headache but had already taken tylenol so I didnt take anything. I got a little dizzy and super sleepy but nothing else on the first day. The next morning I was so tired, drained feeling and very fatigued. I got up for a while but had to lay back down because I was feeling foggy, tired and very fatigued causing me to miss work. About 4pm I felt a little better. The next day I had a mild headache and still felt a little tired but was able to go to work and nothing else since.
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| 59 | 2021-02-03 | feeling abnormal |
I just feel achy and tired like I am coming down with the flu. Sniffles and sore throat, no fever. H...
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I just feel achy and tired like I am coming down with the flu. Sniffles and sore throat, no fever. Have felt progressively worse since my 2nd shot. The day after I was fine and then felt bad the 2nd and 3rd day, today.
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| 59 | 2021-02-04 | feeling abnormal |
Symptoms started a few hours after vaccination. Initial symptoms were injection site pain and tired...
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Symptoms started a few hours after vaccination. Initial symptoms were injection site pain and tiredness. I later developed a mild headache, moderate muscle and joint pain, to which I applied a heating pad. I then developed a low fever and chills. Temp was 99.7 11:30pm on Feb 4, and 99.9 at 10:20 on Feb 5. I then began to feel nauseous and generally terrible, so I went to the bathroom, where I fell and may have passed out.
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| 59 | 2021-02-04 | feeling abnormal |
Five minutes after vaccine pt reported feeling very dizzy and "buzzed." VSS. Pt reported improvement...
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Five minutes after vaccine pt reported feeling very dizzy and "buzzed." VSS. Pt reported improvement in symptoms within 10 minutes and was able to walk out to go home.
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| 59 | 2021-02-04 | insomnia | Insomnia, Temp 101.7 |
| 59 | 2021-02-05 | impaired work ability |
PATIENT WAS OUT OF WORK DUE TO RACTION TO THE SECOND COVID VACCINE. SYMPTOMS WERE BODY ACHES, NAUSEA...
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PATIENT WAS OUT OF WORK DUE TO RACTION TO THE SECOND COVID VACCINE. SYMPTOMS WERE BODY ACHES, NAUSEA AND EYES BURNING.
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| 59 | 2021-02-07 | disturbance in attention, agitation, feeling abnormal |
Mild agitation; soreness at injection site; Head/Brain Fog for 24 hours after injection; feeling "ou...
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Mild agitation; soreness at injection site; Head/Brain Fog for 24 hours after injection; feeling "out of it" and inability to concentrate fully; This is a spontaneous report from a contactable Consumer. A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 11:00 at left arm at single dose for covid-19 immunization. The patient's medical history had allergic to other vaccine ingredients, particularly influenza vaccine ingredient. The patient's concomitant medication included Dietary Supplements. The patient received the first dose of BNT162B2 on 28Dec2020 14:00 at left arm for covid-19 immunization. The patient was not pregnant. The patient experienced mild agitation, soreness at injection site, head/brain fog for 24 hours after injection and feeling "out of it" and inability to concentrate fully on 19Jan2021 16:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events mild agitation, soreness at injection site and 'feeling "out of it" and inability to concentrate fully' was recovered on an unknown date in Jan2021, the outcome of the event head/brain fog was recovered on 20Jan2021 16:00. Information on the lot/batch number has been requested.
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| 59 | 2021-02-08 | anxiety |
Severe fatigue, headache in back of head, sore arm, extremely cold and loss of appetite first 2 day...
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Severe fatigue, headache in back of head, sore arm, extremely cold and loss of appetite first 2 days. Ongoing symptoms: waves of being hot/sweating, blurred visions, intermittent loss of taste and false sense of feeling of drowning or suffocating and/or breathing in heavy smoke, which last for a few seconds to a few minutes. diminished appetite, more easily fatigued, loss of energy. On February 8th, these symptoms began: feeling anxious, fatigued,sleepy, head feels spacey, slight headache, somewhat dizzy, intermittent buzzing sound in head, body aches, severe ache and muscle tenderness in left shoulder blade area down left arm, and muscle spasms in left shoulder and arm. Loss of taste again.
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| 59 | 2021-02-08 | impaired work ability |
Less than 72 hours after receiving the Pfizer vaccine for COVID-19 I had severe joint pains in my ri...
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Less than 72 hours after receiving the Pfizer vaccine for COVID-19 I had severe joint pains in my right hand up into my right elbow and swelling of all my right fingers except my right thumb. It took several days for the symptoms to clear and required that I take one PTO day since I couldn't type or hold a mouse.
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| 59 | 2021-02-09 | excessive sleepiness |
Fever/fever that has been as high as 102 degrees Fahrenheit; Terrible headache; Achy; Stuffy nose; S...
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Fever/fever that has been as high as 102 degrees Fahrenheit; Terrible headache; Achy; Stuffy nose; Sleep-she slept almost the whole weekend; This is a spontaneous report from a contactable consumer, the patient. A 59-years-old female patient (consumer) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249, Expiration Date May2021), via an unspecified route of administration 0.3mL injection to right arm on 22Jan2021 at 15:45 as a single dose, for COVID-19 vaccination. The vaccination was administered at a Hospital. Medical History includes Severe allergic reaction to bee sting (At 14 years of age, stepped on a beehive received 50+ bee stings. Had to use an Epi-pen in response to this possible severe allergic reaction to bees) There were no concomitant medications. No other vaccines were given within 4 weeks. On 23Jan2021 at 08:00 , the patient experienced Terrible side effects, fever that has been as high as 102 degrees fahrenheit; terrible headache; achy; stuffy nose; and sleep-she slept almost the whole weekend. The patient underwent lab tests which included body temperature: 'as high as 102 degrees Fahrenheit' on 23Jan2021. Fever has come down but she still has one. Consumer had no physician office visits, no emergency room visits and no hospitalizations were involved. Caller inquired how long do the side effects generally last, should she get the second dose of the vaccine and should she have a COVID test before she goes back to work? The patient's second dose was scheduled for 12Feb2021 but no dose change made at this time. The clinical outcome of the event fever was recovering, while headache, achy, stuffy nose, slept most of the weekend was unknown .
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| 59 | 2021-02-09 | nervousness |
High pulse rate. Heart rate normally 62-65. 70 at rest today. While making lunch pulse rate 116-130....
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High pulse rate. Heart rate normally 62-65. 70 at rest today. While making lunch pulse rate 116-130. Slept only 4 hours, feel shaky, and can feel pulse in neck and throat.
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| 59 | 2021-02-10 | feeling abnormal, irritability, sleep disorder, disorientation |
7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks throug...
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7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks through left arm down to fingertips... 8:30- shooting shocks through left arm and starting to throb down through hand ... shooting up through next and base of head 9:00am- random shocks throughout my whole body. shoulder pain. 10:30- shocks stopped somewhat, shoulder and arm still achy, extreme fatigue/weakness, fogginess, blurry vision 11:30- extreme fatigue/weakness, fogginess, kind of blurry vision, severe shaking rt hand, had to sit down. Needed to hang on to things to walk. 12:00pm- continued severe fatigue and brain fogginess & still minor blurry vision, and a few shooting shocks in arm, shoulder , neck, 1:00pm? still great fatigue/weak, body aches-more like shocks than aches Neck is especially sore? back of neck up through head 1:10pm- severe fatigue, eyes hurt, foggy vision and cannot focus? off and on? chest pain for a period of time 1:40pm- twinges through body, still extreme fatigue? fogginess, back of neck is super sore.. Shoulder is slightly sore? 2:00pm- shoulder sore, severe fatigue but other symptoms seem to be getting less?. 2:45pm- shocks in left arm? 4:00pm- went home from work? hard to drive and focus.. severe fogginess, disorientation, 4:20- laid on the couch? slept in between nausea, buzzing in my head, severe arm pain going down into my hand, random shocks throughout my body, could not focus, brain was fuzzy, random severe itching, neck pain, eye pain, extremely irritable, extremely thirsty, bad taste in my mouth, extremely cold, no fever, super sensitive to sound & touch, no appetite, trouble peeing, felt extremely dehydrated. Needed to hang on to things to walk. Fri, Feb 5 6:00am- next day? better, but still buzzing, ringing in my head, extremely exhausted & weak, arm pain radiating to hand, hard to focus, coughing, chest heaviness like an elephant sitting on it, sore, scratchy throat, drainage out of head but not stuffed up?, eyes hurt. Severe nausea & bloating, rt hand shaking badly, no appetite 9:30am- everything is a bit better, coughing & chest discomfort gone, still bad taste in my mouth, slight nausea, bloated, eyes hurt, extremely tired, entire arm sore, buzzing in my head?random twinges or jolts in my limbs? 11:00am- still super tired, still not peeing?... weird for me who pees every 2 hrs or so? Still really bloated? still buzzing in my head, 1:30pm- feeling better, no buzzing, no zinging, super tired and drinking a lot but not much peeing? 4:00pm- home and bed.. hard to sleep because of jolts though my body.. Sat, Feb 6 Normal body aches.. finally able to pee decently, arm and hand on shot side sore (this is my good hand side), shooting pain, and hand aching. Fatigue, This has continued into Monday.. arm and hand pain are off and on. Everything is getting better?
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| 59 | 2021-02-10 | sleep disorder |
first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus...
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first injection 01/21/2020- resulted in painful left deltoid region- similar to that after a tetanus shot. swelling, pain to touch and pain with movement or when positioned onto that side. decreased over 36-48 hours second injection 02/09/2020 306 pm received injection left deltoid. Awakened at 1237 am 02/10/2020 with chills, inability to get warm, headache, lightheadedness, sensation of heart pounding, nausea and moderate site tenderness. up most of the night. Nausea resolved about 10 hours after the symptoms resolved, remained without appetite. Fatigue, overall just tired, just not feeling well. temp max about 20 hours after onset of symptoms 101.5 temp broke when awakened from sleep in sweat at 327am 02/11/2020. on /2/11/2020 7am mild- moderate intermittent headache persists. Easy fatigue-as an example- fed cat took dog out and was tired and went back to bed.. Appetite better. felt better than I had on 02/10/2020, but not normal. Noted upon awakening is left axillary lymphadenopathy moderate and mild on the right- unable to press arms down to side as increased pain. also supraclavicular tenderness.
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| 59 | 2021-02-10 | thinking abnormal |
not had a sense of smell or taste; not had a sense of smell or taste; Headache are off and on; littl...
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not had a sense of smell or taste; not had a sense of smell or taste; Headache are off and on; little tired; she cannot think; hoping it is her sinuses; When she gets up and moves around and when up and moving with the mask on, she is lightheaded; nose is stopped up; with her mask on she can hardly breathe; busts out in a sweat; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the left arm on 18Jan2021 07:40 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took cortisone in her both knees and left shoulder from 15Jan2021 for inflammation and could not walk and was making her feel bad. On Friday (22Jan2021), she started having headaches and was a little tired. Everyday, she would take her temperature and she never had a fever. The last couple of days on 24Jan2021, she has not had a sense of smell or taste. She works and sees patients. She cannot think. Headaches are off and on and ongoing. She was hoping it is her sinuses. When she gets up and moves around and when up and moving with the mask on, she is lightheaded and gets tired. When she lays down, she is ok. Her nose is stopped up and she has not gotten up to eat anything today. The patient told it is strange, she hasn't run a fever but if she gets up and moves around with her mask on, she can hardly breathe, she busts out in a sweat, and it gives her a headache and she don't have a taste bud. Therapeutic measures were taken as a result of headache and included treatment with naproxen sodium (ALEVE). Outcome of the intermittent headache, tiredness, loss of smell was not recovered while of the remaining events was unknown.
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| 59 | 2021-02-11 | crying | left eyelid swollen, itchy and a little weepy |
| 59 | 2021-02-15 | impaired work ability |
approximately 2 hours day after receiving the 2nd vaccination ( vaccination was given approximatel...
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approximately 2 hours day after receiving the 2nd vaccination ( vaccination was given approximately 3:15 pm and welt on my right forehead about 530 pm) i took Benadryl and fell asleep. When I woke about 3 hours later the welt was gone. The next day redness started at the injection site. It was slight. That Sunday evening 07Feb2020, the left arm was swollen a bit painful and very red. I took ibuprofen and Benadryl. The next day, Monday, the site was inflamed, i had to take off from work that day. I iced the arm with minimal improvement. That Wednesday, it appeared as if the redness was expanding. I noticed a new area. I showed my arm to an immunologist who recommended I try Zyrtec and Motrin. I took Zyrtec for three nights . I noticed decreased redness and swelling after the first dose of Zyrtec. After the third dose my arm was better. No swelling or redness.
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| 59 | 2021-02-15 | loss of personal independence in daily activities |
Individual developed palpitations and then high blood pressure on the day she received the COVID-19 ...
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Individual developed palpitations and then high blood pressure on the day she received the COVID-19 vaccine (1/4/21). She started having joint pain on the fourth day (1/7/21) and it lasted until 1/11/21. On 1/10/21, she couldn't stand to do dishes. She went to Urgent Care on 1/12/21.
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| 59 | 2021-02-15 | nervousness |
Vaccine given at 1304. Patient reported feeling light headed and sweaty. Patient reported feeling ne...
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Vaccine given at 1304. Patient reported feeling light headed and sweaty. Patient reported feeling nervous. 1310: Patient tried to stand and felt really dizzy. Patient transported via wheelchair to lay down and then syncopal episode lasting 30 seconds. Patient transported to cot. 1318: Blood pressure, in right arm, 110/52, heart rate 88 and oxygen saturation level 98% on room air. 1328: Blood pressure, sitting, 92/48. Patient reports that she took all medications this morning and has been exercising more. 1333: Blood pressure, lying, 110/72, heart rate 85, and oxygen saturation level of 99% on room air. 1339: Patient attempted to sit up. "Feeling a little better." "I'm definitely cooling off. I'm not sweating anymore." 1341: Blood pressure, sitting, 100/68, in right arm. 1349: Blood pressure 118/760, sitting, in right arm
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| 59 | 2021-02-15 | sleep disorder |
Inflammation, headache. Felt like all my organs were swollen. Especially uncomfortable during slee...
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Inflammation, headache. Felt like all my organs were swollen. Especially uncomfortable during sleep from 2-4:30am. Seemed reduced upon waking. Managed to work a few hours at computer, then back to bed with body aches. Pretty much gone within 30 hours of receiving shot.
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| 59 | 2021-02-16 | feeling abnormal |
Weakness, fatigue, injection site sore, clouded thought process. Slept for 10 hours. Woke up to n...
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Weakness, fatigue, injection site sore, clouded thought process. Slept for 10 hours. Woke up to no other symptoms except sore arm.
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| 59 | 2021-02-17 | confusional state, amnesia |
episode of amnesia, occurring on 16 Feb 2021 for about 30 to 45 minutes, (no recall of memory to thi...
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episode of amnesia, occurring on 16 Feb 2021 for about 30 to 45 minutes, (no recall of memory to this time); mild confusion/sluggish thinking lasting about 24 - 36 hours afterwards.. No physical droopiness or paralysis; negative work-up for stroke done in ER, TIA could not be ruled out.
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| 59 | 2021-02-17 | nervousness |
2/14/2021 felt faint and shaky, lasted approximately 30 minutes, very weak and tired after this, MD ...
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2/14/2021 felt faint and shaky, lasted approximately 30 minutes, very weak and tired after this, MD appt on 2/16/2021 (previously scheduled, not for this) had an abnormal EKG, right bundle branch block. No previous heart problems, no family history of heart problems.
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| 59 | 2021-02-17 | nervousness |
Patient was in the observation area and approximately 10 minutes after injection she developed a ras...
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Patient was in the observation area and approximately 10 minutes after injection she developed a rash up her right arm. She felt fine otherwise. She reports she never gets an vaccines and was getting nervous. Paramedics responded patient sat for a long time and the rash disappeared, her vitals were received and she refused further treatment.
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| 59 | 2021-02-20 | anxiety |
Migraine onset with increase in nausea, followed by my throat feeling tight and painful, mouth irrit...
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Migraine onset with increase in nausea, followed by my throat feeling tight and painful, mouth irritation , tingling. Parts of body started to itch intensely, then upper right side of face and forehead started to itch and tingle. Whilst on the phone to a nurse, I took 50mg of Benadryl. The symptoms seemed to stop getting worse for a short time (after about 15 minutes) but then started to get worse again, especially throat, right at the base. And face itching and tingling spread to neck. At the nurses instruction, I went to the closest ER, where they eventually examined me and some time after that gave me Prednisone and Pepsid. The symptoms further subsided after about 30 minutes but I was not check on for another 90 minutes. I was experiencing a lot of anxiety once I arrived at the ER and found the visit caused further anxiety. I was not experiencing anxiety prior to getting to the ER except for a little concern over the symptoms. Over the next two days I experienced fatigue, which got much worse two days after the vaccination. I already suffer from fatigue and this was more extreme.
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| 59 | 2021-02-22 | excessive sleepiness |
With my second shot after eight hours of no symptoms, I had a fever of 101.8 and slept in a very dee...
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With my second shot after eight hours of no symptoms, I had a fever of 101.8 and slept in a very deep sleep for 48 hours. I woke to drink water and use restroom only. On Monday morning I woke up soaked in sweat that smelled like vinegar and the fever was gone. My first shot I had a little soreness in my arm only.
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| 59 | 2021-02-23 | feeling drunk | Tingling in face, lightheaded, tired, feels "drunk", weak |
| 59 | 2021-02-24 | anxiety |
Tingling in L arm that radiated to fingertips. Patient felt like it was anxiety related, refused to ...
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Tingling in L arm that radiated to fingertips. Patient felt like it was anxiety related, refused to be seen by EMS
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| 59 | 2021-02-26 | anxiety, restlessness, sensation of foreign body | SOB, anxiety, restlessness Patient couldn't calm down. Felt like she had a lump in her throat. |
| 59 | 2021-02-28 | insomnia |
Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from...
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Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from a non-contactable healthcare professional (patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 22Jan2021 (12:45) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium, magnesium, vitamin d nos (CAL MAG), calcium carbonate;colecalciferol;phytomenadione (VIT D+K) and fish oil (OMEGA 3). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) on 30Dec2020 (when the patient was 59 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021, the patient had sore arm; insomnia; and chills in the evening ("eve"). On 23Jan2021, the patient had body ache, headache and tiredness. The patient did not receive any treatment for the events. The outcome of the events, 'sore arm', 'insomnia', 'chills', 'body ache', 'headache' and 'tiredness', was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 59 | 2021-03-03 | nervousness | shaky, nervous, palpitations. Evaluated by EMS-Cleared |
| 59 | 2021-03-06 | insomnia |
On March 5,2021, I started to experience a hot red rash on both my cheeks and ran a low grade fever ...
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On March 5,2021, I started to experience a hot red rash on both my cheeks and ran a low grade fever that evening. I took 2 Tylenol and fever went away for that day. 2 days after my vaccine, most of the redness and heat on my cheeks was mostly gone and I felt better. 3 days after my vaccine, which is today, I didn?t sleep at all the prior night because my rash returned and my checks were extremely hot. I?ve taken my temperature throughout today and my body temperature is normal but cheeks are still extremely warm and red
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| 59 | 2021-03-08 | disorientation, impaired work ability |
Approximately 28 hours after receiving the vaccine, I became very dizzy, to the point that my head w...
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Approximately 28 hours after receiving the vaccine, I became very dizzy, to the point that my head was spinning so fast I would pass out. When I would wake up, I was so nauseated that I tried to throw up but hadn't eaten anything, so I had dry heaves. I would wake up and repeat this process over and over. After about 6 hours the dizziness got better but I could not walk by myself as I was so wobbly and weak. My husband tried to get me to the car to take me to the ER but I couldn't stand up. I felt a little better the next day (Sunday) but was unable to keep anything down. I slept a lot as I felt exhausted. I was unable to work on Monday or Tuesday as I was still very disoriented. I would periodically had dizzy spells where I thought I was going to pass out, so when I went back to work on Wednesday, my husband drove me to work and picked me up. At work, when walking I still was very unsteady on my feet and kind of had to hold onto the wall to keep my balance. This stayed with me thru the next week. I felt better the following week and have not had any other issues.
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| 59 | 2021-03-08 | nightmare | Vomiting, Diarrhea, night sweats, chills, low grade fever, fatigue, nightmares |
| 59 | 2021-03-10 | feeling abnormal |
Within five minutes of getting the vaccine I felt the front of my neck/throat had something like pre...
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Within five minutes of getting the vaccine I felt the front of my neck/throat had something like pressure/pressing/swelling. I kept swallowing and it didn't feel like my throat, more like between the outside of my throat/esophagus and skin...in the position where a man's Adam's apple would be, or possibly where my thyroid is. I got flushed, but I could breath ok. I felt odd, but I think I may have been panicking, I don't know. I drove home and saw that my face, neck, chest, even my thighs, were slightly flushed. I took my temperature throughout the evening. I am normally a low temperature of 97.6. It went up to 99.9. The second day my temperature was in the low 98s. However, by second day the roof of my mouth where it meets the throat felt odd, like if you burned it by eating something hot. Third day, today, I woke up and my temperature was only 95.2. I kept taking it, and then used my daughter's thermometer as well. It stayed low for several hours. I also had several bouts of diarreah this morning. Temperature came up into the 98s again. None of this is life threatening, but I still feel the weirdness in the front of my neck. I've never heard of that side effect so it upset me and scared me. I can handle the fever also, but the low temperature also scared me.
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| 59 | 2021-03-10 | insomnia |
I woke up early the next day 3/10/21 nauseous and with diarrhea. I was tired and had a mild headach...
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I woke up early the next day 3/10/21 nauseous and with diarrhea. I was tired and had a mild headache. My arm hurt moderately where the injection site was, but also on the inside of my upper arm. I felt lethargic and nauseous the rest of the day. I did not sleep well. Then 3/11/21 I woke with a mild headache and some nausea, but also severe pain on the inside of my upper arm. It was very sensitive all up to my shoulder on the underarm area and somewhat on the side of my ribcage, but then also radiating down to my wrist. This pain persisted until I am writing this form, approx. 2pm 3/11/21. It has not subsided at this point.
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| 59 | 2021-03-10 | insomnia |
Headache/High Blood Pressure. 186/101. May not be connected but mine is never high. I also couldn...
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Headache/High Blood Pressure. 186/101. May not be connected but mine is never high. I also couldn't sleep after injection, so maybe the excitement of getting the shot. Blood pressure progressively went down to normal with no treatment, in 1-2 days.
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| 59 | 2021-03-10 | sleep disorder |
I started that day with a thick throat and sore throat. No SOB. The next day it evolved into body ...
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I started that day with a thick throat and sore throat. No SOB. The next day it evolved into body aches, joint aches, headache, fatigue, and nausea. The next night I started vomiting. I felt like I had the flu. These symptoms persisted 3-4 days. The sore throat lasted maybe a week or more. No fever at any time. Had the usual arm soreness start the evening of the vaccine, much more than any other vaccine I've received. The arm soreness awakened me at night if I rolled over. FYI: I received the 2nd vaccine 2/4/2021 and only had a sore throat and sore arm.
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| 59 | 2021-03-11 | anxiety |
SOB, wheezing, swelling throat, rash, tachycardia, and coughing following Pfizer COVID-19 mRNA vacci...
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SOB, wheezing, swelling throat, rash, tachycardia, and coughing following Pfizer COVID-19 mRNA vaccine (first dose) IM. Took to ED for evaluation. epinephrine 0.3 mg IM given in addition to methylprednisolone 125 mg IV and diphenhydramine 50 mg IV and famotidine 20 mg IV with a slight improvement in anxiety, throat tightness breath, however patient with persistent wheezing and cough. Albuterol 5 mg trialed without significant improvement in symptoms. Given persistent respiratory symptoms, repeat epinephrine 0.3 mg IM given with continued improvement in symptoms. Monitored patient for 4 hours and symptoms completely resolved. Discharged patient in care of granddaughter with outpatient epinephrine IM prescription.
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| 59 | 2021-03-11 | confusional state |
3/6/21 ER 59 y.o. female who presents with SHORTNESSS OF BREATH FROM NURSING HOME. EMS STATES THA...
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3/6/21 ER 59 y.o. female who presents with SHORTNESSS OF BREATH FROM NURSING HOME. EMS STATES THAT PT HAD COPIOUS ORAL SECRETIONS AND WAS IN REESPIRATORY DISTRESS UPON THEIR ARRIVAL.EMS PRE-ARRIVAL TREATMENT: IV ATTEMPTS UNSUCCESSFUL, PLACED ON BIPAP AND SATS CAME UP TO 98% Presented by EMS from facility with altered mental status confusion Desat 85 on 02 3L NC foaming at the mouth is What nursing home staff reported; EMS unable to get IV access but did apply CPAP at 10 with sat of 99%; patient will wake up with painful stimuli. Nursing Home reports patient wears BIPAP S.T. rate 20/8/10 at night and 2 hours during the Day COVID vaccination Pfizer patient received 1/7/2021 and 1/28/2021 Took insulins this morning and guaifenesin, blood sugar accu check 221 Transferred to higher level of care
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| 59 | 2021-03-11 | sleep disorder |
I had a cardiac ablation done in Dec 2016 and had not experienced any symptoms until my first shot, ...
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I had a cardiac ablation done in Dec 2016 and had not experienced any symptoms until my first shot, which only caused one incident at the time of the first dosage, which went away within 30 minutes. Since the second dosage, I experience rapid heart rate immediately at the time of the vaccination, which occurs periodically, mainly in the late evening hours and during the night, causing me to be awaken. Pulse goes from normal mid-60 resting heart rate to low 100's. Dissipates after approximately 30-45 minutes. Working with Cardiologist to get a Halter Monitor to get details as the events happen. No treatment plan until they receive better data.
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| 59 | 2021-03-11 | thinking abnormal, feeling abnormal | 5hrs of extreme foggy head. Very limited in thought process while working |
| 59 | 2021-03-14 | anxiety |
Day of vaccine my arm was sore and I had a slight headache and my heart rate felt fast but I think ...
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Day of vaccine my arm was sore and I had a slight headache and my heart rate felt fast but I think my heart rate was due to anxiety about the vaccine . That was until Friday morning. I woke up on the 5th at around 1 am shaking . Then got the cold sweats and chills and then burning up and body aching. Then I started throwing up. I started taking some IBProfen which helped with the fever and shakes. Stayed in bed all day and drank water. My heart rate was up to 122 bpm while I was laying on the couch. I was tracking it with my Apple Watch. I stayed on the couch for the next 2 days and Sunday I started feeling better. Each day I was feeling better but now almost two weeks out I still get slight headaches off and on, I have no energy and get the chills and my chest has a heavy feeling. But I don?t feel short of breath. I took a rapid covid test today 3/15/21 and the results were negative for covid and the flu. I am going to see a doctor on wed. as I am not sure I should get the second dose.
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| 59 | 2021-03-14 | crying |
left eyelid swollen; Itchy; A little weepy; This is a spontaneous report from a contactable healthca...
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left eyelid swollen; Itchy; A little weepy; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581 and expiry date unknown), via an unspecified route of administration in the left arm on 10Feb2021 15:00 at a single dose for COVID-19 immunisation. There were no medical history. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Concomitant medications included vitamin D NOS and vitamin C [ascorbic acid]. Patient experienced left eyelid swollen, itchy, and a little weepy on 10Feb2021 18:30. Patient was recovering from the events. No treatment was received for the adverse events. This case was reported as non-serious.
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| 59 | 2021-03-15 | depression, restlessness, anxiety | Feeling of "unsettled " "anxious " feeling of doom " "depressed". Sore arm |
| 59 | 2021-03-15 | insomnia |
Sore arm at injection point Gradual fever culminating at 102.6 at 10pm on 3/13 Loss of appetite and ...
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Sore arm at injection point Gradual fever culminating at 102.6 at 10pm on 3/13 Loss of appetite and extreme fatigue Took 1 motto and went to sleep at 5pm - woke at 10pm - fitful sleep until noon 3/14 Fever continued through 3/14 - 100.2 at noon through 99 at 5pm - light fatigue throughout the day 3/15 - completely back to normal energy and temperature (yay!)
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| 59 | 2021-03-15 | loss of personal independence in daily activities |
Three days after the 2nd vaccine injection I started experiencing muscle weakness in both legs and a...
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Three days after the 2nd vaccine injection I started experiencing muscle weakness in both legs and arms. To navigate stairs in my home I use a banister on both sides, not much difficulty. Since Monday, 3/15/2021, I have much more difficulty using my walker, navigating stairs, getting in and out of cars.
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| 59 | 2021-03-17 | sleep disorder |
No symptoms immediately after first shot except after 13 days later woke up with pain in arm (same a...
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No symptoms immediately after first shot except after 13 days later woke up with pain in arm (same arm as injection). Pain is still present after 3 days. Taking ibuprofen, ben-gay, and heating pad with essentially no effect. If I keep arm elevated the pain is slightly less. Not able to sleep due to discomfort on Day 2 and was able to sleep on Day 3 although woke up at 2am and put on ben-gay and heating pad. Constant pain limiting mobility in arm.
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| 59 | 2021-03-18 | anxiety | lightheaded, anxiety at 0850, BP 178/92, HR 79, RR 20, POX 96%. Symptoms resolved quickly. |
| 59 | 2021-03-18 | disturbance in attention, sleep disorder |
Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and l...
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Within a few hours of shot, I experienced EXTREME tinnitus (very loud), numbness in head, face and lips and hardening of lymph gland in left chest. This lasted for hours. Injection site pain only lasted about 24 hours. Since then, I still have numbness on the right side top of head and intermittent EXTREME tinnitus that interferes with my ability to concentrate, communicate and sleep. It comes and goes but the volume is beyond anything I have ever experienced. Then it goes away. The right side of my head has stayed numb. Will this go away? Should I get the 2nd dose or not?
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| 59 | 2021-03-18 | feeling abnormal, insomnia |
(Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up ar...
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(Note: Difficult to read handwriting on lot number, could also be DOV 6208 or DOV 6Z08) I woke up around 12 hours after having the vaccine and felt a strange sensation in my head, almost like a helmet of fog over my head, sort of a numb feeling, and I noticed that also my eyes and lips felt numb. I ate a grapefruit as I usually do (not sectioned by myself). I felt extremely lethargic, had joint pain and a weakness. I usually have tea and toast in the morning and as I was at the table buttering my toast, I had an overwhelming nausea come on. I then woke up on the floor. My companion told me I went unconscious and slipped off the chair. Perhaps the whole episode was a maximum of 20 seconds. My first words were "Where am I?" and my companion told me. I rest on the floor, directed my companion to read on the internet about stroke and we ascertained I was okay, so I was thinking completely clearly. In any case, I had the fog in my head the entire day, and also today, but I feel a little better and was able to eat after 4 hours of rest. I wasn't able to fall asleep but I rested the entire day and slept a couple of hours during the night, which is not like me. I usually don't have any problem sleeping.
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| 59 | 2021-03-18 | panic reaction |
About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my...
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About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my head feeling pressure like it was inflating and my brain feeling like it was short circuiting and doing alot of misfiring or something (hard to explain but it was like a lot of brain activity) which immediately led to my heart pounding and racing (I don't know if the pounding heart and racing was due to feeling panic because of my brain reaction or the vaccine). The metallic taste and brain issue subsided within a minute (perhaps less) but my heart continued to race for about 3-5 mins and then subsided with a tightness in my chest for nearly 3 hours.
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| 59 | 2021-03-19 | insomnia |
Extreme weakness. Walking was at a shuffle (24 hours) Sleeplessness. Hyper but couldn?t sleep for 3...
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Extreme weakness. Walking was at a shuffle (24 hours) Sleeplessness. Hyper but couldn?t sleep for 3 days. All resolved with no lasting effect. Please note - this was 2d dose. First was 6 weeks prior.
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| 59 | 2021-03-19 | sleep disorder |
about 23 hours after the short I fell tired, weak, I got chills and a fever. That night while sleepi...
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about 23 hours after the short I fell tired, weak, I got chills and a fever. That night while sleeping I woke up to a pain under my arm (armpit) on the same arm as the injection. Later the next morning I had a red splotch on my arm (same as injection but not the same spot). The splotch is warm to the touch, and has a bump or hardening under the skin, it is also a little painful.
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| 59 | 2021-03-20 | anxiety |
PATIENT EXPERIENCED AN ANXIETY ATTACK AFTER VACCINE WAS ADMINISTERED. PARAMEDICS WERE ON SITE TO ASS...
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PATIENT EXPERIENCED AN ANXIETY ATTACK AFTER VACCINE WAS ADMINISTERED. PARAMEDICS WERE ON SITE TO ASSIST THE PATIENT. PATIENT RECOVERED WELL
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| 59 | 2021-03-21 | feeling abnormal |
On March 5th (day 11 after vaccine) I awoke with red rash/hives on palms of both hands and elbows an...
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On March 5th (day 11 after vaccine) I awoke with red rash/hives on palms of both hands and elbows and underside of forearms and upper left thigh. The rash got worse each day spreading all over my body causing me to seek medical treatment first with primary doctor who gave me prednisone pack and injection and then my local emergency room (twice) due to swelling of throat and tongue. I was given prednisone IV treatment and sent home with a high dose of medication for inflammation and hydroxyzine for itch and famotidine for stomach upset. My doctor got me in to see immunologist for tests and treatment. That doctor took blood and diagnosed me as having a moderate to severe delayed allergic reaction post covid vaccination. My liver had elevated levels of bili-rubin my white blood count was over 16,000 and my skin was cover in red, itchy hives and rash from head to bottoms of my feet for over ten days. I was very sick and miserable.
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| 59 | 2021-03-21 | sensation of foreign body |
On Thursday, March 18th I experience mild itchiness on my scalp. On Friday, March 19th I began to fe...
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On Thursday, March 18th I experience mild itchiness on my scalp. On Friday, March 19th I began to feel a lump in my throat and developed large itchy hives all over my body. My lips began to swell up.
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| 59 | 2021-03-22 | anxiety |
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/23/2021 1:26 PM E...
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Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/23/2021 1:26 PM Expand AllCollapse All COVID VACCINE CLINIC 3/19/2021 Patient: DOB: Date: 3/19/2021 MRN: Subjective Patient is a 59 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience heart racing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH: insignificant. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches Heart racing onset 5 minutes after injection. Briefly lasted. Resolved by the time she arrived to the medical bay. NO other symptoms reported. : She ate lunch today. Previous Reactions: none Objective Vitals Vitals: 03/19/21 1412 03/19/21 1422 BP: 137/80 129/65 BP Location: Right arm Pulse: 92 SpO2: 96% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and close monitoring until end of her observation time. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Possible anxiety flare up. Resolution of symptoms by the time of arrival to bay. Pt feels well. She is appreciative of her care today. APRN Electronically Signed 3/19/2021 2:31 PM
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| 59 | 2021-03-22 | feeling abnormal, confusional state |
Pain in right side that night. Confusion and pain in entire body the next day. Foggy then following ...
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Pain in right side that night. Confusion and pain in entire body the next day. Foggy then following two days and another episode of pain on fourth night. Today is day five and feel great.
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| 59 | 2021-03-22 | feeling abnormal |
Patient received first dose of Pfizer COVID vaccine. 10 minutes after vaccination patient reported ...
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Patient received first dose of Pfizer COVID vaccine. 10 minutes after vaccination patient reported mouth felt 'weird' and throat felt 'swollen' although no difficulty swallowing was reported. Assessed by provider Benadryl PO administered. After 20 minutes patient reported symptoms had resolved. Discharged to home with husband.
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| 59 | 2021-03-23 | feeling abnormal, feeling drunk |
I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing...
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I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing tingling sensation on the right side of my face and tongue and top of my head. I also felt very jittery or crawling sensation like I had to much coffee. I called the guards to my car twice and was told it was my nerves. I was released even though I wasn't feeling right and felt like was drunk driving on the way home, the worst of it passed within a hour but the fuzzy feeling lingered with numb spots on my face lasted for a few days. Now I'm afraid to get my second shot due April 3rd.
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| 59 | 2021-03-24 | anxiety |
Patient was seen in my clinic with reports of "flare" of psoriasis after having her second COVID vac...
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Patient was seen in my clinic with reports of "flare" of psoriasis after having her second COVID vaccine. She has a history of well controlled psoriasis BSA 2-3%, today she a rash that is not consistent with psoriasis. Rash presented within 12 hours of vaccine administration. Additionally, she reports within the first 12 hours of second vaccine administration she developed extreme anxiety, shortness of breath, anxiety, and heart palpitations that lasted intermittently for 2 days. She did not seek medical attention. On exam she is alert/oriented, no visible distress. Pending skin biopsy results.
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| 59 | 2021-03-24 | anxiety |
Arm pain for two days, body temperature of 99.7 f Third day: tiredness , chills , 98.5 f, stomach p...
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Arm pain for two days, body temperature of 99.7 f Third day: tiredness , chills , 98.5 f, stomach pain Fourth day: tiredness , chills, stomach cramps. Fifth day. Tiredness, stomach pain, chills Sixth day:headache, ear pain, sneezing, sore throat, tachycardia. Seventh day: Headache, ear pain, sneezing, sore throat , tachycardia. Eighth day: Headache, ear pain, sore throat, sneezing, tachycardia. Anxiety. Ninth day: Headache, ear pain , sore throat . Anxiety and bad mood. I take ibuprofen 600mg every day , my vitamins , lots of fluids.
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| 59 | 2021-03-24 | excessive sleepiness, amnesia |
?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, ...
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?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, possible seizure, tinnitis, pressure in frontal cortex, brain fog, inability to urinate for 1 day, headache, exhaustion-constant sleeping, rapid heart rate, problems speaking-slow and deliberate, dehydration, motor skills slower, sinus's and whole brain feels dry, time going by really fast, ears hurt, teeth hurt, right and left neck hurt, left arm hurt, right shoulder hurt, hot flashes day and night. MEMORY ISSUES SUBSIDED TODAY, still brain fog, still RAPID HEARTBEAT and shaky. If all of this brain fog/rapid heartbeat doesn't subside by Monday March 29, 2021, an EEG will be ordered to look at the brain. I'm on my 2nd weeks bedrest with no exercise and Tylenol every 6 hours, the tylenol every 6 hours seems to help with some of the brain fog and the rapid heart beat, if I forget to take it I am soon reminded as my heart races and the brain fog reappears.
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| 59 | 2021-03-24 | impaired work ability |
3/4/21: Severe pain throughout whole body. The more I moved the worse it got. Left work early. 3/25/...
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3/4/21: Severe pain throughout whole body. The more I moved the worse it got. Left work early. 3/25/21: Woke up with pain started getting ready for work the more I moved the worse it got. Called off work. Severe fatigue. Third day was not as bad but suffered with pain for 1.5 weeks.
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| 59 | 2021-03-25 | nervousness |
15 min after vac pt c/o dizziness, stated I feel like heart is racing, shaky, sweating . EMS whe...
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15 min after vac pt c/o dizziness, stated I feel like heart is racing, shaky, sweating . EMS wheeled to recovery booth. Assess: no LOC, no N/V, Rt deltoid site benign. VS 148/88, HR 91 reg strong, resp 18 reg non-labored, SpO2 99%. . BS taken by ems 106, cold pack placed to back and front of neck pt stated she did not eat or drink today. Checked left port site for CLL benign. Monitored for 40 min, gave water for hydration. dizziness & diaphorsis subsided. 10:10 VS 132/86, HR 85, Resp 12, SpO2 98%. No further complaints. After 40 minutes pt stated I feel ok to leave and walked out. Ok'd to exit. S Reagan RN
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| 59 | 2021-03-26 | confusional state |
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Dif...
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Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: Eye ball rotating
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| 59 | 2021-03-27 | feeling abnormal |
uncontrollable body shakes for 4 hours from midnight to 4 am; muscle aches, fuzzy head, low grade fe...
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uncontrollable body shakes for 4 hours from midnight to 4 am; muscle aches, fuzzy head, low grade fever, extreme fatigue
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| 59 | 2021-03-28 | feeling abnormal | Fever, chills, arm soreness, nausea, headache, eyes hurt, back pain, dizziness, feel bad |
| 59 | 2021-03-28 | insomnia | Local swelling and soreness at injection site Difficulty sleeping following injection for one night |
| 59 | 2021-03-29 | feeling abnormal |
Previously well woman with no history of knee arthritis or dermatitis. 13 days after vaccine adminis...
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Previously well woman with no history of knee arthritis or dermatitis. 13 days after vaccine administration, began to experience myalgias, arthralgias (especially knees, shoulders), fatigue, conjunctival injection, papular rash to L arm>trunk and other extremities. Day 17 after vaccine, seen in ED for above symptoms with neg COVID, HIV, Hepatitis testing. Day 21 after vaccine, seen again in office with persistent arthralgias, noted to have ESR and CRP elevated, returning to normal by 34 days after vaccine. Seen by me on day 47 after vaccination with persistent fatigue, mental fog, and arthralgias in knees.
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| 59 | 2021-03-30 | nightmare |
Joint pain; Nightmares; This is a spontaneous report from a contactable consumer (patient herself). ...
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Joint pain; Nightmares; This is a spontaneous report from a contactable consumer (patient herself). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration at the age of 59-years on 04Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history included asthma and emphysema. Concomitant medications included montelukast sodium (SINGULAIR) at 10 mg for asthma, formoterol fumarate, glycopyrronium bromide (BEVESPI AEROSPHERE) at 9 mcg and beclometasone dipropionate (QVAR) at 80 mcg. Consumer stated, "I would like report some Covid side effects but I am having troubles reading my lot number, so I have to get my lot number first so then I can go ahead and report side effects." Consumer stated about lot number, "On my vaccination record I can E and I can't tell she write 1 or L and then its 9265." When probed for the side effects, consumer stated, "Beside the joint pain on an unspecified date, which I can read on my printouts it's typical, I am also having nightmares on an unspecified date." Consumer stated, "I was taking the naproxen (ALEVE) afterwards as treatment." Due date of second vaccine is 28Feb2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 59 | 2021-03-31 | insomnia, restlessness | unable to sleep / restless sleep. did not seek treatment (yet) |
| 59 | 2021-04-01 | feeling abnormal |
3 days later, when I woke up, my body felt like it was ran over by a dump truck. I had excruciating ...
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3 days later, when I woke up, my body felt like it was ran over by a dump truck. I had excruciating back pain for 3 days. My tongue is red, and it burns when I eat. My teeth are very sensitive, very difficult to brush them. It is now 1 week later, and I feel lethargic. I took aspirin and it helped alleviate the pain in my back.
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| 59 | 2021-04-02 | feeling abnormal, sleep disorder |
I had extreme burning in my throat and lungs. Later the next day my nerves felt like electricity wa...
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I had extreme burning in my throat and lungs. Later the next day my nerves felt like electricity was running thru my whole body. I was unable to sleep for 6 days. .My body temperature when down 95.3. It felt like my blood was racing thru my veins, both arms and legs where tingling and numb feeling. Then I have had veins rupture on my legs, hands and feet with bruising. These problems are still with me 3 weeks after 1st vaccine. This is awful and painful!!!!!! Hopefully I will go back to normal soon.
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| 59 | 2021-04-02 | feeling abnormal | shortness of breath, chest tightness, faint/fogginess - SOB and CP subsided after rest /lying supine |
| 59 | 2021-04-02 | loss of personal independence in daily activities |
Flare of arthritis on right side of body. Extreme pain in R hip, and R ankle making it difficult to...
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Flare of arthritis on right side of body. Extreme pain in R hip, and R ankle making it difficult to walk. Also both hands are stiffer than usual and both shoulders are more sore. For the last year, until a week ago, the symptoms of autoimmune arthritis were very managed. I could run and jump on a trampoline with my granddaughter, very minimal pain, slept well at night without pain but now it has flared up. The vaccine is the only thing different in the past two weeks. I have not been ill or had a fever in over a year. I have not changed any medication or had any new stressors in my life. I am in a lot of pain and cannot perform my normal activities fo daily living. I am trying to get in to see my doctor but they are booked up.
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| 59 | 2021-04-02 | restlessness, irritability |
By 11 pm extremely restless. Feeling confined. Cold outside turned furnace off and open windows. Fel...
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By 11 pm extremely restless. Feeling confined. Cold outside turned furnace off and open windows. Felt fatigued. Easy irritated. Excessive sleep
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| 59 | 2021-04-03 | feeling abnormal, disturbance in attention |
eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; li...
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eyes were itchy; hard to breath; lips felt like they were getting puffy and they were bright red; lips felt like they were getting puffy and they were bright red; tongue tingled but didn't swell; heartrate was 112 / heartrate was high; dizzy / lightheaded; vertigo; brain fog; trouble focusing; right arm was itchy and hot where she got the injection; right arm was itchy and hot where she got the injection; had a hard time forming sentences; really tired and sleepy; really tired and sleepy; chills; headache/I felt like my head was kind of throbbing; where the patient's thyroid is was swollen; couldn't really walk; had no balance; ringing in my ears; lost my voice.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included allergic to a lot of medications/ antihistamines. Concomitant medications were not reported. The patient previously took diphenhydramine (BENADRYL) and was allergic. On 15Mar2021, within 2-3 minutes of vaccination, the patient's heartrate was 112, she started getting dizzy, lightheaded, and had vertigo. Her oxygen level was okay. On 15Mar2021, the patient also had some brain fog and trouble focusing, the right arm was itchy and hot where she got the injection, her eyes were itchy. The patient was then taken back to lie down. It was hard to breathe and she had to take large deep breaths. Her lips felt like they were getting puffy and they were bright red, she had a hard time forming sentences, was really tired and sleepy, had chills and a headache (felt like her head was kind of throbbing). Also, on 15Mar2021, where the patient's thyroid is was swollen, the patient couldn't really walk and had no balance, had ringing in her ears, her tongue tingled but didn't swell, the walls started moving and she lost her voice. The patient was kept for 2 hours and was almost sent to the ER. The patient brought an epinephrine (EPIPEN) but there was concern administering it because her heartrate was high. The patient questioned whether she should receive the second dose as she almost went into anaphylactic shock after the first dose. The clinical outcome of "right arm was itchy and hot where she got the injection" was resolved on 16Mar2021, of eyes were itchy, hard to breath, lips felt like they were getting puffy and they were bright red, tongue tingled but didn't swell, heartrate was 112 / heartrate was high, dizzy / lightheaded, vertigo, brain fog, trouble focusing, had a hard time forming sentences, really tired and sleepy, chills, headache/I felt like my head was kind of throbbing, where the patient's thyroid is was swollen, couldn't really walk, had no balance, ringing in my ears, lost my voice was unknown. Information on the lot/batch number has been requested.
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| 59 | 2021-04-03 | feeling abnormal |
Migraine Nausea Vomiting Diarrhea Headache Dizzy Heart palpitations In a fog Extreme fatigue Muscle ...
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Migraine Nausea Vomiting Diarrhea Headache Dizzy Heart palpitations In a fog Extreme fatigue Muscle & joint pain Loss of appetite Dry mouth Started 4/3/2021 @ 11:00 am Still continuing
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| 59 | 2021-04-04 | feeling abnormal |
25 minutes Post injection: Left eye issues. Itchy, swollen behind the eye and feeling like something...
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25 minutes Post injection: Left eye issues. Itchy, swollen behind the eye and feeling like something was in it or irritating it. It kept driving me to check if something was in it. I put in renu eye drops and did not think any more of it. 40 minutes post injection: both feet red and swollen left foot about half of the top, the whole right foot looked like a giant hive or welted area across the whole top of foot. The injection site began being quite sore, and it also looked welted and felt hot to the touch. I kept checking my left rib cage and my left thumb as I was sure there was going to be hives, because I could not stop rubbing or scratching them as they itched so badly. I continued itching and feeling weird tingly sensations and either rubbed or scratched these areas to no avail. Even my head itched terribly by the second day. 45 minutes post injection: Tightness and scratchiness in throat appeared and my throat was sore, my voice began going out and my voice got hoarse. There was about a two inch area of my throat in which I felt I needed to keep trying to clear something that was stuck. (This made no sense to me as I was able to drink water without any issues.) I had a slight cough every time I stopped drinking, so I continually drank water while I was not trying to sleep. My chest was tight, but because I have asthma I took albuterol and thought nothing of it. (This really did not help, but I did not get worse either.) About an hour after the shot, I constantly felt on the verge of shaking, much like when you have a fever, but I did not think to check my temperature until the following morning when I was extremely tired, felt like I had a sinus headache and possibly did have a fever. My temperature was 99.4 degrees farenheight. At this point, I felt very flu-ish and achy. My armpit area hurt a lot and I chewed two aspirin. I experienced wheeziness, chest tightness, and hoarseness the second and third day as well. I had the morning congestion and stuffiness as well as the need to keep clearing my voice still as of this morning but to much less degree as the initial onset. The skin itchiness is still ongoing, but to a much lesser degree than previously had.
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| 59 | 2021-04-05 | confusional state |
Began to feel ill on the day of the vaccine. Very tired and lethargic. The following morning the p...
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Began to feel ill on the day of the vaccine. Very tired and lethargic. The following morning the patient was very confused and had lost all short term memory. I brought her to the hospital where she was diagnosed with Transient Global Amnesia. She was admitted and by the next morning her memory had returned to normal. She is still very tired from the ordeal.
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| 59 | 2021-04-05 | insomnia | High Grade Fever, Body Aches, Sleeplessness, Cold Sweats, Hot Sweats lack of any appetitie |
| 59 | 2021-04-06 | anxiety |
Presented self with c/o feeling anxious and complained of injection site discomfort. B/P 133/72, HR...
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Presented self with c/o feeling anxious and complained of injection site discomfort. B/P 133/72, HR 68, 98.2, O2Sat 98%
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| 59 | 2021-04-06 | feeling abnormal |
head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then fe...
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head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb, numbness to both hands; started feeling sweaty; shortness of breath; light headed; nausea; blood pressure drop to 40; The initial was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 05Jan2021 (Batch/Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included atrial fibrillation, thyroid problem, hearing problem from an unknown date and unknown if ongoing, Stroke like paralysis from 2014 to an unknown date, gallbladder removal in 2018. Concomitant medications included sotalol, taken for atrial fibrillation from Dec2019 and ongoing; levothyroxine taken for thyroid disorder from 2017 and ongoing; cyanocobalamin (B-12) taken for an unspecified indication from 2014 and ongoing; aspirin [acetylsalicylic acid], taken for an unspecified indication from 2014 and ongoing. The patient experienced 3-5 minutes after the first dose on 05Jan2021, started feeling sweaty, shortness of breath, light headed, nausea, numbness to both hands. Next day 06Jan2021, wake up with numbness to left hands, head aches, chills, weird feeling in head (back left side of head). This went on for about 2 weeks lasted 1 month got better as days went day. It was also reported that she experienced that her left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb for period of 2 weeks. Her blood pressure drop to 40 on 05Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop to 40 on 05Jan2021, sars-cov-2 antibody test: 0 (came out 0 antibodies on my blood work had never been expose to anyone with Covid 19) on 24Nov2019, sars-cov-2 test: negative on 08Jan2021. The patient also reported that on 05Jan2021, she received the dose and had a reaction to it, but that same day her mother was taken to the hospital because she wasn't breathing well and she came out positive to Covid, she passed away 14 days after the patient took a test on Covid 08Jan2021 tested negative. She don't know if it was soon to be tested but other family member tested positive. The patient did not receive treatment for the events and was hospitalized due to the events. The patient did not recover from nausea, headache, chills while the outcome of the other events was unknown.
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| 59 | 2021-04-06 | feeling abnormal |
O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the low...
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O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the lower lungs that was rubbing on her diaphragm; Pneumonia; Cough/bad cough/dry cough; Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage; gastroenteritis; short of breath; she wasn't breathing deep; feels like she doesn't have any energy; feeling bad; nauseated/felt sick to stomach; ate about half of her breakfast, this lasted for several days, she wouldn't eat much; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer. This consumer reported similar event for two patients. This is the first of two reports. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206, expiry date: unknown), via an unspecified route of administration, on 09Mar2021, as single dose, for COVID-19 immunisation. Medical history included exposure to SARS-COV-2 on 02Mar2021 (reported as "daughter tested positive for COVID on 02Mar2021, patient had been around their daughter and their daughter's husband, they went out to eat with them on the night of 02Mar2021"). Concomitant medication included esomeprazole sodium (NEXIUM) taken for an unspecified indication, start and stop date were not reported. On 09Mar2021, the patient received her first shot. About 20 minutes after she took the shot, she started feeling bad and became nauseated/felt sick to stomach. On 09Mar2021, the top part of her stomach would hurt, and she started developing a cough. On 11Mar2021, the patient felt like she doesn't have any energy. The coughing went pretty bad so on 12Mar2021, the patient took a COVID-19 PCR test and it came back negative. The patient kept having a bad cough so then they went to the doctor where they put the patient on prednisone 20 mg and amoxicillin 875 mg on 12Mar2021. On 16Mar2021, the patient went to the family doctor and the doctor put the patient on azithromycin and gave her a steroid shot. Then the patient kept coughing and her stomach was hurting right at the bottom of her rib cage. The patient was never getting better or anything. So, on 18Mar2021, the patient had COVID-19 Virus test where they swabbed her nose and the test came back negative. The patient was taken to the hospital on 19Mar2021 at 11:30 where they did an x-ray of the patient's lungs and her O2 level was 82-86 sitting in the bed (also reported as 84-86 so she was put on oxygen), performed CT scan of her lungs and it looked like there was inflammation in the lower lungs that was rubbing on her diaphragm, and performed Chest CT which determined pneumonia. That night they did another COVID-19 virus test where they went really deep and it came back negative. The patient was admitted to the hospital on the night of 19Mar2021. The patient was given IV ceftriaxone, IV azithromycin, azithromycin (also reported as Zythromax), one breathing treatment, and they said they may have to send the patient home with some oxygen. It was also reported that on 19Mar2021, the patient did really good with coughing, she didn't cough that much. The patient had a dry cough that wasn't productive at all. The patient acted kind of short of breath because she wasn't breathing deep because of the pain in the top part of her stomach, but the reporter doesn't believe it was true shortness of breath. When the patient got out of the hospital on 22Mar2021, she didn't need to come home with the oxygen. The patient's oxygen level is running pretty good at the time of the report, in the lower 90s (Mar2021). The patient was on Decadron 6 mg for 5 days and she's doing pretty good, she still has a little bit of a cough. It was also reported that in Mar2021, the patient only ate about half of her breakfast, this lasted for several days, she wouldn't eat much. The patient pretty much recovered from the nausea. When she ate, it felt like everything would make it to her stomach and just sit there. The emergency room doctor said it could be from gastroenteritis, also they gave the patient several rounds of Protonix. The patient usually takes Nexium every night. The doctor felt that this event could very well be from the vaccine. The reporter asked if the patient could get the second shot on 30Mar2021. The patient was recovering from "Cough/bad cough/dry cough", "Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage", and "O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen"; has recovered from "nauseated/felt sick to stomach" on an unspecified date. The outcome of the events "inflammation in the lower lungs that was rubbing on her diaphragm", pneumonia, "feeling bad", "ate about half of her breakfast, this lasted for several days, she wouldn't eat much", "feels like she doesn't have any energy", "gastroenteritis", "short of breath" and "she wasn't breathing deep" was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329963 Same reporter, drug and event; different patient
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| 59 | 2021-04-07 | anxiety |
Patient experienced vasovagal episode in response to 1st dose of Pfizer vaccine. After an hour of ob...
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Patient experienced vasovagal episode in response to 1st dose of Pfizer vaccine. After an hour of observation, water, snack and trendelenburg, symptoms were not improving. Patient was admitted to ER. In the ED, she stated something similar occurred in the past when she was getting her Shingles vaccine. No hx of irregular heart rhythm or seizures. No prodromal symptoms or postictal state. Vitals significant for elevated BP 180s/100s, otherwise vitals stable. Labs significant only for Na 134. EKG was NSR. Most likely pt suffered from a vasovagal syncopal episode triggered by stress/anxiety. Pt's BP remained elevated as was in the ED, with an anxious affect that resulted in further increase in her BP. She was given xanax 0.25mg with recheck of her BP in 170s/90s. She was also counseled to maintain her hydration to prevent orthostatic changes. Pt agreed with plan, was happy with care, and discharged home in stable condition.
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| 59 | 2021-04-07 | feeling abnormal |
passed out; bad stomach ache; Tired; not normal; This is a spontaneous report from a contactable con...
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passed out; bad stomach ache; Tired; not normal; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), lot no. EN60207, via an unspecified route of administration (left arm) on 19Mar2021 10:15 at a single dose for COVID-19 immunisation. The patient had no relevant medical history. She had no known allergies. No covid prior vaccination. Concomitant medications included levothyroxine, simvastatin, calcium, and multivimi (as reported). Historical vaccine included first dose of BNT162B2 (brand=Pfizer, lot no EN6203) on 26Feb2021 10:15 AM, left arm at age of 59 years. No other vaccine in four weeks. On 20Mar2021, the patient got up to go to bathroom at 4:00am Saturday and passed out. Bad stomach ache Saturday (20Mar2021), Sunday (21Mar2021). On Mar2021, tired and not normal til Thursday. No treatment for the events. No covid test post vaccination. The patient recovered from bad stomach ache on 21Mar2021 and from other events on Mar2021.
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| 59 | 2021-04-07 | impaired work ability |
I was diagnosed with Covid-19 on 2/4/2021. I had shortness of breath, headaches, chills, sore throa...
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I was diagnosed with Covid-19 on 2/4/2021. I had shortness of breath, headaches, chills, sore throat, and fatigue. I was off of work until March 23rd. On March 29th, 30th and 31th, I was able to work 7 hours per day. I got the first dose of the Phizer vaccine on 3/31/2021. I was okay after the vaccine. However, on April 1st the shortness of breath, headache and fatigue started again. On April 5th, the fatique was significantly worse and I began coughing again. On the evening of April 5th, I started having chest pain sometimes when I good a breath and/or coughed. I did not have the chest pain before the vaccine. I feel like I did four or so weeks ago so I suffered a set-back after the vaccine.
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| 59 | 2021-04-07 | mental impairment |
Patient was sleepy after 1st vaccine on 3/16. Waited 30 min after 2nd vaccine with no complaints. ...
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Patient was sleepy after 1st vaccine on 3/16. Waited 30 min after 2nd vaccine with no complaints. Went to her car and son brought her back to clinic with complaints of jaw tightness and difficulty understanding things. Gait was shaky. BP 156/87, O2 sat 98%, resp 18, HR 69, temp normal. O2 sat decreased to 81%, but increased to normal on own. Later, BP 142/82, HR 70, O2 sat 97%, respirations 16 - 20. Felt better and refused ED visit. Improved.
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| 59 | 2021-04-07 | nightmare |
Dizzy immediately following injection. Bad headache, Fever 101.5° and lethargic around 6 hours late...
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Dizzy immediately following injection. Bad headache, Fever 101.5° and lethargic around 6 hours later.
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| 59 | 2021-04-07 | sleep disorder |
First symptom noticed was a very high heart beat rate. I assumed it was a reaction to the sucrose, ...
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First symptom noticed was a very high heart beat rate. I assumed it was a reaction to the sucrose, which appeared as an ingredient in the literature about the vaccine that the pharmacy provided. However, this symptom persisted for 4 days, the rate slowing somewhat on the 4th day. It was so uncomfortable it prevented getting sleep. I made a point of staying well hydrated before and for 4 days after the injection. Other symptoms included jumpy, jittery muscles, feeling I had 4 or 5 rods extending from my shoulders to my brain, a very localized but intense pain in my left shoulder, general muscle ache and stiffness , and an overall feeling of being unwell.
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| 59 | 2021-04-08 | impaired work ability |
Ears filled with fluid, tongue swelling, lips swelling, face and neck swelling, rash all over body, ...
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Ears filled with fluid, tongue swelling, lips swelling, face and neck swelling, rash all over body, itch all over body, burning skin after 1 week. Multiple episodes (at least 10) over the course of 3 weeks - resulted in 3 trips to the ER. Received injected or oral steroids at the ER. This caused loss of work and a great deal of stress. Was put on a course of oral steroids and antihistamines by allergist following ER visits. Had a prior reaction to the flu shot in October 2020. Everything above but the rash and itching. also resulted in a trip to the ER
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| 59 | 2021-04-10 | mental impairment |
Woke up with loud ringing in left ear. Makes it difficult to concentrate. Had permanent tinnitus al...
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Woke up with loud ringing in left ear. Makes it difficult to concentrate. Had permanent tinnitus already in right ear. This is new and started the day after recieving the injection.
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| 59 | 2021-04-11 | impaired work ability, feeling abnormal, depression, depressed mood, confusional state |
Patient was previously healthy and got her second injection in the right arm on 1/25/2021. She had ...
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Patient was previously healthy and got her second injection in the right arm on 1/25/2021. She had severe weakness of the right arm starting the day after the immunization, headaches across the whole head, severe fatigue, confusion (brain fog), worsening depression, body aches, and these all progressed and got worse for at least 14 days. She was unable to work any of those days due to weakness, confusion, and body aches. She saw me in the clinic on March 2 as she was still feeling weak, tired, confused. The clinic notes that day record: "On the next day, the 26th, she had severe pain and couldn't do much. Then she got super depressed and could not get out of bed for 2 weeks, had a lot of fatigue, body aches, and felt down. She tried going to the store one day and by the time she got done she could not get into her truck because she was in so much pain. That would have been about 2 weeks ago. She went back to work last week and was at work the whole week. She was told she does have leave time and that it did not cover the absence of work. She now needs new leave time forms completed. Currently she is in a lot of pain. She has her endocrine appointment on March 15th. The pain is getting worse. The cold is really hard on her. She is barely able to move her right arm at the end of the day, and that is the arm where she had the COVID shot. She is having a lot more weakness. She can not even take one flight of stairs now because everything hurts her. This is a huge difference than before. She used to be able to do several flights, and she can't do that anymore. She has also had vision changes. She has floaters but she is having a harder time focusing. She feels like no one would believe her, but she feels like this is all part of the reaction to COVID. She has a hard time focusing. She feels like she is going insane."
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| 59 | 2021-04-11 | loss of personal independence in daily activities |
Severe muscle pain, spasms in my muscles. Chills, weakness. Extreme fatigue not able to do my daily ...
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Severe muscle pain, spasms in my muscles. Chills, weakness. Extreme fatigue not able to do my daily functions.
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| 59 | 2021-04-12 | disorientation |
Urinary tract infection; She didn't know who she was or what she was doing for 3 days; This is a spo...
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Urinary tract infection; She didn't know who she was or what she was doing for 3 days; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6201; expiry: 30Jun2021), via an unspecified route of administration in left arm on 19Feb2021 (at the age of 59-years-old) as single dose for covid-19 immunisation. The vaccine was not administered at a military facility. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient had no medical history, no concomitant medications and no investigation assessment. The patient experienced urinary tract infection in Mar2021 which was considered serious due to hospitalization from Mar2021 to Mar2021 for 5 days. She was diagnosed with a urinary tract infection. She didn't know who she was or what she was doing for 3 days. She was then kept an additional two days. The patient was supposed to go back on 12Mar2021 to receive the second dose. She was in the hospital at that time and did not receive the second dose. She was asking if she needed to start over since it was past the time for her to get the second dose. The event urinary tract infection required an emergency room visit. The outcome of the event urinary tract infection was recovered on 22Mar2021 while for disorientation was unknown.
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| 59 | 2021-04-12 | sleep disorder |
First shot (Feb 6) was very high on left arm. I waited 15 minutes at sight, but no adverse reaction....
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First shot (Feb 6) was very high on left arm. I waited 15 minutes at sight, but no adverse reaction. The next day, arm was in severe pain. Not at injection sight, from shoulder to elbow. It subsided after one day. (it didn?t go away, just not as painful, but uncomfortable at night while sleeping) Received second shot (Feb 26) not quite as high on the same left arm. Arm still hurt when moved certain ways during the day-night was still uncomfortable. As time has passed, it has gotten more sore during the day, pangs during the day in the shoulder, upper arm, elbow, arm and wrist. At night, the pain has been unbearable, waking me up every night with pain in shoulder, arm, elbow and arm. I have used menthol patches, and taken Aleve to relieve the pain, but still every night I wake up due to pain. Went to doctor yesterday, he said the pain is in my tendon and gave me anti inflammatory Dicflofenac. I have a follow up appt in 3 weeks- if no improvement, we will start physical therapy. I took my first Dicflofenac last night before bed. I was in more pain then ever!!!!
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| 59 | 2021-04-12 | sleep disorder |
Extreme body/joint aches and very sore arm. Lasted about 18 hours. Ibuprophen helped, but could not ...
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Extreme body/joint aches and very sore arm. Lasted about 18 hours. Ibuprophen helped, but could not sleep with the pain. Acetaminophen did not help.
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| 59 | 2021-04-13 | disturbance in attention |
Approximately, one week after my 2nd dose started to experience dizziness and feeling faint on and o...
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Approximately, one week after my 2nd dose started to experience dizziness and feeling faint on and off. (started this past Sunday, today is Weds). Also general feeling of 'wigginess' making it tough to concentrate. Also minor feeling of 'chills' on and off throughout my body. Also VERY cold hands (not on and off but constant). None of this has abated yet -- as of today, Wednesday.
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| 59 | 2021-04-13 | feeling abnormal |
Headaches started slowly along with dizziness feelings of floating or being on a drug and then got ...
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Headaches started slowly along with dizziness feelings of floating or being on a drug and then got more intense after second shot and continued after for weeks until I was told I may have Giant cell Aritise. I had biopsy and was put on high does steroids. That was negative. I still get headaches and have headaches sensitive to the touch.
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| 59 | 2021-04-15 | feeling abnormal |
After taking the first Pfizer shot there was nothing remarkable that followed. Following the 2d dos...
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After taking the first Pfizer shot there was nothing remarkable that followed. Following the 2d dose on 25 Mar, patient was feeling tired, and described mental capacity as being foggy. Lost apatite and wanted to sleep. Described vision as blurry and couldn't focus.
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| 59 | 2021-04-15 | sleep disorder |
Onset of diffuse itchiness starting about 3 - 4 days after second dose of Pfizer. No reaction with f...
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Onset of diffuse itchiness starting about 3 - 4 days after second dose of Pfizer. No reaction with first dose. Itchiness was severe enough to wake me up at night. Also developed small discrete rash on arms. Treated at home with antihistamine. Resolved in one week.
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| 59 | 2021-04-16 | anxiety |
4/17/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination sc...
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4/17/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: tightness to chest and sweety. Assessment : Time of assessment 350pm. Alert and oriented, Anxious, Stridor, Diaphoretic, Nausea and tightness in chest, redness to face. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. VS at 350pm BP- 11/61, P- 81, O2- 97%, r Water given recheck of VS at 418pm BP- 122/71, P- 84, O2- 84% Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/17/2021 3:28 PM 0.3 mL 12/11/2020 Intramuscular
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| 59 | 2021-04-16 | confusional state |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient waited in the observation area after getting vaccinated for 15 minutes, went home and started feeling anaphylactic symptoms around 30 minutes after and drove back to the pharmacy to seek medical attention. She was panicked and hyperventilating upon arrival and I had the patient sit down and to take deep breaths. I was about to give her benadryl but she complained of swollen throat and having a hard time breathing. I injected her with epi-pen and within 5 minutes she was better.
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| 59 | 2021-04-17 | feeling abnormal, fear |
Immediately felt warm sensation flow from upper body to lower.I said something is happening. Felt ji...
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Immediately felt warm sensation flow from upper body to lower.I said something is happening. Felt jittery, flutter in chest and scared. Felt weak like I would pass out. Felt distant from Emt and nurse . Had difficulty getting words out. After about 7 minutes emt took me to his area ck bp it was 130/70. I know it would have been lower had he taken it sooner. I drank 3 waters stayed about an hour after injection.
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| 59 | 2021-04-17 | feeling abnormal |
She is out of breath when she is talking; Can hardly take the pain/all muscles seem to be hurting/th...
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She is out of breath when she is talking; Can hardly take the pain/all muscles seem to be hurting/things really started to hurt in the group of muscles; She started getting bad/shw was awful/she thought she was dying; Vaccine in the right arm, which swelled up for a while; Pinched nerve under my arm sometimes/she has pinching nerves too underneath her arm underneath her underarms; It will go numb (both arms); This is a spontaneous report from a contactable consumer (the patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 24Mar2021 16:45 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunization. Medical history included ongoing spinal stenosis (is in the very bottom of her back and she had three back surgeries, one surgery in the middle of her back, one is the neck and one on the bottom of her back and this is years in the making), ongoing diabetes, fall on 01Feb2021 or 29Jan2021, she fell and her arms were outside and caught her fall and the underarms hurt and she fell onto her breast hard; according to the HCP she had a look and said she pulled the muscles and this is ongoing. She stated that the muscles would be across the top shelf of her breast above the start of cleavage and under her arms on the outer sides of her breast, underneath her shoulder blades and to her spine things are getting better but she was not perfect and is still hurting and now is lucky if she can reach to grab her diet soda; overweight from an unknown date, and tooth infection from Mar2021 (probably about 6 days before getting the vaccine and is taking Clindamycin 300mg capsules and takes it three times per day). There were no concomitant medications. The patient stated she had the first dose of the vaccine on 24Mar2021 and she is supposed to get the second dose on 07Apr2021. She stated she had the vaccine in the right arm which swelled up for a while (in Mar2021) and next day was fine. By Saturday (27Mar2021) things really started to hurt in the group of muscles. By Sunday (28Mar2021), she could hardly take the pain and went to the HCP on a Tuesday. The pain totally changed. All muscles seem to be hurting, pinched nerve under her arm sometimes. Sometimes it will go numb (both arms). Above T11 and 12 by 1 or 2 places that it would go numb. When she lays down it goes away for a while. When she sits up, it is painful. She reported she has never experienced pain like this. This was worse than her fall. Her doctor thought things were exasperated by the vaccine and she was given prednisone. She also took Tylenol#3 every 8 or 9 hours. She was wondering since she is scheduled on 07Apr2021 for the 2nd vaccine if she should take the shot and how to know if she should or not do this to do more pain to herself. She stated that the pain was enough to make her cry and she has pinching nerves too underneath her arm and underneath her underarms the pain goes down if it gets really bad. She stated she saw her primary care HCP after she got the COVID Vaccine and she wanted to go to the emergency room but she figured they would give her some type of medication so she went to see the HCP and waited two days to see the doctor. On a Saturday, 27Mar2021, she started getting bad and then Sunday, 28Mar2021, she was awful and then on Monday 29Mar2021, she thought she was dying and saw the doctor on Tuesday, 30Mar2021. She also stated she is out of breath when she is talking on an unspecified date. The outcome of the event "vaccine in the right arm, which swelled up for a while" was recovered on an unspecified date, and unknown for other events.
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| 59 | 2021-04-18 | anxiety |
4/14-vaccine. Stiff neck, sore left base of skull, beginning w/in 1 hour. Painful arm barely lift-a...
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4/14-vaccine. Stiff neck, sore left base of skull, beginning w/in 1 hour. Painful arm barely lift-able by 9 PM, largely resolved w/ 48 hrs. 4/16, AM awoke w/intense pain in buttock and down leg to knee when trying to walk or crawl. Right and left low back pains. 2 days in bed with ice, Tylenol, CBD balm, diclofenac. By 4/18, able to shuffle. Right buttock soreness. 4/19 cautious walking. Burning in right buttock, off and on. 4/19-Very sore base of skull both sides, stiff and sore right jaw, ear fullness, numb teeth, headache. Anxiety treated w/ herbs, Tylenol for pains, herbal balm for pain.
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| 59 | 2021-04-18 | disturbance in attention, feeling abnormal | Extreme fatigue lasting 4 days, foggy brain (inability to make decisions, concentrate) |
| 59 | 2021-04-18 | feeling abnormal, anxiety, memory impairment |
increased pain in RA flareups; Brainfog; anxiety; sleep deprivation; shortness of memory; stiff and ...
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increased pain in RA flareups; Brainfog; anxiety; sleep deprivation; shortness of memory; stiff and burning sensation in joints; stiff and burning sensation in joints; mouth sores; moving slower much slower; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955), first dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 (reported as 10:30) (at the age of 59 years old, not pregnant), single dose for covid-19 immunization. Medical history included rheumatoid arthritis, fibromyalgia, known allergies: Sulfa and tetracycline, from an unknown date. Concomitant medications included hydroxychloroquine; indometacin sodium (INDOCIN); methotrexate. On 20Mar2021, patient experienced Brainfog, anxiety, sleep deprivation, shortness of memory, increased pain in RA flareups, stiff and burning sensation in joints, mouth sores,moving slower much slower. The outcome of the events was not recovered. No treatment for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information related to batch/Lot no. was requested.
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| 59 | 2021-04-18 | feeling abnormal | fatigue, brain fog, lasting two weeks after second vaccine. |
| 59 | 2021-04-21 | feeling abnormal |
Very bad headache , dizzy now I am not talking right. Have not feel right since. Arm is still red a...
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Very bad headache , dizzy now I am not talking right. Have not feel right since. Arm is still red and swollen
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| 59 | 2021-04-21 | nervousness, anxiety |
Chief Complaint: ? Care Coordination ? Immunization/Vaccine Administration ? Tongue Swelling a 59 y....
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Chief Complaint: ? Care Coordination ? Immunization/Vaccine Administration ? Tongue Swelling a 59 y.o. female with PMHx of HTN, Anxiety, well controlled T2DM and obesity who presented today to receive her first COVID Vaccine. Denies hx of anaphylaxis due to any cause. First COVID Vaccine administered in RD at 9:53 AM 13 min after the vaccine was administered she informed my CMA that she was having throat thickness, tongue swelling and watery eyes. I immediately completed vitals: BP: 178/100 Pulse: 76 RR 16 SpO2: 97% 10:13 am I moved her into my exam room. She stated that within 2-3 min of receiving the vaccine she began experiencing "throat thickness", dry mouth and tongue "thickness" but the symptoms had not progressed. She also c/o postnasal drip and a horse voice. She also c/o watery eyes and swelling around eye but states she had the watery eyes this morning prior to the vaccine. She also c/o numbness of a small area of her left wrist. She has significant environmental seasonal allergies for which she takes Claritin each morning and uses Flonase and montelukast each evening. She ran out of Claritin so she did not take one this morning. All of her symptoms are consistent with her normal environmental allergy symptoms she has been having off and on the last few weeks. She states they just all flared up about 2 min after the vaccine was given. She also states she did not take her BP medication this morning. She states she was very stressed out getting her today because she got lost and thought she would be late. Admits to feeling anxious. Denies hives, itching, difficulty swallowing, throat closing sensation, shortness of breath, chest pain, difficulty breathing, lightheadedness, dizziness, n/v/d, abdominal pain, wheezing, headache. 10:22 am States she has a slight headache but otherwise symptoms are stable Completed physical exam - unremarkable. No stridor, no lip/tongue/posterior pharynx swelling I reviewed her medication list 10:27 am Repeat vitals: BP: 178/102 Pulse: 72 RR 16 SpO2: 99% 10:36 am I continued to monitor her, I completed serial vitals and physical exams as well as continuously asked how she was feeling and doing. She denied difficulty breathing, wheezing, worsening of symptoms, chest pain, lightheadedness, palpitations. I advised giving her liquid benadryl only if she could have someone come pick her up. She declined stating that she did not have someone that could drive her home. She lives 20 min away 10:40 am She states that the eye swelling has resolved and the throat thickness was improving. Her slight headache has resolved. I advised we monitor for another 30 min here in the clinic. 11:10 am She states she is feeling much better. She reports her tongue and throat feel back to normal. Headache has resolved. She denies any difficulty breathing, wheezing, lightheadedness, dizziness, n/v/d, hives, itching, palpitations, throat/tongue itching. Rechecked vitals and physical exam. Vitals (75 min after vaccination) BP: 176/98 Pulse: 78 RR 12 SpO2: 98% ROS: Constitutional: Negative for fatigue, diaphoresis and weakness. Eyes: Negative for blurred vision, eye pain and photophobia. Watery eyes E/N/T: Positive for congestion and hoarseness. Negative for rhinorrhea, odynophagia, stridor and tinnitus. Throat and tongue thickness Cardiovascular: Negative for chest pain, palpitations, tachycardia, edema, dyspnea on exertion, irregular heartbeat and near-syncope. Respiratory: Negative for cough, shortness of breath, wheezing and sputum production. Gastrointestinal: Negative for abdominal pain, diarrhea, stool changes, nausea and vomiting. Integumentary: Negative for dry skin, pruritus, rashes, dry skin and flushing. Neurological: Positive for headaches. Negative for dizziness, weakness, focal weakness, light-headedness and vertigo. Allergic/Immunologic: Positive for environmental allergies. Negative for frequent illnesses, urticaria, hives and persistent infections. PMH: Diagnosis Date ? Abnormal mammogram ? Anxiety ? Essential hypertension, benign ? High cholesterol I reviewed the following historical information during this visit: Tobacco | Meds | Problems | Med Hx | Surg Hx | Fam Hx | Soc Hx OBJECTIVE: Vitals (75 min after vaccination): BP: 176/98 Pulse: 78 RR 12 SpO2: 98% Temp: 97.1 PHYSICAL EXAM CONSTITUTIONAL Vitals reviewed. GENERAL APPEARANCE: Well-developed and obese. GROOMING: Well groomed. LEVEL OF DISTRESS: The patient is nervous/anxious. The patient is not distressed or diaphoretic. She appears to be well. The patient is not lethargic or toxic. The patient does not appear tired. EYES: LIDS/CONJUCTIVA:Positive for Bilat/clear eye drainage.Negative for eye lid edema. No lid edema, no surrounding facial edema Conjunctiva are minimally pink, no erythema PUPILS/IRIS: extraocular movement intact. ENT EXTERNAL EARS/NOSE: External ears and nose are normal. SEPTUM/MUCOSA: Turbinates are mildly swollen. Negative for edematous mucosa, sinus tenderness and pale, boggy nasal mucosa. LIPS/TEETH/GUMS: Normal lips, teeth and gums. No lip edema. OROPHARYNX: Oropharynx normal. Mucosa: Mucosa appears normal. No tongue edema, erythema or rash noted No oropharynx or posterior pharynx swelling noted She is swallowing and breathing normally No stridor NECK: Neck normal. RESPIRATORY EFFORT AND PATTERN: Effort normal. No tachypnea, intercostal retractions, accessory muscle usage, hypopnea and irregular rate. AUSCULTATION: Normal breath sounds with no rales, rhonchi, wheezes or rubs. No inspiratory wheezes, expiratory wheezes or stridor. CARDIOVASCULAR AUSCULTATION: Rate: Is normal. Rhythm: regular. Heart sounds: S1 is normal. S2 is normal. S3/S4 not present. With no murmurs heard. EDEMA/VARICOSITIES: No edema or varicosities. RADIAL: radial pulses normal bilaterally PEDAL PULSE: Normal bilateral posterior tibal pulses. LYMPHATIC OTHER NODES: No neck adenopathy. No supraclavicular or submandibular nodes.Supraclavicular INTEGUMENTARY SKIN INSPECTION: Normal. ECZEMA/PRURITIC CONDITIONS: Negative for urticaria. Skin temp and color normal, no flushing, no diaphoresis, no urticaria Injection site is unremarkable NEUROLOGICAL CRANIAL NERVES: Cranial nerves normal. CN grossly normal GAIT, COORDINATION, REFLEXES Gait: normal PSYCHIATRIC ORIENTATION: She is alert and oriented to person, place and time. MOOD/AFFECT: Appears anxious. Does not appear agitated or depressed. She is not argumentative. She does not act disrepectful, act distrustful or have a flat affect. INSIGHT/JUDGEMENT: Normal insight/judgement. The patient has good insight with good judgment. ASSESSMENT/PLAN: Environmental allergies - Symptoms were consistent with her normal environmental allergy flare ups. - She did not take claritin this morning as usual so this may be why the allergies flared up - Symptoms resolved within 70 min of giving the vaccine without any therapy - I recommended giving liquid benadryl and having someone come pick her up and monitor her at home. She declined stating that she did not have someone who could pick her up and stated that she would rather take benadryl at home. - She stated she felt safe to drive home. I gave strict warnings that if any sx recurred or if any new or concerning symptoms developed that she should call 911. Reviewed signs and symptoms of anaphylaxis. - I advised she take liquid benadryl when she got home and have someone monitor her for the next 4 hours. Essential hypertension - elevated today likely due to increased stress/anxiety and not taking BP medication this morning - I advised that she monitor her BP closely at home. I advised she take her BP medication when she got home if her throat felt normal. - recommended f/u with PCP Encounter for administration of vaccine First Pfizer COVID Vaccine given today I recommended she consult with her PCP about the second vaccine. She expressed understanding and all questions answered. ----------------------------------- Called patient at 2:10 pm to check up on her. She states that she took liquid benadryl about 40 min ago and that all of her symptoms have completely resolved. She states that she is feeling great now. She denies difficulty breathing, throat swelling/tighntess/thickness, tongue swelling, wheezing, headache, n/v/d, lightheadedness, hives, itching, palpitations or chest pain. She states she took her BP medications but has not checked her BP at home yet. I recommended she continue taking benadryl as needed and recommended she follow up with her PCP in 1-2 days. --------------------------------- Patient's PCP) I wanted you to be aware that your patient had a mild reaction vs flare up of her environmental allergies after her first COVID Vaccine today. I called her 4 hours after the vaccine. She had taken benadryl at home and her symptoms had resolved. I was hoping to consult with you about her receiving her second vaccine. Her BP was elevated. She had not taken her BP medication this AM. I recommended she also f/u with you on that as well. --------------------------------- Dr's response "People react to making antibodies. The serious anaphylaxis is rare. Most are having general side affects and flu-like symptoms I would like you to administer the 2nd vaccine. Notes seen on morning of April 20. Responded."
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| 59 | 2021-04-21 | sleep disorder |
Woke with very significant arm pain at the injection site, two days later it had spread to neck, upp...
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Woke with very significant arm pain at the injection site, two days later it had spread to neck, upper back pinched nerve and all the way down right arm. Went to urgent care. Dr prescribed MethyIprednisolone tablets, 4 mg. 21 tablets, and Cyclobenzaprine 10 mg. Neither had any effect at all. Pain is significantly increased overnight. Daytime is uncomfortable. Nightime is terrible. Do not sleep for more than twenty minutes at a time.
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| 59 | 2021-04-22 | anxiety, feeling abnormal |
Left arm hurt numb like feeling . Then overall bad feeling. Anxious from all that. Decided maybe my ...
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Left arm hurt numb like feeling . Then overall bad feeling. Anxious from all that. Decided maybe my blood pressure was high. Oh, both ankles swelled a bit when only one does usually after hot days above 70. Tom BP and it was over 200 on top. Ok diastolic . I took an aspirin, BP medicine , water and put ankles up above heart. After about an hour or 2 bp was down to 156 but diastolic was up to high oddly. More rest , another blood pressure pill and by morning top was fine bottom a bit high and by next morning everything in good numbers and arm finally did not hurt any.
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| 59 | 2021-04-22 | anxiety |
Her heart started pumping really hard; Fast heartbeat/Heart fluttering a lot; She also had pressure ...
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Her heart started pumping really hard; Fast heartbeat/Heart fluttering a lot; She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye.; She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye.; Anxiety; Eye felt red; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: E10142), dose 1 via an unspecified route of administration, administered in left arm on 14jan2021 at 09:00 as single dose for covid-19 immunisation. Medical history included vitamin supplementation, supplementation therapy, cataract (Mother had cataracts; problems with her heart; had a couple of strokes before she died at 59 years of age), cardiac disorder, cerebrovascular accident, pain (Before she had the first dose of Pfizer COVID-19 Vaccine she was not so concerned because she figured she would probably get body aches or headaches, normal side effects), headache, normal side effects. Concomitant medications included ergocalciferol (vitamin d [ergocalciferol), krill oil (megared omega 3 krill oil), vitamin c [ascorbic acid], nigella sativa seed (black seed [nigella sativa seed]), betacarotene, calcium carbonate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, sodium ascorbate, thiamine hydrochloride, tocopheryl acetate (one-a-day vitamin), cyanocobalamin (vitamin b12 [cyanocobalamin]), acetylsalicylic acid (baby aspirin), calcium, magnesium, zinc (magnesium/calcium/zinc) taken for vitamin supplementation and probiotics taken for supplementation therapy. No any other vaccinations within 4 weeks Prior to the first administration. No AE(s) following prior vaccinations: although she did get unknown Shingles vaccine in Sep2020, no AEs associated. She has not gone to get the second Shingles vaccine because she does not want to overlap vaccines while getting Pfizer COVID-19 Vaccine. The patient Was concerned for her 2nd dose which she was scheduled to take tomorrow on 02Feb2021 at 14:30, because of the side effects from her 1st dose. On 15Jan2020, a day after the 1st dose, her heart started pumping really hard and she had a fast heartbeat/ heart fluttering a lot. She also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye. She it was strange because this has never happened to her before up until she got the vaccine. She consulted her eye doctor and mentioned that she will be monitored for the pressure in her right eye. She is also getting anxiety because of this. She was asking if she can go tomorrow to take the 2nd shot. The outcome of events her heart started pumping really hard, she also had pressure on the top part of her head which was tender and a pressure in the back part of her right eye, anxiety and eye felt red was unknow where the outcome of events fast heartbeat/heart fluttering a lot was not recovered. Follow-up attempts are completed. No further information is expected.
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| 59 | 2021-04-22 | feeling abnormal |
3 days after first dose - headache, dry mouth, loss of taste, fatigue, stomach pains, bloating, belc...
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3 days after first dose - headache, dry mouth, loss of taste, fatigue, stomach pains, bloating, belching, reflux, diarrhea, brain fog, no appetite. Saw healthcare provider. Given restricted diet, ordered abdominal ultrasound. Symptoms lasted 13 days. 2 days after second dose - same symptoms, but more intense/extreme. Healthcare provider has ordered abdominal MRI. Still experiencing symptoms.
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| 59 | 2021-04-22 | sleep disorder |
Normally I take a Coreg CR 20 mg @9am, and another one @9pm; blood pressure (BP) was well controlled...
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Normally I take a Coreg CR 20 mg @9am, and another one @9pm; blood pressure (BP) was well controlled for the last 5 years. The day of the 2nd COVID dose I started feeling malaise/weakness around 7-8pm. My BP was 188/106 (3 measurements average). Took the 9pm Coreg at 8pm; didn't feel improvement, my BP increased to 220/118. I took a Labetalol 100mg; in about 2-3 hrs my PB came down to 170/105 and I fell asleep. I woke up several times feeling sick. The next day my BP was higher than usual around 170/112 (in the morning I felt a bit better; but started to feel very sick again in the afternoon; it continued in the evening & during the night). I felt as if my heart was giving up. The only reason I did not go to Emergency was the fear I can get the COVID in the hospital. THIS WAS A VERY SERIOUS, LIFE THREATENING EVENT; if I didn't have Labetalol in the house I believe I would be dead now. Note: I did not panic, my pulse was around 66 the first day. The second day it was around 72. There should be an investigation covering the side effects in people with a high BP history after the 2nd vaccine dose, to make sure their problems were not blamed on their health history. During the side effects/time frame I described, it seemed my BP medication did not have the effect it usually has on me. I found it unacceptable that the only site reporting the spikes in BP as a COVID vaccine side effect was a hospital in another country; if there were such side effects reported by the date of my vaccine, they were not readily available for the public. These heart problems could have been made much better if people like me knew of an increase in BP as adverse reaction to the vaccine's 2nd dose, so we could have been prepared, i.e. take the BP medication BEFORE the BP spikes up so much, so it doesn't reach critical values (especially in the conditions of malaise and general sickness given by the vaccine.)
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| 59 | 2021-04-23 | sleep disorder |
Annoying armpit pain, still have 3 days later. Very strong pain at shoulder blade area going all th...
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Annoying armpit pain, still have 3 days later. Very strong pain at shoulder blade area going all the way to the front. It feels like something is wrong with my lungs and my spine. Pain is much worse when inhaling. Sometimes makes me cough. I had back pain after the 1st shot, and was finally getting better. Now it is back in full force but only between shoulder blades. Constant pain, sometimes get worse, sometimes better but never goes away. Neck pain, and hard to move neck; now getting better. I had first shot in left arm and second in right arm. After 2nd shot my Left arm (the one that got 1st shot) started being sore and i was not feeling anything in the right arm Where i got the shot. Then it finally switched with the added "bonus" of the armpit pain. I was very very tired fist day but then could not sleep for the next two nights Due to back pain and general discomfort. After 2 nights of no sleep i was really beaten up , with a minor headache all day ,maybe because of vaccine but also because of lack of sleep. No fever, when i checked 37.3 A bit of chills night 2
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| 59 | 2021-04-24 | disturbance in attention, abnormal dreams |
SWOLLEN LYMPH NODE NEAR UNDERARM, SOME PAIN-SAME SIDE AS SHOT. (4/21-4/23) LETHARGIC & FEELING ILL, ...
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SWOLLEN LYMPH NODE NEAR UNDERARM, SOME PAIN-SAME SIDE AS SHOT. (4/21-4/23) LETHARGIC & FEELING ILL, WEAK, SLOW/DULL BRAIN-EXECUTIVE FUNCTIONING IS LABORED , SOMEWHAT BREATHLESS AFTER SIMPLE ACTIVITY 4/21 AND CONTINUES THROUGH 4/25 (TODAY). TEMP ROLLS FROM 98 TO 99-COMES IN WAVES. LOSS OF APPETITE. VIVID ACTIVE DREAMS. TAKEN SOME ADVIL, TYLENOL PM, BUT NOT CONSISTENTLY.
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| 59 | 2021-04-24 | insomnia |
soreness on the injection site on the left arm; she couldn't sleep; could barely move; body aches; s...
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soreness on the injection site on the left arm; she couldn't sleep; could barely move; body aches; sweats; chills; diarrhea; stomach doesn't feel great; headache; muscle aches; This is a Spontaneous report from Pfizer program. A contactable 59-years old female consumer (patient) reported that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (Batch/Lot number ER8737) as SINGLE DOSE for covid-19 immunisation. Medical history included torn rotator cuff, tendonitis. The patient's concomitant medications were not reported. The patient reported that she received her first dose of the vaccine on Tuesday, 06Apr2021. Then she started feeling some side effects yesterday 07Apr2021 like, soreness on the injection site on the left arm, she couldn't sleep and could barely move, she had body aches, sweat and chills, diarrhoea, stomach didn't feel great, headache and muscle aches. She stated her arm was feeling a lot better than last night. Outcome of events was not recovered.
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| 59 | 2021-04-25 | feeling abnormal |
First: Chills (severe) for 1 day; second: chills & slight fever; third: extreme exhaustion/tiredness...
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First: Chills (severe) for 1 day; second: chills & slight fever; third: extreme exhaustion/tiredness; fourth: brain fog/wooziness.
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| 59 | 2021-04-25 | insomnia |
Night of 2nd dose: Chills, fever, high pulse rate, unable to sleep, pain at injection site. Next d...
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Night of 2nd dose: Chills, fever, high pulse rate, unable to sleep, pain at injection site. Next day: Tired, achy. Next night: fever, difficulty sleeping, pain at injection site: Following day: Tired (other symptoms gone).
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| 59 | 2021-04-26 | disturbance in attention |
pt says she when she woke up she was dry heaving and severe headache. She had chills, diarhea, naus...
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pt says she when she woke up she was dry heaving and severe headache. She had chills, diarhea, nausea, skin was slightly red and peeling. She had vertigo, sore throat, dry mouth, loss of taste, fatigue, muscle aches and pains. Her right arm hurt more than the left arm where she had the arm that was injected. She had major hair loss and trouble focusing and feels like she has a sinus infection. Patient is taking cold and flu meds. She does feel some better but still has a headache and feels like she has a cold.
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| 59 | 2021-04-26 | emotional distress |
A nurse saw me in distress & caught me before I hit the floor; dizziness & lightheadedness; difficul...
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A nurse saw me in distress & caught me before I hit the floor; dizziness & lightheadedness; difficulty breathing; had a horrific taste in my mouth; A nurse saw me in distress & caught me before I hit the floor; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 11Apr2021 at 11:15 (batch/lot number: EP7533) as a single dose for COVID-19 immunisation. Medical history included cancer history, back injury, right shoulder injury; and known allergies to sulfa, IVP dye, latex, bee stings and mushrooms. The patient was not pregnant. Facility type vaccine was health clinic. No other vaccine in four weeks. No Covid prior to vaccination and not Covid tested post vaccination. Concomitant medications in two weeks included gabapentin, valaciclovir, tramadol, doxycycline and vitamin; all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine, morphine and hydromorphone hcl (DILAUDID) and experienced known allergies to all drugs. On 11Apr2021 at 11:30, also reported as within 2 minutes of getting the vaccine, the patient had a horrific taste in her mouth followed by dizziness & lightheadedness. A nurse saw her in distress & caught her before she hit the floor. She then had difficulty breathing. They administered EpiPen, 50 mg liquid Benadryl & 2 puffs of Ventolin. She was transported to the ER by ambulance. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.
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| 59 | 2021-04-26 | feeling abnormal | legs feet like tickling inside, limp, could barely stand |
| 59 | 2021-04-26 | feeling abnormal |
to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular p...
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to make sure there is no pulmonary embolism; Shaking legs and arms; Lightheaded; PVCs (Ventricular premature beat); Large black bruise on left breast; 40 hrs fever; throwing up/vomiting; nausea 36 hours; intermittent breathing issues/sporadic breathing issues/difficulty breathing and hard to get a breath; She was weak; severe migraine; Headache; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of bnt162b2 (BNT162B2, lot number ER8727, expiration date: 31Jul2021), via an unspecified route of administration in arm left on 07Apr2021 12:00 as single dose for Covid-19 immunisation. Medical history included allergy ( macro Danton, sulfa). Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medication included Nerontin. The patient reviously received flu vaccine and had normal things, previously received first dose of bnt162b2 (Lot Number: EN5318; Expiration Date: 31May2021) in arm left on 17Mar2021 16:00 and experienced acute lymphatic response, brain fog and arm started to hurt. The pateint was calling because her doctor, who she saw yesterday 14Apr2021, told her she should let Pfizer know what was going on. She had a reaction to the Pfizer Covid19 Vaccine. she was now having PVCs. The patient added that all of the events started with a fever, and throwing up. She had a fever and threw up for 36 hours. She had to contact her physician to get medication and to stop vomiting and the nausea and everything. During that time, she was sick. She was having intermittent breathing issues which she did not think she felt too much of until after the other sickness was over. She was weak, like people get after they are sick, and had bizarre shaking legs and arms which was strange. She added that she had breathing issues and difficulty breathing and hard to get a breath. That was what she was dealing with. Treatment: caller took Pedialyte and all the proper things to get back into better shape. The breathing issue still remained. The doctor called in a rescue inhaler. She kept going downhill so he called in a rescue inhaler. Large black bruise on left breast after second vaccine: Caller added that this one will not be believed but on Monday, she woke up and got dressed again and was just weak and had breathing issues but was just doing work on the laptop. She did not fall, she did not run into anything. In the evening, she went to take a bath and saw that when she took her clothes off there was a large black bruise on her left breast, it was probably 2 inches in diameter. It is very large, but does not hurt like a bruise. She checked the rest of her body for blood issues and only saw a couple normal looking bruises. She contacted her doctor, and they questioned her thoroughly on her bruising and activity. This was on Monday. Tuesday, she still felt the same headache, weak, and breathing issues. PVCs (Ventricular premature beat) after second vaccine: Yesterday, 14Apr2021, she started declining and the doctor wanted to see her. Caller stated the doctor heard PVCs in her heart. Caller asked clarification of PVC abbreviation and does not provide. She never had heart issues ever. The doctor did blood work and a chest x-ray, and saw the bruise and was worried about her blood. Caller added that even though these are not listed as side effects of the vaccine, she was worried. Her doctor sent her to a facility for chest x-rays to make sure there is no pulmonary embolism. Caller confirmed this was on 14Apr2021. She has not yet heard back. PVCs after second vaccine: Caller added the doctor said her lungs sounded good but wanted to see what was going on to see how her breathing was because there was difficulty. The doctor wanted to cover bases and check. Today, caller can tell her heart is still not in correct rhythm and that it is in continued PVCs. She still had the same breathing issues, limbs were weak, she was shaky, and she is lightheaded. She was hoping to wake up today and feel better. Fever after second vaccine: started 3am 08Apr2021. She had a fever and was throwing up at this time. Throwing up and nausea after second vaccine: caller add that throwing up and vomiting with nausea occurred at 3 am, all of this occurred 08APR2021. The vomiting lasted 36 hours, and it ended when she took medication. The fever lasted 40 hours. Even after the medication worked for her fever, she had nausea. Around Friday was when it went away. Intermittent breathing issues after second vaccine: caller adds it started with throwing up and fever, but she did not think a lot about this or know when it started because she was dealing with the fever and vomiting. It continued, and it has not subsided or ended. As a matter of fact, there are 2 or 3 times it has gotten bad which is why she was given an inhaler. Treatments: caller took a Phenergan suppository, which she adds is the best medicine in the World for nausea and beats Zofran. She had used two or three doses and it did work. She used a rescue inhaler, Albuterol Sulfate HFA. She took Tylenol for fever. She is also now taking an aspirin daily because of the blood issues. No additional information regarding the products. Weak after second vaccine: caller adds that this started at the same time, she was over the nausea and noticed this. It felt different than what it feels like with the flu. This is still going on, she did not think too much about it but it has persisted. Sometimes there is a little bit of shaking but that is intermittent. Caller states she can not put it into words. Bizarre shaking legs and arms after second vaccine: this goes with the weakness, she is continually weak but she has a shaky feeling that will come every now and then and is random. Large black bruise on left breast after second vaccine: Monday this started, 12APR2021 and it is still there but it is the same. It has not been sore like a bruise but it is black and large. The physician has seen it now and it is bizarre and scary. It is the left breast on the outside. Headache after second vaccine: started probably an hour after the vaccine, pretty quick. There were degrees to this headache because it was an actual migraine for a good 48 hours and even after the fever was gone it was terrible. It started out just a mild headache and then was very severe for a couple of days. Then, after that it was just there but not as severe. PVCs after second vaccine: caller adds that she went to the doctor yesterday 14APR2021 and she can tell every now and again that she is having these but there is nothing she can do about it. Caller adds this is everything new she can think of, but some of it is foggy, she thinks this is the main information. Brain fog after first and second vaccine: Caller then states, by the way, after both vaccines within 2 or 3 minutes of having them her head started feeling foggy and weird. Investigations: caller has not received any results yet. She did get an EKG, Chest XRAY, blood work, and the doctor also rattled off a bunch of things the doctor was going to check. These all were on 14Apr2021 and she is waiting on results. Caller confirms the physician told her she had PVCs while listening to caller's heart. Did any AE require a visit to: Physician office? 15Apr2021 she was in contact with her physician, and the whole week they were on the phone. Yesterday 14Apr2021 the physician wanted to see her. The doctor figured out something was going on with her heart so thankfully the doctor wanted to see her. It was discussed if caller should go to the ER but caller did everything she could not to go because that is the last place she wants to go. Emergency Room: no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of fever, vomiting, nausea was recovered, intermittent breathing issues, shaking legs and arms, weak, severe migraine, headache was not recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-04-26 | excessive sleepiness |
Muscle pain & weakness started at bed time on day of vaccination. Woke up next morning still in pain...
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Muscle pain & weakness started at bed time on day of vaccination. Woke up next morning still in pain with chills. Slept from noon on 2nd day until 7:00 a.m. the next day, then slept off/on all day & night until the following morning. The muscle pain had mostly subsided when I began to notice more pain in my left shoulder (the injection side) & armpit. My armpit/lymph nodes swelled throughout the day, so I used warm/moist compresses and Tylenol to help alleviate the pain. That was yesterday, and today the area remains painful & I'm continuing my home treatment of compresses & Tylenol.
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| 59 | 2021-04-27 | feeling abnormal |
Shingles rash on right side of torso within 9 days of vaccine. Then AGAIN, 2 weeks later along right...
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Shingles rash on right side of torso within 9 days of vaccine. Then AGAIN, 2 weeks later along right leg nerve meridians stretching from thigh all the way down to calf. I've only had one outbreak of shingles in my life 23 years ago (age 37), Other than the slightly "off" feeling from vaccine shot 1, I am in very good health (exercise daily, mostly plant based organic diet, no coffee, etc). I am putting off getting shot 2 until this issue is resolved.
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| 59 | 2021-04-27 | feeling abnormal |
Patient reports receiving 2 Pfizer COVID vaccines. The first one was on 3/17/21 with lot # EN6207 wi...
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Patient reports receiving 2 Pfizer COVID vaccines. The first one was on 3/17/21 with lot # EN6207 with no adverse reactions. She received her second one on 4/5/21 with lot #EP7533. She reports she started "feeling bad" 4/6/21-4/11/21. She noticed left sided neck swelling on 4/11/21. She went to urgent care and was seen by an NP and was told to go to for a CT scan the next day since it was on a Sunday. Patient reports she went home and had further left sided neck swelling and difficulty breathing. She "couldn't catch her breath". EMS was called and she was transported per her request to Hospital. She had a 9 day hospital stay and was told she was having a severe reaction to the vaccine and that she had pneumonia with fluid in her lungs and fluid around her heart. She was treated with 2 antibiotics, IV fluids, and a diuretic. Patient had a follow up with her primary care on Monday 4/26/21 with NP and was told her heart and lungs sounded clear. She has a follow up appt scheduled with her lung doctor Dr on 5/24/21. Patient did not say why she has seen a lung doctor before but that she had been seeing this doctor prior to this adverse reaction. She was told in the hospital that it was not normal to be having this much swelling. Patient states she still feels weak and is still somewhat short of breath.
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| 59 | 2021-04-27 | loss of personal independence in daily activities |
She got her vaccine, went home and has been real sleepy, drained and tired. She has a rash on her n...
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She got her vaccine, went home and has been real sleepy, drained and tired. She has a rash on her neck real bad and itchy, patchy type which grew to other parts of her neck. She cannot get anything done due to the fatigue and loss of appetite. These reactions still continue as of 4/28/21. She has not taken anything for this reaction. She is going to call her PCP today.
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| 59 | 2021-04-28 | depressed mood |
blood clot under her eye; bright red bruise in the corner of the eye to the middle of the eye undern...
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blood clot under her eye; bright red bruise in the corner of the eye to the middle of the eye underneath; feeling crummy; she was down; headaches; couldn't move; arm hurt all the way below her arm pit into her breast; arm hurt all the way below her arm pit into her breast; arm hurt all the way below her arm pit into her breast; got very sick; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 08:30 (at the age of 59years) as single dose for Covid-19 immunization. Medical history included ongoing rheumatoid arthritis and osteoarthritis (not bad enough that she takes treatment, but she is diagnosed; she was diagnosed way back in 2006). Concomitant products: patient stated she takes some medications (not further specified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she had her first dose of the Pfizer Covid-19 vaccine on 05Apr2021 and got very sick. She was down for two days and after day 10 (as reported) she has a blood clot under her eye. She would like to know what would happen if does not get a second dose. She consulted if there is any talk on whether or not people should receive an additional dose of the Pfizer Covid-19 vaccine next year. The patient further reported that on 06Apr2021 she woke up feeling crummy right away and a couple of hours into that day she couldn't lift her arm, literally couldn't lift arm for 6 inches and stated it went on for 2 days. She further stated that her arm hurt all the way below her arm pit into her breast. She stated that it all ended on 08Apr2021 and she went back to work on 08Apr2021. The patient added that she was down for two days, had headaches, and stated she never knew what people meant when they said they got hit by train. She doesn't believe she had a fever and couldn't move. The patient further stated that she got pretty darn sick and this morning 14Apr2021, she woke up with a blood clot under her eye. She is an esthetician and is pretty good with skin. She stated that she doesn't know how she could get this overnight unless she injured herself in her sleep, but she is a light sleeper. She does not know if it is a clot. She also stated that she called a medical esthetician who told her to take a baby aspirin and cold compress. The patient clarified that she didn't feel so good and today she feels better. She doesn't know that it is a blood clot, it is not raised and not hard, it looks like she has a bright red bruise in the corner of the eye to the middle of the eye underneath, not in the eye. She wants to make it clear she doesn't know if it is a blood clot. She feels like if she hurt herself, that would be the reason, but it would be painful, and it is not. She added that the bruise is about the same. Therapeutic measures were taken as a result of the events (except for feeling down and couldn't move). The outcome of events thrombosis and contusion was not recovered; the outcome of other events was recovered on 08Apr2021.
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| 59 | 2021-04-28 | feeling abnormal |
pt says she developed a severe headache, nausea and was shivering. When she laid down she could fee...
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pt says she developed a severe headache, nausea and was shivering. When she laid down she could feel her heart beating. She took Tylenol. She woke up feeling like she had the flu. She was very fatigued. Her lack of motility symptoms have intensified. She had these symptoms for several days so went to her PCP which told her to monitor her symptoms. A week after taking the vax she started feeling very cold, had shivers, body aches, and developed a cough. She took Tylenol and went to bed. She woke up with a debilitating headache. She was weak and dizzy so took more Tylenol. She continued to be dizzy, felt fatigued and had brain fog. She called the vax nurse help line and was instructed to go to the ER. She went to the University. She had blood test, EKG, and Brain CT which were normal. She was dehydrated and was given IV fluids. She was monitored and sent for Covid and Sars testing which were normal. She still has shivers, chills, body aches and feels very tired and feels like this has interrupted her cognition.
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| 59 | 2021-04-28 | excessive sleepiness |
Headache started small then blinding pain for 12-14hrs then faded away after 1 day: fever 99-100 deg...
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Headache started small then blinding pain for 12-14hrs then faded away after 1 day: fever 99-100 degrees for 2 days: body aches for 3 days: slept for 4 days.
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| 59 | 2021-04-28 | irritability |
Two weeks after first Covid Pfizer shot, I started with fatique, then painful left ear ache, which w...
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Two weeks after first Covid Pfizer shot, I started with fatique, then painful left ear ache, which was pulse like in nature. Painful and kept coming and going. Dr. appt and said ear was good, might be a lymphnode but no infection. Thought maybe a tooth issue. Dentist said no. Fatigue progressed, with irritability and a dull pain started in left chest muscle but I thought it was from lifting weights. Then extreme itching in center of back, thought a spider bite? Couldn't see it. 24 hrs before my 2nd shot appt, asked son to look at my back. Small rash size of a quarter. Changing my shirt, I noticed two more quarter size rashes on side of left breast. Never any fever. Uploaded photos and telemed dr confirmed shingles. Prescribed Valacyclovir for 7 days. Was told it looked like a mild case. First symptoms started 4/10/21, rash discovered 4/16/21 but probably started 4/13/21. No blisters developed. Back only itched but left breast pain grew worse to under arm and entire breast. But rash did not spread. Rash just starting to fade April 28, but pain still persists. Dr. advised not to get 2nd shot until after antiviral med finished, but I am still waiting 2 more weeks and hope to get 2nd shot May 7th, before the 42 day window closes even if I still have pain. I flew to get first shot as I was eligible there. I needed vaccine asap due to childcare and my Medicare business seeing over 65 population. I will probably try to get the 2nd shot now only because it is slowly but finally opening up with some vaccine availability. Hope this helps.
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| 59 | 2021-04-30 | anxiety, feeling abnormal |
Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure;...
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Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure; Severe chills; Strange redness across her shoulders; Arm hurt after shot; Pressure in head; Very loose stools; Nausea; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 13:30 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation (Age at vaccination: 59 years) . Medical history included liver disorder , hypersensitivity, hepatitis C from , osteopetrosis , arthropod sting allergy , drug hypersensitivity , gluten sensitivity (She is borderline celiac, and she will get really bad gastro problems for 2 or 3 days after digesting gluten) , penicillin hypersensitivity (She has itching, rash, nausea) , peanuts allergy (Keeps an EPI pen for this). Concomitant medications included d-ribose, polypeptide (TRANSFER FACTOR [D-RIBOSE;POLYPEPTIDE]) taken for hepatitis C from 2003 to 03Apr2021; ascorbic acid (VITAMIN C ACID) taken for an unspecified indication from an unspecified start date to 03Apr2021; vitamin D3 (VITAMIN D3) taken for osteopetrosis from an unspecified start date to Apr2021; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient experienced high bp/pressure in head and high blood pressure on 05Apr2021 with outcome of unknown , fatigue on an unspecified date with outcome of unknown , severe chills on 05Apr2021 with outcome of unknown , low body temperature on an unspecified date with outcome of unknown , strange redness across her shoulders on 05Apr2021 with outcome of recovered , arm hurt after shot on 05Apr2021 with outcome of unknown , pressure in head on 05Apr2021 with outcome of unknown , very loose stools on 05Apr2021 with outcome of unknown , nausea on 05Apr2021 with outcome of unknown , brain fog on 06Apr2021 with outcome of not recovered , anxiety on an unspecified date with outcome of unknown. Hypertension was considered an Important Medical Event. The remaining events were non serious. The patient underwent lab tests and procedures which included blood pressure increased: 179/98, 170/97 on unknown date , blood pressure measurement: 152/87 on 06Apr2021 , body temperature decreased: low No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-04-30 | feeling abnormal |
acute lymphatic response/severe pain in lymph nodes, the ones around her ovaries/severe pain like cy...
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acute lymphatic response/severe pain in lymph nodes, the ones around her ovaries/severe pain like cysts except both sides were hurting; had trouble catching breath with the pain; arm pain; brain fog/head started feeling foggy and weird; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 16:00 (Lot Number: EN5318, Expiry date: 31May2021) on left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. Historical Vaccine included flu shots. The patient stated her physician told her she had an acute lymphatic response. She added there was something about 3 am (18Mar2021) because she woke up at 3 am and had severe pain in some of her lymph nodes. In particular, the ones around her ovaries. She added that she was old and her ovaries had not worked in a long time. She had severe pain like cysts except both sides were hurting. She also had trouble catching breath with the pain. This lasted 45 minutes and subsided. The next morning 18Mar2021, when she got up some of her lymph nodes were very panful and there was one even that was a node visible down her throat almost at the base of her neck in the center. She could see it sticking out, it was crazy. It went down in about three days. The pain and the weirdness in all of her other lymph's was about 3 or 4 days. It was an odd response and people told her it was just her body acting like a young person and was going to work. This was the first issue she had with the vaccines. The patient also experienced brain fog after first vaccine on 17Mar2021: within 2 or 3 minutes of having them her head started feeling foggy and weird. It was after the first vaccine, she thought it was psychological but it did not go away and it was not psychological. It was like a weird foggy and like taking sinus medication, no additional details. When it happened with the first vaccine, it did not concern her as much as the first one. It went away after the first vaccine probably late that evening (17Mar2021), around 10:30 pm right when her arm started to hurt. She did not have arm pain that was severe. She added maybe it lasted a day. The next day it hurt but it was not anything bad, it just hurt to touch it and to lift it hurt for a day. Maybe this was for 36-40 hours before the pain went out. The outcome of event "trouble catching breath with the pain" was resolved on 18Mar2021 03:45, outcome of event "brain fog/head started feeling foggy and weird" was resolved on 17Mar2021, outcome of other events were resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-04-30 | memory impairment |
memory issue; Got covid; Got covid; This is a spontaneous report from a non-contactable consumer. A ...
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memory issue; Got covid; Got covid; This is a spontaneous report from a non-contactable consumer. A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. On unspecified date, the patient was diagnosed with COVID and she just got out of hospital before day. The reason why the patient called was she was supposed to take the second dose next day. The patient was still under quarantine and her brother was supposed to get the shot. The patient cannot take him. The patient brother stayed with her cousin and he wanted to take the second shot. The patient was not underage but had some memory issues. The patients brother needed someone to be with him. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 59 | 2021-05-06 | confusional state |
Pt is a 59 YOF who received her first COVID-19 Pfizer vaccination on 4/16/21. She has PMH significan...
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Pt is a 59 YOF who received her first COVID-19 Pfizer vaccination on 4/16/21. She has PMH significant for diabetes mellitus type II, hypertension, COPD. Almost immediately post vaccine, patient started exhibiting signs of slurred speech and right side weakness. Patient started improving when being moved to triage however after a few minutes, slurred speech and confusion returned. 911 called and patient transported to ED. On admission neurology consulted and initial CT head negative. Patient received IV tPA and MRI brain was obtained which showed left medial pontine infarct. Diagnosis: Left pontine stroke. NIH 4 on admission and discharge. No history of TIA nor stroke. Unclear if stroke is related to vaccine...
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| 59 | 2021-05-07 | feeling abnormal |
Tiredness; brain fog; headache; Day 1 Sore arm; This is a spontaneous report from a non-contactable ...
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Tiredness; brain fog; headache; Day 1 Sore arm; This is a spontaneous report from a non-contactable Other Health Professional, the patient. A 59-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EK5730), via an unspecified route of administration as a single dose on 30Dec2020 for COVID-19 immunisation. The patient medical history was not reported. No allergies to medications, food, or other products reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium/magnesium/ vitamin d nos (CAL MAG), calcium carbonate/colecalciferol/phytomenadione (Vit D+K), fish oil (OMEGA 3) and multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020, the patient experienced sore arm on day 1 of vaccination and on 31Dec2020 experienced tiredness, brain fog and headache. No treatment was received for the events. The outcome of the events were recovered on an unknown date. No follow-up attempts are possible. No further information is expected.
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| 59 | 2021-05-07 | insomnia |
head pressure (specifically left ear area, also mild hearing loss left ear); Headache; head pressure...
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head pressure (specifically left ear area, also mild hearing loss left ear); Headache; head pressure (specifically left ear area, also mild hearing loss left ear); Tinnitus; loss of appetite; insomnia (still have tinnitus and ear pressure as well as insomnia); insomnia (still have tinnitus and ear pressure as well as insomnia); This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration (at the age of 59-years-old), administered in Arm Left on 23Mar2021 12:45 (Lot Number: ER8730) as single dose for COVID-19 immunization. Medical history included known allergy to penicillin. The patient was not pregnant. Not diagnosed with COVID prior vaccination. No concomitant medications received. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 59-years-old), administered in Arm Left on 02Mar2021 08:15 AM (Lot Number: EN6202) as single dose for COVID-19 immunization. The patient experienced headache, head pressure (specifically left ear area, also mild hearing loss left ear), tinnitus, loss of appetite, insomnia (still have tinnitus and ear pressure as well as insomnia) on 28Mar2021 12:00. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 30Mar2021. No treatment received for the events. The outcome of the events was not recovered. The event mild hearing loss left ear was considered as serious (medically significant). Facility type vaccine was Hospital. No other vaccine in four weeks.
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| 59 | 2021-05-07 | poor quality sleep |
spots where she bleeds from scratching; red spots on her arms that weren't there before. She wouldn'...
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spots where she bleeds from scratching; red spots on her arms that weren't there before. She wouldn't call those spots a rash; itching kept her up all night/ She was up all night; rash and welts and the rash was moving up in her face; welts; hands started itching/itching moved up her arms and down her legs and then her whole body was itching; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 05Feb2021 13:30 (Lot Number: EN5318) as single dose for covid-19 immunisation. Medical history included high blood pressure and did have surgery in Jan2021, a week before she received the Covid 19 vaccine. She had screws placed in her foot. Her foot had been injured from being twisted too many times. It was an old injury. Concomitant medications included atenolol; omeprazole; venlafaxine; and hydrochlorothiazide, valsartan (VALSARTAN/HCTZ TEVA); all ongoing. Probably about 15 years ago, she received a flu vaccine where her husband worked. His place of employment offered flu vaccines to employees and their families every year. She went to get the flu vaccine and that was probably around 9:00AM and by the time she got off work that day she was so sick with the chills that she crawled into bed. It felt like she had the flu. The next day she felt better just worn out. She hasn't had a flu vaccine since then. She received her first Covid 19 vaccine on 05Feb2021 and about 20 minutes after (05Feb2021 13:50), she received the vaccine her hands started itching and she didn't think a lot about it. As time wore on, the itching moved up her arms and down her legs and then her whole body was itching. By Sunday, 07Feb2021 she had a rash and welts and the rash was moving up in her face. She went to the emergency room on Sunday, 07Feb2021 because the rash was on her face. She was getting scared. She was miserable. She was taking Benadryl and it wasn't doing anything for her. The emergency room gave her a Benadryl injection and liquid steroids and prescribed 2 epinephrine pens (Epi-pens) in case she started to have problems breathing. She did not have trouble breathing. She also received pills to help with her itching. She was still taking those pills because she was still itching. As of 23Apr2021, it was still persisting nothing has improved slightly. It keeps her up at night, making her miserable, and described it as severe. She had spots where she bleeds from scratching. She was up all night two days ago because the itching was so bad. The pills do help but she has to work so she can not take too many or she will be asleep at her desk. Patient hoped that Pfizer would have something to tell her healthcare provider about what to do for her. She was advised by her doctor to not get the second Covid 19 vaccine. She went to her family doctor about a week later and explained what had happened with the Covid 19 vaccine and her doctor was able to review her emergency room visit paperwork. Her primary care doctor prescribed more of the pills for itching because she had gone through the pills that the emergency department prescribed. She reported that the rash has improved but at times, all of a sudden, she'll start itching and it's the type of itching that she can't stop scratching. With scratching it will grow into welts and a rash and then it goes away. She doesn't like to take the pills prescribed for itching because she doesn't like to take medicine. The itching kept her up all night in different parts of her body. The itching will ease down and then the itching will stop and then probably a good hour will pass and the rash will go away. The only thing that was left to see was where she scratched on her body. She still has red spots on her arms that weren't there before. She wouldn't call those spots a rash. The pill she was prescribed for itching is Hydroxyzine 25mg take one by mouth every 6 hours as needed for itching. This one helps but she doesn't want to take it because it can make her tired and she has to work. Outcome of the event "hands started itching/itching moved up her arms and down her legs and then her whole body was itching" was not recovered while unknown for other events.
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| 59 | 2021-05-09 | agitation, mental status changes |
o ED Course Medical decision making arrival to ED 5:54 am on 5/10/21 Patient with altered mental s...
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o ED Course Medical decision making arrival to ED 5:54 am on 5/10/21 Patient with altered mental status from an unknown cause. Her pupils were dilated and slow to react and she was in some respiratory distress and very diaphoretic. At this point airway was controlled 5 oh endotracheal intubation using the glide scope and during the intubation patient was noted for copious amounts of dark brown vomitus coming from her esophagus which was guaiac positive. Her blood pressure was low she was sedated initially with propofol etomidate was used for the intubation however because of her hypotension the propofol was slowed and she was given Versed which did seem to control her agitation and maintain her blood pressure. Patient had IV fluid initiated wide open and CT scan was obtained of head chest abdomen pelvis given the fact that her altered mental status could be from some kind of intracerebral catastrophe and the patient's abdominal exam being unobtainable certainly possible that her GI bleeding could be from a perforated viscus. CT scan of the brain does not demonstrate any stroke that appears to be acute however there may be some ischemia present although it may be remote and an MRI will need to be done when the patient is more stable. CT of the chest abdomen pelvis shows what is likely an aspiration pneumonia on the right as well as a perforated viscus in her abdomen. Radiology feels is probably somewhere in the right colon terminal ileum. At this point the patient was given Cipro and Flagyl and that should also aid with her aspiration pneumonia. Her blood pressure did start to decrease her temperature was noted to be elevated at 101.8. She was given Tylenol rectally and fluids were allowed to run wide open. Her blood pressure continued to decline and Levophed was instituted. Case was discussed in detail with surgery and she will go to the OR immediately. Her temperature continued to rise and was 104.5 upon transfer to the operating room as blood pressure was 78 systolic ED COURSE: o ED Course Medical decision making Patient with altered mental status from an unknown cause. Her pupils were dilated and slow to react and she was in some respiratory distress and very diaphoretic. At this point airway was controlled 5 oh endotracheal intubation using the glide scope and during the intubation patient was noted for copious amounts of dark brown vomitus coming from her esophagus which was guaiac positive. Her blood pressure was low she was sedated initially with propofol etomidate was used for the intubation however because of her hypotension the propofol was slowed and she was given Versed which did seem to control her agitation and maintain her blood pressure. Patient had IV fluid initiated wide open and CT scan was obtained of head chest abdomen pelvis given the fact that her altered mental status could be from some kind of intracerebral catastrophe and the patient's abdominal exam being unobtainable certainly possible that her GI bleeding could be from a perforated viscus. CT scan of the brain does not demonstrate any stroke that appears to be acute however there may be some ischemia present although it may be remote and an MRI will need to be done when the patient is more stable. CT of the chest abdomen pelvis shows what is likely an aspiration pneumonia on the right as well as a perforated viscus in her abdomen. Radiology feels is probably somewhere in the right colon terminal ileum. At this point the patient was given Cipro and Flagyl and that should also aid with her aspiration pneumonia. Her blood pressure did start to decrease her temperature was noted to be elevated at 101.8. She was given Tylenol rectally and fluids were allowed to run wide open. Her blood pressure continued to decline and Levophed was instituted. Case was discussed in detail with surgery and she will go to the OR immediately. Her temperature continued to rise and was 104.5 upon transfer to the operating room as blood pressure was 78 systolic CRITICAL CARE: o Critical Care Indication patient was critically ill... o Critical Care Indication Patient was critically ill with a high probability of imminent or life threatening deterioration. o Critical Care Time Spent 75-104 minutes (1 hour 15 minutes-1 hour 44 minutes) 2 hours and 50 minutes ED WORKING DIAGNOSIS: Perforated abdominal viscus (R19.8): Status: Active Septic shock (A41.9): Status: Active DISCHARGE/ADMISSION/TRANSFER DISPOSITION: o Disposition admitted o Admit To To OR CONDITION ON DISCHARGE/ADMISSION/TRANSFER: o Condition Critical Date of OR Procedure o Date of Procedure 05/10/2021 10:01 Pre Op Dx, Post Op Dx, Procedure o Pre Operative Diagnosis: Perforated viscus o Post Operative Diagnosis: Ischemic bowel, most likely from shower emboli. Most of the small intestine and large intestine was affected. o Procedure: Exploratory laparotomy, ICG injection for evaluation of perfusion Indication and Consent Findings: . Findings: Even after the ICG injection. There was spotty tissue necrosis from mid jejunum all the way through sigmoid colon. Most areas were blackened with a foul smell. There was some highlighted areas secondary to the ICG but not a significant amount that would lend for an anastomosis. Black ascites was present throughout the abdomen. Unfortunately after much contemplation there was no surgical intervention. Procedure Procedure: Patient was placed in supine position. Was intubated in the emergency room so, we were able to proceed with resuscitation through our anesthesia team. Patient's abdomen was prepped and draped in usual fashion. Proceeded to make a midline incision. The blood supply in the subcutaneous tissues did not even bleed. Appeared to be darkened and almost coagulated. As we entered through the fascia we were able to open the peritoneum between 2 hemostats. The large rush of free air through from the abdomen. We then proceeded to open the abdomen for the length of her incision. This was done with electrocautery. From here there was a black ascites present within the abdomen. There was a large amount of dead intestine that we could immediately see. I worked my way to the ligament of Treitz. There was no adhesions so this was easily found. That intestine did appear to be pink. It lasted for about a foot. After that area everything was either black or purple in color with a few pink spots in between. This went all the way down to the terminal ileum where pneumatosis was visualized. We then looked at the colon from cecum through rectum. It appeared to be blackened as well. Not knowing whether all of this intestine was dead or not especially with patient being hypotensive I injected ICG dye approximately 2 cc. This was to evaluate perfusion. Unfortunately perfusion was no better than what I could visualize. I could not even find enough room of the colon or small intestine to make an anastomosis. Was very hard decision, however, we did not resect any bowel. I closed the patient's abdomen. Patient will be taken to ICU on ventilator. Discussed with daughter with pastor present.
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| 59 | 2021-05-10 | impaired work ability, feeling abnormal |
I felt feverish and tired the day after which I expected. But I never really felt "myself" after, a...
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I felt feverish and tired the day after which I expected. But I never really felt "myself" after, always a bit tired. Then 8 days later had stomach distress and aches and pains and have so much fatigue it is difficult to work. I do not have covid, and have not been anywhere to be exposed to anything else. I also have severe back pain that started after my first shot.
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| 59 | 2021-05-14 | insomnia, memory impairment |
weak; blood pressure (BP) and it was 131/104, her pulse was 104; cognitive problems/forgetting words...
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weak; blood pressure (BP) and it was 131/104, her pulse was 104; cognitive problems/forgetting words/forget what she was going to say it would take a while, like a brain fog; forgetting words/forget what she was going to say it would take a while, like a brain fog; she would forget what she was doing; she felt unwell; she was wheezing a bit; exhaustion; cough; body aches/bad pain; pain in all of her left arm where she got the injection; pain in the left side of chest; her heart was hurting; her heart was really pounding, like she was in a race/pulse was 104; her temperature it was not too high, it was 99.5 so not over 100; very severe headache with dizziness; nausea; very severe headache with dizziness; she could not fall asleep; pre-existing condition (chronic motility issues) got worse; pre-existing condition (chronic motility issues) got worse; upset stomach; severe abdominal pain; This is a spontaneous report from a contactable consumer (who is also the patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170), via an unspecified route of administration, on 16Apr2021, as 1st dose, single, for COVID-19 immunisation. Medical history included hypotension from an unspecified date, and chronic motility issues from 2017 and ongoing. The patient's concomitant medications were not reported. On 16Apr2021, the patient received the first dose of BNT162B2 and got slightly dizzy immediately after the vaccine. Her arm did not hurt, and she was okay until she went home. She had nausea and headache. She went to sleep and woke up after 12 midnight (17Apr2021) with a really bad headache and her heart was pounding like she was in a race. She also had pain in all of her left arm where she got the injection, body aches and pain in the left side of chest, like her heart was hurting. She checked her temperature it was not too high; it was 99.5 so not over 100. She took Tylenol 100 mg. She woke up at 2:00 and still had headache. It took all night to help her headache and she took another Tylenol 500 mg. When she woke up next morning, she still had a headache but not as severe. She thought okay this is going to be the usual thing and go away in a couple of days. She reported that from 16Apr2021, she could not fall asleep and would get a headache which got worse as she was not falling asleep. On 17Apr2021 and 18Apr2021, the patient experienced really bad pain, her arm was hurting, and she kept taking Tylenol. On 18Apr2021, she started coughing so she took Robitussin for the cough. On the same day, 18Apr2021, she had body aches, nausea and was exhausted. She mentioned that she is a very active person, an avid cyclist, and normally walks 10 miles, but when she walked a couple of miles, she was exhausted and could not do anything else. It was very difficult for her and it was unusual. She was still experiencing the events on 19Apr2021 and 20Apr2021. So, on 21Apr2021, she went to her primary care physician's office but saw another doctor who was available that day. The doctor checked if her legs were swollen and checked her lungs. The doctor stated the patient was wheezing a bit but did not see anything else. The doctor advised her not to take the second dose. The patient mentioned that her pre-existing condition (chronic motility issues) got worse. In Apr2021, experienced upset stomach, severe abdominal pain. On 22Apr2021, she woke up and felt totally fine. She thought the symptoms were finally going away. But at 17:00, she felt unwell, had body pain, headache, and she was coughing again. She went to sleep and woke up on 23Apr2021 at 04:30. She woke up with a severe headache, extreme nausea (no vomiting), was really weak, dizzy, absolutely exhausted. She still had exhaustion, nausea, body aches, and cough. She checked her blood pressure (BP) and it was 131/104, her pulse was 104. She took Tylenol 1000 mg and the symptoms did not go away so she took another Tylenol 500 mg. After an hour, her headache was not better, dizziness was bad, but her BP was going down. She called the nurse line and was advised to go to the ER. At the ER, she was given IV fluids to hydrate and pain medications. She was then tested for COVID-19 which came back negative. The patient also had cognitive problems. By the time she got to the ER, she was forgetting words (she would try to say something and she would forget what she was going to say it would take a while, like a brain fog) and she would forget what she was doing. She would catch herself forgetting and not remembering words. The patient wanted to know if she should get the second dose, how long should she wait until she gets her second dose, how long do the side effects last, will the side effects from the second dose be worse, how the vaccine works, asked the ingredients of the vaccine, and asked if there is a need for a third dose. The patient assessed the events dizziness, nausea, headache, pain in arm, chest pain, fatigue, body aches/bad pain and cough as serious (medically significant). The patient was recovering from dizziness, headache, body aches/bad pain, hypertension, cognitive disorder, aphasia and memory impairment. The outcome of the events nausea, fatigue, and cough was not recovered. The outcome of the remaining events was unknown.
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| 59 | 2021-05-19 | feeling abnormal |
Developed tinnitus shortly after2nd vaccine/ Within 2 days of 2 bf vaccine on 20Feb2021 o developed...
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Developed tinnitus shortly after2nd vaccine/ Within 2 days of 2 bf vaccine on 20Feb2021 o developed tinnitus in my left ear and fullness; I have had a constant hissing sound in my head since with little relief; This is a spontaneous report from a contactable other health care professional. A 59-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 20Feb2021 (Batch/Lot number was not reported; 59-years age at time of vaccination) as single dose for covid-19 immunisation. The patient medical history was not reported. The concomitant medications includes Statin. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in Left arm on 30Jan2021 12:00 for COVID-19 immunisation. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination includes Statin. On 21Feb2021 13:00, patient developed tinnitus shortly after2nd vaccine within 2 days or so. have now had it for 6 weeks. Also reported "Within 2 days of vaccine on 20Feb2021, developed tinnitus in my left ear and fullness. I have had a constant hissing sound in my head since with little relief. I have never had tendinitis or experienced anything like this it has been debilitating I am furious and expect a response from Pfizer". treatment received with Vitamins, treated with steroid. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The events outcome was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Tinnitus and Fuzzy head. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 59 | 2021-05-19 | memory impairment |
stroke like symptoms; similar to migraines; mini-strokes; Passing Out; Blind spots in her vision; Na...
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stroke like symptoms; similar to migraines; mini-strokes; Passing Out; Blind spots in her vision; Nausea; Believes it effected her memory; stroke like symptoms; similar to migraines; mini-strokes; This is a spontaneous report received from a contactable consumer. A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Apr2021 (Lot Number: EW0153; Expiration Date: 31Jul2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 59 years). Medical history included ongoing strokes, ongoing third and fourth Nerve Palsy. Concomitant medications included dabigatran etexilate mesilate (PRADAXA) taken for blood thinner; metoprolol for Stroke, Heart regulation; lovastatin taken for Stroke, Heart regulation. The patient states that she went to the Emergency Room on 17Apr2021 and then went again on either 18Apr2021 or 19Apr2021. The patient states she does not know if she was admitted or not. States that she thinks she just was in the emergency room the time that she was there. Says that after the Covid Vaccine she was having stroke like symptoms; similar to migraines; mini-strokes. She was passing out, had nausea, blind spots in her vision, and she believes it effected her memory. The events occurred on 17Apr2021. Also, she said on her first emergency room visit they did a CT Scan and on her second emergency room visit they did a MRI and both was not reported. States they told her there was no issues. The patient underwent lab tests and procedures which included CT Scan: and MRI: not reported on Apr2021. Outcome of the event vision impairment was not recovered while outcome of the event nausea was recovered on Apr2021. Outcome of the event memory impairment was recovering while outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-05-19 | nervousness |
Immediately after administration, patient stated tingling in throat, sweating and shakiness. Asked ...
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Immediately after administration, patient stated tingling in throat, sweating and shakiness. Asked if patient is diabetic ( she did say no to all chronic health conditions on question form). stated she could be hypoglycemic and nervous. We monitored for 5 minutes and she complained of difficulty breathing upon which I asked if she wants me to administer EpiPen and she said "yes". I administered EpiPen 0.3mg in right tight. After EpiPen she seamed to calm dowm. 911 was called as the EpiPen was administered. After EMS came, patient walked on her own to get her vitals checked. Shortly after leaving, pharmacy received call from patient her self that she is home and feel normal. Followed up with patient an hour later and she is still doing well.
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| 59 | 2021-05-25 | anxiety |
Anxiety; Blood Pressure increasingly getting higher; This is a spontaneous report from a contactable...
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Anxiety; Blood Pressure increasingly getting higher; This is a spontaneous report from a contactable patient. A 59-year-old adult non-pregnant female patient received first single dose of BNT162B2 (batch number was EL9264) via an unspecified route of administration on right arm on 12Feb2021 at 12:30PM for COVID-19 immunisation. Medical history included severe kiwi allergy (IGE Level of 56) and negative reactions to gabapentin and penicillin, unknown autoimmune disease with erosive arthritis, hypothyroidism, hypertension. Concomitant medications (within 2 weeks of vaccination) included adalimumab (HUMIRA), lisinopril for hypertension, levothyroxine, omeprazole. Prior to vaccination, she was not diagnosed with COVID-19 and no other vaccines was received within 4 weeks prior to the COVID vaccine. She has undergone nasal swab test on 01Mar2021 and 08Mar2021 (after the vaccination) and was tested negative both the time. On 22Feb2021, within one minute of receiving vaccine, her heart started racing and fluttering. So, her doctor at the clinic told her it was anxiety. When she left 30 minutes later, it was at 120 beats per minute. One hour later when BP (blood pressure) was checked it was high, and increasingly getting higher. Within 3-4 hours, it reached 184/121 (unit unknown) with a heart rate of 120-130 (unit unknown). It remained elevated for three days, with an increased dose of lisinopril being taken. The increased dose of lisinopril (from 2.5 mg to 5.0 mg) has been continued (she did this myself - she could not reach her doctor) and BP was down, but higher than it was on the 2.5 mg. She called my PCP (primary care physician) and told the staff what was happening and she has have not heard back despite her efforts to reach him. Therefore, she ended up in urgent care that first evening and they really didn't do anything at all, except telling her to go to emergency room if it gets worse. She did not feel like if she has recovered 100 percent. No other therapeutic measures were taken to treat these events. The clinical outcome of the events blood pressure reading high and anxiety was reported as recovered/resolved with lasting effects (sequalae). No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-05-25 | feeling abnormal, confusional state |
Within 2 minutes and her heart rate was over 112 beats per minute. Alsolso felt dizziness, lighthead...
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Within 2 minutes and her heart rate was over 112 beats per minute. Alsolso felt dizziness, lightheaded, vertigo, brain fog, tinnitus, rash on upper back, puffy red lips, white spots on the soles of the feet, stomach cramps, had problems forming sentences,had a hard tine even trying to call husband, itchy eyes, felt itchy and hot on her injection arm, had difficulty breathing, had to to take deep breaths, chills, freezing, headache, tongue started to swell, neck started to swell in the thyroid area, started to feel tired and sleepy, had to get assisted to the bathroom, the walls started to move in. The patient took Claritin 1 hour and a half i because they didn't want to give her her epi pen because her heart rate was too high and she is allergic to Benadryl. Stayed at the site for 2 hours, drank a lot of water, couldn't walk and she had to stay in a wheelchair. She said it took around 2 weeks to feel normal. She had spells of feeling dizzy and confused with brain fog for 2 weeks. Felt tinnitus for around 10 days after the vaccine. tinitis lasted 10 days brain fog 2 weeks: didn't know how to figure out how to turn car on. fatigue lasted about 4 weeks white spot on feet went away 2 weeks.
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| 59 | 2021-05-28 | feeling abnormal |
The day after my second injection I began to feel Painful Numbness & Tingling in my hands/arms and m...
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The day after my second injection I began to feel Painful Numbness & Tingling in my hands/arms and my legs and feet. Swelling of my legs & feet, socks leaving big indents in my skin. Off and on headaches, an intense itch at times, all over, blisters on my butt(2) that "popped" and left the skin open and raw. I also just feel "off", do not feel like myself, a little bit unsure about my footing...
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| 59 | 2021-05-31 | loss of personal independence in daily activities |
on same day as 2nd injection I began to have flu like symptoms and a fever of 103-104 this continued...
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on same day as 2nd injection I began to have flu like symptoms and a fever of 103-104 this continued for 4 days until 3/9/21. Since then my temperature seldom goes below 99 degrees and everyday I wake up fatigued and aching. I did not have these symptoms prior to the injections. It really makes it hard to get through the day or accomplish normal physical tasks. I want to know when I can expect to feel better. I really hope someone reads this message.
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| 59 | 2021-06-01 | excessive sleepiness |
3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with l...
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3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; Could not lift my arm and the pain was like an 8 of 10.; 3 days & 9 hours after 2nd vaccine I broke out in a rash on my chest neck and behind my ears, with lumps under my skin and felt hot.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non stop until 6pm that evening.; Also my left arm hurt so bad for 3 days; with lumps under her skin; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EWO179) via an unspecified route of administration on left arm on 03May2021 11:30 as 2nd dose, single for covid-19 immunization. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EWO158) via an unspecified route of administration on left arm on 12Apr2021 at 10:30 as 1ST DOSE, SINGLE for COVID-19 immunisation. Known allergies were none. Medical history and concomitant medications were not reported. She did not take any other vaccine in four weeks and no other medications within two weeks. On 06May2021 at 20:30 3 days & 9 hours after 2nd vaccine patient reported that she broke out in a rash on her chest neck and behind her ears, with lumps under her skin and felt hot. Took Benadryl at 21:00, in morning rash moved to stomach and left side. Event resulted in Doctor or other healthcare professional office/clinic visit. Then took Claritin and it disappeared. Day 6 woke up with headache (front forehead) and had dry heaves for about an hour and then slept non-stop until 18:00 that evening. Also, her left arm hurted so bad for 3 days that she took Tylenol on day 2 after vaccine. Could not lift her arm and the pain assessment was like an 8 of 10 on 06MAY2021. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. The clinical outcome of all events was resolved on an unspecified date of 2021. No follow-up attempts are possible. No further information is expected.
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| 59 | 2021-06-02 | disturbance in attention |
I had overall pain and low fever (100's F). Pain in my joints, fatigue, Felt very tired. After 4 wee...
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I had overall pain and low fever (100's F). Pain in my joints, fatigue, Felt very tired. After 4 weeks my right wrist was swallow. Called the doctor and told her about my condition and had difficult time concentrating. He gave me another medicine for the pain. Still have the pain. Contacted a Primary Care Doctor and gave pain medication (Midodrine).
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| 59 | 2021-06-02 | loss of personal independence in daily activities, sleep disorder |
My left should and upper arm, started becoming sore and stiff the same evening I received the inject...
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My left should and upper arm, started becoming sore and stiff the same evening I received the injection which was on a Friday and by Sunday my arm was very painful and I could not move my arm in any direction. Dr. diagnosed it as being a frozen shoulder due to the injection being improperly administered. Currently going through 8 weeks of physical therapy and if my arm and shoulder haven't had significant improvement by the end of June, I may have to have surgery. Constant pain every day now for 3 months, can't sleep well as pain keeps me up at night, difficulty getting dressed and undressed, driving a car and doing my hair, can't lift anything and every time after therapy I suffer from severe pain for two to three days after.
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| 59 | 2021-06-03 | feeling abnormal |
Feeling funny; face, hands, arms redness; This is a spontaneous report from a contactable consumer, ...
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Feeling funny; face, hands, arms redness; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old, non-pregnant female patient received first dose of BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine; lot number ER2613) via an unspecified route of administration on arm left as a single dose for COVID-19 immunisation on 18Mar2021 at 16:00 hours. The patient's medical history reported of diabetes 2, transthyretin-mediated amyloidosis and irritable bowel syndrome. The patient had allergies to sulfa, PHENERGAN, lisinopril, codeine, MINOCIN. The concomitant medications included BASAGLAR, CELEXA, losartan (MANUFACTURER UNKNOWN), NOVOLOG and simvastatin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 18Mar2021 at 16:15, approximately 15 minutes after injection the patient began to feel funny. On same day, the patient noticed she was turning red. The patient was taken to medication area for evaluation. The patient feeling off got progressively worse as did the redness and the patient also had redness on face, hands and arms. 50 mg of BENADRYL was administered via intramuscular route. After about 30 minutes reaction had subsided and it took about 3.5 hours before she felt herself again. The clinical outcome of the events feeling funny, redness on face, hands, arms was recovered on 18Mar2021. No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-06-03 | nervousness, anxiety |
pt. feels heart rate fast upon assessment at 230pm 168/86 pulse 77 @245 bp 169/95 pulse 76 at 3pm 16...
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pt. feels heart rate fast upon assessment at 230pm 168/86 pulse 77 @245 bp 169/95 pulse 76 at 3pm 168/104/84 no pain no SOB pt. is advised to go to the ER for high bp ans sweating. patient stated it happens to her before she will talk to her physician. patient refused to go to the ER - Signed statement patient stated she feels nervous and having anxiety BP will lower down when she feels calm. - Patient
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| 59 | 2021-06-03 | sensation of foreign body |
PATIENT WAS MONITORED FOR 15 MINUTES BUT STATED SHE FELT LIKE SHE HAD A LUMP IN HER THROAT. SHE HAD...
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PATIENT WAS MONITORED FOR 15 MINUTES BUT STATED SHE FELT LIKE SHE HAD A LUMP IN HER THROAT. SHE HAD NO SHORTNESS OF BREATH OR ANY OTHER REACTIONS. SHE KEPT SAYING HER THROAT WAS BOTHERING HER AND SHE ASKED US TO CALL EMS. THEY ARRIVED AND SHE LEFT WITH THEM.
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| 59 | 2021-06-07 | insomnia |
couldn't read or write; couldn't read or write; inflammation in the tongue; cannot turn from her nec...
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couldn't read or write; couldn't read or write; inflammation in the tongue; cannot turn from her neck because it was swollen; couldn't sleep and toss and turn; Sweating; sharp pain in her head; pain from her neck; sharp pain coming from her ear; feeling the pain/feeling the pain when laying down and she cannot handle the pain; It hurt, even when eating her throat hurt and it hurt to swallow and pass food; gaining weight; cheek and tongue swollen, it was swollen; cheek and tongue swollen, it was swollen; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Jan2021 (at age of 59-year-old) as single dose for covid-19 immunisation. Medical history included ongoing human immunodeficiency virus (HIV). The patient's concomitant medications were not reported. Patient received the first dose of Covid vaccine on 28Jan2021. Patient had inflammation in the tongue and she cannot turn from her neck because it was swollen. It was been 3 months since she received the vaccine (Apr2021). She went to the emergency room and also to her primary care provider and they just cannot find anything. She has had it, the vaccine, and it was good and she had good health when she got the first dose. Mentioned she couldn't read or write. On unspecified date in 2021, she would like to file a safety report because at night she couldn't sleep and it felt like a sharp pain in her head and she started sweating. Feels the pain from her neck and sharp pain coming from her ear. She couldn't sleep and toss and turn. Told the doctor and was informed to buy pills to sleep and even with the pills the pain still wakes her up. Clarified pills as Melatonin. Mentioned she had called before to this number (Pfizer), but they just do not answer. Has tried this number a couple days ago. Had not spoken to safety. Wanted to know what to do because she was feeling the pain. What was she going to do during the day when feeling the pain when laying down and she cannot handle the pain. She went 3 times to the emergency room and 3 times to the primary care provider and they cannot recommend anything because this was from the shot she was given. Wanted to know if the doctor couldn't give her any medicine, why did they give vaccine to her. Said if she took this to the tv or media and said she got the vaccine and it was not working and cannot get any good advice for a doctor what was she to do. Not sure if it was because she does not understand because she does not read or write. Has been gaining weight even though she did not eat. The inflammation of the tongue was noticed since the first vaccine. She had called the doctor and he told her to take allergy pills. So she went to the pharmacy, got it and nothing it did help her. She still felt like that with the cheek and tongue swollen, it was swollen. Clarifies pilled as Benadryl. Issues, pain with neck have all been since the first vaccine and it got worse after the second dose. It hurt, even when eating her throat hurt and it hurt to swallow and pass food. Went to the emergency room 15 days after the second dose because she could not handle the pain. The sharp pains, sweating, pain in ear came and gone and really felt it when laying down she felt the sharp pain in the head. Had to be upside down in order to feel better. The pain waked her up from sleep. No other vaccines given the same day and no problems with vaccines in past. At clinic there were tests ordered and exams, x-ray for the neck and on Tuesday they took 5 bottles of blood to see what the labs look like. When she was at the emergency room, they took x-rays and the doctor ordered those exams and all came out fine. They gave her the shot (covid) so soon because she has HIV. She was perfectly fine for 19 years and was fine with all her medicines and treatments. All exams came out fine and everything. Clarified HIV (human immunodeficiency virus) diagnosed and treatment/medications were before she received the Covid vaccines. The outcome of the events "feeling the pain/feeling the pain when laying down and she cannot handle the pain", "gaining weight", "cheek and tongue swollen, it was swollen" was unknown, for other events was not recovered. Information about lot/batch number has been requested.
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| 59 | 2021-06-07 | loss of personal independence in daily activities |
I got a really really bad severe case of vertigo; Nausea; Dizziness; Headache; Fatigue; My backache ...
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I got a really really bad severe case of vertigo; Nausea; Dizziness; Headache; Fatigue; My backache that problem have like tripled it got much much worse since I got the shot you know like the muscle ache you know my arm hurt really bad; My backache that problem have like tripled it got much much worse since I got the shot you know like the muscle ache you know my arm hurt really bad; My backache that problem have like tripled it got much much worse since I got the shot you know like the muscle ache you know my arm hurt really bad; I didn't feel good; I couldn't eat, couldn't walk, couldn't get myself once a dinner; I couldn't eat, couldn't walk, couldn't get myself once a dinner; Abdominal discomfort; I couldn't eat, couldn't walk, couldn't get myself once a dinner; This is a spontaneous report received from a contactable consumer (the patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EW0187, Expiration date: not reported) via an unspecified route of administration in left arm on 24May2021 (Monday) (at the age of 59 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history included Asthma, Head trauma, Had car accidents, Allergies from on unknown date and unknown if ongoing. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for Asthma and loratadine (CLARIDIN) taken for Allergies on daily, start and stop date were not reported. On 27May2021, Patient stated that got a really really bad severe case of vertigo yesterday which was like what 72 hours after the shot, I got it on monday and it happened yesterday so I woke up with it like actually like really bad nausea and severe vertigo and I still have it and you know I can't get to a doctor to get it or therapist to get it treated because they don't have any availability but I tried to doing head movement myself but I haven't really had any relief. Consumer stated, when I got vertigo it can take weeks for it to go away. Unless I can get treatment from a therapist who specializes and then she was not available then I can suffer for weeks so three weeks from now you know If we gonna get severe dizziness and vertigo that's gonna really distrust people from gonna go and get the second one. I went for my shot at noon time on Monday and then on Thursday, 27May I woke up with really upset stomach which is typical in vertigo. So, I got severe vertigo exactly 3 days later so a little bit less than 24, 48 a little bit less than whatever it is 72 hours later. Consumer stated, Yeah but you know what else I got within 5 minutes of getting the shot I started getting the horrible headache and then It just got progressively worse. I mean my asthma so you know I have like a lousy immune system (further not clarified) so I think I'm more prone to having side effects but I didn't realize it was gonna be that bad also so on the 24 within 5 minutes of getting it. I've started getting wild headache and then horrible headache and I took Motrin for like 24 hours(treatment) and it didn't even help the headache not one single bit. It was so like my head was like in a vice like someone was squeezing it in a vice that's how severe it was like to disabling. On May2021, I couldn't eat, couldn't walk, couldn't get myself once a dinner or anything. It was terrible that's how bad it was so and then you know the nausea started immediately so a mild upset stomach on May2021 for about 48 hours and then the third day it was much much more worse because of the vertigo so it was severe headache all over. It was horrible, it felt like someone was hitting the head with sludge hammer and the dizziness started immediately on 24May2021, the headache started immediately on 24May2021 and the extreme fatigue on 24May2021 that haven't gone away since I got it. So I don't know what you need to write down but that's it. Those are side effect. and then I take on a daily basis for my bad back I mean I have really really bad back on 24May2021, so I've actually my backache seems to when I took Motrin(treatment) obviously but my backache that problem have like tripled it got much much worse since I got the shot you know like the muscle ache you know my arm hurt really bad for 48 hours the minute it stopped, but my bad back has been horrible since I got the shot because its been much much worse and like I said I haven't done anything to exacerbate so. Then the vertigo started 3 days, little bit less than 3 days later I woke up with it horrible vertigo pretty severe. It was slightly better today, well it was earlier but the more I move around so since I got the shot 4 days ago the more I move around the more I do whether its like doing laundry getting lunch or whatever like the dizziness will just come back like full force. If I try to sit and rest and don't leave and only watch TV it stabilizes a little bit but yeah the dizziness I've talked to a lot of people and they've all had the side effect not just from the shot I got but from the other shots as well. So, Its crazy. Consumer stated that I don't know, I will try to go back in the couple of weeks. So, whatever date that is, 14 may be. On 14Jun2021 I'm gonna try to go back. These are the 14 or 15 but they just told to come back in 3 weeks afterwards so that's what I'm gonna do. Medical Condition was reported as so I have you know thin fever but I don't have any other issue the only thing I have is asthma you know all my doctor saying Oh you have asthma so you should really get it so like an idiot If I had known I was gonna have this horrible you know side effect the first time I never would have getting it first place so you know that all these people would these horrible side effects are saying screw it we are not gonna get back for second shot you know who wants to suffer like this again its been an entire week and I'm not any better than I was on Monday So, you know the headache is better the upset stomach is better but the dizziness I can deal with the headache and the upset stomach but the vertigo, if you have ever experienced it. It is pure hell because you know you can't lay down and sleep you can't and I live alone so that's really scary you know what I'm saying. I can't get anything to eat. I can't go out. I can't drive when I get vertigo but I do have a history of it. I think the last time I had it might've been like February or March maybe when I get treated for it you know but I haven't done anything at all to set it off. I haven't been doing any heavy lifting or heavy cleaning or bending or whatever which sometimes sets it off. So, I'm just you know been resting since Monday. I haven't done anything or left the house. The outcome of the events she got a really really bad severe case of vertigo, nausea was not recovered and other events were reported as unknown. Information on Lot/Batch number was available. Additional information has been requested.
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| 59 | 2021-06-07 | memory impairment, feeling abnormal |
A couple of days not more than a week after the vaccine was administered I got heart palpitations,...
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A couple of days not more than a week after the vaccine was administered I got heart palpitations, heart racing, headaches and tiredness and very forgetful and did not feel l like myself. I still have some of these symptoms but not as often.
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| 59 | 2021-06-08 | impaired work ability |
3 weeks post vaccine on March 15 at 10 am, I began to have severe abdominal epigastric pain for 3-4 ...
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3 weeks post vaccine on March 15 at 10 am, I began to have severe abdominal epigastric pain for 3-4 weeks, severe knee joint pain never experienced before and seems to be progressing, heart palpitations and arrythmias, nausea, fatigue, still occuring and have never experienced any of this prior to vaccine. I have had to miss work due to illness and I NEVER do that. I am a retired Veterinarian and cannot explain any of this except for the vaccine
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| 59 | 2021-06-08 | insomnia |
After about 15 to 16 days, patient reported hives/rash that are round in shape with sharp clear bord...
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After about 15 to 16 days, patient reported hives/rash that are round in shape with sharp clear borders. Initially light red in color, turned red then dark red, then faded with border becoming more diffuse. Rash occurs on right thigh and back of right arm. The rash feels hot, a feeling of heat, like she was touching a hot burner. Vaccine was administered on right deltoid. Severe insomnia, could not sleep at all. Headaches. Today 6/9/2021 the rash appears to have subsided, became more diffuse and lighter but still there.
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| 59 | 2021-06-08 | sleep disorder |
Chief Complaint Patient presents with ABDOMINAL PAIN Pt reports right sided abd pain almost to right...
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Chief Complaint Patient presents with ABDOMINAL PAIN Pt reports right sided abd pain almost to right flank area since last night with urinary frequency and soft stools x 2 days HPI Per patient during my interview: Patient presents emergency department as noted above. Patient with right-sided flank and abdominal pain since last night. Patient notes lately evening and kept her up most of the night. Notes she had difficulty sleeping or finding a position of comfort due to discomfort. Had to lay on her left side. Reports pain persistent mainly when taking a deep breath. Also somewhat tender in the right upper quadrant. No nausea or vomiting. No fevers or chills. No lower abdominal pain. Denies any urina HPI Per patient during my interview: Patient presents emergency department as noted above. Patient withm right-sided flank and abdominal pain since last night. Patient notes lately evening and kept her up most of the night. Notes she had difficulty sleeping or finding a position of comfort due to discomfort. Had to lay on her left side. Reports pain persistent mainly when taking a deep breath. Also somewhat tender in the right upper quadrant. No nausea or vomiting. No fevers or chills. No lower abdominal pain. Denies any urinary complaints. No vaginal complaints. No recent cough or URI symptoms. She works from home and denies any Covid contacts. No prior history of gallstones or kidney stones. She states she is uncomfortable however denies having taking any medicine at home. Has had normal bowel movements and did so this morning. Did not relieve her pain. Felt like she had trapped gas. Denies alcohol. She is otherwise in her baseline health. Physical exam: Constitutional: BP 126/46 | Pulse 75 | Temp 98.6 °F (37 °C) | Resp 18 | Ht 1.6 m (5' 3") | Wt 91.6 kg (201 lb 15.1 oz) | SpO2 96% | BMI 35.77 kg/m² No acute distress. Does not appear ill. Speaking clear and coherent sentences. Pleasant and articulate. No cause was found. No treatment was provided. The pain slowly went away on its own over several days.
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| 59 | 2021-06-08 | sleep disorder |
The next day after vaccine on 04/13/2021 I was lethargic. I drank lots of liquids. I was very tired ...
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The next day after vaccine on 04/13/2021 I was lethargic. I drank lots of liquids. I was very tired with a headache, nausea, chills (very slight). 04/15/2021 I woke up in the middle of night and it felt like the nerves in my body were exposed and the next day I didn't have that pain anymore but I was still very lethargic. Nausea went away pretty quickly. The 2nd week after vaccine, I had the same pain but in my upper thigh and wrist. The following week I ended up with shingles. I did go to the Doctor that diagnosed me with shingles. 2 weeks after I noticed a thick red band on my mouth towards my neck. I started on antiviral medications that the Doctor prescribed me.
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| 59 | 2021-06-09 | agitation, nervousness |
at 25 minutes after injection, left side of my throat felt numb; Red rash developed on right throat ...
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at 25 minutes after injection, left side of my throat felt numb; Red rash developed on right throat andspread to chest and left side of throat; Agitated; Shaky; Hard toswallow; Blood pressure went highover 200; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on the right arm on 15Mar2021 at 14:00 (at the age of 59-year-old), as single dose for COVID-19 immunisation. Medical history included hypothyroidism, high blood pressure, kidney cancer. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included lisinopril, levothyroxine, milk thistle. Past drug included penicillin for which patient developed allergy. On 15Mar2021 at 14:25, after 25 minutes of vaccination, the patient's left side of the throat felt numb, then a red rash developed on right throat, spread to chest and then to left side of throat, then patient felt agitated, shaky, was unable to swallow and blood pressure went high over 200. After about 30 minutes events started to reverse. It was unknown whether the patient received treatment for the events. The clinical outcome of events numbness throat, red rash, agitated, shaky feeling, unable to swallow and blood pressure went high was resolved in Mar2021. Information about lot number cannot be obtained. No further information is expected.
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| 59 | 2021-06-09 | memory impairment, loss of personal independence in daily activities |
found on the floor between the toilet and wall.; Shortness of breath; has a cough and is bring up co...
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found on the floor between the toilet and wall.; Shortness of breath; has a cough and is bring up cold stuff; She was so sick; Diarrhea; Chills; Fever; Nausea; Headache; couldn't get out of bed; remembered getting up and going to the bathroom but doesn't remember much after that; She was told she was allergic to the shot; pain in pelvis area; she was dehydrated; she was not able to give urine; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered into the arm on 01May2021 (at the age of 59-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease for 5 years, ongoing asthma for 5 years and smoking. The patient's concomitant medications were not reported. On 03May2021, patient was reportedly so sick, she was having diarrhea, chills, fever, nausea, headache and couldn't get out of bed; the patient remembered getting up and going to the bathroom but doesn't remember much after that, her husband found her on the floor between the toilet and wall. The ambulance was called and patient was brought to the emergency room. Patient was told that she was allergic to the shot. Patient underwent MRI and X-ray to check her pelvis because she was in pain in the pelvis area but with unknown results on 03May2021. It was reported that due to dehydration she was not able to give urine on 03May2021. It was also reported that on 03May2021 she had shortness of breath, has a cough and is bring up cold stuff, that is why she was using a breathing machine. The patient received treatment for the events "found on the floor between the toilet and wall", "she was dehydrated", "she was not able to give urine" and "Nausea"; patient was kept for 12-13 hours in the emergency room treated with antibiotics and other medications. Outcome of events "shortness of breath", "has a cough and is bring up cold stuff", "headache" was recovering; events "found on the floor between the toilet and wall", "she was so sick", "remembered getting up and going to the bathroom but doesn't remember much after that", "she was dehydrated", "she was not able to give urine" and "was told that she was allergic to the shot" recovered on an unspecified date; the outcome of all other events recovered on an unspecified date in May2021. Information on the lot/batch number has been requested.
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| 59 | 2021-06-10 | feeling abnormal |
strong pain in his abdomen and right side of his body; strong pain in his abdomen and right side of ...
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strong pain in his abdomen and right side of his body; strong pain in his abdomen and right side of his body; took his body temperature and it was at 99.14 Farenheit (F); He checked his temperature which was recorded as 101.66 F; he recorded his temperature to be at 101.67 F; patient was feeling bad; he felt bad all Friday and was in bed for the whole day; This is a spontaneous report received. A contactable consumer (patient) reported a non-pregnant 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unknown route of administration, administered on left arm on 02Mar2021 16:00 (Batch/Lot number: EL9262) as 1st dose, single dose (at the age of 59 years old) for COVID-19 immunisation. Patient's medical history included Barrett's esophagitis (Barret esophagus) on an unspecified date and penicillin allergy. Concomitant medications included pantoprazole via an unspecified route of administration from an unspecified date at 40mg daily for an unspecified indication. On 11Mar2021 01:30, the patient reported waking up in the middle of the night with a strong pain in his abdomen and right side of his body. He thought it was because of his gallbladder and claimed that he had the vaccine last week so he wasn't sure. The next morning (yesterday (reported)), the patient was feeling bad so he took his body temperature and it was at 99.14 Fahrenheit (F). He stated that he felt bad all Friday and was in bed for the whole day. He checked his temperature which was recorded as 101.66 F (pyrexia) and took one ibuprofen (ADVIL LIQUID GEL) at 07:15. At 09:20, he recorded his temperature to be at 101.67 F. The patient was asking for advice. The patient did not receive treatment for the other events other than pyrexia. The outcome of the reported events were not recovered. No follow-up attempts are possible. No further information is expected.
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| 59 | 2021-06-10 | impaired work ability |
2/8/21 at 8PM Chills started and then they kept me up half the nigh and headache the next day I stil...
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2/8/21 at 8PM Chills started and then they kept me up half the nigh and headache the next day I still had chill but not that bad then SOB began and had no energy I had to take the day off and I got a cough with the SOB I had achy joint through out the body. By Monday the 15th I felt back to normal.
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